Each day, an estimated 13,400 people worldwide are newly infected with HIV; more than 20 million have died from AIDS since 1981. HIV is transmitted both sexually (through sexual intercourse with an infected person) and nonsexually (through the sharing of needles or syringes with an infected person; unsafe blood transfusions; or the passing of the virus from mother to child through pregnancy, childbirth, or breastfeeding). The majority of HIV infections worldwide are transmitted sexually. About two- thirds of the estimated 40 million people currently living with HIV/AIDS are in sub-Saharan Africa where, according to the Joint United Nations Programme on HIV/AIDS, adult HIV prevalence averaged 7.4 percent in 2004. As the entity responsible for developing the U.S. global HIV/AIDS strategy and administering PEPFAR, OGAC has defined five prevention program areas--abstinence/faithfulness (AB), "other prevention," prevention of mother-to-child transmission (PMTCT), blood safety, and safe medical injections. These areas are divided into two groups: those aimed at preventing sexual transmission--AB and "other prevention"--and those aimed at preventing nonsexual transmission--PMTCT, blood safety, and safe medical injections. (See fig. 1.) AB activities encourage abstinence until marriage, delay of first sexual activity, secondary abstinence, faithfulness in marriage and monogamous relationships, reduction of sexual partners among sexually active unmarried persons, and social and community norms related to the above practices. "Other prevention" activities include the purchase and promotion of condoms, management of sexually transmitted infections (if not in a palliative care setting), and messages or programs to reduce injection drug use and related risks. In fiscal year 2004, the U.S. Congress appropriated $2.4 billion for global HIV/AIDS efforts, directing $865 million of this amount to four accounts: (1) the GHAI account, which received most of the funding; (2) the Child Survival and Health account; (3) the Prevention of Mother to Child Transmission account; and (4) CDC's Global AIDS Program. In our April 2006 report, PEPFAR funding refers to funds appropriated to these four accounts for the 15 focus countries, as well as bilateral HIV/AIDS funding for the five additional countries that receive at least $10 million in U.S. government HIV/AIDS funding. Each year, to receive country-level funding for the coming fiscal year, country teams submit budgets, or "operational plans," to OGAC outlining planned activities and the organizations that will implement them (implementing partners). These plans are subject to OGAC's review and approval. Focus country teams also receive central funding--multicountry awards that are managed by U.S. agency headquarters in Washington, D.C. For fiscal years 2004 and 2005, PEPFAR funding figures are central and country-level appropriations allocated by OGAC. For fiscal year 2006, PEPFAR funding consists of planned allocations of central and country-level appropriations. The Leadership Act specifies the percentage of PEPFAR funds to be allocated for HIV/AIDS prevention, treatment, and care for fiscal years 2006-2008. The act recommends that 20 percent of funds appropriated pursuant to the act be spent on prevention and 15 percent on palliative care for those living with the disease. The act also requires that, beginning in fiscal year 2006, at least 55 percent of funds appropriated pursuant to the act be spent on treatment and at least 10 percent on orphans and vulnerable children. (See fig. 2). The Leadership Act further requires that at least one-third of prevention funding appropriated pursuant to the act be spent on abstinence-until- marriage programs, starting in fiscal year 2006. (The act also recommended this spending distribution for fiscal years 2004 and 2005.) In June 2004, OGAC notified Congress that it defines abstinence-until- marriage activities as programs that address both abstinence and faithfulness. The Leadership Act states that "behavior change, through the use of the ABC model, is a very successful way to prevent the spread of HIV." The model, which the Leadership Act defines as "'Abstain, Be faithful, and use Condoms,' in order of priority," is based in part on the experience of Uganda, which implemented an ABC campaign in the 1980s and observed a decline in HIV/AIDS prevalence by 2001. Although substantial debate exists about the extent to which each component of the model is responsible for reducing HIV prevalence in individual countries, there is general consensus that using the ABC model can have a positive impact in combating HIV/AIDS. In November 2004, a key consensus statement authored by leading public health experts and endorsed by more than 125 prominent figures and world leaders observed that "all three elements of are essential to reducing HIV incidence, although the emphasis placed on individual elements needs to vary according to the target population." The PEPFAR prevention goal is to avert 7 million infections in the 15 focus countries by the year 2010. This goal is cumulative; that is, infections averted in 2004 through 2009 will count toward the final total of infections averted by 2010. In addition, this goal is to be reached both through PEPFAR activities and through interventions by other donors and host nations. OGAC plans, over time, to estimate progress toward this goal by using a statistical model of epidemiological trends developed by the U.S. Census Bureau. This analysis will compare "expected" HIV incidence rates in particular countries with "actual" incidence rates, using those comparisons to estimate the number of infections that have been averted through PEPFAR and other prevention programs. However, it cannot attribute this change to any specific intervention or to the success of particular types of programs. The approach involves substantial challenges and the reliability of the estimates is not known, according to Census officials. Key challenges include a lack of data on prevalence rates in many developing countries and the fact that impacts of behavioral change programs can occur over a period of time. OGAC initially considered using a different methodology--the Goals model--that links estimates of infections averted to specific types of prevention programs carried out under PEPFAR and their spending levels. However, OGAC concluded that this model could yield misleading results and was not the best method to adopt. To acquire information about the effectiveness of specific PEPFAR prevention programs, especially in the AB area, OGAC plans to fund targeted evaluations on a very limited scale. PEPFAR prevention funding increased significantly between fiscal years 2004 and 2006, while the proportion of total PEPFAR funding dedicated to prevention declined. Country teams reported varying allocations among the five prevention program areas. We found that challenges and inconsistencies in country teams' categorization of funding for certain ABC programs and broad sexual transmission prevention activities resulted in some limitations in the reliability of reported allocations for sexual transmission prevention. PEPFAR prevention funding in the 15 focus countries increased by more than 40 percent, from $207 million in fiscal year 2004 to $294 million in fiscal year 2005. It further increased by about 10 percent, to $322 million, in fiscal year 2006. (See fig. 3.) At the same time, the proportion of PEPFAR funding dedicated to prevention in the 15 focus countries declined from 33 percent in fiscal year 2004 to 20 percent in fiscal year 2006, consistent with the Leadership Act's recommendation that one-fifth of funds appropriated pursuant to the act be spent on prevention. (See fig. 4.) OGAC's fiscal year 2004 operational plan predicted this decline, noting that the proportion of total PEPFAR funding allocated to prevention would likely begin to decrease relative to the proportion allocated to care and treatment. The total proportion of PEPFAR prevention funding that the 15 focus country teams reported allocating to each of the five prevention programs varied to some extent across fiscal years 2004-2006. (See fig. 5.) Challenges and inconsistencies in country teams' categorization of funding for certain integrated ABC activities and some broad sexual transmission prevention activities cause some limitations in the reliability of the allocations reported for AB and "other prevention." For example, in their country operational plans, some teams categorized integrated ABC programs entirely as "other prevention," while others divided some or all of these programs between the AB and "other prevention" categories. In addition, certain broader components of sexual transmission prevention programs that are not clearly defined as AB or "other prevention," such as activities to prevent substance abuse, may appear in either program area in the teams' operational plans. The lack of a standardized method for categorizing these programs means that, to some extent, the varied numbers of funding reported across fiscal years may reflect the variations in categorization methods rather than actual differences. The PEPFAR strategy for preventing sexual transmission of HIV is shaped largely by three components: the ABC model, the abstinence-until- marriage spending requirement, and local prevention needs. The model should be applied in accordance with local prevention needs. Prevention activities should be integrated. Prevention activities should be coordinated with the HIV/AIDS strategies of host governments. Prevention interventions should be driven by best practices. OGAC's guidance to the field states that "the optimal balance of ABC activities will vary across countries according to the patterns of disease transmission, the identification of core transmitters (i.e., those at highest risk of transmitting HIV), cultural and social norms, and other contextual factors." The ABC guidance also specifies the components of the ABC model that should be targeted to certain populations and sets parameters on the prevention messages that may be delivered to youths. For example, although PEPFAR funds may be used to deliver age-appropriate AB information to in-school youths aged 10 to 14 years, the funds may not be used to provide information on condoms to these youths. When students are identified as being at risk, they may be referred to out-of-school programs that provide integrated ABC information and that provide condoms. Under these rules, PEPFAR funds may be used to give integrated ABC information to youths older than 14. Other rules include the following: PEPFAR funds may not be used in schools for marketing efforts to promote condoms to youths. PEPFAR funds may not be used in any setting for marketing campaigns that target youths and encourage condom use as the primary intervention for HIV prevention. PEPFAR funds may be used to target at-risk populations with specific outreach, services, comprehensive prevention messages, and condom information and provision. At-risk groups include, among others, sexually active discordant couples and those who have sex with one whose HIV status is unknown. To meet the 33 percent abstinence-until-marriage spending requirement, OGAC issued policies in late August 2005 instructing each of the 15 focus country teams and 5 additional teams to spend at least 50 percent of their prevention funding on sexual transmission prevention and at least 66 percent of that amount on AB activities. To show compliance with the spending requirement, country teams' operational plans must isolate the amount of funding dedicated to AB activities. OGAC allows country teams to request exemption from its 50 percent and 66 percent policies. However, the guidance cautions that, in a generalized epidemic, a very strong justification is required for not meeting the 66 percent policy and adds that OGAC expects all focus country teams, particularly those with total PEPFAR funding exceeding $75 million, to adhere to the policies. Finally, OGAC directed country teams to apply the spending requirement to all PEPFAR prevention funding (about $357 million in fiscal year 2006), although it determined that, as a matter of law, the requirement applies only to funds appropriated to the GHAI account (about $322 million in fiscal year 2006). As our April 2006 report discusses, country teams face challenges related to both the ABC guidance and the Leadership Act's abstinence-until- marriage spending requirement. Two-thirds of focus country teams reported that a lack of clarity in aspects of the ABC guidance has led to interpretation and implementation challenges. About half of the country teams indicated that adherence to the spending requirement can undermine the integrated nature of HIV/AIDS prevention programs. In addition, most country teams required to meet the requirement, absent exemptions, reported either in structured interviews or exemption requests that the requirement challenges their ability to allocate prevention resources in accordance with local HIV/AIDS prevention needs. Finally, OGAC's policy of applying the spending requirement to all PEPFAR prevention funding, including funds not appropriated to the GHAI account, may further constrain country teams' ability to address local prevention needs. We reported in April 2006 that, although many focus country teams told us that they generally found the ABC guidance to be clear and several said that it did not present implementation challenges, 10 of the 15 focus teams cited instances where components of the guidance were ambiguous and caused confusion. First, 6 focus country teams expressed uncertainty regarding the populations that should be considered at-risk in accordance with the guidance, and 5 of these teams expressed concern that certain populations that need ABC messages in their countries might not receive them because they do not fit the ABC guidance definition of at-risk. Second, teams reported that the ABC guidance does not clearly delineate permissible condom-related activities, causing confusion about proper use of PEPFAR funds. For example, 5 focus country teams reported that, in their understanding, PEPFAR funds may not be used for broad condom social marketing, even to adults in a generalized epidemic. Third, the ABC guidance does not discuss how the age cutoff for providing condom information should be applied to groups that include youths younger and older than 15. We reported in April that OGAC officials told us they were working to clarify confusing components of the guidance, including distributing to country teams a document with some additional clarification on how to apply the ABC guidance. In several of our structured interviews, focus country teams endorsed the ABC model and noted the importance of AB messages. For example, one team told us that, because of the country's high HIV/AIDS prevalence rate, abstinence is an appropriate message for both youths and adults. However, the abstinence-until-marriage spending requirement presented challenges to country teams' ability to implement integrated prevention programs. Because the abstinence-until-marriage spending requirement requires them to segregate AB funding from funding for "other prevention," 8 of the 15 focus country teams reported that the spending requirement can undermine their ability to design and implement programs that integrated the components of the ABC model. For example, one focus country team told us that artificially splitting programs for the military (traditionally considered an at-risk group) between AB and "other prevention" disaggregates activities that should be integrated and potentially lowers effectiveness. In addition, 17 of the 20 PEPFAR country teams required to meet the abstinence-until-marriage spending requirement, absent exemptions, reported that the requirement presents challenges to their efforts to respond to local prevention needs. Ten of these 17 teams requested exemptions, citing a variety of concerns, such as reduced spending for PMTCT, limited funding to deliver appropriate prevention messaging to high-risk groups, lack of responsiveness to cultural and social norms, cuts in medical and blood safety activities, and elimination of care programs. The remaining 7 teams, which did not meet OGAC's proposed criteria for requesting exemptions, also identified a variety of constraints related to meeting the requirement, including difficulty in reaching certain populations with comprehensive ABC messages, limited or reduced funding for programs targeted at high-risk groups, reduced funding for PMTCT services, and difficulty in funding programs for condom procurement and condom social marketing. The analysis in our April 2006 report showed that, with the approval of all 10 exemption requests, OGAC should just meet the overall 33 percent target for AB activities for fiscal year 2006 by effectively allowing exempted teams to spend less than 33 percent on AB programs and requiring nonexempted teams to spend more than 33 percent. Our report found that all but one of the exempted teams planned to dedicate less than 33 percent of funds to AB activities--about 23 percent on average--while, on average, each of the nonexempted country teams planned to spend around 37 percent. In allocating funds to meet the spending requirement, country teams are primarily limited to shifting resources among three prevention program areas--AB, "other prevention," and PMTCT. (This limitation occurs because the overwhelming majority of funds spent on safe medical injections and blood safety are centrally awarded funds, over which the country teams have no budgetary control.) If, for example, a country team's planned funding has less than a 2-to-1 ratio of AB funds to "other prevention" funds, the team can increase AB funding to reach the required ratio by reducing funds in "other prevention," PMTCT, or a combination of the two. The team can also consider taking funds from the treatment and care program areas and placing them in the AB category. Our analysis found that nonexempted country teams' allocations for "other prevention" funding declined between fiscal year 2005 and fiscal year 2006. For the nonexempted focus country teams, total funding for "other prevention" declined by about $5 million from fiscal year 2005 to fiscal year 2006, falling from about 23 percent to about 18 percent of total prevention funding, while total funding for AB activities increased by about $25 million, rising from about 27 percent to about 36 percent of total prevention funding. By contrast, in the focus country teams that received exemptions, total prevention funding for "other prevention" increased slightly, by about $700,000, remaining at around 21 percent of total prevention funding, and total prevention funding for AB activities increased by about $7 million, from about 23 percent to about 28 percent of total prevention funding. Figure 6 shows the allocation of prevention funds by nonexempted and exempted focus country teams for fiscal years 2005 (actual funds) and 2006 (planned funds). As figure 6 shows, overall levels of PMTCT funding stayed relatively constant for both nonexempted and exempted focus country teams. Overall, the proportion of funding dedicated to PMTCT in the focus countries was about 23 percent in fiscal year 2005 and about 22 percent in fiscal year 2006. Focus countries' total PMTCT funding was $66.3 million in fiscal year 2005 and $67.5 million in fiscal year 2006. Finally, OGAC's decision to apply the spending requirement to all PEPFAR prevention funding--although OGAC had determined that, as a matter of law, the requirement applies only to funds appropriated to the GHAI account--may further challenge some teams' ability to address HIV prevention needs at the local level. For fiscal year 2006, non-GHAI prevention funds amounted to about $35 million (10 percent) of PEPFAR prevention funding--that is, about $6 million (2 percent) of the focus country teams' planned PEPFAR prevention funds and about $29 million (82) percent of the five additional country teams' planned PEPFAR prevention funds. Because of OGAC's policy, some country teams are constrained from allocating non-GHAI funding to meet local needs if the allocations do not comply with the spending requirement. In conclusion, our analysis of HIV/AIDS prevention efforts funded under PEPFAR reported in our April 2006 report showed that, although country teams consistently value the ABC model as a useful tool for preventing HIV, the Leadership Act's 33 percent abstinence-until-marriage spending requirement has presented challenges to their ability to adhere to the PEPFAR sexual transmission prevention strategy. In particular, it has challenged their ability to integrate the components of the ABC model and respond to local needs, local epidemiology, and distinctive social and cultural patterns. OGAC's application of the spending requirement to $35 million in funds not appropriated to the GHAI account may further hamper some country teams' ability to develop locally responsive prevention programs. OGAC may be able to address some of the constraints country teams face by reconsidering this policy, but the amount of non-GHAI funding is relatively small and the underlying challenges that country teams face in having to reserve a specific percentage of their prevention funds for abstinence-until-marriage programs would remain. Because meeting the 33 percent abstinence-until-marriage spending requirement can challenge country teams' ability to allocate prevention resources in a manner consistent with the PEPFAR sexual transmission prevention strategy, our April 2006 report recommended that the Secretary of State direct the U.S. Global AIDS Coordinator to take the following actions: Collect information from the country teams each fiscal year on the spending requirement's effects on their HIV sexual transmission prevention programming. This information should include, for example, the justifications submitted by country teams requesting exemption from the spending requirement. Provide this information in an annual report to Congress. Use the information collected to, among other things, assess whether the spending requirement should be applied solely to funds appropriated to the Global HIV/AIDS Initiative account, in line with OGAC's legal determination that the requirement applies only to these funds. In commenting jointly on a draft of our April 2006 report, the Department of State/OGAC, HHS, and USAID reiterated their strong commitment to fight HIV/AIDS and also noted the importance of the ABC model in preventing sexual transmission of HIV. The agencies agreed with our recommendation to collect information regarding the effects of the Leadership Act's abstinence-until-marriage spending requirement. They disagreed with a draft recommendation regarding applying the abstinence- until-marriage spending requirement only to funds appropriated to the GHAI account, citing concerns about the effect on a unified budget approach and noting the small amount of non-GHAI funding that the focus countries receive. We modified our recommendation to recommend that they consider this policy change after collecting information on the effect of the spending requirement. However, we noted that the five additional countries required, absent exemptions, to meet the spending requirement received more than 80 percent of their funds through non-GHAI accounts. Given the challenges that meeting the abstinence-until-marriage spending requirement presents to country teams attempting to implement locally responsive and integrated HIV/AIDS prevention programs, our April 2006 report also suggested that Congress, in its ongoing oversight of PEFAR, should review and consider the information provided by OGAC regarding the spending requirement's effect on country teams' efforts to prevent the sexual transmission of HIV and use this information to assess the extent to which the spending requirement supports the Leadership Act's endorsement of both the ABC model and strong abstinence-until-marriage programs. Mr. Chairman and members of the committee, this concludes my prepared statement. I will be happy to answer any questions you may have at this time. For information on this statement, please contact David Gootnick, Director, International Affairs and Trade, at (202) 512-3149. You may also reach him by email at gootnickd@gao.gov. Other individuals who made key contributions to this testimony include Celia Thomas (Assistant Director), Elizabeth Singer, Chad Davenport, and Reid Lowe. This is a work of the U.S. government and is not subject to copyright protection in the United States. It may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately.

Summary:
The U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 authorizes the President's Emergency Plan for AIDS Relief (PEPFAR). It promotes the ABC model (Abstain, be faithful, or use Condoms); recommends that 20 percent of funds appropriated pursuant to the act be spent on prevention; and requires that, starting in fiscal year 2006, 33 percent of prevention funds appropriated pursuant to the act be spent on abstinence-until-marriage activities. The Office of the U.S. Global AIDS Coordinator (OGAC) oversees PEPFAR and administers the Global HIV/AIDS Initiative (GHAI) account, the main repository for PEPFAR funds. For our April 2006 report, GAO reviewed PEPFAR prevention funding trends; described the PEPFAR strategy to prevent sexual transmission of HIV; and examined related challenges. The report recommended that the Coordinator collect and report information on the effects of the abstinence-until-marriage spending requirement and use it to, among other things, assess whether the requirement should apply only to the GHAI account. OGAC agreed to collect information but disagreed with applying the requirement only to certain funds; GAO modified the recommendation. GAO also suggested Congress use the information to assess how well the requirement supports the Leadership Act's endorsement of both the ABC model and strong abstinence programs. As GAO reported in April 2006, PEPFAR prevention funding in 15 focus countries increased by 55 percent between fiscal years 2004 and 2006, rising from about $207 million to $322 million. During this time, the prevention share of PEPFAR funding in these countries fell by about one-third, in accordance with the Leadership Act's recommendation that 20 percent of funds appropriated pursuant to the act support prevention. The PEPFAR strategy for preventing sexual transmission of HIV/AIDS is largely shaped by three elements--the ABC model, the abstinence-until-marriage spending requirement, and local prevention needs. In addition to adopting the ABC model, OGAC developed guidance for applying it--for instance, that prevention interventions should be integrated and responsive to local needs and cultural norms. To meet the 33 percent spending requirement, OGAC mandated that country teams (PEPFAR officials in the field) spend at least half of prevention funds on sexual prevention and two-thirds of those funds on abstinence/faithfulness (AB) activities. OGAC permitted certain country teams to seek exemptions from this policy. OGAC also applied the spending requirement to all PEPFAR prevention funding as a matter of policy, although it determined that as a matter of law it applies only to funds appropriated to the Global HIV/AIDS Initiative account. GAO also reported in April 2006 that OGAC's ABC guidance and the abstinence-until-marriage spending requirement, while valued by country teams, have presented challenges to most teams. First, two-thirds of focus country teams told us that ambiguities in some parts of the guidance led to uncertainty about implementing the model; OGAC officials commented they were clarifying the guidance for country teams. Second, although several teams indicated that they value the ABC model and noted the importance of AB messages, some teams also reported that the spending requirement can limit their ability to design programs that are integrated and responsive to local prevention needs. Most country teams reported, either in structured interviews or exemption requests, that fulfilling the spending requirement, including OGAC's policies implementing it, presents challenges to their ability to respond to local needs. Seven focus country teams--primarily those with smaller PEPFAR budgets--received exemptions from the requirement, allowing them to dedicate less than 33 percent of prevention funds to AB activities. In general, the nonexempted teams are spending more than 33 percent of prevention funds on AB activities, and OGAC should just meet the overall spending requirement for fiscal year 2006. However, to meet the abstinence-until-marriage spending requirement, teams have in some cases reduced or cut funding for certain prevention programs, such as those to deliver comprehensive messages to certain populations. OGAC's decision to apply the spending requirement to all PEPFAR prevention funds may further challenge country teams' ability to address local prevention needs.