PEPFAR Central Programs: FY 2008

Project Title: Abstinence and Be Faithful (AB)

Budget: FY 2008 GHCS-State: $26,715,315

Implementing Mechanism: USAID grants with Non-governmental Organizations (NGOs) and Community/Faith-Based Organizations (CBOs/FBOs) include the following organizations: Adventist Development Relief Agency (ADRA), American Red Cross, Catholic Relief Services (CRS), Children’s AIDS Fund, Food for the Hungry, HOPE Worldwide South Africa, International Youth Federation, Pact, Program for Appropriate Technology in Health (PATH), Salesian Missions, Samaritan’s Purse, World Relief, and World Vision.

Contact Person(s): John Crowley (USAID/GH)

Program Description:

This program provides central funding for multi-country grants to NGOs to expand programs that promote avoidance of risky behavior: i.e., delaying sexual activity, increasing “secondary abstinence” among young people; and promoting mutual fidelity and partner reduction, among both youth and the general population. Specific activities include the following:

• Providing skills-based HIV education for young people;
• Stimulating community discourse on healthy norms and behaviors;
• Strengthening the role of parents and other protective influences;
• Promoting initiatives to address sexual coercion and gender-based violence; and,
• Targeting early intervention with at-risk youth.

There are 14 cooperative agreements awarded to carry out AB activities. These 14 Partners work with over 30 local faith-based organizations such as Anglican Church of Kenya Western Diocese, Fellowship of Christian Unions, Kenya Students Christian Fellowship, as well as many secular indigenous community-based organizations. Programs supported include culturally appropriate prevention activities for young people emphasizing “Abstinence” and “Be Faithful” (AB) messages, as well as medically accurate information about condoms for older and at-risk youth and referrals to health providers where at-risk youth can obtain other HIV services. These efforts complement ongoing USAID-funded prevention programs that target risky adult behaviors and contribute to the overall national prevention programs.

In FY 2007 partners provided HIV/AIDS prevention education that emphasized abstinence and/or fidelity through a variety of HIV and AIDS prevention strategies including peer education, life skills training, as well as the promotion of safer norms and behaviors. During FY 2007, partners also contributed to the expansion of cross-country technical leadership and knowledge through the sharing of sound practices and experiences. As integrated programs at the country level, partners continued to implement community outreach programs promoting abstinence and/or being faithful with a majority of beneficiaries receiving abstinence messages.

With the feedback from the FY2006 AB program evaluation, partners continued to adjust programming to reflect the evaluation findings and were asked to outline steps taken in response to the evaluator’s recommendations. For each program, partners detailed the addition of information on partner reduction, fidelity, condom use, or cross-generational and transactional sex. Additionally, partners were asked to describe how they planned to ensure sexually active youth, or those who may become sexually active, are referred to comprehensive programs as recommended in agency guidance.

FY 2008 Program:

With an estimated forty percent of all new infections occurring in youth aged 15-24, FY 2008 funding will continue to scale up youth-oriented AB prevention programs in 14 PEPFAR focus countries and improve on the quality of their delivery. Activities will continue to expand the promotion of primary and secondary abstinence, faithfulness, monogamous relationships, and avoidance of unhealthy sexual behaviors among youth. Many partners are focusing on expanding their program to reach more parents, men, and other adults who act as barriers to abstinence and fidelity and affect the environment in which youth make decisions. All of these programs are expected to continue to achieve their targets, thereby contributing to the PEPFAR goal of preventing seven million new infections.

Time Frame: FY 2008 – FY 2009

Project Title: Antiretroviral Treatment (ART)

Budget: FY 2008 GHCS-State: $104,909,943

Implementing Mechanism: HHS Cooperative Agreements with Non-governmental Organizations (NGO), including Columbia University, Elizabeth Glaser Pediatric AIDS Foundation, Harvard University, and AIDSRelief.

Contact Person(s): Ted Ellerbrock (HHS/CDC/GAP) and Barbara Aranda-Naranjo (HHS/HRSA/HAB)

Program Description:

PEPFAR funds provide central support to four U.S. organizations working in 13 of the 15 PEPFAR focus countries. These Department of Health and Human Services (HHS) awarded grants, which were selected based on competitive bidding, to the Mailman School of Public Health of Columbia University, the Elizabeth Glaser Pediatric AIDS Foundation, Harvard University School of Public Health, and AIDSRelief (formerly, the Catholic Relief Services Consortium) have sub-contracted with local in-country organizations, such as: Ministries of Health; faith-based hospitals in nine countries; Muhimbili National Hospital, Tanzania; Moi Teaching and Referral Hospital, Kenya; University of Transkei, South Africa; and Lusaka Health District, Lusaka, Zambia.

The grant recipients are engaged in providing clinical HIV care, including ART, drug and health commodities management, laboratory services for diagnosing HIV infection and opportunistic infections, training of health care workers, community services, and monitoring and evaluation. Areas of focus include the following:

• Providing comprehensive HIV care, including ART, and diagnosing and treating TB and other HIV-related opportunistic infections;
• Selecting and procuring the appropriate ART drugs in accordance with U.S. and host government policies;
• Ensuring the availability and appropriate use of laboratory services for diagnosing HIV infection and opportunistic infections; and
• Providing training to increase capacity of local staff and encourage local ownership.

As of September 30, 2007, more than 339,000 patients were on ART at 565 medical facilities in 13 countries through this program. As of January 2008, the number of patients receiving ART through this program is projected to increase to approximately 400,000. Further expansion is dependent on the receipt of funding from country budgets.

FY 2008 Program:

HHS will use FY 2008 funding to provide HIV care and treatment for those enrolled in the program through February 2009. Funding for scientific and technical advice, assistance, and monitoring for this program and management and administrative costs associated with the program are reflected in the technical oversight and management.

This program will contribute to achieving critical PEPFAR goals, including supporting treatment for two million HIV-infected individuals.

Time Frame: FY 2008 – FY 2009

Project Title: Orphans and Vulnerable Children (OVCs) Affected by HIV/AIDS

Budget: FY 2008 GHCS-State: $24,796,320

Implementing Mechanism: USAID cooperative agreements with Non-Governmental Organizations (NGOs) and Community/Faith-based Organizations (CBOs/FBOs), including the following: Africare, Association of Volunteers in International Service (AVSI), CARE USA, Catholic Relief Services (CRS), Christian Aid, Christian Children’s Fund, Family Health International (FHI), HOPE Worldwide South Africa, Opportunity International, Plan USA, Project Concern International, Project HOPE, Salvation Army, Save the Children, and World Concern.

Contact Person(s): John Crowley (USAID/GH/ISD)

Program Description:

This PEPFAR-funded program continues to fund activities in multiple countries that increase care and support to OVCs affected by HIV. The activities supported through this program provide essential services and comprehensive care to improve the quality of life for OVCs, and aim to strengthen the quality of OVC programs through the implementation, evaluation, and replication of best practices. These projects support one or more of the following strategic approaches:

• Strengthening the capacity of families and caregivers to cope and address OVC needs;
• Mobilizing and strengthening community-based responses;
• Increasing the capacity of children and young people to meet their own needs;
• Building host government capacity to develop appropriate policies, including legal and programmatic frameworks, as well as essential services for the most vulnerable children;
• Raising awareness within societies to create an environment that enables support for children affected by HIV/AIDS while minimizing stigma;
• Developing, evaluating, disseminating and applying sound practices;
• Creating strong partnerships with local in-country organizations; and,
• Forming public-private alliances.

There are 15 cooperative agreements awarded to carry to OVC activities. In FY 2007, these 15 partners provided care and support to OVCs with a wide range of psychosocial, food and nutrition, educational, recreational, and protection services through the mobilization and capacity building of local organizations. During FY 2007, partners contributed to the expansion of cross-country technical leadership and knowledge through the sharing of sound practices and experiences. As integrated programs at the country level, partners continued to implement a strategy of reaching communities primarily through their local community/faith-based partners. This has proven effective in engaging sustainable, community-based responses by using a trusted and established mechanism within a community. In Haiti, for example, one partner works through a network of children’s safety net organizations that help link OVC caregivers with other local groups such as agricultural and nutrition programs in addition to partnering with FBOs.

FY 2008 Program:

In FY 2008, funding will support OVC partners to carry on collaboration with locally-based organizations to implement and scale up activities that:

• Strengthen the capacity of families and caregivers to address OVC needs in their local context
• Support OVCs through microfinance programs for caregivers of OVCs;
• Increase capacity of children and youth to meet their own needs;
• Strengthen the capacity of local organizations to provide care for OVCs;
• Work toward reducing the stigma and discrimination of OVCs and their caregivers; and,
• Increase OVC access to essential programs and services, specifically in education, psychosocial support, health and livelihood training.

Partners will continue to work with schools, local government and social programs to help identify vulnerable children and to establish links for support including referrals for home based care, food/nutrition, and psychosocial needs. With all 15 partners entering their third full year of implementation, program activities will continue to reach more OVC, while an emphasis on quality will help ensure that interventions are truly making a measurable difference in the lives of children affected by HIV/AIDS.

This program will contribute to achieving the PEPFAR goal of supporting care for ten million people infected or affected by HIV/AIDS, including orphans and other vulnerable children.

Time Frame: FY 2008 – FY 2009

Project Title: Blood Transfusion Safety

Budget: FY 2008 GHCS-State: $49,300,000

Implementing Mechanism: HHS/CDC Cooperative Agreements with National Blood Transfusion Services or Ministries of Health in 14 focus countries (Botswana, Côte d’Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda and Zambia) and with five technical assistance organizations (American Association of Blood Banks; Sanquin Blood Consulting; Safe Blood for Africa; Social and Scientific Systems, Inc.; and the World Health Organization). Funding also supports technical assistance to these 19 grantees from the Atlanta headquarters-based CDC Blood Safety team.

Contact Person(s): Lawrence Marum, HHS/CDC/NCHHSTP/DGA/HPB

Program Description:

PEPFAR Track 1 funds have supported blood safety activities in 14 Focus countries in FY 2005, FY 2006 and FY 2007. These funds have supported the development of centralized national blood transfusion services. These national services are designed to manage the national blood supply through direct implementation or via oversight of parastatal organizations (e.g., Red Cross Societies). National Blood Transfusion Service (NBTS) partners (and their partners) are responsible for blood donor recruitment; blood collections; appropriate laboratory screening for transfusion-transmissible infections (TTI); proper processing, storage (e.g., cold chain) and distribution of blood; and training for clinicians, laboratory technicians and other associated healthcare workers in the appropriate handling, screening and use of blood and blood products. In addition to these technical activities, NBTS partners are responsible for developing human capacity to manage these administrative and technical systems, and ensure that adequate records are kept to conduct routine and annual monitoring and evaluation (M&E) and reporting.

The PEPFAR-funded blood safety program also supports expert blood safety organizations to provide guidance, advice, and training to NBTS and Ministry of Health partners. The technical assistance program pairs internationally recognized blood safety organizations with an NBTS partner. The technical assistance (TA) providers advise the NBTS partners in seven main technical areas: 1) Policy development; 2) Infrastructure (limited to advising on facility design and equipment selection, not construction); 3) Blood collections; 4) Laboratory screening of blood and the production of blood components; 5) Transfusion and blood utilization practices; 6) Training; and 7) Monitoring & Evaluation.

FY 2008 Program:

In FY08, PEPFAR funds will continue to support coordinated efforts by National Blood Transfusion Service grantees and the expert blood transfusion technical assistance providers, to build on progress made in years 1-3 (FY 2005-2007) to strengthen national blood systems and improve the safety and availability of blood nationwide. Technical emphasis areas for FY 2008 will include, but not be limited to, improving hemovigilance systems; strengthening links to counseling and testing through provision of or referral for results counseling for HIV testing; mapping service delivery areas to streamline cold chain dependent logistics; continuing on-going renovation projects; linking blood safety surveillance activities with anemia surveillance sites being established by the President’s Malaria Initiative; and conducting high-level analyses on five years worth of blood safety indicator data collected with a new data collection tool. Initiation of a task order to assist with assessment and planning for non-focus countries in FY 2008 will begin to share lessons learned and provide a start for the provision of safer blood in these countries, consistent with the health covenants in the reauthorization of PEPFAR.

This program will contribute to achieving the critical PEPFAR goal of prevention of seven million new HIV infections through the elimination of HIV transmission by unsafe blood transfusion and will also contribute to system strengthening of national systems for care and laboratory services.

Time Frame: FY 2008-FY 2009

Project Title: Safe Medical Injections

Budget: FY 2008 GHCS-State: $30,485,996

Implementing Mechanism: USAID Task Order Proposal Requests through existing Indefinite Quantity Contracts, including John Snow Inc., University Research Co. LLC , Chemonics International, Initiatives, Inc.

Contact Person(s): Robert Ferris, Megan Gerson, Glenn Post, & David Stanton (USAID)

Program Description:

PEPFAR funds provided central support for injection safety activities in FY 2007 through an integrated approach that included improving the safety of medical practices through technical innovations; developing behavior change communications, education and training campaigns; providing sufficient quantities of injection materials, including needles, and syringes; strengthening logistical systems and management; and strengthening waste management systems for sharps.

In FY 2007, this program area experienced a significant reduction in funding. Despite the cutbacks, injection safety partners continued activities in safe injection by supporting commodity management and limited procurement support, including the procurement and distribution of syringes for medical use in PEPFAR focus countries. They also continued capacity building and training in injection practices, supply management, waste handling, and interpersonal communications; reduced the excessive use of injectable pharmaceuticals; developed a standardized system for sharps disposal; and conducted a formal assessment of injection safety and healthcare waste management practices using standardized tools.

FY 2008 Program:

In FY 2008, the USG will continue to implement strategies for wider public understanding and support for the availability of safe medical injections in the PEPFAR focus countries; decrease the frequency of unnecessary and unsafe injections; improve the supply and distribution systems for commodities needed for safe injections; and improve waste management of sharps. Focus will be on prioritizing sharps procedures with highest risk of HIV transmission (e.g., phlebotomy) and cost-effective strategies (e.g., ensuring availability of sharps containers at point of sharps use).

This program will contribute to achieving the PEPFAR goal of supporting prevention of seven million new HIV infections.

Time Frame: FY 2008 - FY 2009

Project Title: Drug Quality Assurance

Budget: FY 2008 GHCS-State: $3,700,000

Implementing Mechanism: HHS/FDA direct expenses and contracts.

Contact Person: Beverly Corey (HHS/FDA) and HHS/OGHA Liaison

Program Description:

When the PEPFAR program was inaugurated, the Food and Drug Administration (FDA) was challenged to develop a process that would help assure that anti-retroviral medications purchased with PEPFAR dollars were quality products and that would also help keep the costs of these products as low as possible. Knowing the plethora of counterfeit products and substandard products available for purchase in developing economies, the leadership of PEPFAR wanted to assure that the products distributed under its auspice were going to help those who took them and were not going to exacerbate the overarching disease problem by contributing to the development of viral resistance to the medications.

In direct support of the President’s Emergency Plan for AIDS Relief (PEPFAR), the Department of Health and Human Services’ (HHS) Food and Drug Administration implemented an expedited process to help ensure that the United States can provide safe, effective, and quality manufactured antiretroviral drugs to the 15 focus countries. HHS/FDA published guidance for the pharmaceutical industry that encouraged sponsors to submit applications for approval (or tentative approval, if U.S. patents blocked issuance of approval for U.S. marketing) of fixed dose combinations (FDCs – new products that combine already-approved individual HIV/AIDS therapies into a single dosage) or co-packaged versions of previously HHS/FDA-approved FDCs or single-entity antiretroviral therapies for the treatment of human immunodeficiency virus (HIV). Drugs approved or tentatively approved under this expedited process meet all FDA standards for drug safety, efficacy, and manufacturing quality.

HHS/FDA’s involvement includes the following activities:

In order to address this challenge, FDA developed a special initiative that was widely publicized and made open to any drug manufacturer in the world who wished to participate. The initiative involves four main components:

• Manufacturer Assistance: FDA works intensively with manufacturers who have not interacted with FDA previously to help them prepare a high quality FDA marketing application and to help them prepare for the requisite FDA inspections of their clinical trials or bioequivalence trials and for the inspection of their manufacturing facilities.
• Priority Application Review: Due to the significant global public health impact of these products, FDA prioritizes the review of these marketing submissions and, to date, has met its announced commitment to complete the reviews in an expedited fashion after submission of a high-quality application.
• “Tentative” Approvals: FDA reviews the submitted marketing applications to ensure that the products meet all of FDA’s standards for safety, effectiveness, and manufacturing quality. If an application meets these standards, and there are no existing patent and/or marketing exclusivity protections that prevent the approval of the product in the U.S., the application receives a full approval. If, however, another company’s existing patents and/or marketing exclusivity prohibits FDA from approving the product for marketing in the U.S., FDA issues a "tentative approval". The "tentative approval” signifies that the product meets all safety, effectiveness, and manufacturing quality standards for marketing in the U.S., but the existing patents and/or marketing exclusivity prevent its approval for marketing in the U.S. With either a full approval or a “tentative approval,” a company can tender its product for purchase under the PEPFAR program in the PEPFAR focus countries. In this manner, the only products being offered under this program to the focus countries are products that meet the scientific and manufacturing standards for products we would offer our own citizens.
• Cooperation with Other National Drug Regulatory Agencies and the World Health Organization (WHO): Finally, FDA has engaged proactively with its counterpart national drug regulatory agencies in the PEPFAR focus countries and with the WHO Pre- Qualification Unit to help them understand the initiative and the science behind FDA’s regulatory decisions. As a result, they can more readily utilize the FDA efforts in their local registration decisions. FDA has entered into a Confidentiality Agreement with the WHO Pre-Qualification Unit so that the WHO can immediately add those products FDA has either “approved” or “tentatively approved” to its PQ list without having to re-review them, thus saving WHO resources. Often being on the WHO PQ list helps with national registration of these products.
• Outreach Activities: HHS/FDA is developing and implementing comprehensive outreach programs that target drug manufacturers and national drug regulatory authorities in focus countries. These programs include training in the general marketing application review process; disseminating current good manufacturing practices, review and standards for active pharmaceutical ingredients; and monitoring post-authorization drug safety and manufacturing reporting.

In addition, in FY 2007 HHS/FDA sponsored two technical assistance drug regulatory forums for regulatory agencies that included PEPFAR focus countries. The purpose continues to be to educate and support these government agencies in their interpretation and evaluation of the findings and outcomes of the HHS/FDA approval process with the goal of reducing the time to actually register, procure, and distribute antiretrovirals (ARVs) in countries receiving PEPFAR support following HHS/FDA approval.

Noted Accomplishments:

• Since December 2004, HHS/FDA has approved or tentatively approved 57 antiretroviral therapies under the PEPFAR expedited review program. These products are listed on the FDA website at www.fda.gov/oia/pepfar.htm.
• From FY-2005 through 2007, FDA conducted a total of 80 pre-approval inspections associated with PEPFAR applications. These were 26 Active Pharmaceutical Ingredient, 16 Finished Dosage Pharmaceutical, and 38 Bioequivalence/GCP inspections.
• In August 2007, the first fixed-dose anti-HIV product designed to treat children under the age of 12 years (pediatric triple-fixed-dose combination tablet of lamivudine, stavudine and nevirapine) was tentatively approved.
• As of March 31, 2007, PEPFAR supported life-saving anti-retroviral treatment for over 1.1 million men, women and children in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean. Because of the FDA PEPFAR work, it is estimated that approximately $107 million has been saved during the first nine months of 2007 alone in the purchase of antiretroviral products.
• In addition, FDA continues to work to strengthen the knowledge and training of in-country, national drug regulatory authorities in the PEPFAR focus countries, alone and in collaboration with each other, so that they can better help assure the quality of the medical products available to their citizens. Since 2005, FDA has held five drug regulatory fora for international regulatory authorities. Fourteen of the 15 focus countries attended the first forum and some countries have been able to send colleagues to subsequent fora in an attempt to train multiple members of their staffs.

FY 2008 Program:

FY 2008 funding will be used to continue to finance the following HIV drug marketing application review and inspection activities necessary for the evaluation of drugs for PEPFAR:

• The review of new drug and generic drug marketing applications;
• Pre-approval inspections of active pharmaceutical ingredients manufacturing facilities;
• Pre-approval inspections of finished dosage manufacturing facilities;
• Pre-approval inspections of bioequivalence studies; and,
• For cause inspections to target manufacturing problems.

Funds may also be required to facilitate activities related to providing consultation and documentation to the World Health Organization (WHO), and to facilitate listing of FDA approved and tentatively approved products on the WHO Prequalification drug website.

In addition, HHS/FDA will plan and attempt to provide regional in-country training to support registration by local drug regulatory authorities of ARVs that have been tentatively approved by HHS/FDA so that they can be procured and distributed to patients in those countries.

This program will contribute to achieving critical PEPFAR goals, including supporting prevention of seven million new HIV infections and supporting care for ten million people infected or affected by HIV/AIDS, including orphans and vulnerable children.

Time Frame: FY 2008—FY 2009

Project Title: New Partners Initiative (NPI)

Budget: FY 2008 GHCS-State: $65,000,000

Implementing Mechanisms: USAID Cooperative Agreements, HHS/CDC, and HHS/HRSA awards with Non-Governmental Organizations and Community/Faith-based Organizations (C/FBOs) include the following: American Refugee Committee International, Baptist Aids Response Agency, CAMFED USA Foundation, Children’s Emergency Relief International, Comprehensive HIV/AIDS Management Programme, Handicap International Rwanda, Integrated Community Based Initiatives, Matibabu Foundation Kenya, Sophumelela Clinic Inc., Tearfund UK, THETA, St. Boniface Haiti Foundation, Inc., Woord en Daad, and World Conference on Religions for Peace.

Contact Person(s): Susan Adams (OGAC), Kevin Ryan (CDC), Blanch Brown (HHS/HRSA), Megan Petersen (USAID/GH), Maggie Wynne (HHS/OGHA)

Program Description:

NPI is a means to increase the number of PEPFAR partners by establishing a competitive grants process for organizations with the desire and the ability to help implement the President's Emergency Plan, but which may have little or no experience in working with the federal government. NPI will increase the total number of EP implementing partner organizations and, importantly, improve their capacity to respond effectively to help meet the President's goals. Additionally, the initiative will develop indigenous capacity so that affected countries and communities can address HIV/AIDS on their own toward long-term sustainability.

In coordination with OGAC, USAID will initiate the following actions in order to continue NPI implementation:

• Issue Cooperative Agreements to six of the 14 new partners in Round Two and a to-be-determined number in Round Three. (During the second round of NPI, 14 new partners were selected out of 471 concept papers submitted to USAID.);
• Manage Round Three process through the Annual Program Statement; and
• Improve the capacity and implementation of new partners, including indigenous partners in affected countries, to respond effectively by making available post-award technical (TA) and capacity-building (CB) assistance through an identified partner, competent in providing both TA and CB.

In coordination with OGAC, HHS/CDC and HHS/HRSA will initiate the following actions in order to continue NPI implementation:

• Issue awards to seven of the 14 new partners in Round Two and a to-be-determined number in Round Three.
• Improve the capacity and implementation of new partners, including indigenous partners in affected countries, to respond effectively by making available post-award technical (TA) and capacity-building (CB) assistance through an identified partner, competent in providing both TA and CB.

FY 2008 Program:

The 14 partners identified from Round Two will implement prevention and care programs in six of the PEPFAR focus countries. Post-award activities, including program implementation, will incorporate technical and capacity building assistance such as:

• Conducting needs assessments of the partners to identify priority areas for organizational and technical assistance;
• Reviewing activities, strategies, implementation steps, and outcomes for consistency with the priorities, goals and strategies of PEPFAR;
• Reviewing geographic scale and beneficiaries to ensure that the programs reflect priority needs (e.g., difficult or underserved populations) and are targeted with appropriate strategies;
• Developing clear plans for devolution to indigenous service providers and promotion of sustainability;
• Ensuring that programs are applying evidence-based strategies, reflect best practices and are consistent with national guidelines and policies;
• Developing and implementing a monitoring and evaluation plan to ensure quality;
• Ensuring a high level of involvement of local partners in program implementation and building their capacity; and
• Ensuring sufficient organizational and technical assistance to allow new partners to compete for USG funding as prime partners.

Additionally, in FY2008, PEPFAR expects to compete and select additional new partners in Round Three through a competitive process.

This program will contribute to achieving critical PEPFAR goals, including supporting prevention of seven million new HIV infections and supporting care for ten million people infected or affected by HIV/AIDS, including orphans and vulnerable children.

Time Frame: FY 2008 – FY 2009

Project Title: Supply Chain Management System

Budget: FY 2008 GHCS-State: $16,250,000

Implementing Mechanism: The Partnership for Supply Chain Management

Contact Person(s): Carl Hawkins (USAID/GH)

Program Description:

In order to sustain the number of patients being treated and tested for HIV, the Supply Chain Management System (SCMS) will continue to deliver high-quality supplies to PEPFAR programs while building the capacity of in-country organizations to maintain sustainable procurement and distribution systems. SCMS is ensuring the lowest priced, highest-quality drugs are available for antiretroviral treatment and care programs.

During FY 2007, SCMS continued to scale up its efforts in all 15 PEPFAR focus countries and supported the USG programs through commodity procurement, technical assistance or coordination of key stakeholders and donors. To date, SCMS has an established field presence in all PEPFAR focus countries and delivered more than 760,000 patient years of ARV treatment. Over 90% of the ARVs procured by SCMS were generic FDA-approved or FDA tentatively approved.

Additionally, SCMS contributes to the coordination of significant, donor-funded initiatives, such as the World Health Organization/Joint United Nations Programme on HIV/AIDS (UNAIDS) effort to prepare a global demand forecast for antiretroviral drugs (ARVs) through 2008. As the technical secretariat of the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Bank, and PEPFAR’s joint procurement planning initiative, SCMS facilitates national procurement planning and supply chain management of HIV/AIDS commodities in several countries.

FY 2008 Program:

SCMS will continue to build an uninterrupted supply of commodities while building capacity for long-term sustainable procurement and distribution. With FY 2008 funds, SCMS will continue to: improve procurement and distribution; support countries that experience unforeseen stockouts; coordinate with international organizations to increase efficiency; maintain transparent procurement, quality assurance and control systems; provide freight forwarding and warehousing services; and build on procurement information management systems.

Central funds will be used to support SCMS home office functions such as maintaining supply plans that support the 17 field offices procurement needs and coordinating with manufacturers and vendors on supply needs; coordinating technical assistance activities in more than 20 countries; managing drug and other product quality assurance measures; and maintaining information systems. Central funds will also be used for the procurement of HIV commodities in emergency stock-out situations and on follow-up technical assistance to prevent further stockouts. With central funding, SCMS will also continue to help lead a coordination effort between major donors and stakeholders such as the Global Fund and the World Bank in the area of commodity procurement and supply chain strengthening.

This program will contribute to achieving two critical PEPFAR goals, including supporting treatment for two million HIV-infected individuals; and supporting care for ten million people infected or affected by HIV/AIDS.

Time Frame: FY 2008 - FY 2009

Project Title: Technical Leadership and Support

Budget: FY 2008 GHCS-State: $40,000,000

Implementing Mechanism: USAID, HHS and State Department contracts and grants

Contact Person(s): Caroline Ryan (OGAC), Debbi Birx (HHS/CDC), Deborah Parham (HHS/HRSA/HAB), and Paul Mahanna (USAID/GH/OHA)

Program Description:

Technical Leadership and Support programs fund technical assistance and other activities to further PEPFAR policy and programmatic objectives in the field, at headquarters, and internationally. In addition to supporting USG technical assistance, this program utilizes existing contractual and grant mechanisms within USAID, HHS, and the State Department to the maximum extent possible.

FY 2008 Program:

Southern Africa HIV/AIDS Prevention Initiative:
Southern Africa has a highly generalized HIV epidemic, with prevalence throughout the region of over 16% in the population aged 15-49—and twice as many women as men infected. Most new infections occur through heterosexual intercourse in the general population, followed by mother-to-child transmission. Surveys in the region indicate that HIV prevalence varies greatly by race, sex, age, and locality. However, rapid growth in and high current levels of HIV prevalence mean there is a very high average risk of infection. In such a severe epidemic virtually all population segments have some need for prevention services. Yet HIV prevention programs can have the greatest impact by focusing their efforts on those segments of the population where the majority of new infections are occurring, and on those behaviors responsible for most new infections.

Many of the prevention issues are not unique to the individual countries but rather are common to the region. This funding will be utilized to address the data and program gaps in present prevention programming. Programs will prioritize prevention among young women and the men who put them at risk. Women in their twenties in this region have among the highest incidence. Prevention efforts will also address older age groups. Although incidence rates are higher in 15-24 year olds, adults over age 25 account for over half of new infections, owing to their larger absolute numbers. Prevention efforts will be intensified in selected high risk localities. Survey data indicates that urban informal settlements, which attract large numbers of migrant workers, have by far the highest incidence. The initiative will also address stigma and discrimination and changing social norms. Many social norms in the South African context increase vulnerability to HIV. Multiple, concurrent sexual relationships are widely accepted. Marriage rates are low with many young adults in “visiting” relationships. A significant minority of young women have partners five or more years older, which increases their risk of HIV roughly two-fold. Additionally, increasing risk perception is an urgent priority for prevention programs.

This program will contribute to achieving two critical PEPFAR goals, including supporting treatment for two million HIV-infected individuals; and supporting care for ten million people infected or affected by HIV/AIDS.

Time Frame: FY 2008 – FY 2009

Project Title: Twinning Center

Budget: FY 2008 GHCS-State: $2,000,000

Implementing Mechanism: Cooperative Agreement with the American International Health Alliance (AIHA)

Contact Person(s): Carolyn Hall (HHS/HRSA/HAB), Sera Morgan (HHS/HRSA/HAB)

Program Description:

The American International Health Alliance (AIHA), through a Cooperative Agreement with the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS), has established the HIV/AIDS Twinning Center (www.TwinningAgainstAIDS.org) to support twinning and volunteer activities as part of the implementation of PEPFAR.

The Twinning Center strengthens human resource and organizational capacity necessary to scale up and expand HIV/AIDS prevention, care, treatment, and support services in countries targeted for assistance by:

• establishing volunteer-driven institutional partnerships that draw on the extensive experience of one partner (a hospital, university, professional association, or NGO, for example) to build similar capacity at the other; and
• facilitating the long-term placement of highly qualified healthcare and allied professionals at PEPFAR-supported organizations through the Volunteer Healthcare Corps (VHC).

Twinning Center partnerships and initiatives provide technical assistance using the knowledge and skills of experienced physicians, nurses, administrators, educators, allied health professionals, and civic leaders. Whether they focus on expanding ART services; meeting the needs of orphans and vulnerable children; developing new educational programs and curricula; preventing the spread of HIV among sero-discordant couples; or training clinicians, health educators, medical technologists, and community-based caregivers, partnerships are designed to effectively respond to community needs.

The Twinning Center uses a flexible, collaborative, results-oriented model that stresses low-tech, economically-viable ways of increasing productivity and quality of care without imposing new burdens that would impede long-term success and sustainability. Collaborative activities facilitate the transfer of knowledge and appropriate technologies while at the same time nurturing a strong sense of ownership of both the programs and the methodology in the host community.

AIHA and its partners work closely with HRSA, host country officials and Ministries of Health, and U.S. Government country teams to create partnerships that advance each country’s Strategic HIV/AIDS Plan and Country PEPFAR Operational Plan (COP).

To date, partnerships have been established in Botswana, Cote d’Ivoire, Ethiopia, Kenya, Mozambique, Namibia, South Africa, Tanzania, and Zambia. The first Twinning Center partnerships were formed in mid-2005, with a second round established in early 2006 and a third in 2007. As of December 2007, 27 partnerships and three volunteer programs had been initiated and one partnership had graduated to direct U.S. Government funding.

FY 2008 Program:

FY 2008 funding supports the expansion of existing successful partnerships and the initiation of new ones as determined in the COPs. Funding received from the U.S. government in Ethiopia, South Africa, and Tanzania supports VHC initiatives to recruit and place volunteers with the prerequisite knowledge and expertise needed to strengthen the provision of HIV/AIDS services at selected institutions.

This program will contribute to achieving two critical PEPFAR goals, including supporting treatment for two million HIV-infected individuals; and supporting care for ten million people infected or affected by HIV/AIDS.

Time Frame: FY 2008 – FY 2009