Background Since 2004, the US President's Emergency Plan for AIDS Relief (PEPFAR) has supported the tremendous scale-up of HIV prevention, care and treatment services, primarily in sub-Saharan Africa. We evaluate the impact of antiretroviral treatment (ART), prevention of mother-to-child transmission (PMTCT) and voluntary medical male circumcision (VMMC) programmes on survival, mortality, new infections and the number of orphans from 2004 to 2013 in 16 PEPFAR countries in Africa.
Methods PEPFAR indicators tracking the number of persons receiving ART for their own health, ART regimens for PMTCT and biomedical prevention of HIV through VMMC were collected across 16 PEPFAR countries. To estimate the impact of PEPFAR programmes for ART, PMTCT and VMMC, we compared the current scenario of PEPFAR-supported interventions to a counterfactual scenario without PEPFAR, and assessed the number of life years gained (LYG), number of orphans averted and HIV infections averted. Mathematical modelling was conducted using the SPECTRUM modelling suite V.5.03.
Results From 2004 to 2013, PEPFAR programmes provided support for a cumulative number of 24 565 127 adults and children on ART, 4 154 878 medical male circumcisions, and ART for PMTCT among 4 154 478 pregnant women in 16 PEPFAR countries. Based on findings from the model, these efforts have helped avert 2.9 million HIV infections in the same period. During 2004–2013, PEPFAR ART programmes alone helped avert almost 9 million orphans in 16 PEPFAR countries and resulted in 11.6 million LYG.
Conclusions Modelling results suggest that the rapid scale-up of PEPFAR-funded ART, PMTCT and VMMC programmes in Africa during 2004–2013 led to substantially fewer new HIV infections and orphaned children during that time and longer lives among people living with HIV. Our estimates do not account for the impact of the PEPFAR-funded non-biomedical interventions such as behavioural and structural interventions included in the comprehensive HIV prevention, care and treatment strategy used by PEPFAR countries. Therefore, the number of HIV infections and orphans averted and LYG may be underestimated by these models.
- ANTERETROVIRAL THERAPY
- MATHEMATICAL MODEL
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The US Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 authorised the US President's Emergency Plan for AIDS Relief (PEPFAR) from 2004 to 2008 with a budget of over $18 billion. In 2008, President George Bush signed into law the Tom Lantos and Henry J Hyde US Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act, which reauthorised PEPFAR for the next 5 years. President Obama signed the PEPFAR Stewardship and Oversight Act of 2013 at the end of 2013, extending authorisation for an additional 5-year period. As of Fiscal Year (FY) 2013, USA had provided more than $42 billion for PEPFAR bilateral programmes. Aggressive targets commensurate with these financial commitments to address the global epidemic were introduced to focus efforts in treatment, prevention and care. In 2004, these targets included 2 million persons on treatment, 7 million infections averted (IA) and 10 million persons enrolled in care by the end of 2008. In conjunction with the 2008 reauthorisation and later successes, targets were revised to 6 million persons in treatment, 12 million IA and 12 million persons in care, as cumulative totals since the start of the initiative in 2004 until the end of 2013.
The breadth of PEPFAR programming within each country varied by the extent of the HIV/AIDS epidemic and the needs of a country's health system. These country portfolios shared many characteristics, but a major differentiation followed the scale of financial resources provided to high-priority countries (ie, where the epidemic was most virulent) versus those to lower-priority countries. PEPFAR support to these diverse service delivery implementers within each country also varied substantially, some having received funding to account for nearly 100% of the service cost while most others received some fraction thereof. PEPFAR has been one of several partners in these programming efforts, and consequently there are few circumstances, if any, in which service support can be attributed solely to PEPFAR.
Monitoring progress of these efforts was based on a limited set of indicators. These metrics documented individuals as recipients of services supported with PEPFAR funding. Persons were counted, regardless of the proportional contribution offered by PEPFAR to support a specific service delivery site. One service delivery recipient at a site supported by PEPFAR at a scale of 95% was the same as a recipient at a site supported by PEPFAR at a scale of 40%. The PEPFAR figures used in the calculations of this analysis represent the aggregated totals for all programmes across all countries.
Using these totals in mathematical modelling calculations assumes that PEPFAR is responsible for 100% of each person counted. Consequently, these figures are an overestimate of PEPFAR's contribution to impacts. Available data do not allow for a more refined approach; recent changes associated with the current PEPFAR 3.0 agenda will expand the utility of newly reported data and improve our ability to infer the strength of PEPFAR's contributions to these national responses.1 In this current analysis, comparing estimates ‘with PEPFAR’ support to those ‘without PEPFAR’ offers some boundary parameters, how effectively this HIV response is progressing, and how PEPFAR's contribution can be evaluated.
PEPFAR has supported treatment programmes in over 30 countries worldwide, and during the first 10 years of PEPFAR (2004–2013), the provision of antiretroviral treatment (ART) accelerated dramatically: in 2004,i PEPFAR supported 63 300 persons on treatment, increasing to 6.7 million persons on ART in 2013. As of 30 September 2013 (end of the FY), PEPFAR supported a total of 2.2 million voluntary medical male circumcision (VMMC) procedures this 1 year, for a cumulative total of 4.15 million since the programme's inception in 2010. PEPFAR provided prevention of mother-to-child transmission (PMTCT) support for approximately 762 800 HIV-positive pregnant women in 2013, for a cumulative total of 4.15 million since the start of the initiative in 2004.2 Numerous studies have examined the unprecedented scale-up of ART in PEPFAR partner countries.3–5 An overwhelming majority of PEPFAR support for ART has been focused in Africa, which accounts for the majority of the HIV/AIDS epidemic. Of the 6.7 million persons supported on ART in 2013, over 98% were from African countries. South Africa alone accounts for 31% of persons supported through ART in the PEPFAR treatment portfolio from 2004 to 2013.
PEPFAR services are comprehensive and extend much beyond treatment and the complementary components of PMTCT and VMMC as a core biomedical prevention strategy.6–8 For the purpose of this article, however, ART, PMTCT and VMMC services delivered will serve as the main variables examined in estimating the impact of PEPFAR on the HIV epidemic. Also of note, PEPFAR is one of several partners supporting diverse HIV interventions, and in most, if not all, cases these programmes are interwoven. Consequently, one cannot identify impacts that are specific to PEPFAR, while others are associated with other partners. Inferences drawn from these analyses recognise that PEPFAR is a contributor to these impacts, oftentimes over the course of the initiative to a very significant degree.
Recent reports, including the Institute of Medicine's Evaluation of PEPFAR, and a report by the Government Accountability Office on PEPFAR, call for increased efforts to examine the impact of PEPFAR programmes.9 ,10 The massive scale-up of ART, PMTCT and VMMC in Africa merits examination to determine the extent to which PEPFAR, its partner countries and other stakeholders have contributed to reversing the epidemic. This article will provide an overview of PEPFAR's support for ART, PMTCT and VMMC in Africa and use existing modelling software to estimate impact on the following outcomes: life years gained (LYG), number of orphans averted (OA), and number of HIV IA.
No individual identifiers are received through the aggregate reporting of country-specific indicator data to the Office of the Global AIDS Coordinator; therefore, patient consent was not required for this analysis. Country-specific demographic projections and epidemiological parameters are publicly available and used extensively to fit the models.ii
From 2004 to 2013, all countries receiving PEPFAR funds for ART programmes collected clinic-level data on the current number of adults (aged 15 years or older), pregnant women and children (less than 15 years of age) receiving ART through PEPFAR support. These programme data are reported to Office of the Global AIDS Coordinator on a semiannual basis. All partner countries receiving PEPFAR funding collect data on the total annual numbers of HIV-infected pregnant women provided PMTCT antiretroviral prophylaxis through PEPFAR support, and the type of PMTCT prophylaxis regimen used.iii Submissions of programmatic data are checked and cleaned by the implementing partners, the Ministry of Health and PEPFAR interagency teams. These data on ART, PMTCT and VMMC are used to model impact of the interventions through the Spectrum suite of models.
The quality of information reported from countries has improved significantly. Countries began to report data in response to the call for information found in the United Nations General Assembly Special Session on HIV/AIDS Declaration of Commitment on HIV/AIDS in 2001.11 The initial submission of data from countries was in 2002. In these early years, countries had limited capabilities to collect, clean and report data, due to lack of well-defined, standard protocols and procedures and of electronic data management systems. During the next decade, country systems and workforce improved significantly—in conjunction with the quality of the data.
PEPFAR's early reporting was built on many of these same country systems, but with the leverage afforded by the structure of the initiative, some degree of standardisation was implemented. Data quality in the early phase suffered many of the same issues of paper-based systems, consolidation across a wide diversity of sites and the introduction of new reporting requirements. Given the ongoing leverage of the PEPFAR initiative, the quality of data exhibited significant improvement over time, although issues remain. Many of these current concerns will be resolved as the data components of PEPFAR 3.0 begin implementation. Full standardisation, electronic systems and site-specific data will support significantly greater data quality for monitoring and managing the PEPFAR effort. This transition is continuing, and many partner countries are engaged in the same processes.
The Spectrum Software Suite of Models, V.5.03, developed by Avenir Health in collaboration with WHO, the Joint United Nations Programme on HIV/AIDS (UNAIDS), the US Agency for International Development and the United Nations Children's Fund, is used by UNAIDS to make estimates of disease burden in national and global contexts.12 Spectrum was developed under the auspices of the UNAIDS Reference Group on Estimates, Modelling and Projections.13 The software is regularly updated to reflect the latest knowledge on the HIV epidemic. Many papers have examined the use of Spectrum to inform programmatic efforts and show disease trends of HIV, including estimation of the potential impact of HIV treatment as a prevention tool.14–18 Through the Gates HIV Modelling Consortium, Spectrum has been evaluated along with other mathematical models regarding the impact of treatment intervention; there was broad agreement among the models as to epidemiological treatment impact in the short run.19
The Spectrum modules used for this analysis were DemProj, AIM (AIDS Impact Model) and Goals. These three modules interact in various ways to model the impact and future course of the HIV epidemic at the population level. The DemProj module produces population projections using cohort-component methodology. The module uses recent United Nations Population Division's population estimates and projections. The AIM module is used to assess the outcomes of AIDS orphans and LYG. The Goals module is used to assess the number of new IA. More information about these modules is included in the online supplementary appendix.
We compared the current (baseline) scenario of PEPFAR-supported interventions for ART, PMTCTiv and VMMC with a counterfactual scenario that subtracts the direct contribution of PEPFAR for these services. In the counterfactual scenario, PEPFAR's contribution to ART, PMTCT and VMMC was subtracted from national programme statistics reported by UNAIDS. However, we emphasise that there are other organisations contributing in the effort to mitigate the HIV epidemic. We only examined the impact of PEPFAR's non-participation in these efforts. All other inputs were held constant in both scenarios. The country scenarios were run separately.
From 2004 to 2013, PEPFAR provided ART support in the 16 African countries for a cumulative number of 6 708 396 adults and children, medical male circumcisions for 4 154 878 men and ART for 4 154 478 pregnant women through PMTCT programmes (table 1). The PEPFAR programme support for 6.7 million persons on ART in FY 2013 represented 73% of all persons on ART in these countries. The top five countries, accounting for 72% of PEPFAR ART users, were South Africa at 37%, followed by Kenya at 10%, and Nigeria, Uganda and Zambia with 8% each.
In 2013, a total of 9.1 million persons were on ART in the 16 African PEPFAR countries (figure 1, Panel A). Figure 1, Panel B shows the proportion of ART supported by PEPFAR as a percentage of all ART provided in the 16 African PEPFAR countries. The number of HIV-infected pregnant women who received ART for PMTCT increased from 47 242 in 2004 to 762 804 in 2013. The top seven countries accounted for 82% of the 762 804 HIV-infected pregnant women who had been provided ART for PMTCT in the 16 African countries in 2013. South Africa led with 29%, followed by Mozambique and Uganda at 12%, Zimbabwe at 8%, and Kenya, Tanzania, and Zambia at 7% each.
PEPFAR support for VMMC began in 2010. In 2010, PEPFAR supported 218 716 procedures. In 2013, PEPFAR support for VMMC increased to 2.2 million. This expansion resulted in over four million male circumcision procedures cumulatively supported through PEPFAR since 2010.
We estimate that through PEPFAR ART and VMMC, 1.9 million HIV infections have been averted among adults. Among children, PMTCT support from PEPFAR has resulted in 756 620 IA. Combined, PEPFAR support for ART, VMMC and PMTCT is estimated to have averted approximately 2.7 million HIV infections in Africa. We also estimate that PEPFAR support for ART has resulted in approximately a 13% reduction of new HIV infections among adults. PEPFAR support for PMTCT is estimated to have resulted in a 23% reduction of new infections among children (table 2). The ART and VMMC interventions were not analysed separately as the goal was not to examine each adult intervention individually since the combined impact is more consistent with the country situations. In addition, the combined result is somewhat less than the sum of the individual impacts.
Our estimates suggest that PEPFAR support for ART and PMTCT has resulted in 11 560 114 LYG from 2004 to 2013 and moreover, this support also helped avert 8 920 720 orphans in the same period (figure 2). The authors did not conduct sensitivity analysis. However, this can be done through use of a tool available in the Spectrum software.
Since 2003, USA has authorised $42 billion for PEPFAR HIV/AIDS programmes in resource-limited countries, and these commitments have been aligned with bold targets. Estimating the impact of PEPFAR is essential to justify these investments. To our knowledge, this is the largest evaluation of the complete PEPFAR biomedical portfolio in Africa. Our findings suggest that PEPFAR has accelerated ART, PMTCT and VMMC programmes, and these interventions were tied to large gains in life years, OA and IA.
ART, PMTCT and VMMC programmes often act synergistically and in a continuum within a larger HIV response in each of the PEPFAR countries. Programming for testing and counselling, general and key population prevention, gender equity and health system strengthening also play a critical role in scaling up clinical services and engaging in community level prevention. Consequently, restricting this analysis to ART, PMTCT and VMMC—while accounting for the greater part of PEPFAR's contribution to controlling the HIV epidemic—the exclusion of other interventions results in some underestimation of the total contribution.
Another limitation of this analysis is that we cannot know what the national response would have been if the PEPFAR programme had never existed. In addition, the impact of ART calculated by the model is sensitive to the distribution of new ART patients by CD4 count at the initiation of treatment, but little information is available for most of the countries modelled here to validate the estimated distribution. Few countries have death registration systems that are sufficiently complete to validate mortality estimates. Issues tied to data quality also require some caution, while PEPFAR's method for counting accomplishments results in some overestimation of PEPFAR's impact.
It is also important to note that estimates of a grand total of IA are likely to be lower than the targets associated with PEPFAR legislation. This is due in part to the breadth of interventions evaluated, in addition to improvements in the underlying model used for these estimates, to greater quantities and better quality of programme and assessment data from countries, and to heightened understanding of the efficacy and effectiveness of interventions.
As biomedical interventions exist within a larger context, PEPFAR similarly operates within a larger partner consortium and its wider impact, as an extension of the global response to HIV. These partners include, most importantly, ministries of health, members of civil society and multilateral stakeholders such as the Global Fund, WHO and UNAIDS.20
With the second phase of PEPFAR ending at the close of FY 2013, and the third phase underway, it is important to consider how these evaluation methods can be incorporated for improved accountability and reporting. Consistent with former Secretary of State Hillary Clinton's release of the Blueprint for an AIDS-free Generation,21 ,22 this third phase of PEPFAR focuses greater attention on accountability, transparency and impact. Assessing progress in meeting the ambitious goals outlined in the Blueprint requires that PEPFAR and its partners provide support to better measure the reduction of new HIV infections in children and adults, and monitor the coverage, outcomes and quality of interventions employed.23
Steps are already taking place at PEPFAR to marshal various tools to improve monitoring and evaluation.24 For example, this third phase of PEPFAR incorporates improved indicators to better assess impact, using methodologies similar to those presented in this paper. In addition, PEPFAR is collecting and using much more detailed subnational data and supporting implementation of HIV Impact Assessment surveys to obtain more precise measures of programme interventions. Areas of opportunity for improved monitoring and evaluation will also include special considerations for key populations who do not exhibit the same epidemiological parameters as those in the general populations, and, therefore, pose challenges in estimating impact in terms of the measures presented in this article.25 It is also worth exploring the impact of OA through these biomedical interventions as it relates to improving assessments for PEPFAR's provision of HIV care and support. When PEPFAR was first launched, 10% of its budget was designated to support programmes reaching orphans and vulnerable children, making it the leading funder of such programmes globally. PEPFAR has played a key role in establishing the importance of a strong care and support network for orphans and vulnerable children that complements biomedical efforts to end the HIV/AIDS epidemic.26 Our results are limited to the biomedical portfolio, but we anticipate that the effect of PEPFAR is greatly underestimated given the wide array of interventions employed. We anticipate future evaluation or estimation efforts will be able to account for the services that are not captured in the current model.
President's Emergency Plan for AIDS Relief (PEPFAR) accelerated treatment, prevention of mother-to-child transmission (PMTCT) and voluntary medical male circumcision (VMMC) programmes. These interventions were tied to large gains in life years, and orphans and HIV infections averted.
PEPFAR was one of several partners supporting a range of HIV prevention interventions, therefore, one cannot identify impacts specific to PEPFAR efforts alone.
The next phase of PEPFAR includes improved indicators, subnational level data and HIV impact assessment surveys to better assess impact.
Improved monitoring and evaluation must include consideration of key populations who do not exhibit the same epidemiological parameters as those in the general population.
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
- Data supplement 1 - Online supplement
Handling editor Jackie A Cassell
Contributors RL and JF conducted the initial data analysis. LMH, PDB, TBF and JS updated and finalised the results. TBF, RL and MM reviewed the manuscript. LMH and PDB revised the final manuscript. All authors approved the final manuscript.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
↵i Year designation is shorthand for fiscal year, which extends from 1 October to 30 September for the US Government, for example, FY 2004 was defined as 1 October 2003 to 30 September 2004.
↵ii Please refer to appendix for description of model parameters used.
↵iii Regimen data for ART-based prophylaxis were first available in FY 2011 reporting.
↵iv PEPFAR PMTCT ART prophylaxis and infant IA data were obtained from published sources.
Each year, the infant infections averted totals were calculated on the basis of available data and estimated impact associated with the ART-based prophylaxis. From 2004 to 2010, PEPFAR data included only the number of women receiving the prophylaxis (ie, not the specific type), and the IA were estimated assuming that interventions were all single-dose nevirapine-based. For years 2011 and 2012, reported data included the regimen breakout of prophylactic interventions (ie, single-dose, double-dose, triple-dose or treatment), and infections averted calculations were tied to transmission rates matching those used in the Spectrum model. For 2013 results, the same regimen data were available, and the calculation of infections averted employed a composite transmission rate accounting for the different regimens and for breast feeding (also derived from Spectrum). These variations resulted in higher cumulative values than those produced through current Spectrum calculations.