ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

1. Training of the CAPRISA site team in pediatric HIV care: the site personnel had no previous experience,

and therefore needed to be trained on the complexities of pediatric care. This was achieved by the

development and implementation of a program of training on the principles of chronic care management

and treatment of children with HIV and AIDS. Training activities included formal didactic training, workshop

and specific training program attendance, a program of twinning of our staff with staff experienced in

pediatric care at McCord Hospital and Escourt, Grey's and Northdale provincial Hospitals, and adaptation

and implementation of best practice of service delivery in pediatric care provision and support. Further

specific training on adherence support counseling, phlebotomy in children, immunization and management

of common childhood infections were also conducted.

2. Development of referral pathways for patients into and out of the facility. Dr Neil McKerrow, a pediatrician

with many years experience in the management of pediatric HIV, has been engaged to play a supportive

role in providing technical expertise and clinical management oversight in patients that may require

specialist level clinical intervention, and up-referral. CAPRISA has also established linkages with the

Umgungundlovu District Social welfare department, to fast track single care grants for children enrolled into

the program.

The adjacent Mafakhatini Clinic adds to CAPRISA'S services by providing a one-stop service for the

children, by scheduling appointments for immunization and nutrition support and TB screening, on the same

day as their HIV care appointments are scheduled. Community leaders and surrounding clinics have been

informed about the roll-out of pediatric care and have been encouraged to refer suitable patients in. Clinics

providing antenatal care and prevention of mother-to-child transmission (PMTCT) services in the district

have also been informed about the rollout of pediatric care and have also been encouraged to refer suitable

patients in.

3. Development of site tools: These tools have been developed and implemented for monitoring of clinical

care, response to antiretrovirals, and the collection of program indicators for reporting to PEPFAR

4.Procurement of supplies: Pediatric antiretroviral therapy (ART) formulations, and drugs used for common

ailments have been procured. Specialized equipment such as pediatric scales, medicine dispensers etc

have been purchased.

Strengthening systems for decanting stable patients into DOH supported sites:

While down referral remains a challenge, it is not insurmountable as CAPRISA continues to work with the

clinics and hospitals which are part of the district and provincial Department of Health as well as other

PEPFAR partners in our efforts to down refer stable patients. In an attempt to strengthen the down referral

process from CAPRISA sites to Department of Health antiretroviral (ART) roll-out sites, we have established

relationships with key role players (such as the Medical Superintendent or Hospital Manager) at each of the

down referral facilities and are negotiating procedures and logistics that will ensure the smooth flow of

patients, with uninterrupted access to drugs and services. We have assisted the Umgungundlovu District

Health Office in their efforts to expand HIV services by conducting training for key staff and strengthening

processes and systems in individual referral facilities to enable them to accept down referrals from the CAT

program. This has been a slow process of building rapport, strengthening logistics, undertaking supportive

ongoing training, and maintaining strong lines of communication for referral back to CAPRISA, if this is

needed.

CAPRISA has ongoing communication with the facilities we decant to, regarding the number of CAPRISA

patients that can be accommodated in their ART programs per week, the individual accompanying

documentation needs to facilitate continued treatment and care of the patient, setting up of clinic

appointments for patients to secure a place in the ART programs and referring patients that are appropriate

to the government facilities' designated drainage area.

By decanting small numbers at a time and maintaining regular communication with facilities and Department

of Health Liaison officials, the process has been slow and deliberate but has not compromised any patients'

care.

Positive Prevention for Patients in Care

Prevention among Positives: All patients are offered condoms, and messages on HIV transmission

prevention, as they queue for HIV related services in the HIV clinic. In addition patients are educated on the

need to disclose to partners, availability of on-site testing for partners, and the need to treat STI's timeously.

During post test counseling with patients that test negative, counselors would address the following issues:

(a) Returning for testing in three months, due to possible testing in the window period when HIV antibodies

are undetectable;

(b) Dispel any beliefs that the individual is invulnerable to HIV;

(c) Promote condom use to remain HIV negative;

(d) Discuss possible risky sexual behavior that the individual maybe engaging in and safer lifestyle

practices.

-------------------------

SUMMARY:

Activities are carried out to provide clinical, spiritual and psychosocial support to the HIV-infected patients

and family members affected by the disease at two established treatment sites in KwaZulu-Natal. With FY

2008 funding the CAPRISA AIDS Treatment (CAT) Program will be continued and expanded at these two

Activity Narrative: sites. Pediatric services will be introduced at the Vulindlela site.

BACKGROUND:

CAPRISA was established in 2002 as a not for profit AIDS research organization by five major partner

institutions: University of KwaZulu-Natal, University of Cape Town, University of Western Cape, National

Institute for Communicable Diseases, and Columbia University. The headquarters of CAPRISA are located

in the Doris Duke Medical Research Institute at the Nelson R Mandela School of Medicine, University of

KwaZulu-Natal. The PEPFAR-funded CAPRISA AIDS Treatment (CAT) Program was initially started as a

supplemental effort to deal with the large volume of HIV-infected clients that were screened out of

CAPRISA's other research studies. It has since evolved into one of the pillars of CAPRISA and is evidence

of the ongoing commitment to provide comprehensive services to communities. The CAT Program was

initiated in June 2004 and currently provides an integrated package of prevention and treatment services.

The program provides an innovative method of providing ART by integrating the tuberculosis (TB) and HIV

care as well as counseling and testing, family planning, sexually transmitted infections (STI) treatment,

prophylaxis and treatment for opportunistic infections (OIs), and other HIV associated conditions at both a

rural and urban site. The CAPRISA eThekwini Clinical Research Site is an urban facility attached to the

Prince Cyril Zulu Communicable Disease Clinic (CDC) which is a large local government clinic for the

diagnosis and treatment of STIs and TB, for which it provides free treatment. The HAART provision at this

clinic integrates TB and HIV care into the existing TB control program. Patients are either self referred, or

enter the HIV care continuum via the adjoining TB or STI services. The CAPRISA Vulindlela Clinical

Research Site is a rural facility located about 150 km west of Durban in KwaZulu-Natal. The Vulindlela

district is home to about 500,000 residents whose main access to health care is at seven primary health

care (PHC) clinics that provide comprehensive services. The CAT Program at Vulindlela is an entirely rural

nurse-driven service with doctors available for the initial eligibility assessment and for advice and referral. At

the Vulindlela Site, by the end of June 2007, 2654 people have been enrolled into HIV care and 1002

people had been initiated on ART, with 857 currently actively accessing ART services. At the eThekwini

Site, which was initiated in September 2004, 818 people had been ever initiated on ART, with 696 currently

actively accessing ART and 2803 people accessing palliative care by the end of June 2007

ACTIVITIES AND EXPECTED RESULTS:

The CAT Program offers a range of free services including treatment services as well as extensive

counseling and education around HIV, care and support, disclosure, and HIV treatment adherence. Patients

are also encouraged to bring partners in for testing. For women of child-bearing age, program synergy is

facilitated at both sites by provision of onsite injectable and barrier methods of contraception, pap smears

and pregnancy testing. Both the eThekweni and Vulindlela sites operate with a multi-skilled team of people.

Each site has an administrative division, a team of doctors, pharmacists, nurses and counselors. Field

workers and peer educators complement the clinic teams as they interact with the community through

providing information and education on HIV as well as assisting with patient retention at the clinic.

At the eThekweni site, currently all injectable contraceptives and pap smear analyses are provided free of

charge from the eThekwini Municipality. Patients are referred from TB and STI clinics or other CAPRISA

research studies. Patients from throughout the greater Durban area who may have TB are routinely

evaluated at the communicable disease clinic and are routinely offered counseling and HIV testing. HIV-

negative patients are invited to participate in ongoing prevention activities at both facilities.

At the Vulindlela site, all injectable contraceptives and pap smear analyses, TB sputum analysis and basic

OI medication is provided free of charge from the Mafakhatinin Clinic. Patients who test positive for HIV are

offered HIV specific care through the CAT Program. Concurrent TB diagnostic care and treatment services

are accessed via the CAT program from the adjacent TB services. The CAT Program offers extensive

counseling and education around HIV, wellness maintenance, disclosure, and HIV treatment adherence.

Patients are encouraged to bring partners in for testing. In addition counselors liaise with social welfare

departments and other community-based organizations (CBOs) to assist in enhancing social support for

patients. HIV clinical care services that are offered include Bactrim prophylaxis, routine screening for OIs,

via clinical examination, and blood, urine or sputum testing where required. The CAT project has the

capacity to treat commonly occurring OIs at site level and these include pulmonary and extrapulmonary TB,

candidiasis, pneumonia, gastro-enteritis, and other respiratory infections. The CAT project also accesses

and supplies drugs such as diflucan from DoH PMSC. Patients are referred to tertiary level facilities if they

require investigation and inpatient management out of the scope of the clinic management. Referral

networks exist for the triaging of sick patients into district and tertiary facilities at both treatment sites. All

patients that test HIV positive through the counseling and testing service are offered a routine CD4 count

test, which may be repeated at 3, 6 or 9 monthly intervals depending on the level at screening. All patients

in the CAT Program with CD4 counts < 200 cells/mm3 see a clinician monthly for clinical and laboratory

follow-up and if they are willing to participate in the program, they will also get offered a viral load test.

Ongoing adherence support is provided by trained community educators, as well as counselors.

For patients who are TB/HIV co-infected, the TB management is undertaken routinely at the CDC and in

accordance with the South African National TB control program. Patients at Vulindlela are referred from the

Mafakhatini PHC clinic, research (e.g., non-PEPFAR funded microbicide trial, adolescent cohort, community

-based CT Project, community referrals) from community health workers, community advocates and 30

youth peer-educators. The CAT program in Vulindlela aims to address issues of stigma and discrimination

and is linked to an Oxfam-funded project which addresses Stigma and Discrimination in the community. The

CAT program provides support for disclosing to family members and assists patients in obtaining disability

grants. CAPRISA has an extensive community program which supports and facilitates community

involvement and informed participation for all CAPRISA projects This includes pre and post-test counseling

for HIV infection, treatment and adherence education and support, implementation of ARV treatment,

prophylaxis for OIs, management of OIs, adverse events and severe adverse events. These are done at the

clinic and through appropriate referral channels when needed. Women account for approximately 70% of

participants at both Vulindlela and the eThekweni clinic. Additionally, the majority of staff employed by the

CAT project are women. Additionally, a "one stop shop" is available to female participants in that patients

Activity Narrative: access family planning services, STI services, and ART services within the CAT program at both sites.

Additionally, Vulindlela patients are also able to access PMTCT services from the adjacent Mafakathini

clinic. Male peer educators are employed in order to encourage men's participation in health care, and their

uptake of counseling and testing for HIV. This is in keeping with CAPRISA's policy to increase gender equity

in their programs. Professional nurses employed are trained and developed to take over routine care

activities that are traditionally performed by doctors. This includes ART eligibility assessment, treatment of

minor opportunistic infections, and the prescribing of prophylactic agents like contraceptives, cotrimoxazole

to program participants. In addition, nurses have been trained to perform a nutritional assessment and

identify those participants that may benefit from the nutrition program. Peer educators have been trained to

perform a range of activities that have traditionally been performed by nurses, and this includes the

provision of health education to participants and provision of support to patients and their caregivers. As

part of CAPRISA's retention strategy the CAT program offers services, including ART to all staff employed

by the CAT program. This is done in a manner that preserves the privacy and confidentiality of the staff

member accessing care. Further, staff training is supported by assistance with fee remuneration, and time

to attend training activities.

These results contribute to the PEPFAR 2-7-10 goals by providing facility-based HIV-related palliative care

to HIV-infected individuals by providing clinical prophylaxis and treatment for TB/HIV co-infected patients

prior to initiation of ARVs.

New/Continuing Activity: Continuing Activity

Continuing Activity: 13857

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

13857 3814.08 HHS/Centers for University of 6634 520.08 CAPRISA $239,500

Disease Control & Kwazulu-Natal, Follow On

Prevention Nelson Mandela

School of

Medicine,

Comprehensive

International

Program for

Research on AIDS

7499 3814.07 HHS/National University of 4441 520.07 CAPRISA NIH $350,000

Institutes of Health Kwazulu-Natal,

Natal University

for Health

3814 3814.06 HHS/National University of 2696 520.06 CAPRISA NIH $350,000

Institutes of Health Kwazulu-Natal,

Natal University

for Health

Emphasis Areas

Health-related Wraparound Programs

* TB

Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.08:

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

In an effort to increase its ability to enroll new patients onto treatment without impacting on current capacity,

CAPRISA has established referral networks with various Department of Health (DOH) antiretroviral (ARV)

sites for decanting of stable, virologically suppressed treatment patients. The South African Government

first line regimen is a twice-daily d4T, 3TC and EFV. Treatment patients who have exceeded 24 months in

the CAPRISA treatment program and who are stable and virologically suppressed undergo a single drug

switch from ddI to d4T. Clinicians, nurses and adherence counselors monitor and assist these patients over

a one-month period ensuring treatment compliance and good immunological response. Patients are then

transferred out to their nearest DOH ARV site and clinic staff liaise with DOH sites to set appointments for

patients. Patients are given a one-month supply of drug by the CAPRISA pharmacy, and appointments to

decanting sites are usually made within the first two weeks after the last CAPRISA appointment.

-------------------------

SUMMARY:

Activities are carried out with FY 2008 funding to continue the provision of HIV care and antiretroviral

treatment (ART) services to patients already initiated on treatment and to expand access to treatment at two

established treatment sites in KwaZulu-Natal. The major emphasis area is human capacity development

and local organization capacity building. The target population is people living with HIV (PLHIV). Pediatric

services will be introduced at our Vulindlela site to create a shift to a family centered approach to delivering

HIV and AIDS care.

BACKGROUND:

CAPRISA was established in 2002 as a not-for-profit AIDS research organization by five major partner

institutions; University of KwaZulu-Natal, University of Cape Town, University of Western Cape, National

Institute for Communicable Diseases, and Columbia University. The headquarters of CAPRISA are at the

University of KwaZulu-Natal. The PEPFAR-funded CAPRISA AIDS Treatment (CAT) Program was initially

started as a supplemental effort to deal with the large volume of HIV-infected adult clients that were

screened out of CAPRISA's other research studies. The current CAT Program provides an integrated

package of prevention and treatment services and provides an innovative method of providing ART by

integrating TB and HIV care. The CAT program operates from two facilities: CAPRISA eThekwini Clinical

Research Site and Vulindlela clinical research site.

The CAPRISA eThekwini Clinical Research Site, is an urban facility attached to the Prince Cyril Zulu

Communicable Disease Clinic (CDC) which is a large local government clinic providing free diagnosis and

treatment of STIs and TB.. The ART provision at the CAPRISA eThekwini clinical research site integrates

TB and HIV care into the existing TB directly observed therapy (DOT) programs. This allows for the

opportunity to initiate HIV care and ART for patients identified as HIV-infected during TB treatment as well

as to be able to continue such management for those who develop TB during HIV treatment.

The CAPRISA Vulindlela clinical research site is a rural facility located about 150 km west of Durban,

KwaZulu-Natal. The Vulindlela district is home to about half a million residents whose main access to

health care is at seven primary healthcare clinics that provide comprehensive services. The CAT Program

at Vulindlela is an entirely rural nurse-driven service with doctors available for the initial eligibility

assessment and for advice and referral.

Those with CD4 counts under 50 are identified and followed up with home visits by PEPFAR-supported

nurse aides and community health workers, The clinic is open Monday to Friday and is operated by 2 full-

time and one part-time doctor, 4 nurses, 3 counselors, a pharmacy assistant and a full-time pharmacist.

Patients from throughout the greater Umgungundlovu district are referred to the Vulindlela CAT program for

HIV treatment and care. Regular meetings (imbizos) between the Vulindlela treatment site personnel and

leaders in the local community occur, which enhances community participation, acceptance and utilization

of the HIV treatment service. CAPRISA has worked closely and has established strong links with TAI, a

community-based organization that assists the Vulindlela CAT program with the provision of trained

community educators who do peer education and adherence motivation among our patients, home visits, as

the implementation of our nutrition program. TAI is also actively involved with care and support of the

extended families, including orphans and vulnerable children, of the program clients.

ACTIVITIES AND EXPECTED RESULTS:

The eThekweni CAT Program has established strong referral networks with surrounding tertiary level DOH

facilities for the management of sick and complicated patients requiring tertiary level admission and

management. The CAT program provides the ongoing HIV care in partnership with these facilities while co-

morbid conditions are being managed, until patients are stabilized and get discharged back to the facility.

CAT patients diagnosed with MDR/XDR TB are fast-tracked for admission to the local MDR hospital, the

King George V Hospital. Patients admitted to this facility are visited, and have their ART medicines

delivered, by a CAPRISA nurse. Once these patients are stabilized, and deemed non-infectious, they are

transported to the CAPRISA facility for follow-up visits. CAT patients that are receiving standard TB therapy,

are referred to one of the step-down TB hospitals in the community, and again are visited, and have their

ART medicines delivered, by a CAPRISA nurse.

Discussions with the DOH ART Program Manager around the transitioning of eThekweni CAT patients have

occurred, and processes are being developed together with the local district office to transition patients who

have completed more than 24 months with the CAT program to DOH facilities.

Patients at Vulindlela are referred from the Mafakhatini primary healthcare clinic, research programs

(including the non-PEPFAR funded microbicide trial, adolescent cohort, community-based VCT Project) and

Activity Narrative: community referrals (community health workers, community advocates and 30 youth peer-educators). The

CAT program in Vulindlela will address issues of stigma and discrimination and is linked to an Oxfam-

funded project which addresses stigma and discrimination in the community. The CAT program provides

support for disclosing to family members and assists patients in obtaining disability grants. CAPRISA has an

extensive community program which supports and facilitates community involvement and informed

participation for all CAPRISA projects. Comprehensive services are provided to HIV-infected participants

where appropriate. This includes pre- and post-test counseling for HIV infection, treatment and adherence

education and support, implementation of ARV treatment, prophylaxis for opportunistic infections, and

management of OIs, adverse and serious adverse events. These are done at the clinic and through

appropriate referral channels when needed. Only adolescents 14 years or older are targeted. Currently no

HIV-related services are offered by CAPRISA to a pediatric population.

Preparations for DOH accreditation visit are at an advanced stage, for the Vulindlela site being accredited

as an ART Initiation site. The visit by DOH is expected to take place in August 2007. With the accreditation

in place, surrounding public primary health care (PHC) clinics will be scaled up to offer chronic care to

stable patients on ART. The Vulindlela CAT program will then commence transitioning stable patients to the

PHC facilities. Discussions have been ongoing with the KwaZulu-Natal ARV manager and the DOH District

Office to facilitate the smooth transition of patients. It is anticipated that five patients per week will be

transitioned which will not overburden the receiving facilities, and the initial patients transitioned will be

those from areas with an existing ART roll-out. Transitioned patients will be followed up 6-12 monthly, to

ensure successful transitioning.

EXPECTED RESULTS:

ART will be expanded in FY 2008 at both the eThekwini and Vulindlela sites. CAPRISA does not anticipate

having to expand the space or staff at these facilities to reach the FY 2008 targets. Laboratory services will

continue to be performed at the CAPRISA Laboratory. It was anticipated that by October 2006, patients will

start to be transitioned to the Department of Health at a rate of approximately 20 per month from each site

and new patients will be enrolled to maintain a steady cohort, however this process has been delayed and

these figures have yet to be finalized.

These results contribute to the PEPFAR 2-7-10 goals by increasing the number of newly initiated patients

on antiretroviral therapy.

New/Continuing Activity: Continuing Activity

Continuing Activity: 13860

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

13860 3072.08 HHS/Centers for University of 6634 520.08 CAPRISA $2,180,200

Disease Control & Kwazulu-Natal, Follow On

Prevention Nelson Mandela

School of

Medicine,

Comprehensive

International

Program for

Research on AIDS

7497 3072.07 HHS/National University of 4441 520.07 CAPRISA NIH $350,000

Institutes of Health Kwazulu-Natal,

Natal University

for Health

3072 3072.06 HHS/National University of 2696 520.06 CAPRISA NIH $350,000

Institutes of Health Kwazulu-Natal,

Natal University

for Health

Emphasis Areas

Health-related Wraparound Programs

* TB

Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.09:

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

CAPRISA AIDS Treatment (CAT) Program at the eThekwini site has been enhanced in the following way:

PEPFAR-funded patients receiving tuberculosis (TB) care through the Prince Cyril Zulu Communicable

Disease Clinic (PCZCDC) have been identified to receive field-based DOT. Extensive analysis of the areas

with poor performance in TB treatment completion and cure rates was undertaken. The area of Welberdacht

in Durban was identified as being most in need of a TB-related intervention. Meetings with the relevant

community leaders and CAPRISA management were held to establish links within the community and

identify ways to integrate the program within the community. Field workers, trackers, a program coordinator

and community liaison officers have been identified. Training on TB infection control and management has

been conducted with team members by a representative of the local municipality. CAPRISA is currently

securing TB drugs to be used for field-based directly observed therapy (DOT). These will be acquired from

the TB services at PCZCDC.

-------------------------------

BACKGROUND:

CAPRISA was established in 2002 as a not for profit AIDS research organization by five major partner

institutions: University of KwaZulu-Natal, University of Cape Town, University of Western Cape, National

Institute for Communicable Diseases, and Columbia University. The headquarters of CAPRISA are located

in the Doris Duke Medical Research Institute at the Nelson R Mandela School of Medicine, University of

KwaZulu-Natal. The PEPFAR-funded CAT Program was initially started as a supplemental effort to deal

with the large volume of HIV-infected clients that were screened out of CAPRISA's other research studies. It

has since evolved into one of the pillars of CAPRISA and is evidence of the ongoing commitment to provide

comprehensive services to communities. The CAT Program was initiated in June 2004 and currently

provides an integrated package of prevention and treatment services. The program also provides an

innovative method of providing ART by integrating the TB and HIV care as well as counseling and testing,

family planning, sexually transmitted infections (STI) treatment, prophylaxis and treatment for opportunistic

infections (OIs), and other HIV associated conditions at both a rural and urban site.

The CAPRISA eThekwini Clinical Research Site is attached to the Prince Cyril Zulu Communicable Disease

Clinic (CDC) which is a large local government clinic for the diagnosis and treatment of STIs and TB, for

which it provides free treatment. The HAART provision at this clinic integrates TB and HIV care into the

existing TB control program. This allows for the opportunity to initiate HIV care and HAART for patients

identified as HIV infected during TB treatment as well as to be able to continue such management for those

who develop TB during HIV treatment. Patients are either self referred, or enter the HIV care continuum via

the adjoining TB or STI services.

South Africa in general and the province of KwaZulu-Natal (KZN) in particular has seen a dramatic rise in

the prevalence of TB which has largely been fuelled by the HIV epidemic. Due to the large scale of the TB

epidemic, and the large number of patients attending designated TB facilities, in last few years, there has

been many operational changes in the way TB is managed at the eThekwini Prince Cyril Zulu

Communicable Disease Clinic (PCZCDC). For the most part, patients are referred from PCZCDC to their

communities for DOT for TB. There has however been a significant reduction in treatment completion rates

and cure rates for TB, largely as a result of a loss to follow-up of patients referred out to community facilities

to receive their supervised treatment. The burden of daily DOT has financial implications for patients, in

terms of transport costs, as well as employed patients' ability to present for treatment daily. Consequently,

there has been a shift to community-based supervised DOT, the success of which has not yet been

measured.

Retention to the ART treatment program, as well as measurable ART treatment outcomes, which draws

from the same population of patients, has been surprisingly good, mostly as a result of good tracking efforts

by fieldworkers.

PEPFAR-funded patients receiving TB/HIV care through the CAT program will be identified to receive field-

based DOT. Patient visits will be conducted by fieldworkers, and an adherence assessment as well as an

observation of DOT will be made. Patients who do not adhere to treatment x will be referred back to clinic,

for specialized adherence education and support.

Fieldworkers will be employed via the CAPRISA Community Program and will be supervised by CAPRISA

Community Liaison Officers. A treatment program coordinator will provide additional oversight, as well as

assist with record collation and management. In-house trainers and coordinators will be identified. Trackers

will be employed via the CAPRISA community research support group which is made up of community

organizations and key stake holders from the community that are working in the field of HIV/AIDS and TB. A

program of training of these field workers will be implemented prior to project start up. An ongoing

monitoring and evaluation system will form part of the proposal to establish efficacy and effectiveness of

field-based DOT. A comprehensive proposal for the expanded field-based DOT is being developed. TB

drugs used for field-based DOT will be acquired from the TB services at PCZCDC. HIV-infected patients

receiving ART and TB therapy via the eThekweni CAT program will be selected. Those unwilling to

participate, or require daily clinic visits, or have MDR-TB will be excluded.

Currently all clinic information regarding TB diagnosis, clinical course and management is recorded on an

electronic database available to both the TB services as well as the CAT. All treatment outcomes derived

via the field-based DOT program will be entered and updated onto this electronic system. This will allow us

to do efficacy and outcome analysis. It will also form the basis of doing quality assurance reviews.

Additionally, a process will be developed to examine the cost-effectiveness of implementing field-based

DOT.

Activity Narrative: These results contribute to the PEPFAR 2-7-10 goals by providing facility-based HIV-related palliative care

to HIV-infected individuals by providing clinical prophylaxis and treatment for TB/HIV co-infected patients

prior to initiation of ARVs.

New/Continuing Activity: Continuing Activity

Continuing Activity: 13862

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

13862 13862.08 HHS/Centers for University of 6634 520.08 CAPRISA $291,000

Disease Control & Kwazulu-Natal, Follow On

Prevention Nelson Mandela

School of

Medicine,

Comprehensive

International

Program for

Research on AIDS

Emphasis Areas

Health-related Wraparound Programs

* TB

Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.12:

This is a new PHE for FY09 that has been approved for $666,051.

PHE tracking number: ZA.09.0263

Title: The TRuTH Study (TB Recurrence upon Treatment with HAART)

New/Continuing Activity: New Activity

Continuing Activity:

Emphasis Areas

Human Capacity Development

Public Health Evaluation

Estimated amount of funding that is planned for Public Health Evaluation $666,051

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.12:

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

The counseling and testing (CT) activities at the CAPRISA eThekwini site have been enhanced in the

following way: Negotiations between management of the Prince Cyril Zulu Communicable Diseases Centre

(PCZCDC) and CAPRISA ensured that tuberculosis (TB) patients presenting at PCZCDC would be actively

referred by staff to the CAPRISA site. This has been the single-most successful step in ensuring that the CT

coverage of the TB facility increased. In order to manage the high volumes of patients coming across from

PCZCDC group pretest counseling sessions are held at the CAPRISA clinic and a shortened one-on-one

pretest counseling session is conducted with those patients that accept the test. Informed consent is

obtained from all patients that accept testing. Since the initiation of the group pre-test counseling, there has

been a significant increase in the number of patients testing for HIV. This in turn increases the number of

patients entering palliative care and entering onto treatment.

-------------------

SUMMARY:

Activities are carried out to support comprehensive counseling and testing (CT) services in the rural area of

Vulindlela and the CAPRISA eThekwini Clinical Research Site, which is located next to the TB clinic in

Durban. In addition, activities will involve the continuation of expanding CT among two high-risk groups at

two established treatment sites in KwaZulu Natal. These high-risk groups include sexually transmitted

infection (STI) patients, and an adolescent population in rural Vulindlela. CAPRISA follows the National

Department of Health's recommended algorithm for rapid HIV testing.

The primary emphasis area for this activity is Human capacity development, with minor areas of emphasis

on community mobilization and on information, education and communication. Specific target populations

include children and youth (non-OVC), out-of-school youth and men and women of reproductive age.

BACKGROUND:

CAPRISA was established in 2002 as a not-for-profit AIDS research organization by five major partner

institutions: University of KwaZulu-Natal, University of Cape Town, University of Western Cape, National

Institute for Communicable Diseases (NICD), and Columbia University. The headquarters of CAPRISA are

located in the Doris Duke Medical Research Institute at the Nelson R. Mandela School of Medicine,

University of KwaZulu-Natal. The PEPFAR-funded CAPRISA AIDS Treatment (CAT) Program was initially

started as a supplemental effort to deal with the large volume of HIV-infected clients that were screened out

of CAPRISA's other research studies. The existing counseling and testing services at two treatment sites

will be continued with FY 2007 funding. The strength of the current CAT program is that it provides an

integrated package of prevention and treatment services and provides an innovative method of providing

antiretroviral treatment (ART) by integrating the TB and HIV care at both an urban and rural site. In 2006,

CAPRISA began offering counseling and testing services to two high-risk populations in order to enhance

the uptake of counseling and testing in these populations. This service has enabled the CAT program to

create a synergy between treatment and prevention services while simultaneously identifying high-risk HIV

individuals to enhance their prevention potential through ART.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Voluntary Counseling and Testing

The voluntary counseling and testing (VCT) services will be continued in the rural primary care clinic in

Vulindlela and the eThekwini Clinical Research Site based at the Prince Cyril Zulu Communicable Disease

Centre (CDC) in Durban. All CT is currently offered in conjunction with an NGO, known as Open Door, to

patients attending these two facilities. The CT that is offered includes prevention education and condom

distribution.

ACTIVITY 2: Provider-Initiated Testing and Counseling

Provider-initiated testing and counseling (PITC) will be offered to all TB and STI patients at the Prince Cyril

Zulu Communicable Diseases Centre (CDC). The Centre is a large local government clinic that provides

free diagnosis and treatment of TB and sexually transmitted infections (STIs). Annually, approximately

4,000 cases of STIs, are treated at this clinic, with an average of about 135 STI patients per day. Given the

high HIV prevalence of 63% in this group, these patients are a high-risk group for acquiring and transmitting

HIV. The clinic sees approximately 8,000 TB patients per month, with a HIV/TB co-infection rate of

approximately 65%. All patients attending both the STI clinic, as well as the TB clinic are routinely offered

counseling and testing by the STI nurses and the health educators located in the TB facility. Male and

female patients seeking STI or TB care at the clinic are offered group counseling and individual HIV testing.

Those who test HIV-infected are individually post-test counseled and referred for ongoing supportive

counseling and medical care in the CAT program. The CAT program has partnered with a community-based

organization, (CBO), TAI for the provision of health education, peer education and support to program

participants. Although the TB clinic sees approximately 8,000 cases per month, more than 95% of these are

repeat visits for either follow-up clinic visits, or X-Ray visits. Approximately 400 newly diagnosed TB patients

are counseled each month. It is likely that the Centre will reach the target of 7,500 when efforts are

combined with the STI patients and with the activities for adolescents described below.

ACTIVITY 3: Routine Testing for Adolescents

This program targets the adolescent population in rural Vulindlela. South African adolescents, particularly

young women, are at high risk of acquiring HIV. Adolescents in the area, primarily those utilizing the primary

healthcare services for antenatal, family planning or STI services are routinely offered counseling and

testing. The counseling and testing is coordinated with other programs and projects in the area. In addition,

Activity Narrative: youth peer educators have been integrated within this program.

Thus far, antiretroviral treatment rollout activities have targeted those people that are most accessible, like

those people visiting health facilities. This implies that activities has have not met the challenge of using

ART provision to enhance prevention, especially prevention in HIV-infected individuals. In FY 2008

CAPRISA plans to continue targeting the two high-risk groups with client and provider-initiated testing and

counseling. The expanded counseling and testing program will continue to exploit the synergy that exists

between the

promotion of counseling and testing and availability of high-quality HIV care to enhance both prevention and

treatment in TB patients, STI patients and adolescents. HIV-infected persons will be referred to the CAT

Program for follow-up treatment and care. HIV negative persons will be referred to other CAPRISA,

government or NGO prevention programs. Importantly, this strategy begins to address the ethical dilemma

of how scarce resources for HIV can be used effectively by focusing on high-risk groups and utilizing access

to ART to enhance counseling and testing for treatment and prevention.

During FY 2008, the expanded counseling and testing service will not require additional counselors or field

workers. However, the counselors and fieldworkers will receive ongoing training in counseling with role-

playing to ensure high quality counseling and testing. As part of an internal quality assurance process, a

senior counselor often analyzes counseling sessions, and training is based on common areas of

deficiencies identified. A constant review process has been established to reflect of reasons for refusal of

uptake of CT, and strategies have been implemented to address common reasons for refusal. A high

refusal rate for testing was initially seen by male patients counseled by female counselors, and this was

addressed by

having male counselors on hand to see male patients. In addition, regular debriefing sessions are

scheduled to allow counselors suffering from burnout to distress and support one another.

These results contribute to the PEPFAR 2-7-10 goals by improving access to and quality of CT services in

order to identify HIV-infected persons and increase the number of persons receiving ARV services in three

high risk groups; TB patients, STI patients and adolescents.

New/Continuing Activity: New Activity

Continuing Activity:

Emphasis Areas

Health-related Wraparound Programs

* TB

Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.14:

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

In order to increase TB case finding among HIV-infected patients attending follow-up visits CAPRISA has

implemented a quick TB symptom screening checklist. The TB symptom checklist is administered by nurses

and consists of a series of questions pertaining to common TB symptoms and requires patients to indicate

the duration of symptoms.

Positive prevention strategies implemented at both sites include sexually transmitted infection (STI)

screening and management, adopting new STI management guidelines and procuring drugs that have now

been introduced in STI management, such as Acyclovir and Cephotaxime. Clinicians encourage female

patients to go for their pap smears, which are available on-site. Risk assessment combined with risk

reduction counseling, follow-up on high risk behavior at subsequent clinic visits, disclosure counseling, with

follow-up on barriers to disclosure are some of the behavioral interventions that are implemented.

---------------------------------------

SUMMARY:

Activities are carried out to continue the provision of antiretroviral drugs to patients already initiated on

treatment and to expand access to treatment to additional patients at two established treatment sites in

KwaZulu-Natal. The emphasis area is human capacity development. The target population is people living

with HIV (PLHIV). Pediatric services will be introduced at our Vulindlela site to move to a family-centered

approach to delivering HIV care.

BACKGROUND:

The Centre for the AIDS Program of Research in South Africa (CAPRISA) was established in 2002 as a not-

for-profit AIDS research organization by five major partner institutions: University of KwaZulu-Natal,

University of Cape Town, University of Western Cape, National Institute for Communicable Diseases, and

Columbia University. The headquarters of CAPRISA are located at the University of KwaZulu-Natal. The

PEPFAR-funded CAPRISA AIDS Treatment (CAT) program was initially started as a supplemental effort to

deal with the large volume of HIV-infected clients that were screened out of CAPRISA's other research

studies. The current CAT program provides an integrated package of prevention and treatment services and

provides an innovative method of providing ART by integrating TB and HIV care. The CAPRISA eThekwini

clinical research site is attached to the Prince Cyril Zulu communicable disease clinic, a large local

government clinic providing free diagnosis and treatment of sexually transmitted infections and TB. The

antiretroviral treatment (ART) provision at this clinic integrates TB and HIV care into the existing TB directly

observed therapy (DOT) programs. This allows for the opportunity to initiate HIV care and ART for patients

identified as HIV-infected during TB treatment as well as to be able to continue such management for those

who develop TB during HIV treatment.

The CAPRISA Vulindlela clinical research site is a rural facility located about 150 km west of Durban,

KwaZulu-Natal. The Vulindlela district is home to about half a million residents whose main access to health

care is at seven primary health care (PHC) clinics that provide comprehensive services. The CAT program

at Vulindlela is an entirely rural nurse-driven service with doctors available for the initial eligibility

assessment and management of suboptimal ART efficacy and for advice regarding OI management and

referral.

ACTIVITIES AND EXPECTED RESULTS:

At the eThekwini/Prince Zulu site, all patients in the CAT program with CD4 counts less than 200 see a

clinician monthly for clinical and laboratory follow-up. These patients are initiated on ART following a clinical

and laboratory safety assessment, and three or more intensive sessions of adherence support counseling.

At the eThekwini site, a once daily regimen is used, as per South African treatment guidelines and

protocols.This, however, excludes drugs used for contraception, Diflucan, the treatment of TB and drugs

used for the outpatient management of OIs, as these are procured from the adjacent eThekweni and

Mafakhatini clinic at the respective sites.

In Vulindlela, the first-line regime includes: Lamivudine, Stavudine and NVP and second-line therapy

includes: EFV, AZT, 3TC and ABC. PEPFAR funds are used for the purchase of these drugs. The senior

research pharmacist, based at the CAPRISA offices in Durban, places all ARV drug orders. Bulk stocks are

received at the central CAPRISA pharmacy in Durban and then distributed to the sites as appropriate. The

senior research pharmacist ensures that sufficient study product is always on hand for at least two months'

anticipated usage.

At the eThekweni clinic, the first-line therapy used is 3TC, ddI, and Efavirenz. The most common second-

line regimen is Kaletra, ABC, and ZDV. The first-line regimen was chosen for its suitability to be co-

administered with TB drugs, as well as its ability to be dosed once daily. Thus far, more than 90% of the

eThekweni CAT patients are on first-line therapy, with approximately 95% still adherent to the program.

At each monthly visit, the pharmacist does a pill count of all unused medication returns and conducts a real-

time assessment of adherence to treatment with each patient. The pharmacist's assessment of adherence

at the time may generate additional adherence support counseling of the patient. This pharmacy data may

be linked to clinical data such as viral load and resistance testing and may trigger review of existing regimen

choices.

Pharmacy records in the form of repeat treatment cards also maintain a detailed chronological log of all non

-ARVs prescribed to the participant and may be linked to regimens to inform healthcare workers on the

range of side-effects to medication.

The pharmacy maintains a system that allows early tracking of potential defaulters by alerting the tracking

Activity Narrative: department of non-arrivals to the pharmacy for pill collection. The first alert occurs on the day of the

scheduled visit if missed and is verified with the trackers for resolution by the end of each week. This

indicator also allows for the identification of patients too ill to come into the clinic. A missed visit for pill

collection identified by the pharmacy works successfully and allows the program to intervene outside the

boundaries of the clinic to ensure that the patients receive the appropriate care when they need it.

As trained pharmacists are a scarce resource in South Africa, pharmacy assistants have been recruited and

employed to assist with the large volumes of treatment patients presenting with scripts each day. Tasks that

are usually done by pharmacists have been shifted to the pharmacy assistants resulting in an overall

increased efficiency in service delivery.

Currently the ARV procurement system meets the needs of the program and purchases are obtained

commercially via wholesalers at the SEP (single exit price) or directly from the company (access pricing e.g.

Glaxo-SmithKline). Technical assistance will be sought to further strengthen these systems and maintain

the optimal stock levels for the duration of the treatment program.

Training and human capacity building: The scale-up of the ART care and treatment program over the past

three years in CAPRISA has been unprecedented. The CAT program is producing a skilled cadre of health

care workers specializing in the management of HIV and HIV-TB co-infection. These skills range from

scaling up voluntary counseling and testing services to monitoring responses to ARVs.

Meetings have been held with representatives from the KwaZulu-Natal Department of Health and there is a

commitment to engage in discussion about the integration of services between CAPRISA and the DOH,

particularly in the poorly resourced Vulindlela area in the Inadi District. The first steps have been initiated by

preparation of the CAPRISA Vulindlela site for accreditation by the DOH. Accreditation as an ARV rollout

site is the only way to down refer stable patients into the DOH structures. Accreditation of the Vulindlela site

also has the ripple effect of the upgrading and staffing of the clinics in the surrounding areas so that the

down referral system is effective and sustainable.

These results contribute to the PEPFAR 2-7-10 goals by ensuring that there is an uninterrupted supply of

drugs for persons initiated on ART.

New/Continuing Activity: Continuing Activity

Continuing Activity: 13859

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

13859 3073.08 HHS/Centers for University of 6634 520.08 CAPRISA $1,906,300

Disease Control & Kwazulu-Natal, Follow On

Prevention Nelson Mandela

School of

Medicine,

Comprehensive

International

Program for

Research on AIDS

7498 3073.07 HHS/National University of 4441 520.07 CAPRISA NIH $900,000

Institutes of Health Kwazulu-Natal,

Natal University

for Health

3073 3073.06 HHS/National University of 2696 520.06 CAPRISA NIH $900,000

Institutes of Health Kwazulu-Natal,

Natal University

for Health

Emphasis Areas

Health-related Wraparound Programs

* TB

Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.15: