ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

SUMMARY

This activity will continue antiretroviral therapy (ART) and HIV clinical management for approximately 1,500

South African National Defense Force (SANDF) personnel and family member dependents that were

previously receiving ART via the Phidisa II clinical trial. The Phidisa II clinical trial, initiated in 2004,

compared four combination ART arms and was terminated in December 2007. 1,400 patients have been

transferred, beginning in April 2008, to an observational cohort study entitled Phidisa IA, with continued

research collection. The Phidisa Project established the infrastructure, staffing, and procedures for ART

and HIV clinical management capability at all three of the South African Military Health Service (SAMHS)

hospitals, and in three rural sickbays. With the national roll-out, the strategy of the SAMHS Masibambisane

Program has been to extend the geographical coverage of ART primarily to rural sites other than the

Phidisa clinic and to have a well defined presence in the three SAMHS hospitals. In these hospitals, the

Phidisa Project is managing the majority of HIV-infected SANDF personnel and dependent family members;

however, a transition has begun to ultimately transfer routine HIV management and care of these patients to

the SAMHS. This has been slowed primarily due to lack of uniformed human services to staff these clinics.

The SAMHS has been challenged in filling these much needed posts for doctors, nurses, and pharmacists -

despite active recruitment. The Charisma Phidisa staff continues to be one source of recruitment, although

the numbers have been small. A more feasible strategy for sustainability will be the addition of SANDF

resources to support the key Charisma personnel necessary. To this end, co-location and integration of the

Phidisa clinic and the SAMHS ARV roll-out clinic is in process. In two of the three hospital sites, where the

SAMHS roll-out is also available, patients newly initiated on ART are offered a choice of participating in the

Phidisa observational cohort or being followed by the SAMHS roll-out. In those rural sick bays that are

Phidisa Project only, patients who choose not to be enrolled in Phidisa 1a are managed by the Phidisa clinic

staff, without research collection. HIV management will continue to be comprehensive, with opportunistic

infection (OI) prophylaxis and treatment given according to the South African national guidelines. There will

continue to be a translation and communication of the Project Phidisa research findings to the SAMHS and

to the greater South African and PEPFAR professional community.

ACTIVITIES AND EXPECTED RESULTS:

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

PEPFAR funds will continue to support a percentage of the costs (ranging from 10% to 50%) for positions

comprised of physicians, pharmacists, nurses, and laboratory technicians as detailed in the FY 2008 COP.

Modifications to this activity include the increasing SAMHS Masibambisane ARV roll-out capacity, which

has begun at the three SAMHS hospital sites, as detailed above. All three hospitals will have co-located

clinics with an ultimate goal of sufficient SAMHS human resource capability (uniformed and civilian) to

adequately manage routine HIV ART care and management for active duty members and their families .

Periodic training of staff in clinical management and quality assurance will continue without modification.

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

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

Activity Narrative: 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.

New/Continuing Activity: Continuing Activity

Continuing Activity: 17720

Continued Associated Activity Information

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

System ID System ID

17720 17720.08 HHS/National South Africa 7861 7861.08 $2,000,000

Institutes of Health National Defense

Force, Military

Health Service

Emphasis Areas

Military Populations

Workplace Programs

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:

SUMMARY:

This activity will continue antiretroviral therapy (ART) and HIV clinical management for approximately 1,500

South African National Defense Force (SANDF) personnel and family member dependents, including

children, that were previously receiving ART via the Phidisa II clinical trial. The Phidisa II clinical trial,

initiated in 2004, compared four combination ART arms and was terminated in December 2007. 1,400

patients have been transferred, beginning in April 2008, to an observational cohort study entitled Phidisa IA,

with continued research collection. The Phidisa Project established the infrastructure, staffing, and

procedures for ART and HIV clinical management capability at all three of the South African Military Health

Service (SAMHS) hospitals, and in three rural sickbays. With the national roll-out, the strategy of the

SAMHS Masibambisane Program has been to extend the geographical coverage of ART primarily to rural

sites other than the Phidisa clinic and to have a well defined presence in the three SAMHS hospitals. In

these hospitals, the Phidisa Project is managing the majority of HIV-infected SANDF personnel and

dependent family members; however, a transition has begun to ultimately transfer routine HIV management

and care of these patients to the SAMHS. This has been slowed primarily due to lack of uniformed human

services to staff these clinics. The SAMHS has been challenged in filling these much needed posts for

doctors, nurses, and pharmacists - despite active recruitment. The Charisma Phidisa staff continues to be

one source of recruitment, although the numbers have been small. A more feasible strategy for

sustainability will be the addition of SANDF resources to support the key Charisma personnel necessary.

To this end, co-location and integration of the Phidisa clinic and the SAMHS ARV roll-out clinic is in

process. In two of the three hospital sites, where the SAMHS roll-out is also available, patients newly

initiated on ART are offered a choice of participating in the Phidisa observational cohort or being followed by

the SAMHS roll-out. In those rural sick bays that are Phidisa Project only, patients who choose not to be

enrolled in Phidisa 1a are managed by the Phidisa clinic staff, without research collection. HIV management

will continue to be comprehensive, with opportunistic infection (OI) prophylaxis and treatment given

according to the South African national guidelines. There will continue to be a translation and

communication of the Project Phidisa research findings to the SAMHS and to the greater South African and

PEPFAR professional community.

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 Department of Defense (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 1,800 SANDF personnel and their family members have been randomized to one of

four ART regimens over the past five 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 support a percentage of the cost (ranging from 10% to 50%) of 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, it directly addresses building indigenous SAMHS HIV treatment and care capacity.

PEPFAR funds will support periodic training of staff in clinical management and quality assurance.

SAMHS Masibambisane ARV roll-out capacity, which has begun at the three SAMHS hospital sites, will be

increased with FY 2009 funding. All three hospitals will have co-located clinics with an ultimate goal of

sufficient SAMHS human resource capability (uniformed and civilian) to adequately manage routine HIV

ART care and management for active duty members and their families.

Activity 2: Patient Care

Pediatric 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

Activity Narrative: 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 has carried out all laboratory data reporting, arranged courier service for all clinical samples

from all six SAMHS sites, maintains samples, and keeps a historical database of all results.

At the military hospitals where there are pediatric clinics, HIV-infected children will be referred to those

clinics for treatment and care. For sites where the three rural sites where there are no pediatric clinics,

children under 14 years of age will receive antiretroviral treatment via the PHIDISA clinic.

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

support the PEPFAR 2-7-10 goals.

New/Continuing Activity: New Activity

Continuing Activity:

Emphasis Areas

Military Populations

Workplace Programs

Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.11:

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

This activity will continue antiretroviral (ARV) drug procurement for approximately 1,560 South African

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

collaborative clinical trial with the SANDF, HHS/NIH/NIAID, and the U.S. Department of Defense (DOD).

The clinical trial, with approximately 1,260 participants currently on therapy, was initiated in 2004 and is in

the process of being transferred to an observational cohort study entitled Phidisa IA. 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 antiretroviral therapy (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). All subjects transfer from the original trial

will remain on their latest ARV regimens and all new patients will be prescribed ARVs and managed

according to South African Government (SAG) national guidelines.

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.

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. A total of 1,771 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 DOD, via SAIC, have been well integrated into

the six military base hospitals and clinics and are working effectively.

Activity 1: Procurement and delivery of ART

PEPFAR funds will be used to support treatment for 1,260 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

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.

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

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 Narrative: 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.

New/Continuing Activity: Continuing Activity

Continuing Activity: 17721

Continued Associated Activity Information

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

System ID System ID

17721 17721.08 HHS/National South Africa 7861 7861.08 $1,000,000

Institutes of Health National Defense

Force, Military

Health Service

Emphasis Areas

Military Populations

Workplace Programs

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: