SUMMARY:

Columbia University (Columbia) will support implementation and expansion of comprehensive prevention of

mother to child transmission and linkages with treatment, care and support. The emphasis areas include

gender, human capacity development, and local organization capacity building. The target population

includes infants, men and women, pregnant women, family planning clients, people living with HIV (PLHIV)

and healthcare workers in the public and private sectors.

BACKGROUND:

Columbia has been a PEPFAR partner since FY 2004, and supports services to strengthen integration of

PMTCT activities into HIV chronic care in all supported HIV care and treatment outlets. Columbia's

geographical coverage includes the Eastern Cape (EC) and KwaZulu-Natal (KZN) provinces. FY 2008

funding will ensure expansion to the Free State (FS). Columbia's PMTCT component is designed to support

the national scale-up of PMTCT programs by assisting the government in implementation of strategies and

plans; capacity building and training, infrastructure support; monitoring and evaluation support; and

development of key tools and standard operating practices (SOPs) for program implementation.

ACTIVITIES AND ANTICIPATED RESULTS:

Columbia's PMTCT comprehensive approach will focus on HIV counseling and testing (CT) to all pregnant

women seeking care; ARV prophylaxis for PMTCT; and, counseling and support for infant feeding. The

interventions will be underscored by treatment, care and support including maternal health for women living

with HIV, their children and families. The planned activities will ensure that HIV-infected pregnant women

are identified early and enrolled into treatment, care and support programs. This approach will ensure that

prevention, care, treatment and support services cover pregnancy, delivery, neonatal, and infancy periods.

ACTIVITY 1: PMTCT at clinics and maternity obstetric units

Columbia will improve the quality of antenatal care and maternity services at the 14 sites and integrate key

interventions to prevent MTCT. This will ensure that women have greater access to high-quality antenatal,

labor, delivery and postpartum care, including counseling and support for infant feeding, and use existing

services more frequently and earlier in pregnancy. CT will be the pivotal component of the PMTCT program.

Expanding provision of PMTCT services to include both antenatal clinics and maternities at the sites will

significantly increase access to both maternal and infant HIV prophylaxis regimens. The program will focus

on:

1. Conducting readiness assessments for implementation of basic PMTCT services

2. Conducting infrastructure renovations/refurbishment to allow for PMTCT implementation

3. Providing supplies and additional equipment as needed

4. Hiring additional health workers to provide support to sites

5. Training staff in CT within ANC setting

6. Implementing routine rapid CT as an integral part of antenatal care

7. Providing simple/short course prophylaxis regimens for PMTCT, with access to more complex and

effective regimens as capacity and national guidelines allow

8. Developing replicable models of PMTCT in the 14 sites of EC, KZN and FS

9. Provision of CT during labor and delivery for pregnant women of unknown HIV status

10. Promoting safer delivery practices

11. Devising referral mechanisms to ensure patient follow-up post-delivery

12. Improving activities for optimal obstetric care including development/adaptation of SOPs.

ACTIVITY 2: Provide HIV-related care, treatment and support

Columbia will ensure extension of services beyond the PMTCT to the treatment and care services for the

HIV-infected women, their infants and family members. This will be done through the early identification and

referral of HIV-infected pregnant women who are eligible for treatment, enhanced laboratory capacity to

monitor and conduct CD4 and other recommended tests for HIV care and treatment; establishment of

mechanisms for prioritization and fast tracking of HIV infected pregnant women for ART; providing

screening, diagnosis and treatment of TB; providing screening, diagnosis and treatment of STIs; providing

cotrimoxazole prophylaxis to eligible mothers according to national guidelines; establishing a family

centered case management approach with particular attention to establishing continuity of care; enhancing

referral systems to ensure continuum of care post-partum; providing counseling and care relating to

maternal nutrition and psychosocial support; establishing appropriate linkages and referral for HIV negative

mothers tested; develop best practice models in pediatric and maternal care which can be replicated at

national level and other sites; support continuation of routine health care including VIA for cancer of the

cervix screening; and testing other family and household members and enroll them into care and treatment

programs within clinic setting.

ACTIVITY 3: Provide early diagnosis, care and support to infants and children who are HIV-exposed or

infected

Columbia will institute regular infant follow-up care. This includes infants who have received ARV

prophylaxis, because HIV exposure increases risk of illness and failure to thrive, whether or not the infant

has HIV infection. In addition, the PMTCT interventions will only reduce, but not eliminate the risk of HIV

transmission from the mother to the infant. The focus of interventions will be to ensure PCR testing at 6

weeks and enrollment in ART for eligible infants. In order to scale up PCR testing, health care workers will

be trained to identify HIV exposed infants and to ensure follow-up, provide cotrimoxazole prophylaxis. In

addition, health care workers will be trained to provide counseling and support for infant feeding options and

to establish functional appointment systems for regular health assessment and promotion visits for HIV-

exposed infants. Particular attention will be given to establish functional linkages between the MCH health

care workers with the care and treatment sites for follow-up of HIV infected women and HIV-exposed

infants. Technical laboratory assistance for early infant diagnosis that includes training and providing

essential lab equipment in the EC and FS will be provided. Columbia hire a laboratory adviser and support

staff for technical expertise and mentoring on early infant diagnosis. With FY 2008 reprogramming funding,

Activity Narrative: Columbia will strengthen support in Free State, including strengthening early infant diagnosis and additional

space in some facilities.

ACTIVITY 4: Promote linkages to community-based services and psychosocial support for comprehensive

family care

Columbia will establish formal links with community resources through Columbia's adherence and social

support unit to provide the resources that can help women cope with the impacts of HIV diagnosis. The

focus of interventions will be to: increase behavior change communication activities focusing on access to

PMTCT and treatment literacy to mobilize community in PMTCT and to develop/adapt tools to improve the

follow-up of HIV-infected mothers and tracking at community level.

ACTIVITY 5: Mentor Mothers Approach

Columbia proposes to expand the scope of services of the mothers to mothers program (m2m) - a PEPFAR

prime partner since FY 2007 - through an existing sub-agreement. The mentor mothers will provide support

to the PMTCT component. Based in the antenatal, delivery and post-natal units, the primary duties of these

mentor mothers will include: promoting counseling and testing among the pregnant women; linking mothers

who test positive to PMTCT services; providing psychosocial support and education (individual and group)

to mothers in PMTCT programs; forming and facilitating support groups of HIV-infected mothers; linking

PMTCT mothers with necessary HIV care and treatment.

ACTIVITY 6: Engaging Stakeholders

Columbia will engage stakeholders in the planning and management of the program through meetings,

sensitization workshops and feedback reports. The stakeholders include: DOH officials, District Managers,

Health Facility managers, Clinic supervisors, Laboratory personnel, Staff representatives (doctors, nurses

etc) and community members. In addition, Columbia will engage any other PEPFAR partners engaged in

PMTCT activities in the same provinces in the stakeholder planning and management.

ACTIVITY 7: Quality of Care

Columbia will focus attention on the quality of PMTCT services provided in each of the facilities, since the

quality of the services will influence the program outcomes. Particular attention will be given to ensuring

quality in service delivery during the site level operational planning, implementation and M&E of the

program in order to support two overarching principles of quality assurance i.e. supporting clients' rights and

addressing providers' needs. Clients' rights will be addressed by: ensuring provision of complete and

accurate information to the mothers; facilitating access to all the PMTCT and ART services; ensuring safety

of PMTCT service delivery; providing privacy and confidentiality; ensuring provisions that take into account

patients dignity, comfort and expression of opinion and ensuring continuity of care from PMTCT, to

treatment, care and support.

Systems and capacity will be developed to support the work of the providers which include: Establishing

good quality management and supervisory support at all levels; provision of adequate information,

competence-based training and skills development; and provision of adequate supplies, equipment and

infrastructure

All the PMTCT activities are in line with the South Africa Government (SAG) National Strategic Plan 2007-

2011 and PEPFAR program goals. The interventions will contribute to PEPFAR's country level goal of

supporting at least 80% of pregnant women with PMTCT services, and reducing MTCT by 40%.

SUMMARY:

Columbia University (Columbia) carries out activities to support implementation and expansion of

comprehensive HIV treatment and care. The major emphasis area for this program will be human

resources, with minor emphasis on infrastructure development, technical assistance and training,

community mobilization, quality assurance and supportive supervision and strategic information. The target

population will include infants, children and youth (non-OVC), men and women (including pregnant women

and family planning clients), people living with HIV (PLHIV) and healthcare workers in the public and private

sectors.

BACKGROUND:

Columbia, with PEPFAR funds, began supporting comprehensive HIV care and treatment activities in South

Africa, in 2004. HIV palliative care has included training of healthcare workers in providing standard care for

opportunistic infections (OI) management, use of cotrimoxazole prophylaxis for common OIs, and the

provision of information on when and where to refer for end-of-life care. In FY 2006, in response to

provincial HIV care and treatment priorities, Columbia began strengthening the down-referral of services

from hospitals to primary health clinics. This resulted in a total of 42 health facilities receiving technical and

financial support from Columbia, including public hospitals, community health centers, primary health care

(PHC) and an NGO-run care support center. In FY 2007 additional health facilities in KwaZulu-Natal (East

Griqualand and Usher Memorial Hospital and the Kokstad Community Clinic) received technical and

financial assistance for HIV care and treatment services.

In FY 2008 Columbia will expand its reach by providing basic care and support to PLHIV in Free State. The

health facilities to be supported will be determined after negotiations with the Free State DOH.

ACTIVITIES AND EXPECTED RESULTS:

All activities are in line with South African Government (SAG) policies, and activities will be undertaken to

create sustainable comprehensive HIV care and treatment programs and primarily include four activities:

ACTIVITY 1: Training and Onsite Clinical Mentoring

Currently healthcare providers rendering services at ART sites participate in ongoing didactic training

events and are continuously supported with regular clinical and supportive supervision. In FY 2007

Columbia initiated a Nurse clinical training with emphasis on the development of a comprehensive HIV

nurse preceptor (NP) training and support program. The outcome of this training was to have NPs; situated

at the Columbia-supported ART sites, focusing on building the capacity and skills of facility-based nurses to

deliver high quality HIV patient care and treatment including elements of the preventive care package for

adults and children including OI screening and prophylaxis (including cotrimoxazole, TB

screening/management), counseling and testing for clients and family members, safe water and personal

hygiene strategies to reduce diarrheal disease. Initially, trained NPs would be responsible for providing daily

clinical guidance and constructive feedback, using custom designed assessment and training tools, to

facility-based site nurses providing basic HIV patient care and treatment. In keeping with the Department of

Health HIV and AIDS and STI strategic Plan 2007-2011 (NSP) objective of increasing the level of nurse

participation in management of HIV individuals including those on ART - with nurses initiating ART in 20%

and 50% of eligible HIV-infected adults in 2008 and 2009, respectively. The NP program has included: (1)

one-week didactic training that includes clinical material currently in development by the WHO as part of

their second-level, competency-based 'Integrated Management of Adolescent and Adult Illness' (IMAI)

training program; (2) onsite mentoring of patient triaging, provision of complex care and treatment, modeling

on how to conduct basic and complex patient case conferences, evaluation of nurses' basic HIV care and

treatment skills and developing instructional plans to address the performance gaps and assisting NPs in

practicing teaching; and (3) a series of at four continuing education sessions lasting two to three days.

By FY 2008 the first nurse mentorship initiative training would have been completed and Columbia will

review the recommendations of this initiative to make a determination as to whether similar training activities

need to be rolled out in the Eastern Cape, KwaZulu-Natal and/or in Free State.

ACTIVITY 2: Community-based Support

Columbia is involved in the implementation of Peer Educator (PE) programs to enhance retention into care

and to maximize adherence to treatment. More than 30 Columbia-supported PEs are currently working at

St. Patrick's, Holy Cross, Frere and Cecilia Makiwane, Dora Nginza and Livingstone Hospitals. PEs work

under supervision of the ART site coordinator or his/her designee to provide: elements of the preventive

care package, education on HIV and AIDS care, living positively; psychosocial counseling and emotional

support; adherence to care and treatment support; promoting referral linkages to clinic/hospital and other

networks; where possible conduct home visits; and attend PE-specific and general PLHIV support groups.

Approaches to PLHIV support were initially centralized with the development of care support centers; the

current implementation strategy through FY 2007 will be supporting the decentralization of PLHIV services.

In Free State, Columbia proposes to implement Peer educator programs, provide HIV clinical training and

mentorship for health professional staff, support the design and implementation of HIV information system

and support the integration of PMTCT and TB programs into HIV chronic care

ACTIVITY 3: Strengthening Program Integration Activities

District hospitals and public healthcare facilities have co-located TB, PMTCT and STI services, and

integration activities to strengthen these services with holistic palliative care will be carried out in

collaboration with the following programs at district and provincial levels:

a. PMTCT: Support early infant diagnosis through the use of dry blood spots (DBS) for PCR testing. This

activity will include training PMTCT nurses in specimen collection, information gathering to assess the

uptake of DBS and referral linkages of HIV-infected children to chronic care, ensure that HIV-exposed

children receive cotrimoxazole. DBS training activities will be carried out in collaboration with the Local

Activity Narrative: Service Area authority and the National Health and Laboratory Services (NHLS).

b. TB: Support active TB case finding and referral for TB treatment for the TB/HIV co-infected. Columbia will

support the implementation of TB screening and diagnosis algorithm for HIV-infected patients to include the

adaptation of a simple questionnaire for use as a screening tool for active TB at the designated HIV clinics

and incorporating the questionnaire into routine clinical care.

ACTIVITY 4: HIV Care and Treatment Information System

Columbia will continue to support the implementation of a provincial information system that captures

information on HIV palliative care and ART. Activities in FY 2008 will include:

a. Implementation of facility paper-based non-ART registers that captures non-ART indicators. These facility

registers will be introduced mainly at the primary and community health clinics that are designated by the

provinces as down-referral sites for HIV care and ART services.

b. In collaboration with the Department of Health and other partners in the Eastern Cape, support the

development and implementation of standardized individualized patient records for use at health facilities.

c. Strengthen the paper-based data collection systems at HIV care and treatment sites in the Eastern Cape

in preparation for computerization of a minimum set of key data elements.

d. Work with ART managers and facility site staff to support the utilization of information to improve service

delivery and patient care.

In all of the above activities, PLHIV will receive at least one clinical and one other category of palliative care

service. Palliative care to family members of PLHIV or OVC will be provided in at least two or the five

categories of palliative care services.

With FY 2008 reprogramming funds, Columbia will facilitate greater adherence and reduce loss to follow-up

through starting a pilot to using text messaging with cell phones.

By providing basic healthcare and support to people in need in Eastern Cape, KwaZulu-Natal and Free

State, Columbia's activities will contribute to the realization of the PEPFAR goal of providing care to 10

million people. These activities also support efforts to meet the care and support objectives outlined in the

USG Five-Year Plan for South Africa.

SUMMARY:

Activities support implementation and expansion of best-practice models for integration of tuberculosis (TB)

and HIV services in public sector facilities in Eastern Cape (EC) and KwaZulu-Natal (KZN). TB/HIV activities

are implemented through technical assistance and will result in a decrease of TB in HIV-infected children

and adults, increase prevention and early detection of TB in HIV-infected children and adults, and provide

overall support to provincial TB/HIV activities. The emphasis area for this program will be human resources.

The target population will include infants, children and youth (non-OVC), men and women (including

pregnant women and family planning clients), people living with HIV (PLHIV) and public and private sectors.

BACKGROUND:

Columbia University (Columbia) began TB/HIV integration activities in FY 2006. Health facilities initially

identified in EC included 3 TB hospitals (Nkqubela, Fort Grey and Empilweni Hospitals) and 8 HIV care and

treatment sites (Holy Cross, St. Patrick's, Rietvlei, Cecilia Makhiwane, Frere, Dora Nginza and Livingstone

Hospitals, Ikhwezi Lokusa Wellness Center). In the TB hospitals inpatients are counseled and tested for

HIV, initiated on cotrimoxazole prophylaxis if they are found to be HIV-infected and if they are eligible,

started on antiretroviral treatment (ART). On discharge from TB hospitals, patients are linked to primary

health care clinics or nearest facility where they can access HIV and TB treatment services. In FY 2006,

Columbia began training of nurses, doctors and lay health workers on TB/HIV integration in both

programmatic and clinical aspects: active TB case finding among HIV-infected patients, ART for eligible

TB/HIV co-infected clients, and leveraging existing referral services to provide comprehensive HIV support.

In FY 2008 Columbia will continue to implement activities in these 3 TB hospitals and 38 HIV care and

treatment sites, for a total of 42 health facilities, in EC and KZN. Four new health facilities in Free State (FS)

will be identified in FY 2008 for TB/HIV support. In FY 2007, Columbia formed a new partnership with Yale

University AIDS Program in support of TB/HIV integration activities in Tugela Ferry, KZN, which will

continue in FY 2008.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: TB hospitals in Eastern Cape

Activities will include:

1. Provide ongoing TB/HIV clinical support by conducting didactic and onsite TB/HIV training for doctors,

nurses and lay health staff to improve knowledge and practice around managing TB/HIV patients. Provide

clinical mentorship through case presentations and discussion.

2. Continue to support the hiring and placement of doctors, nurses, and peer educators to improve uptake

of HIV counseling and testing and to increase enrollment of TB/HIV co-infected patients into ART.

3. Provide technical support for monitoring and evaluation (M&E) activities by implementing a system to

track/monitor referrals and patients between HIV and TB programs. This activity includes training and use of

the pre-ART and ART facility registers.

ACTIVITY 2: HIV Care and Treatment Sites

Activities in the 38 HIV care and treatment sites will be focused on strengthening:

1. TB case-finding among clients enrolled into HIV care and ART. Columbia is in the process of

implementing a facility held patient record that captures information on TB case finding within the patient

record. Columbia is training doctors and nurses in the supported facilities to use the patient record to

improve TB/HIV clinical care and treatment. These staff will be routinely mentored by Columbia nurse

mentors/clinical advisors.

2. Referral linkages with the TB program to initiate TB therapy for those in HIV care and/or ART. The

Columbia supported community health centers and primary health clinics (PHCs) with HIV care and

treatment services also have TB services on site where Columbia supports TB services by improving

referrals of TB/HIV co-infected clients on ART to on site TB services to receive TB treatment. This includes

development of a referral slip to the TB services and also ensuring the facility held patient record in the HIV

clinic is updated with the relevant TB information.

With FY 2008 reprogramming funding, Columbia will support infection control activities in 5 sites in EC.

ACTIVITY 3: Yale University Partnership

Columbia will partner with the Yale University to develop the following services at the Church of Scotland

Hospital (COSH), Tugela Ferry:

1. Increase HIV counseling and testing (CT) of clients accessing TB services in the COSH. This will be

implemented through the introduction of various models of provider-initiated CT at the TB treatment

programs (drawing on experiences from other settings) that is inclusive of training of TB treatment staff in

HIV CT, training in HIV pre- and post-test counseling with establishment of strong linkages to laboratory HIV

diagnostic services, and training of TB treatment staff in the referral of TB patients to CT services.

2. Prevent the development of multidrug-resistant tuberculosis (MDR-TB) cases and improving treatment

completion rates by strengthening the existing TB DOTS program and integrating with HIV treatment. Under

the Yale partnership the program components for this specific program activity will include:

-Defining the baseline TB treatment completion and cure rates

-Overall program improvement by: providing routine HIV counseling and testing, developing effective TB

screening tools for HIV-infected patients, use of a standardized once-daily ARV regimen to be administered

concurrently with standard TB regimen for TB/HIV co-infected patients, using modified observed therapy,

family and community-based health workers as treatment supporters, providing TB treatment literacy

materials at ART initiation and training of case management teams to strengthen treatment follow-up and

Activity Narrative: completion by tracing defaulters in the community

3. Prevent nosocomial transmission of MDR-TB and extensively drug-resistant tuberculosis (XDR-TB) by

instituting infection control. This will include; a. evaluation of nosocomial spread of MDR and XDR-TB by

supporting sputum culture testing on all new and suspected TB cases (months 0, 2, 6), spoligotyping on

selected isolates and confirmed MDR-TB isolates to determine timing of acquisition and possibility of

nosocomial spread; spoligotyping of sensitive TB isolates and non HIV infected TB patients to determine if

KZN strain confined only to MDR and XDR and HIV or more widely distributed; b. Improve program

implementation by screening HIV-infected patients for TB, creating isolation facilities, improving air handling

within wards, educating healthcare staff in personal infection control practices and provide personal

protective equipment to minimize their risk, minimizing number of TB patients hospitalized, decreasing the

length of stay for all TB patients by developing and evaluating protocols for earlier hospital discharge, and

increase community-based care for TB treatment to absorb shift of TB care from inpatient to outpatient

setting.

4. Implement a decentralized MDR-TB treatment program. Patients found to have MDR-TB travel 120 km to

Durban to be admitted to King George V Hospital for second line therapy however the average waiting time

for a bed is 2-3 weeks. Key components would include: Sputum culture testing on all suspected and

confirmed TB cases in both inpatient and outpatient settings to identify cases of MDR-TB; Initiate a

treatment program to provide second line TB treatment locally; Develop a contact tracing program for all

MDR-TB and re-treatment cases to identify MDR-TB cases in community; spoligotyping MDR-TB isolates

5. Screen for active TB among HIV-infected patients through use of standardized screening questionnaires

and/or algorithms by all types of healthcare workers followed by standardized follow-up and diagnostic

algorithms of TB suspects and supported by the introduction of effective recording and reporting systems for

these activities.

Originally support to COSH was to include a PHE, but as this PHE was not approved, the funding is

reprogrammed back into the TB-HIV services to support service delivery in Tugela Ferry, in partnership with

Yale.

In FY 2008 Columbia will embark on these additional activities:

ACTIVITY 4: Scale up use of TB screening tool at HIV care and treatment facilities

Columbia will ensure that the PHC record (which incorporates TB signs and symptoms) is used at all

supported HIV care and treatment outlets. This TB screening tool will improve the quality of TB services

provided at the HIV clinic and also increase TB case finding in this high risk population. In addition, this

activity will dovetail with the proposed TB screening PHE about to be conducted in select health facilities.

ACTIVITY 5: Targeted TB prevention and control strategies

TB infection control activities targeted at 2 health facilities in EC (Motherwell Community Health Centre in

Port Elizabeth and Cecilia Makiwane Hospital in East London). The objective of this activity is to minimize

the risk of nosocomial TB transmission through minimizing source infectiousness. Activities include:

assessing TB infection control procedures for gaps and needs for each facility; establishing work practice,

clinical management and administrative procedures to minimize the nosocomial transmission of TB;

assessing the impact of these interventions; and developing practice manual and educational tools for

health care workers. New health facilities in FS will be determined in collaboration with the Health

Department to receive support for TB/HIV and proposed activities to be implemented include those outlined

above.

Columbia's activities will contribute to the realization of the PEPFAR goal of providing care to 10 million

people.

SUMMARY:

Columbia University (Columbia) and its identified partners in the Eastern Cape have been supporting the

care and treatment of patients dually infected by HIV and tuberculosis (TB) since FY 2006. This activity

focuses on HIV counseling and testing (CT) for TB patients and will be an ongoing activity for Columbia in

FY 2008. The major emphasis area for this program will be human resources, with minor emphasis on

development of network/linkages/referral systems, linkages with other sectors, quality assurance and

supportive supervision, strategic information and training. The target population will include people infected

and affected by TB and HIV including infants, children and youth (non-OVC), men and women (including

pregnant women and family planning clients).

BACKGROUND:

Columbia will use FY 2008 funds to continue strengthening the Eastern Cape Department of Health's

capacity to provide routine HIV counseling and testing (RCT) services to tuberculosis patients. In the latter

part of FY 2006, Columbia began RCT activities in three TB hospitals: Empilweni, Nkqubela and Fort Grey.

In FY 2008, PEPFAR funds will be used to continue to screen TB inpatients for HIV, implement TB/HIV

patient prevention education and to ensure that TBand HIV co-infected patients are referred for appropriate

HIV care and treatment services. Referral mechanisms with adjacent health facilities (including hospitals

and primary health clinics) have already been identified and established. Ongoing program emphasis area

will be on the development of network/linkage/referral systems that will eventually result in retention into HIV

treatment services for the TB and HIV co-infected after completing of TB treatment and improved

adherence to TB and HIV therapies.

ACTIVITIES AND EXPECTED RESULTS:

In FY 2008 Columbia University will continue to implement four activities in three TB hospitals: Fort Grey,

Nkqubela and Empilweni.

ACTIVITY 1: Support Routine HIV Counseling and Testing for TB patients

Columbia will provide assistance through hiring and training of additional clinical staff (nurses and peer

educators) to increase the uptake of HIV testing among TB patients. Columbia will actively promote provider

-initiated testing and counseling for HIV (PITC) for TB patients. Registered nurses at each hospital will be

responsible for performing the HIV tests and post-test counseling, and trained peer educators will provide

pre-test counseling.

ACTIVITY 2: Provide Patient HIV Prevention Education

This activity will consist of collaboration with the Eastern Cape Department of Health, community-based

organizations and other local non-governmental organizations to provide information and education on

TB/HIV. In addition, trained peer educators will be actively involved in one-to-one patient education.

ACTIVITY 3: Referrals for TB Patients

Practitioners will continue to take advantage of and support the existing referral systems for TB patients into

HIV care and treatment activities, and where feasible, develop and promote more efficient referral linkages.

ACTIVITY 4: Monitoring and Evaluation

Data collection and reporting will be strengthened by training and hiring data staff, as needed, to collect

accurate counseling and testing patient information and to provide monitoring and evaluation technical

support for data interpretation and dissemination that will result in program improvement.

In FY2008, Columbia proposes the following additional activities:

ACTIVITY 5: Strengthen Provider-Initiated HIV Counseling

Columbia will expand provider-initiated testing and counseling services to all the 36 antiretroviral treatment

(ART) sites that will be supported in FY 2008. With this approach, people attending the health care services

or those seeking specific medical attention can also receive CT. Pre-test counseling will be conducted by

peer educators and reinforced by the health unit staff or by HIV and AIDS counselors during post-test

counseling.

ACTIVITY 6: Provision of Mobile Counseling and Testing Services in KwaZulu-Natal

In order to make HIV and AIDS care and treatment more widely available to inaccessible populations, a

mobile clinic is being procured for the Kokstad area, in KwaZulu-Natal. A mobile CT team will be integrated

with the care and treatment team to provide services at fixed times at a variety of outreach sites in Kokstad.

Pre-advertising will be conducted (via fliers and public announcements), to provide potential clients with

information, maps and schedules for the mobile service. Rapid tests will be used to ensure immediate

results for clients within the same day and session.

Activity 7: Provision of Group Counseling at 36 ART sites

In the facilities supported by Columbia, the patients wait for some period of time after checking into the

clinics and before seeing the healthcare providers. Through peer educators, Columbia will motivate and

support this opportunity to tell the patients that it is recommended that all patients are tested for HIV and to

provide them with information about HIV and TB (group pre-test counseling). Brochures will be developed in

liaison with the Department of Health and will be given to patients when they check in to read in the waiting

room. Posters will also be placed in waiting rooms and throughout the clinic, noting the importance of

knowing one's HIV status to facilitate the pre-test counseling sessions. Those who opt for the test will then

be privately counseled post-test.

Activity Narrative: ACTIVITY 8: Creation of a Functioning Referral System for Counseled and Tested Patients

Functional links will be established between the different departments at the health facilities including the

ART clinics to facilitate cross-referral. Mechanisms for referral to post-test diagnostic and care services will

be established including regular clinical meetings.

ACTIVITY 9: Establishment of Quality Assurance Systems for Testing and Counseling Services

Columbia will support two overarching principles of quality assurance: (a) supporting clients' rights, and, (b)

addressing providers' needs. To meet the clients rights, Columbia will refurbish the facilities to ensure

private and confidential space (aural and visual privacy) at each of the facilities providing CT services. The

sites will be supported to undertake rapid counseling and testing. Mechanisms will be instituted for sample

referral for quality assurance testing (10% of samples to be confirmed centrally) in an external

facility/laboratory.

To support the work of providers, Columbia will guarantee accurate documentation and information

management procedures to ensure accuracy and confidentiality of all patient test and diagnostic

information. Adequate supply of simple/rapid tests, condoms and client information materials from the DOH

will also be ensured. In addition good quality management and supervisory support including information,

training and skills development will be supported by Columbia.

Activity 10: Engaging Stakeholders

Columbia will engage stakeholders in the planning and management of the program through meetings,

sensitization workshops and feedback reports. The stakeholders include Department of Health officials,

district managers, health facility managers, clinic supervisors, laboratory personnel, and staff

representatives, including doctors and nurses.

By providing HIV counseling and testing to patients on TB treatment, Columbia's activities will contribute to

the realization of the PEPFAR goal of providing care to 10 million people. These activities will also support

efforts to meet HIV and AIDS care and support objectives outlined in the USG Five-Year Plan for South

Africa.

SUMMARY:

Columbia University (Columbia), in collaboration with the Eastern Cape Health Department (ECDOH) will

support antiretroviral (ARV) drug purchase for two treatment sites and support commodity supply chain-

related training, and logistics for 34 current antiretroviral treatment (ART) service delivery sites in the

Eastern Cape and two new ART sites in KwaZulu-Natal (KZN). Major emphasis is given to human capacity

development, local organization capacity building, and strategic information. The target population will

include infants, children and youth, men and women (including pregnant women) and people living with HIV

(PLHIV).

BACKGROUND:

Columbia and the ECDOH will continue to support procurement and distribution of needed ARV drugs using

PEPFAR FY 2008 funds. In FY 2006 Columbia formed a partnership with the United Nations Children's

Fund (UNICEF) to procure ARV drugs from local pharmaceutical companies that are licensed by the South

African Medicines Control Council (MCC). These drugs are distributed to two non-governmental

organizations, Ikhwezi Lokusa Wellness Center (Ikhwezi) in East London and the Cato Manor Community

Health Center in Durban. Columbia purchases generic medications that are in compliance with the USG

PEPFAR Task Force requirement for both U.S. Federal Drug Administration and Medicines Control Council

(MCC) approval. Columbia provides technical assistance to improve HIV-related pharmacy practices in 34

public health facilities. In these 34 public sector sites, the relevant provincial department of health provides

all required HIV drugs.

In FY 2007 Columbia provided support for pharmaceutical services in the Qaukeni local service area in the

Eastern Cape and Sisonke districts in KZN. One of the challenges encountered while providing this

essential support is the regular stock-out of drugs such as cotrimoxazole. As a result Columbia provided in-

service trainings for pharmacists and pharmacy assistants on drug stock management, In addition,

Columbia purchased copies of the South Africa Medicines Formulary and the Daily Drug Use for 30 clinics

in the same catchment area. Columbia also distributed copies of the Essential Drug List for use in these

clinics.

Similar pharmaceutical services support is carried out in Port Elizabeth and this activity will continue into FY

2008.

ACTIVITIES AND EXPECTED RESULTS:

Specific areas of programmatic focus include:

(1) Technical support for ARV stock management and distribution at the pharmacy depot (in Port Elizabeth)

and public ART sites. Activities include:

(a) Train pharmacists and pharmacist assistants in ARV stock management.

(b) Support the implementation of a province-endorsed pharmacy tracking tool to prevent ARV drug stock-

outs at health facilities.

(c) Support the province-endorsed training of pharmacist assistants at identified health facilities.

(2) Purchase and distribute ARV drugs for Ikhwezi Lokusa Wellness Center and Cato Manor community

health clinic. In FY 2006, Columbia initiated discussions with the ECDOH to propose that the ARV drug

procurement and distribution for Ikhwezi is managed by the ECDOH. In FY 2007, the ECDOH and Ikhwezi

developed an Memorandum of Understanding which will be signed before the end of FY 2007. The

ECDOH organized for Ikhwezi to be part of the Pfizer Diflucan donation program and currently patients with

cryptococcoal meningitis and esophageal candidiasis can obtain free Diflucan for this initiative. Similar

discussions with the KwaZulu-Natal Health Department (KZNDOH) are anticipated in FY 2008 and are

expected to begin for the Cato Manor community health clinic in Durban.

(3) Utilization of ARV drug pharmacy practice to improve clinical management. In a bid to improve ARV

prescribing practices in the Ikhwezi and Cato HIV treatment services, Columbia in FY2007 and FY2008, will

ensure that information generated that best describes and linkages between prescribed ARV drug regimen

and clinical outcomes and laboratory indicators is disseminated to the clinicians in these 2 facilities.

Columbia will continue collaborating with the South African Department of Health in support of ARV

procurement mechanisms to ensure uninterrupted ARV supply at Columbia-supported sites. The specific

quantities of ARV drugs that would be needed will take into consideration relevant medical conditions (TB,

adverse drug reactions). Columbia will continue to strengthen the ARV drug distribution system by providing

technical assistance at designated pharmacy depots to coordinate distribution of ARVs with the NDOH, as

well as participate in furthering the ARV quality assurances activity initiatives as developed by the NDOH.

In the Eastern Cape a public-private partnership consortium outsourced by the ECDOH will manage the

Department of Health pharmacy depots. Therefore Columbia will not be providing ongoing assistance at the

Mthatha Depot effective 2008. However, Columbia will continue to provide technical assistance for

Pharmaceutical services in all SAG supported health services.

By providing ARV drugs and related services, Columbia's activities will contribute to the PEPFAR goal of

providing treatment to 2 million people. These activities will also support efforts to meet HIV and AIDS care

and support objectives outlined in the USG Five-Year strategy for South Africa.

SUMMARY:

Activities are carried out in FY 2008 to support implementation and expansion of comprehensive HIV

treatment and care primarily through human resources and infrastructure development, technical assistance

and training and community education and support, primarily in public sector facilities in the Eastern Cape,

Free State (new geographic focus area) and KwaZulu-Natal (KZN). Columbia University will support these

activities by using funds for human capacity development, local organization capacity building, and strategic

information. The degree of activity effort will vary in each site, but the emphasis areas will be addressed in

all sites. The target population will include infants, children and youth, men and women (including pregnant

women) and people living with HIV (PLHIV). Columbia will continue to support the recruitment of doctors,

nurses, pharmacists and pharmacist assistants.

BACKGROUND:

Columbia University (Columbia), with PEPFAR funds, began supporting comprehensive HIV care and

treatment activities in FY 2004. Health facilities were initially identified in the Eastern Cape and in FY 2006,

due to new boundary demarcations and additional PEPFAR funds, Columbia started providing similar

assistance in KZN. In FY 2006, in response to provincial HIV care and treatment priorities, Columbia began

strengthening the down referral of services from hospitals to primary health clinics. This resulted in a total of

36 health facilities receiving technical and financial support from Columbia, including public hospitals,

community health centers, primary health clinics and a non-governmental wellness center. In FY 2007 an

additional two health facilities in KZN received technical and financial assistance for HIV care and treatment

services.

ACTIVITIES AND EXPECTED RESULTS:

All activities are in line with South African government (SAG) policies and protocols, and activities will be

undertaken to create sustainable comprehensive HIV care and treatment programs, and primarily include

six programmatic areas:

ACTIVITY 1: Support Recruitment and Placement of Health Staff

Since FY 2005 Columbia has been involved in the recruitment of staff to support the HIV comprehensive

program at health facilities. High staff attrition rates of Department of Health (DOH) recruited personnel

have been a challenge in guaranteeing a steady enrolment of eligible PLHIV into care and treatment.

Columbia will continue to support the recruitment of doctors, nurses, pharmacists and pharmacist assistants

through existing partnerships with University of Fort Hare, Nelson Mandela Bay Metropolitan Municipality,

Ikhwezi Lokusa Wellness Center, University of KwaZulu-Natal Cato Manor, and the Foundation for

Professional Development (FPD). Columbia supported the recruitment and placement of approximately 15

doctors, 30 nurses (registered and enrolled nurses), 4 pharmacists, 7 pharmacist assistants and 15 trainee

pharmacist assistants. These health personnel provide direct patient care in the hospitals and clinics

including: clinical assessment, screening for tuberculosis (TB) and antiretroviral treatment (ART) eligibility,

opportunistic infections (OI) diagnosis and management, offering OI prophylaxis and treatment, and ART.

The health providers also develop patient treatment plans as part of the multidisciplinary team in the health

facility; and assist patients to access relevant SAG social grants.

ACTIVITY 2: Training and Clinical Mentoring

Columbia has established a partnership with FPD to provide ARV didactic training in all supported health

facilities. A second partnership with Stellenbosch University assists the rural health facility staff (St.

Patrick's, Holy Cross and Rietvlei hospitals and their referral clinics), with the management of patients on

ART by conducting case discussions on a monthly basis. Columbia has clinical advisors as part of its South

African team consisting of nurse mentors, and medical officers who provide day-to-day clinical guidance on

the management of patients on ART.

ACTIVITY 3: Strengthen ART Down and Up Referral Linkages Between Hospitals and Primary Healthcare

Clinics

In the early phases of the ART program, all patients are evaluated and initiated on therapy at hospital level.

Within three to six months of providing support to the hospital-based ART program, designated referral

clinics are integrated into the services. In the rural health facilities, a small team of health providers, usually

comprising of a medical officer, professional nurse and peer educator, travel to the primary healthcare

clinics (PHC) to screen patients for OIs and to determine suitability for ART. This approach has enabled

expansion of ART services at PHC level and has resulted in improving and increasing access to treatment.

The team of health providers has also developed capacity of the onsite health providers and the goal is to

have the onsite DOH health staff eventually provide the full package of HIV care and treatment services. In

FY 2008, Columbia will continue to support linkages with the public clinics and the development of a more

sustainable system of service provision.

ACTIVITY 4: HIV Care and Treatment Information System

Columbia will continue to support the implementation of a provincial information system that captures

information regarding HIV palliative care and ART. Activities in FY 2008 will include:

(a) Continued implementation of facility paper-based ART registers that capture both adult and pediatric

ART indicators.

(b) In collaboration with the Eastern Cape Department of Health (ECDOH) and other partners in the Eastern

Cape, support the development and implementation of standardized individualized patient records for use at

health facilities that incorporates information on client ART use.

(c) Implement an ART software system. In FY 2007, Columbia in partnership with Africare (a PEPFAR

partner) and Health Information System Program (HISP) customized and developed ART software that

captures and collates HIV and AIDS program data. This is being adapted for data entry, and installation is

Activity Narrative: expected before the end of FY 2007. The system is being piloted at three health facilities in East London. In

FY 2008, after assessing results from the pilot sites, Columbia will engage the ECDOH in discussion on

how the module could be added into the existing District Health Information System to efficiently generate

reports on the HIV program, and thereafter implemented at more ART services outlets.

In addition, in 2007 Columbia begun a new partnership with Disease Management system (DMS) - a patient

-centered health management information system (HMIS) that operates at the patient level of care to assist

health care professionals initially at 4 identified Columbia supported health facilities in Port Elizabeth to

provide comprehensive care management of people living with HIV, as well as providing management

information for relevant stakeholders. In FY 2008, with lessons learned from the implementation of this

system, Columbia in partnership with ECDOH proposes to extend the use of this information system in all

HIV and ART service delivery points, where feasible. In addition, by FY 2008, Columbia will support the

implementation of similar program activities (as specified above) in newly identified health facilities in the

Free State (to be determined).

d. In an effort to improve and monitor quality of activities being implemented, Columbia in FY 2007

developed a standard operating procedure (SOP) for data quality. Dissemination and use of this SOP is

currently underway in all Columbia-supported facilities. In FY2008, Columbia plans to recruit a quality

assurance officer who will be responsible to monitor quality of implemented activities from both a data and

program perspective.

ACTIVITY 5: Improve Retention into Care and Treatment and Reduce Loss-to-Follow-Up

In FY 2006/7 Columbia begun implementing strategies to establish and mitigate the losses to follow-up in

the HIV program. In the supported sites in East London, dedicated staff were hired to assist tracing and re-

introducing patients lost-to-follow-up. In partnership with the Buffalo City Municipality and the ECDOH,

Columbia has created an external referrals director for HIV and AIDS services for the East London environs.

With the lessons learned in this initial work of tracing patients in HIV care and treatment and the

development of the referral directory, Columbia plans to initiate similar support across all supported facilities

in FY 2008. In addition, Columbia is developing Adherence and Social Support Unit guidelines to

standardize procedures used across supported health facilities. Dissemination of these guidelines will take

place in early 2008.

ACTIVITY 6: Improve and Increase Enrollment of Infants and Children into HIV Chronic Care and Treatment

In the Eastern Cape, pediatric ART enrollment is centralized at the regional and tertiary facilities, where

pediatricians are heavily involved in the care and treatment of children and infants and decentralization of

pediatric ART services to PHCs that are providing ART for adults has been very slow. In FY 2007 services

of pediatricians were retained to train and/or mentor health staff at the facilities to improve pediatric HIV

care and treatment, and this will continue in FY 2008. In addition, Columbia will continue to take advantage

of the established partnership with Stellenbosch-Tygerberg to train nurses and doctors in pediatric HIV care

and treatment. Recruitment for a pediatrician to spearhead all pediatric HIV activities in the Eastern Cape,

KZN and Free Sate is currently ongoing.

By providing support for ARV services in the public sector and two NGO sites, Columbia's activities will

contribute to the realization of the PEPFAR goal of providing care to 2 million people.

TYPE OF STUDY: Continuing.

TITLE OF STUDY: Identifying Optimal Models of HIV Care and Treatment in the Eastern Cape.

TIME AND MONEY SUMMARY: The International Center for AIDS Care and Treatment Programs at

Columbia University's Mailman School of Public Health (Columbia-ICAP) is using PEPFAR FY 2006 funds

for this study. This study will take place over 24 months. Activities for this PHE started in FY 2007 and are

expected to be completed in early 2009. No additional funding is requested for completion. No funding has

been leveraged/contributed from other sources.

LOCAL CO-INVESTIGATOR: Coceka Noguduka, Eastern Cape Department of Health (ECDOH), HIV/AIDS

Directorate.

PROJECT DESCRIPTION: The main objective of this protocol is to combine and analyze de-identified data

that are collected as part of routine service delivery on patients receiving HIV care and treatment at sites

support by the Department of Health and Columbia University-ICAP.These sites are primarily located in the

Eastern Cape Province, South Africa. Combined data will be used to assess and to better understand the

relationship among individual-level factors, site- and program-level factors and HIV care and treatment

outcomes. The results from this protocol will aid the interpretation of observed differences in key outcomes

across sites as suggested by the aggregate care and treatment indicators.

This study was undertaken with the following objectives:

(1) Assess the degree of variation in patient outcomes across HIV care and treatment delivery sites,

independent of differences in the characteristics of patient-level factors across sites. Firstly, data on pre-

antiretroviral treatment (ART) patients will be assessed to compare the risk of loss to follow-up (LTF), ART

initiation among eligible patients, and survival across sites before and after controlling for patient-level

factors (age, sex, stage of disease, baseline CD4). Secondly, data on patients on ART will be assessed to

compare the risk of LTF and survival among patients on ART across sites, before and after controlling for

patient-level factors (age, sex, stage of disease, baseline CD4); and the changes in viral load, body weight

and CD4 counts after ART initiation across sites before and after controlling for patient-level factors (age,

sex, stage of disease, baseline CD4).

(2) Identify site-level and contextual factors that are associated with HIV care and treatment outcomes, after

adjusting for patient-level factors. This second objective includes (a) assessing the degree to which

individual macro-level factors (defined above) are associated with the patient outcomes listed in each

objective above; (b) combining macro-level factors into composite scores to assess whether programs with

more comprehensive services have more favorable patient outcomes than those with less comprehensive

services; and (c) examining whether patients enrolled in family-focused care and treatment programs have

better survival than patients in conventional care and treatment programs due to earlier initiation of ART.

(3) Determine the cost and clinical benefits associated with modifying specific site-level and contextual

factors that influence HIV care and treatment outcomes. This objective includes (a) assessing the costs and

clinical benefits associated with introducing macro-level factors found to be important; and (b) determining

the cost effectiveness of introducing an optimal package of site-level service features.

This study will utilize a retrospective and prospective cohort design based upon secondary analysis of

existing, routinely collected, de-identified, service delivery data. It will also include an analysis of cost-

effectiveness. Currently, data on patients from each site supported by Columbia University-ICAP are

collected in the form of paper-based registers, clinic health patient cards, and flow sheets. These data are to

be transferred to an electronic database scheduled to be implemented in mid-late 2007. This protocol

involves analysis of these data from the electronic database. De-identified baseline and follow-up clinical

data from all patients ever enrolled in HIV care and treatment at 10 sites from the start of each site's HIV

program will be abstracted from the database on a monthly basis. All data collected from patients since the

time of enrollment in care will be included. Data from site-level assessments performed routinely every 6

months will also be included. The site-level characteristics data, including resources for costing of program

components will be merged with patient data to determine the relationship between individual-level factors,

macro-level factors, and HIV care outcomes. Patients are routinely followed according to the National

Antiretroviral Treatment Guidelines (SA National Department of Health), which include visits every six

months for pre-ART patients and every month for ART patients.

STATUS OF STUDY/PROGRESS TO DATE: In FY 2007, meetings took place between site leaders and

Columbia University-ICAP. In addition, the final protocols were developed in collaboration with site facility

staff, Columbia University-ICAP and CDC. Proposals were submitted for in-country Institutional Review

Board (IRB) review to University of Fort Hare and Walter Susulu University for ECDOH clearance. Some

study staff have been recruited and hired and in FY 2008 the full complement of staff will be realized.

Data collection will begin after local IRB and Columbia University IRB approval has been granted.

INFORMATION DISSEMINATION PLAN: Results from this study will be disseminated in site level

presentations and reports to participating sites, ECDOH, other Columbia University programs, and

USG/CDC.

ACTIVITIES: Planned FY 2008 activities include finalizing data collection, conducting data analysis and

widely disseminating findings.

TYPE OF STUDY: Continuing

TITLE OF STUDY: Understanding ARV Treatment Initiation among Clinically Eligible Patients Receiving Pre

-ART Care for HIV Infection in the Eastern Cape, South Africa.

TIME AND MONEY SUMMARY: The International Center for AIDS Care and Treatment Programs at

Columbia University's Mailman School of Public Health (Columbia-ICAP) is using PEPFAR FY 2006 funds

for this study. This study will take place over 24 months. Activities for this PHE started in FY 2007 and are

expected to be completed in early 2009. No additional funding is requested for completion. No funding has

been leveraged/contributed from other sources.

LOCAL CO-INVESTIGATOR: Coceka Noguduka, Eastern Cape Department of Health (ECDOH), HIV/AIDS

Directorate.

PROJECT DESCRIPTION: Columbia-ICAP is currently supporting HIV care and treatment activities in 42

ART service points in the Eastern Cape province of South Africa. As of December 31, 2006, it is estimated

that 50% of patients across all ICAP-supported sites are clinically eligible but have not yet initiated ART. In

some cases, the number of eligible patients not receiving ART actually exceeds those on ART. The reasons

for this anomaly are probably complex and manifold and are as yet unknown. Columbia-ICAP proposes to

systematically identify and intervene upon key factors that enable or prevent those who enroll in HIV care

and are deemed clinically eligible for ART, yet do not initiate ART within two months of being clinically

eligible for ART. The primary objective of this study is to identify enablers and barriers to treatment initiation

amongst clinically eligible patients already receiving pre-ART care for HIV infection. The evaluation will

assess (a) the role of patient-related factors (e.g., disease stage, TB co-infection) in delaying treatment

initiation; (b) the perceived role of facility- and provider-related factors in delaying treatment initiation; and

(c) the role of the federal social disability grant in deferred treatment initiation.

A multiphase descriptive analysis and case-control study design will be used. Cases are defined as persons

enrolled into HIV care who meet clinical ART eligibility criteria yet have not initiated ART within two months

from date of eligibility. Controls are defined as persons enrolled into HIV care that meet eligibility criteria and

have initiated ART within two months of the date of eligibility. Cases and controls will be matched on the

date of eligibility (~ one month) during Phase 1. Site-level, provider-level, and patient-level enablers and

barriers to treatment will serve as the exposures to be compared among the matched cases and controls.

Patient registers will be used as a sampling frame from which a sample, stratified by site and eligibility

period, will be selected. Given that participation is sought from those who have discontinued from the

program, a ratio of 2-1 controls per case will be sampled.

The study duration is 24 months and consists of four phases:

Phase I (three months) includes a retrospective review and analysis of pre-ART and ART register data at

each facility.

Phase II (three months) involves final classification of cases and controls by medical chart review for a

sample of patients at each facility.

Phase III (three months) consists of focus group discussions with patients to gain a better understanding of

the different enablers and barriers to ART initiation.

Phase IV (eight months) is comprised of a survey of cases and controls through structured face-to-face

interviews.

POPULATION OF INTEREST: Survey population include men and women = 18 years of age, clinically

eligible for ART, and enrolled at facilities supported by Columbia-ICAP.

SAMPLE SIZE:

Phase I: Data on 5,700 patients enrolled in HIV care at study sites since January 2005 will be abstracted

from paper-based clinic pre-ART and ART registers.

Phase II: Medical records will be reviewed in reverse chronological order to the register in order to classify

100 patients as cases and 200 patients as matched controls per site.

Phase III: Up to 70 participants will be recruited for 9 focus group discussions at 2 to 3 clinic sites.

Phase IV: A sample of patients confirmed as either cases or controls in Phase II will be recruited for

individual patient interviews as part of the case-control investigation.

STATUS OF STUDY/PROGRESS TO DATE: In FY 2007, meetings took place between site leaders and

Columbia University-ICAP. In addition, the final protocols were developed in collaboration with site facility

staff, Columbia University-ICAP and CDC. Proposals were submitted for in-country Institutional Review

Board (IRB) review to University of Fort Hare and Walter Susulu University for ECDOH clearance. Some

study staff have been recruited and hired and in FY 2008 the full complement of staff will be realized.

Data collection will begin after local IRB and Columbia University IRB approval has been granted.

INFORMATION DISSEMINATION PLAN: Results from this study will be disseminated in site level

presentations and reports to participating sites, ECDOH, other Columbia University programs, and

USG/CDC.

ACTIVITIES: Planned FY 2008 activities include finalizing data collection, conducting data analysis and

widely disseminating findings.

TYPE OF STUDY: Continuing

TITLE OF STUDY: Assessing the effectiveness, acceptability, replicability and cost benefit of a peer

educator program to improve long-term adherence to antiretroviral treatment (ART) among adults receiving

HIV care and treatment in the Eastern Cape, South Africa.

TIME AND MONEY SUMMARY: The International Center for AIDS Care and Treatment Programs at

Columbia University's Mailman School of Public Health (Columbia-ICAP) is using PEPFAR FY 2006 funds

for this study. This study will take place over 24 months. Activities for this PHE started in FY 2007 and are

expected to be completed in early 2009. No additional funding is requested for completion. No funding has

been leveraged/contributed from other sources.

LOCAL CO-INVESTIGATOR: Ebrahim Hoosain, Manager, Public Health Surveillance Unit, Nelson Mandela

Metropolitan Municipality.

PROJECT DESCRIPTION: Columbia-ICAP is currently supporting HIV care and treatment services in 42

sites in the Eastern Cape and KwaZulu-Natal provinces. As of December 2006, over 36,000 patients had

been enrolled in care, including 20,000 who had initiated ART. Adherence support for patients on ART is

provided on an individual basis by clinicians during routine clinic visits, as well as by pharmacists when

patients return for medication refills, although the extent and quality of this support varies. In some sites, a

range of informal providers also provides adherence support as part of broader hospital-, community- and/or

home-based services they support. The study aims to assess the effectiveness of a site-level peer-based

adherence support program, identify factors associated with sub-optimal adherence, determine the

acceptability of a peer-based adherence support program, and estimate the costs and clinics benefits of a

peer-based adherence support program. A separate sample pre-post design will be used to assess the

impact of a peer-based adherence support program. Adherence interviews with a sub-set of patients

enrolled in pre- and post-program implementation cohorts, focus group discussions (FGDs) with a sub-set

of the patients interviewed, and data abstraction of routinely collected immunological and virological data for

all patients (i.e. those enrolled and not enrolled in the cohorts) before and after the program implementation

will be conducted.

The study will run for approximately 24 months. Interviews with a retrospective cohort of patients who

initiated ART before the implementation of the peer-based adherence support program (i.e. pre-program

cohort), FGDs with a sub-set of patients interviewed, and data abstraction for all of the pre-program patients

will begin in January 2008 and run for about 3 months. The peer educator (PE) program will be initiated in

April 2008 and run continuously for the duration of the study and, depending on the study results, potentially

after the study end. Interviews with a prospective cohort of patients initiating ART after the implementation

of the peer-based adherence support program (i.e. post-program cohort), FGDs with a sub-set of patients

interviewed, and data abstraction for all of the post-program patients will begin in April 2008 and run for

about 9 months.

Pre-program cohort: At each of the study sites, a retrospective pre-program cohort consisting of a sample of

ART-naïve patients who started ART in the previous 11-13 months relative to a specified baseline time will

be identified and enrolled in the study. A single interview will be done approximately 12 months after the pre

-program cohort participants initiated ART.

Post-program cohort: A post-program cohort consisting of a sample of ART-naïve patients starting ART

after the beginning of the peer program will be recruited prospectively in the first 3 months following the

baseline. Each participant in the post-program cohort will be followed for 12 months after ART initiation and

interviewed 6 and 12 months after ART initiation (3 interviews in total).

The proportion of patients 100% adherent at 12 months after ART initiation will be compared in the pre- and

post-program cohorts to estimate the effectiveness of the peer-based program. In both cohorts, factors

associated with sub-optimal adherence will also be examined. Interim analyses will also be conducted at the

end of Year 1 and in mid-Year 2.

Focus group discussions (FGDs) with a convenience sample of patients participating in the pre- and post-

program cohorts will be conducted to learn about their experiences taking ART and to probe further into

barriers and facilitators of ART adherence. Data collected in the FGDs with the pre-program implementation

cohort will also serve to refine the PE adherence support program. The FGDs conducted with post-program

cohort members will be done after their 12-month interview and thus will address the acceptability of the PE

program as per Study Objective 4. Additionally, the FGDs will allow the researchers to gather information

on other potential benefits of the PE program, beyond those related to adherence. At each site, about 2

FGDs with 6-8 participations per FGD will be conducted both before and after the implementation of the PE

program at each site, for a total of 8 FGDs. Where possible, FGDs will be limited to individuals of the same

sex and age (e.g. <30 and =30 years) who started ART roughly at the same time.

A final approach to assess the impact of the program at the site level will entail abstraction from patient

charts of the following data elements that are routinely captured on all ART patients:

(a) routinely collected baseline, 6 and 12-month CD4 cell count measures;

(b) routinely collected baseline, 6 and 12-month viral load measures;

(c) pharmacy refill data; and

(d) number of scheduled and missed visits within the first 12 months after ART initiation.

Each of these measures will be abstracted for both the pre- and post-program cohort members and non-

cohort members (i.e. patients who initiated ART during the specified pre- and post-program cohort periods

but are not enrolled in the cohorts). The socio-demographic characteristics of cohort and non-cohort

members will be compared to assess the potential impact of participation bias in the cohorts. Median

change in CD4 cell count and viral load 12 months after ART initiation will be compared for the patients

enrolled in a study cohort (i.e. pre-program cohort vs. post-program cohort) and for those not enrolled in a

study cohort (i.e. all patients not exposed to program vs. all patients exposed to program). Similarly, the

proportion of patients obtaining ART refills in a timely manner will be compared for the patients enrolled in a

study cohort (i.e. pre-program cohort vs. post-program cohort) and for those not enrolled in a study cohort

(i.e. all patients not exposed to program vs. all patients exposed to program). Abstracting and analyzing

Activity Narrative: data for non-cohort members will allow us to obtain more valid clinical outcome data given the potential for

selection bias when recruiting individuals into the cohorts.

STATUS OF STUDY/PROGRESS TO DATE: In FY 2007, meetings took place between site leaders and

Columbia University-ICAP. In addition, the final protocols were developed in collaboration with site facility

staff, Columbia University-ICAP and CDC. Proposals were submitted for in-country Institutional Review

Board (IRB) review to University of Fort Hare and Walter Sisulu University for ECDOH clearance. Some

study staff have been recruited and hired and in FY 2008 the full complement of staff will be realized. Data

collection will begin after local IRB and Columbia University IRB approval has been granted.

INFORMATION DISSEMINATION PLAN: Results from this study will be disseminated in site level

presentations and reports to participating sites, ECDOH, other Columbia University programs, and

USG/CDC.

ACTIVITIES: Planned FY 2008 activities include finalizing data collection, conducting data analysis and

widely disseminating findings.