Continuing activity: Replacement narrative

Evaluation of eligibility for Anti-Retroviral Therapy (ART) in Mozambique by clinical staging performed for

HIV-infected pregnant women by antenatal care / prevention of mother-to-child (ANC/PMTCT) personnel

and comparison to CD4 and total lymphocyte count (TLC)

This project aims to evaluate techniques used for determining ART eligibility among pregnant women by

comparing various algorithms of clinical staging, CD4 count, total lymphocyte count, and

hemoglobin/hematocrit. Sensitivity and specificity of these tools will be compared when used by maternal

child health (MCH) nurses in the context of ANC PMTCT services in Mozambique. The study will help

determine the best method for evaluating eligibility for ART among pregnant women, in particular for sites

with limited or no access to laboratory services.

The Mozambican Ministry of Health (MOH) National PMTCT protocols currently recommend initiation of

ART for pregnant women if they are stage III or IV, or have a CD4 of less than 250/mm3 . While a network

of laboratories is being established with PEPFAR support that will in the future increase access to CD4

testing, many remote PMTCT sites will not have easy access to laboratory services for the next years. This

fact, coupled with the scarcity of skilled and trained personnel available to clinically assess patients leads to

a large contingent of HIV-infected pregnant women who are not adequately assessed for ART eligibility.

As part of conducting this PHE, training in clinical staging will be provided for participating nurses.

This activity was conceptualized in FY06 but protocol has not yet been finalized. New MOH PMTCT

program direction and staff reorganization in the PMTCT program has significantly delayed progress during

the first year. At this time, these institutional issues have stabilized. ICAP, the proposed USG implementing

partner, has significantly expanded their Mozambique-based research team. Money will be reprogrammed

from FY06 to Columbia University International Center for AIDS Care and Treatment Programs (ICAP) to

collaborate and facilitate study administration and logistics. Additional FY08 funding will also be allocated to

support completion of this activity. CDC Mozambique is actively recruiting a study coordinator who is

expected to be in place by late September or early October, 2007, to function as the lead for this activity.

To date, discussions to refine study design and implementing issues have taken place. A draft protocol has

been developed and will be presented and shared with implementing partners and other MOH staff

involved. The protocol and instruments will be vetted through the appropriate ethical reviews in the US as

well as the Mozambican Bioethics Committee in country. Principal investigators are Dra. Lilia Jamisse,

MOH Adjunct National Health Director, and Dra. Elsa Jacinto, MOH Reproductive Health Program Director

and PMTCT Program Coordinator.

Stakeholders (MOH, USG, ICAP) will participate in the planning and presenting of the data at meetings and

conferences, as well as disseminating information through routine channels within the USG PMTCT

partners community and MOH organizational structure. Results will be submitted for publication in an

appropriate peer reviewed journal.

After the protocol has been cleared by the appropriate ethics boards, the assessment will take place in two

ICAP-supported PMTCT sites, with laboratory support available either on site or within proximity at the

provincial hospital laboratory. Three potential sites are currently under evaluation, and initial site

assessments have taken place. Staff will be trained in assessing patients in clinical staging according to

WHO guidelines; initial development of materials has started and is expected to be completed by

September-October 2007.

Study activities and data analysis are expected to be complete by the end of FY08.

Budget Justification: $150,000 will be rolled over from FY06/FY07 and reprogrammed to Columbia. To

enable completion of the project, $37,500 in additional funds will be allocated for FY08.

Cost centers will be 1) Personnel support, $68,000; 2) Equipment, $26,000; 3) Supplies, $12,000; 4) Travel

and specimen transport, $38,000; 5) Training (material development and courses), $23,500; 6)

Dissemination meetings, $12,000; 7) Other, $8,000.

Participant incentives will not be issued as per current MOH guidance.

Continuing Activity: Replacement Narrative

The Columbia University International Center for AIDS Care and Treatment Programs (ICAP) will complete

implementation of the PHE, "Moving from single dose Nevirapine to more complex antiretroviral prophylactic

regimens in PMTCT programs: assessing implementation successes and barriers." This activity was

previously titled "Assessment of access, uptake and adherence to single-dose nevirapine (sdNVP)

prophylaxis among HIV-infected pregnant women." Since this project was conceptualized for FY06

planning, rapid changes have occurred in international standards for PMTCT practice, and MOH guidelines

have been revised. The protocol has been updated accordingly, and the scope has been expanded to move

beyond sdNVP to include complex ARV prophylaxis regimens.

This activity was conceptualized in FY06; new MOH PMTCT program direction and staff reorganization in

the PMTCT program has significantly delayed progress during the first year. At this time, these institutional

issues have stabilized. ICAP has significantly expanded their Mozambique-based research team.

At the moment the protocol is under final revision with headquarter & Mozambique in-country teams. The

protocol is planned to be submitted to appropriate local and US-based IRBs in October 2007. The

implementation is expected to be concluded in January 2009. Principal investigators are Dra. Lilia Jamisse,

MOH Adjunct National Health Director, and Dra. Elsa Jacinto, MOH Reproductive Health Program Director

and PMTCT Program Coordinator.

The main objectives of the study are: 1) To identify patient-level determinants of maternal and pediatric

PMTCT outcomes; 2) To identify contextual, programmatic and site-level determinants of maternal and

pediatric PMTCT outcomes; 3) To identify facility and program level characteristics that are associated with

HIV care and treatment outcomes, after adjusting for patient-level characteristics.

This study will include retrospective and prospective cohort follow-up with data from medical records and

interviews with women as well as a descriptive study of site and program characteristics. This work is vital

to identifying important programmatic aspects of HIV care and PMTCT programs for use in planning future

programs and improving existing ones in Mozambique and elsewhere.

Work will start in the field in January 2008. Findings will be shared with participants, study sites and ICAP

supported sites involved. It is also in the public interest that findings be made available to a broader range

of HIV/AIDS health care providers.

Stakeholders (MOH, USG, ICAP) will participate in the planning and presenting of the data at meetings and

conferences, as well as disseminating information through routine channels within the USG PMTCT

partners community and MOH organizational structure. Results will be submitted for publication in an

appropriate peer reviewed journal.

The estimated costs are USD 220,000; USD 70,000 will be continue to be rolled over from the FY06 budget,

and in FY08 an additional USD 150,000 is requested to fund completion of the project.

Budget justification: 1) Personnel: USD 90,000; 2) Equipment: USD 18,000; 3) Supplies: USD 10,000 4)

Travel: USD 40,000; 5) Dissemination of findings: USD 12,000; 6) Training (material development and

courses), USD 15,000; 7) Other: USD 35,000.

Participant incentives will not be issued as per current MOH guidance.

Ongoing activity: Replacement narrative

Ongoing Support for existing and expansion of PMTCT Activities ($2,260,450):

In FY08, Columbia University International AIDS Care and Treatment Program (ICAP) is proposing to

continue supporting PMTCT activities supported in FY07 at the 2 PMTCT model centers and 35 existing

sites (including maternities). Integration of PMTCT services with HIV care & treatment services will be a

critical area of focus in providing more effective PMTCT interventions to HIV-infected pregnant women as

well as optimal care for their disease.

Particular focus for transition to more complex PMTCT regimens will be fundamental to successful provision

of optimal services. Additional training on drug procurement, distribution, training of staff on PMTCT-plus

(e.g., testing and counseling services integrated into ANC and maternity; CD4 testing of all HIV positive

women; malaria prophylaxis; TB screening; partner testing, etc.) will encompass essential components of

strengthened PMTCT programs.

Regular follow-up of women and children will be necessary to promote safer infant feeding practices and

improve infant outcomes. Peer educators will be trained in outreach services and defaulter tracing in an

attempt to improve program adherence. Enhancing infant and child health care initiatives will also be

prioritized. Activities will include identification of HIV exposed infants by routinely checking infant health

cards, early and consistent follow up of HIV exposed infants in ARCC, roll-out of early infant diagnosis in

additional health centers to facilitate infant HIV diagnostic testing, training and mentoring on growth

monitoring, counseling and support on postnatal services by enhancing quality of infant feeding support. A

family centered approach to PMTCT will also be prioritized with the goal of engaging families, their partners

and their children, in family-focused services addressing their medical as well as psychosocial needs.

Maternal and child health services will be coordinated to ensure patient follow-up. Mother support groups

and infant feeding support groups will be established and continued at all ICAP supported PMTCT sites.

Family days will also be supported at sites offering collocated PMTCT and ART services.

In addition to continuation of services at the existing ICAP supported PMTCT sites, ICAP is proposing to

expand PMTCT services to an additional 12 facilities in an attempt to provide ANC/MCH services to

complete district coverage of PMTCT services in the geographic area of Nampula . This model of

implementation will also be followed in Maputo City and Inhambane as a way of ensuring increased

coverage of PMTCT services within a particular district/region. Funds will be used for rehabilitation of space

to improve privacy for provision of PMTCT services, training of MCH staff in PMTCT and infant follow-up,

and technical support to establish linkages and referral between services. Counseling and testing services

will be implemented at antenatal, maternity and At Risk Child Consultations. District health teams will also

be trained as PMTCT mentors to provide continued support to these sites. Support will also include initial

assessments of facilities and amelioration to the overall patient flow of services.

Enhance PMTCT Monitoring and Evaluation activities ($330,000):

The core aspect of this activity will be ICAP support for the national PMTCT program in coordinating efforts

to develop a standardized national database. ICAP will continue enhancing PMTCT program monitoring and

evaluation efforts by supporting provincial level M&E trainings to increase the number of staff, both

provincial and district level, trained in management of PMTCT program data. District and provincial level

PMTCT staff will be trained on how to use data to improve PMTCT services including highlighting program

strengths and/or weaknesses. ICAP will also support the implementation of a PMTCT data collection

system using uniform PMTCT indicators that correspond to national and PEPFAR required indicators. In

collaboration with the MOH PMTCT Technical team, ICAP will support the review of PMTCT program

registers and assist in strengthening data links between PMTCT services, care and treatment and infant

follow-up. Personnel will be hired to support this activity (as below).

In addition, ICAP will follow on FY07 activities which included development and pilot of a PMTCT patient

level database that links HIV positive mothers across the health system (ANC, maternity, care and

treatment and exposed infant follow-up). The pilot database has been implemented at the two PMTCT

model centers. In FY08, ICAP is proposing to expand programmatic coverage of the electronic patient

tracking system so that it integrates all aspects of service delivery (ANC, Maternity, exposed infant

consultation, family planning and care and treatment services) and implement the database at additional

PMTCT sites.

PMTCT Clinical Mentoring and Training ($457,000):

In addition to supporting the development of replicable models of care, the model centers will also serve as

training sites to complement the ongoing PMTCT training program developed by the MOH. The goals of the

mentorship program will be to complete development of the model centers as part of the continuum of

education for MCH nurses in Nampula and Maputo Provinces, as well as potential participation of nurses

from regional areas. Nurses partaking in the rotation will have the opportunity to practice experience-based

learning focusing on professional development. Training will be aimed at health workers to provide a "hands

on" experience that will support their ability to recreate simplified models for PMTCT service provision at

primary health centers. Two core nurse mentorship teams will be established to continue to provide central

and provincial level technical and professional support over time. ICAP has been collaborating with ITECH

in the development of training curricula and facilitation modules to assist in material development

appropriate for the launch of the mentorship program. During FY08, ICAP will continue this collaboration as

needed to evaluate tools, and revise as necessary. A total of 72 MCH staff, including staff supported by

other USG partners, will be offered the opportunity to rotate through the clinical mentorship program in

FY08. Using the district team approach to monitoring PMTCT activities, an additional 20 staff from the

district teams will be trained as mentors/supervisors to oversee PMTCT program implementation at district

health centers. In addition to the clinical mentoring program, ICAP will also continue to support provincial

level PMTCT trainings thereby increasing the number of MCH staff trained in PMTCT services, including

counseling and testing, pediatric HIV diagnosis, and infant follow-up.

Activity Narrative:

Central level Ministry of Health Personnel Support ($404,000):

ICAP will continue to support the national PMTCT program by providing direct technical assistance in the

area of PMTCT M&E activities. The PMTCT M&E Technical Advisor will support the national PMTCT

program supporting the development of PMTCT Information System and implementation of national

database, as well as finalized national PMTCT registers and monthly reporting forms for programmatic

areas. ICAP will continue its support to the national PMTCT program by supporting the provincial level

Ministry of Health in two provinces, Nampula and Inhambane. PMTCT technical advisors will be recruited

and seconded to the above mentioned provincial directorates to further support national roll-out and

supervision of PMTCT services. In addition, due to the lack of PMTCT support at a central level within the

Ministry of Health, ICAP will continue supporting the staffing costs of a data entry clerk to help with national

PMTCT program monitoring and data entry, as well as, an administrative assistance to facilitate national

PMTCT program coordination and communication with various partners and program implementers.

Per guidance sent by CDC/GAP, this activity represents approximately 1/12 of the funding originally

allocated to Columbia University for this program area under activity 5208.08. Funding is provided to pay

for that activity from February 23 - April 1, 2009.

Per guidance sent by CDC/GAP, this activity represents approximately 1/12 of the funding originally

allocated to Columbia University for this program area under activity 5198.08. Funding is provided to pay

for that activity from February 23 - April 1, 2009.

Columbia University works in 7 provinces in Mozambique (Maputo, Gaza, Inhambane, Nampula, Zambezia,

Maputo City, and Tete province where Columbia works with the military to provide services. In all these

sites, support is provided for the implemention of HIV care and treatment programs that include staff training

and mentoring, infrastructure improvements, procurement of materials and supplies needed at facility level,

hiring of staff to support service provision and program monitoring and evaluation, as well as technical and

clinical advisors. These activities are also described in other parts of this document.

During FY08 Columbia University-ICAP will continue to support and expand HIV related care activities at

these sites with a view of decentralising services to remote facilities while improving patient follow up,

referral and initiation of ART services. The following activities will be implemented:

1. Strengthen the management OI drugs at supported Care and treatment facilities through: training of

pharmacy staff in OI management including how to monitor adherence; implementation of drug

management systems (computer and paer based), support provincial warehouse to strenghthen referral

systems, logistics systems and staff training in drug managment; Procurement of OI medication for

treatment of adults, infants and children in case of stock outs at CU supported sites: additionally CU will

continue to work with the MOH and SCMS in ensuring that sites implement recommended drug mangment

procedures to strenghthen the current logistics system.and Implement logistic systems to help ensure

continuous supply of medications (in coordination with CMAM/SCMS);

2. Support the diagnosis and treatment of Opportunistic Infections: Implement syndromic approach for

treatment of STIs and screening for HPV/cervical cancer through training and procurement of equipment

and supplies;. Implement case-finding, prevention and treatment of Malaria through training and in

collaboration with PMI and the PSI programs, procurement of bed nets and other supplies; Support

improvement and expansion in the detection and treatment of Kaposi's Sarcoma through training health

staff in chemotherapeutic agents preparation/KS treatment, renovation and outfitting of treatment areas, and

implementation of an M&E system to track incidence and prevalence of KS; Implement patient follow up for

patients not yet initiating ART ensuring that they receive cotrimoxazole, have access to nutrition programs

(World Food Program) are followed up regularly and initiated on ART once they are eligible for treatment

3. Improve links with community HIV care programs through development of Memoranda of understanding,

sub-agreements, with Comunity based organistaions and PLWHA support groups.

Support diagnosis, treatment and prevention of opportunistic infections: Implement syndromic approach for

treatment of STIs and screening for HPV/cervical cancer; Provide training, lab testing, and procurement of

equipment and supplies for diagnosis and t

Strengthening OI management by providing training to pharmacists, implementation of software ,

monitoring of adherence , continued education for health staff, supervision and M & E and procurement of

essential Oi drugs

Funds for this activity will be used to continue TB/HIV activities initiated in FY07:

The key interventions include:

1. Continue to support HIV counseling and testing for TB patients at the TB clinics linked to ART clinics;

Implement referral systems of TB/HIV co-infected patients to ART clinics for care, treatment, follow up and

support

2. Support infrastructure development at ART clinical and related TB sites to include ensuring adherence to

standard infection control measures, supplies and equipment for provision of quality TB/HIV services

3. Implement TB screening for all HIV positive patients who are reviewed at the ART supported sites using

a standard screening tool. In addition to TB screening for pregnant women enrolled in PMTCT programs.

4. Develop health workers skills in the diagnosis and management of TB and HIV through implementation of

the following activities at provincial and site level:

-Train clinical staff, including clinical officers ("técnicos de medicina") and nurses, in prevention, diagnosis

and management of TB, TB/HIV, drug resistant TB, TB in children; uses of INH prophylaxis among HIV

patients

5. Implement TB/HIV M&E systems and patient medical records to be able to better monitor important

program indicators for TB/HIV program management the. This includes working with the National TB

Program (NTP) to revise and update data collecting tools, training staff, providing computers for sites with

high patient loads, and hiring data management staff.

6. Support the NTP in the implementation of electronic patient tracking systems for TB; Provide technical

support, equipment and supplies to develop and implement TB electronic patient tracking system (TB E-

PTS) that directly links to HIV E-PTS already in use at large volume ICAP -supported facilities

Additionally, Columbia University through the TB technical advisor will continue to work closely with the NTP

through participation in the TB/HIV task force, TBCAP coordination meetings as well as assist in training

and site supervision.

Per guidance sent by CDC/GAP, this activity represents approximately 1/12 of the funding originally

allocated to Columbia University for this program area under activity 16282.08. Funding is provided to pay

for that activity from February 23 - April 1, 2009.

The International Center for AIDS Care and Treatment (ICAP)/Columbia University (CU) has been involved

in HIV/AIDS services delivery and technical assistance (TA) provision in Mozambique since September

2004. All ICAP activities are supported by USG and guided by Mozambique's national HIV strategic plan. In

collaboration with the Ministry of Health (MOH), ICAP/CU is currently supporting 31 HIV care and treatment

sites in six provinces: Maputo City, Maputo Province, Gaza, Inhambane, Nampula and Zambezia. In

addition, ICAP is currently supporting 11 maternities and 17 CARCs (Child-At-Risk Consultations), both in

Maputo and Nampula.

In 2006, 860 hundred HIV positive mothers delivered in ICAP supported maternities. Within the context of

PMTCT and pediatric treatment services in Mozambique, access to early diagnosis remains a challenge

and of great concern to USG, ICAP/CU and other partners. In June 2007, ICAP/CU reported 9314 HIV

positive children in care and 2514 on treatment at sites provided with ICAP/CU care and treatment support.

Although numbers of children tested and enrolled in treatment have started to increase, PMTCT and

treatment program data suggest that follow-up and testing for the HIV exposed infant, access to HIV testing

for children and enrollment of HIV-infected children need further improvements.

Caregivers and parents often do not know that it is the children's right to be tested if they are exposed to

HIV or if they have any AIDS related symptoms. In addition, social and psychological issues as well as

stigma and discrimination can present a significant barrier to accessing to HIV testing. Samo Gumo (2007)

conducted a qualitative research with mothers of HIV positive children assisted at the José Macamo

Pediatric Day Hospital (ART service site) in Maputo province. One of the main findings was that mothers

were afraid of testing their children because they relate HIV/AIDS to death. This finding shows the

importance of counseling to help overcome their fears and to address issues related to the meaning of HIV

for those families. Access to HIV testing for children urgently needs to be improved, HIV infected children

who would benefit from therapy be referred, including early diagnosis in infants to improve survival

outcomes for babies infected through vertical transmission.

Counseling and Testing (CT) for children needs special considerations. Particular attention should be given

on how to provide technical information to children and families. Issues related to the implications for the

mother with unknown HIV status must be considered during counseling sessions. Consent and assent to

testing, implications of test results, comprehension and management of results by the child and the family

are as well important issues that must be taken into account during CT sessions. Counseling must be

structured to address issues related to parents' stigma and feelings of guilt in relation to the HIV status of

their children, as well as barriers to talk about AIDS with them. On the other hand, health workers must be

prepared to deal with their own fears to manage and treat children, to know when and how to prescribe

ART, and to develop skills to counsel children and family. Again, specific pre and post test counseling skills

and materials are needed in the context of early diagnosis with the DNA PCR testing for early infant

diagnosis recently made available in Mozambique at a first site in Maputo. Counseling materials and

contents need to address issues around breastfeeding and infant nutrition in relation to Mother-to-Child

transmission.

Providers working in a busy clinic or ward may have limited time to provide counseling to parents because

their primary goal is to provide medical care and treatment. This issue must be taken into account as we

consider how best to provide CT to pediatric patients. To improve the quality of children and family

counseling and follow up, we have to face some challenges such as: facilitate disclosure, improve

counseling and psycho-social support tools, create children friendly environments, provide outreach visits,

develop individual relationships with the children, involve children in peer education and preparedness for

treatment where appropriate and applicable.

To help health providers to offer structured counseling for children and their family, this activity will assist to

adapt/develop psychosocial support tools, training materials for health providers, counseling charts, job

aids, and Information Education, and Communication (IEC) materials for children. These IEC materials will

be tailored to address children's questions and challenges, and to provide information appropriate to their

age, development, and culture.

This activity will support the adaptation of a module for HIV Testing and Counseling for Infants, Children,

and Adolescents from the generic Provider-Initiated HIV Testing and Counseling (PITC) in Clinical Settings

Manual developed with USG support. This material covers the provider-client interaction with pediatric and

adolescent patients and their parents or caregivers. It discusses how to tailor the provider initiated testing

and counseling process for patients in each age group, including the appropriate level of involvement for

parents or guardians. Adaptation to the Mozambican context will involve health workers, PLWHA, and

patients assisted at ICAP sites. Funding under this activity will also support the piloting of the materials at

selected sites, and dissemination of final products and pilot experiences to stakeholders.

Per guidance sent by CDC/GAP, this activity represents approximately 1/12 of the funding originally

allocated to Columbia University for this program area under activity 16276.08. Funding is provided to pay

for that activity from February 23 - April 1, 2009.

Continuing activity from FY06 - activity number 5250.06

Columbia University will continue to conduct the PHE called "Identifying Optimal Models of HIV Care and

Treatment in Mozambique" (this study was entitled "Assessment of influence of quality of services on

clinical outcomes" in COP 2006) approved by local and Columbia University IRB in June 2007, and

expected to be concluded in June 09. The study will be submitted to CDC Atlanta IRB in Sept 2007. The

estimated costs are 50,000 USD. 54% of the total amount will be expended by February 2008. The local co-

investigators are: Dr Americo Assane, Chief of Department of Medical Assistance, Mozambican Ministry of

Health; Dr. Florindo Mudender, Department of Medical Assistance, Mozambican Ministry of Health. The

main objectives of the study are: 1) To assess the degree of variation in patient outcomes across HIV care

and treatment delivery sites, independent of the differences in patient-level characteristics across sites; 2)

To identify facility and program level characteristics that are associated with HIV care and treatment

outcomes, after adjusting for patient-level characteristics; 3) To assess the costs and clinical benefits of

modifying facility and program-level characteristics that appear to influence HIV care and treatment

outcomes and quality adjusted life years (QALYs). Secondary analysis of routinely collected patient data

combined with data from routine assessments of facility and program level characteristics will be used. This

work is vital to identifying important programmatic aspects of HIV care and treatment programs for use in

planning future programs and improving existing ones in Mozambique and elsewhere. Current status: the

first round of data collection is expected to start in October 2007. Findings will be shared with participants,

study sites and ICAP supported sites involved. It is also in the public interest that findings be made available

to a broader range of HI/AIDS health care providers. For FY08 is expected to continue the following rounds

of data collection. Budget justification: 1) Salaries: USD 22,400; 2) Equipment: USD 11,600; 3) Travel: USD

16,000. Total: USD 50,000>

Note: This evaluation in one of three PHEs that come from activity 5250.06. The total amount of funds for

these evaluations remain at USD 500,000, although individual studies have changed their initial budget

totals (in agreement with CDC GAP Mozambique).

Continuing activity from FY06 - Activity number 5250.06

Columbia University will continue to conduct the PHE called "Assessing the acceptability, effectiveness and

cost benefit of two interventions to improve long-term adherence to ART among adults receiveing HIV care

and treatment in Mozambique" (it was designated as "Assessment of the effectiveness of peer-based

adherence support in maintaining and improved adherence to ART" in COP 06). The analysis regarding

cost effectiveness will conducted by CDC Atlanta. The protocol is in development and should be submitted

to Local, Columbia University and CDC Atlanta IRBs in October 2007. The estimated costs are USD

150,00. 54% of the total amount will be expended by February 2008. The local co-investigators are: Dr

Americo Assane Chief of Department of Medical Assistance, Mozambican Ministry of Health; Dr. Florindo

Mudender, Department of Medical Assistance, Mozambican Ministry of Health. The main objectives of the

study are to: 1) assess the effectiveness of two adherence support interventions, 2) identify factors

associated with sub-optimal adherence to ART at 3, 6, and 12 months after ART initiation, 3) estimate the

costs and clinics benefits and determine the acceptability of these two adherence support interventions.

Design: A two-pronged separate sample pre-post design will be used to assess the impact of a two

adherence support intervention. Both adherence interviews with patients enrolled in pre and post-

interventions cohorts 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 intervention's

implementation will be conducted.This work is vital to identifying relevant programmatic enablers and

barriers for long term ART adherence in adults. Current status: the protocol is in final phase of development

and should be submitted to local, Columbia University and CDC Atlanta IRBs in October 2007. Findings will

be shared with participants, study sites and ICAP supported sites involved. It is also in the public interest

that findings be made available to a broader range of HIV/AIDS health care providers. Budget justification:

1) Salaries: USD 137,000; 2) Equipment: USD 4,000; 3) Travel: USD 6,000; 3) Office supplies: USD 3,000,

Total: USD 150,000

Note: This evaluation in one of three PHEs that come from activity 5250.06. The total amount of funds for

these evaluations remain at USD 500,000, although individual studies have changed their initial budget

totals (in agreement with CDC GAP Mozambique).

Continuing activity - FY06 Activity number 5250.06

Columbia University will continue to conduct the PHE called "Establishment of sentinel cohorts of patients in

HIV care and treatment services in Mozambique" (it was nominated as "Assessment of Viral load as a

predictor of therapeutic failure as compared to CD4 Count) and future clinical outcomes " in COP 06). At the

moment the protocol is under NY & in-country team revision. It should be submitted to Mozambican,

Columbia University and CDC Atlanta IRB in October 2007. The study is expected to be completed by

December 09. The estimated costs are 300,000 USD. 65% of the total amount will be expended by

February 2008. The local co-investigators are: Dr Americo Assane, Chief of Department of Medical

Assistance, Mozambican Ministry of Health; Ilesh Jani, Department of Immunology, National Institute of

Health. The main objective of the study is to characterize the clinical, immunologic and virologic

characteristics and keys short-term (early) program outcomes among adult (= 15y) and pediatric (<15y)

patients with confirmed HIV infection who are enrolled in HIV care and treatment programs in Mozambique.

It will be a multi-site, prospective cohort study. This work is vital to identifying important programmatic

aspects of HIV care and treatment programs for use in planning future programs and improving existing

ones in Mozambique and elsewhere. Current status: to be sent to local, Columbia University and CDC

Atlanta IRBs in October 2007. Findings will be shared with participants, study sites and ICAP supported

sites involved. It' is also in the public interest that findings be made available to a broader range of HI/AIDS

health care providers. For FY08 is expected to continue the next rounds of data collection. Budget

justification: 1) Personnel: USD 71,000; 2) Equipment: USD 4,000; 3) Travel: USD 10,000; 4) Supplies:

USD 215,000. Total: 300,000

Note: This evaluation in one of three PHEs that come from activity 5250.06. The total amount of funds for

these evaluations remain at USD 500,000, although individual studies have changed their initial budget

totals (in agreement with CDC GAP Mozambique).

This is a continuing activity: Update to an existing narrative

This activity is a continuation of treatment activities that were initiated in FY04-7 as part of Columbia

University Track 1.0 supplemental funding. Funding will be used to continue supporting 30 ART sites

(including 3 military facilities and initiate support to 4 new ART facilities), as well as training of health

workers, technical assistance to the district and provincial and central level MOH and ensure quality of

services provided through continuous program monitoring and evaluation, site supervision and linkage with

Community Based Organizations. Funding during FY08 will be used for the recruitment of doctors,

counselors and nurses, and to support the provision of a broad range of technical services directly to

Provincial and District Health Authorities.

Support will be provided to pediatric treatment scale up at all CU supported ART sites as well as specifically

to the pediatric Day Hospitals in Maputo and Nampula Central hospitals. CU will support the logistics

required to undertake PCR using DBS at site level, train, mentor and provide supervision for staff in

pediatric HIV care and treatment, develop linkages to PMTCT, pediatric Counseling and testing services

and general health services for children to increase the number of children receiving HIV care and

treatment.

Additional activities that will be included with this funding are:

1) Develop sub- agreements to finance community organizations to implement patient follow up and provide

adherence support

2) Support establishment of "moonlight" ART Pilot site(s) to increase access to ARV treatment for

vulnerable populations (such as drug users and commercial sex workers), improving access and services

for these particular groups at selected sites in Maputo and Nacala (Nampula province).

This activity will be informed by results from a qualitative assessment (I-RARE) conducted in November

2007, providing information about needs and barriers to access for HIV counseling and testing, and ART for

HIV-infected high-risk-group populations. Community-based and CT activities that will contribute to

increased identification and referal of high-risk group members in need of services are described in other

parts of the plan. It will be of crucial importance for ART sites to be prepared and provide services that are

open and user-friendly from the perspective of this particular group.

3) Include funding for a Provincial Treatment Coordinator support for Inhambane Province - (includes office

costs, vehicle, fuel, maintenance, security, driver and recruitment of a Technical Advisor). This will allow

Columbia University/ICAP to provide province-wide support to the ART scale up in Inhambane, ensuring

provision of quality ART services as well as program reporting. Inhambane Province currently provides

approximately 5% of CU's total number of people enrolled on ART)

4) Follow up military personnel identified as HIV positive during the prevalence study and ensure they are

referred and enrolled into HIV/AIDS care and treatment services. This will include training nurses working at

military bases on follow up of patients receiving ART (under supervision of Military doctor), management of

opportunistic infections and treatment adherence.

5) Pilot a comprehensive HIV care and treatment program in the Civil Prison targeting men, women and

their children, guards, and their families. This intervention includes provision of HIV counseling and testing

(CT), risk reduction and behavior change interventions, PMTCT services for female inmates, screening and

treatment for Sexually Transmitted Diseases (STDs), TB and other Opportunistic Infections (OIs), and ART

services for eligible HIV-infected persons identified.

Once released from prison, HIV positive in-mates will be provided with referrals and assigned a case

manager to assure that they have been able to access care and treatment within the general community.

Funding to support this activity will be used to provide training for doctors, nurses and other health staff

working in the two selected pilot sites, as well as to ensure availability of necessary supplies; to support

program monitoring, a peer educator program and treatment support groups, disseminate IEC materials for

treatment literacy including PwP messages.

FY07:Follow up the military personnel identified as HIV positive during the prevalence study and make sure

they are all enrolled in HIV/AIDS treatment sites. Train nurses working at military bases on ART prescription

and identification of OIs. These nurses will be responsible to provide CT, collect the drugs for each ART

eligible soldier in his unit at the nearest treatment site, and assist them on how to take the drugs. To ensure

TB/HIV treatment adherence, they will be trained using already existing treatment adherence materials

including those being newly developed by Columbia University. The nurses will report to the military doctor

in each location.

Provincial TX Coordinator Support for Inhambane - office costs, vehicle, fuel, maintenance, security, driver

and Technical Advisor