SUMMARY:

This activity will support antiretroviral (ARV) drug procurement for approximately 1325 South African

National Defense Force (SANDF) personnel and family members that were previously receiving ARVs via a

collaborative clinical trial with the SANDF, HHS/NIH/NIAID, and US DoD. The clinical trial with

approximately 1200 participants currently on therapy was initiated in 2004 and will be terminated in early

2008. This PEPFAR funding will ensure continued ARV therapy for these individuals as they are

transitioned from the clinical trial to HIV treatment and care still provided through Phidisa clinics and service

delivery personnel. There will also be continued accruement of an estimated additional 475 patients on

ART in these clinical care programs, as they are identified from a natural history cohort. This is a very high

priority for the SANDF and the South African Military Health Service (SAMHS) and all ART will be

prescribed and managed according to South African Government national guidelines.

PEPFAR funds allocated to ARV Drugs under this activity will be used by HHS/NIH/NIAID to procure and

distribute ARV drugs to the six existing SAMHS clinical sites to continue coverage for 1200 patients. The

ARVs will be purchased using a fully-functional, effective, existing infrastructure and logistics strategy set up

by NIAID via a contractor, Science Applications International Corporation (SAIC). This method of ARV drug

procurement and supply chain management is strongly preferred by SAMHS. Under this system, the ARVs

are delivered and stocked in the SAMHS depot and distributed to the six clinical sites, as requested by the

site pharmacists based on stock levels and needs. The process is carefully monitored and has been

effectively used for four years.

BACKGROUND:

Project Phidisa initiated Protocol II, a randomized clinical trial, in January 2004 at the request of the SANDF,

with the support of the US Ambassador to South Africa, and the US DoD. In addition to answering scientific

questions important to South Africa, including a comparison on efficacy and toxicity of South African MOH

ART regimens, this protocol also helped SAMHS provide access to ARVs for SANDF personnel and their

family members. Through Phidisa and the implementation of this protocol, capacity to deliver ART has been

developed in all three military hospitals and three rural military sick bays. Approximately 1800 SANDF

personnel and their family members have been randomized to one of four ART regimens over the past four

years. Drug procurement procedures which were established by HHS/NIHNIAID and US DoD, via SAIC,

have been well integrated into the six military base hospitals and clinics and are working effectively. It is the

aim of this PEPFAR activity to maintain continuity of the ARV drug supply chain, which has been well

integrated with the military clinical sites and which has been specifically requested by the SANDF/SAMHS,

one of the key PEPFAR South African Government partners.

ACTIVITIES AND EXPECTED RESULTS:

Activity 1: Procurement and delivery to ART

PEPFAR funds will be used to support treatment for 1200 SANDF personnel and family members living with

HIV with continued accruement of patients at all six sites. This will be conducted within South African

Government Guidelines, and through the appropriate leadership of the SAMHS. The Head of

Pharmaceutical Services of the SAMHS in coordination with NIH, SAIC, and the Military Health Base Depot

(MHBD) acquire and stock drugs at the MHBD, for secure distribution at the six clinical sites. The clinical

pharmacist at each site is responsible for ensuring adequate supplies of ARVs at the site, including

monitoring of expiration dates of the ARV stock. ARV orders are issued on SAMHS approved forms, which

are forwarded to the SAMHS main ordering Pharmacy. These are automatically transmitted to the MHBD,

and subsequently activated by the SAMHS pharmacy personnel. Documentation processes have been

established to maintain records of ARV supply and demand.

These activities will contribute to the number of persons receiving treatment and care in the military, and

support the PEPFAR 2-7-10 goals.

SUMMARY:

This activity will continue antiretroviral therapy (ART) for approximately 1200 South African National

Defense Force (SANDF) personnel and family members that were previously receiving ART via a

collaborative clinical trial with SANDF, HHS/NIH/NIAID, and US DoD. The Phidisa clinical trial with

approximately 1325 participants on therapy was initiated in 2004 and will be terminated in early 2008.

PEPFAR funding will ensure continued ARV therapy for these individuals as they are transitioned from the

clinical trial to HIV treatment and care still provided through Phidisa clinics and service delivery

professionals. There will also be continued accruement of patients on ART. These patients will be on ART

regimens consistent with the national guidelines, with research collection. A priority for the South African

Military Health Service (SAMHS) is maintaining the human capacity that has been developed, and the ARV

services logistics established in the six clinical trial/patient management sites. The existing staff and

mechanism for ARV services support that have been built into these 6 SAMHS clinical sites will be retained

with anticipated accommodation into the SAMHS ART program as it gains capacity in two or three years.

Therefore, the major emphasis of this activity is responding to SAMHS to support the recruitment, training

and provision of human resources, including the physicians, nurses, and pharmacists. Minor areas are

commodity procurement (ARVs) and quality assurance. The main targets for the ARV treatment

intervention are SANDF personnel, their spouses and family members who are living with HIV.

BACKGROUND:

Project Phidisa initiated Protocol II, a randomized clinical trial, in January 2004 at the request of SANDF

with the support of the US Ambassador to South Africa and the US DoD. In addition to answering scientific

questions important to South Africa, including a comparison on efficacy and toxicity of South African

Government ART regimens, this protocol also helped SAMHS provide access to ARVs for SANDF

personnel and their family members. Through Phidisa and implementation of this protocol capacity to

deliver ART has been developed in all three military hospitals and at three rural military sick bays.

Approximately 1800 SANDF personnel and their family members have been randomized to one of four ART

regimens over the past four years. Civilian South African health care personnel, including physicians,

nurses, pharmacists, and clinical administrative support personnel have been recruited, trained, and

retained to augment a core of SAMHS military health care personnel. The clinical trial sites and staff were

the only ART capacity within the SAMHS through 2005 and were critical to SAMHS being able to expand

ARV care with PEPFAR support over the last two years. Building on Phidisa's foundation, the SAMHS ARV

roll out has generated additional intrinsic capacity, which now includes different clinical sites. Due to

unanticipated slower endpoint accrual, NIH/NIAID, SANDF, and US DoD came to an agreement to

terminate the trial and to mine existing data for scientific results. A very high priority for SAMHS is to

maintain HIV care and treatment for Phidisa-recruited participants, and to maintain the infrastructure and

human resources that have been developed. Medical staff recruitment can be particularly challenging for

the SANDF, with additional screenings and delays due to military policies. These shortages have been

overcome with employment by civilians through an indigenous NGO, Charisma, which has been able to

comply with SANDF screenings and policies. ARV clinics have been successfully manned, with integration

of the Charisma staff with the SAMHS clinical personnel. These six clinical sites will remain a training site

for the SAMHS ARV-rollout clinical staff.

Additionally, since 2004, Lancet Laboratory has provided laboratory support and performed virological,

immunological, serological, and safety laboratory tests and procedures under the certification by South

African National Accreditation System (SANAS).

ACTIVITIES AND EXPECTED RESULTS:

Activity 1: Retention of clinical staff and capacity at the six ART sites

PEPFAR funds will support five physicians, 7 full time and 1 part-time pharmacists, nine nurses, and a part

time laboratory technician. Recruitment of these clinical personnel has been done in close coordination with

the SAMHS in order to appropriately hire staff in accordance with the South African military guidelines so

that these individuals can be transitioned into SAMHS uniformed or SAMHS civilian personnel. This

process, has complicated the hiring process for Charisma, and it is acknowledged that the transition to

South African military support is lengthy (1 - 2 years), however directly addresses building indigenous

SAMHS HIV treatment and care capacity. PEPFAR funds will support periodic training of staff in clinical

management and quality assurance.

Activity 2: Patient Care

Patients will be prescribed drugs according to South African Government guidelines. Regular scheduled

follow-up is crucial for patients receiving ART, in order to assess responses to treatment as well as to detect

side effects. Procurement of laboratory support for ART management will be provided through Lancet,

through Science Applications International Corporation (SAIC). Assessment of responses to ART will

include measurement of immunologic status (CD4+ count) and virologic response (viral load), every six

months or with treatment failure. This information is critical to detect treatment success or failure. In the

cases where patients' CD4 count has risen to > 200 cells/mm3 for more than three months, prophylaxis

against Pneumocystis jerovici pneumonia can be discontinued.

Lancet also performs courier services for all clinical samples from the six SAMHS sites, also has carried out

all laboratory data reporting, arranged courier service for all clinical samples from all six sites, and

maintained a sample, certified, repository, besides has historical database of all results.

These activities will contribute to the number of persons receiving treatment and care in the military, and

support the PEPFAR 2-7-10 goals.