Protecting Africa's children from extreme risk: a runway of sustainability for PEPFAR programmes.

PEPFAR looks to the future

HIV and AIDS continue to have a calamitous effect on individuals living on the continent of Africa. U.S. President George W. Bush implemented the President's Emergency Plan for AIDS Relief (PEPFAR) with the objective of committing approximately $15 billion from 2004 through 2008 to assist with the reduction of the HIV pandemic worldwide. The majority of the PEPFAR policy and funding focused on 12 countries in sub-Saharan Africa: Botswana, Cote d'Ivoire, Ethiopia, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zambia. The policy question this research paper seeks to analyze is whether the PEPFAR funding (as a % of Gross Domestic Product (GDP)) allocated to the 12 countries in Africa had any effect on the decrease of HIV infection rates of males and females between the ages of 15 and 49. A fixed-effects panel regression analysis was conducted to determine if this association exists. This study examined the 12 African countries that received PEPFAR funding over the years 2002 to 2010; even though PEPFAR was only active from 2004 through 2008, this research included two years prior and two years after this timeframe in order to better estimate the effect of PEPFAR funding on HIV reduction. The results illustrate that on average, ceteris paribus, for every 1 percentage point increase in PEPFAR funding per GDP a country received, the country's HIV infection rate decreased by 0.355 percentage points. While the empirical findings in this study suggested that the correlation between PEPFAR funding and HIV reduction is statistically significant, the practical significance is perhaps less obvious. Arguably, the reduction rate should be higher given the extent of funding targeted to this project. The conclusion of this research provides suggestions on future research and the policy implications of PEPFAR.

Obama vs McCain on global health

PEPFAR and the fight against HIV/AIDS

HIV/AIDS and food insecurity

The President's Emergency Plan for AIDS Relief (PEPFAR) has provided billions of US tax dollars to expand HIV treatment, care, and prevention programs in sub-Saharan Africa. This investment has generated significant health gains, but much less is known about PEPFAR's population-level economic effects. We used a difference-in-differences approach to compare employment trends between ten countries that received a large amount of PEPFAR funding (focus countries) and eleven countries that received little or no funding (control countries). We found that PEPFAR was associated with a 13percent differential increase in employment among males in focus countries, compared to control countries. However, we observed no change in employment among females. In addition, we found that increasing PEPFAR per capita funding by $100 was associated with a 9.1-percentage-point increase in employment among males. This rise in employment generates economic benefits equal to half of PEPFAR's cost. These findings suggest that PEPFAR's economic impact should be taken into account when making aid allocation decisions.

There are limited data measuring the impact of expanded human immunodeficiency virus (HIV) prevention activities on the tuberculosis epidemic at the country level. Here, we characterized the potential impact of the US President's Emergency Plan for AIDS Relief (PEPFAR) on the tuberculosis epidemic in sub-Saharan Africa. We selected 12 focus countries (countries receiving the greatest US government investments) and 29 nonfocus countries (controls). We used tuberculosis incidence and mortality rates and relative risks to compare time periods before and after PEPFAR's inception, and a tuberculosis/HIV indicator to calculate the rate of change in tuberculosis incidence relative to the HIV prevalence. Comparing the periods before and after PEPFAR's implementation, both tuberculosis incidence and mortality rates have diminished significantly and to a higher degree in focus countries. The relative risk for developing tuberculosis, comparing those with and without HIV, was 22.5 for control and 20.0 for focus countries. In most focus countries, the tuberculosis epidemic is slowing down despite some regions still experiencing an increase in HIV prevalence. This ecological study showed that PEPFAR had a more consistent and substantial effect on HIV and tuberculosis in focus countries, highlighting the likely link between high levels of HIV investment and broader effects on related diseases such as tuberculosis.

As part of the global response to the HIV/AIDS epidemic, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is committed to the provision of high‐quality services and ensuring testing accuracy. Two recently published papers focusing on HIV testing and misdiagnosis in sub‐Saharan Africa by Kosack et al. report on evaluations of HIV rapid diagnostic tests (RDTs) and found lower than expected specificity and sensitivity on some tests when used in certain geographic locations. The magnitude of PEPFAR's global HIV response has been possible due to the extensive use of RDTs, which have made HIV diagnosis accessible all over the world. We take the opportunity to address concerns raised about the potential implications that these findings could have on real‐world HIV testing accuracy. PEPFAR supported countries adhere to the normative guidance by World Health Organization (WHO) supporting algorithms which require sequential positive tests for diagnostic accuracy. An analysis of Médecins Sans Frontières (MSF) RDT site‐specific data applied to PEPFAR in‐country protocols demonstrate a variation in the diagnostic accuracy of the testing algorithms, but with a very small population‐level effect. The data demonstrate, with the use of these algorithms, that the RDT outcomes found in the study by Kosack et al. would be largely mitigated and would not be expected to have a significant impact on diagnostic accuracy and overall programming in most countries. Avoiding any misdiagnosis is a priority for PEPFAR, and it remains vital to gain a deeper understanding of the causes and the extent of diagnostic errors and any misclassification. Extensive quality control mechanisms and continued research are essential. With a focus on epidemic control and ensuring diagnostic accuracy, PEPFAR recommends that all countries use WHO pre‐qualified RDTs within the recommended strategies and algorithms for HIV testing. We also support validation of HIV testing algorithms using in‐country specimens to determine optimal performance, and the reverification testing of all people diagnosed with HIV prior to starting treatment as an essential quality assurance measure.

In June 2011, the Joint United Nations Programme on HIV/AIDS, the US President's Emergency Plan for AIDS Relief (PEPFAR), and other collaborators outlined a transformative plan to virtually eliminate pediatric AIDS worldwide. The ambitious targets of this initiative included a 90% reduction in new pediatric HIV infections and a 50% reduction in HIV-related maternal mortality--all by 2015. PEPFAR has made an unprecedented commitment to the expansion and improvement of prevention of mother-to-child HIV transmission (PMTCT) services globally and is expected to play a critical role in reaching the virtual elimination target. To date, PEPFAR has been instrumental in the success of many national programs, including expanded coverage of PMTCT services, an enhanced continuum of care between PMTCT and HIV care and treatment, provision of more efficacious regimens for antiretroviral prophylaxis, design of innovative but simplified PMTCT approaches, and development of new strategies to evaluate program effectiveness. These accomplishments have been made through collaborative efforts with host governments, United Nations agencies, other donors (eg, the Global Fund for AIDS, Tuberculosis, and Malaria), nongovernmental organizations, and private sector partners. To successfully meet the ambitious global targets to prevent new infant HIV infections, PEPFAR must continue to leverage the existing PMTCT platform, while developing innovative approaches to rapidly expand quality HIV services. PEPFAR must also carefully integrate PMTCT into the broader combination prevention agenda for HIV, so that real progress can be made toward an "AIDS-free generation" worldwide.

What has the US Global Health Initiative achieved?

BackgroundIn 2014, the Joint United Nations Program on HIV/AIDS (UNAIDS) issued treatment goals for human immunodeficiency virus (HIV). The 90-90-90 target specifies that by 2020, 90% of individuals living with HIV will know their HIV status, 90% of people with diagnosed HIV infection will receive antiretroviral treatment (ART), and 90% of those taking ART will be virally suppressed. Consistent methods and routine reporting in the public domain will be necessary for tracking progress towards the 90-90-90 target.Methods and findingsFor the period 2010–2016, we searched PubMed, UNAIDS country progress reports, World Health Organization (WHO), UNAIDS reports, national surveillance and program reports, United States President’s Emergency Plan for AIDS Relief (PEPFAR) Country Operational Plans, and conference presentations and/or abstracts for the latest available national HIV care continuum in the public domain. Continua of care included the number and proportion of people living with HIV (PLHIV) who are diagnosed, on ART, and virally suppressed out of the estimated number of PLHIV. We ranked the described methods for indicators to derive high-, medium-, and low-quality continuum. For 2010–2016, we identified 53 national care continua with viral suppression estimates representing 19.7 million (54%) of the 2015 global estimate of PLHIV. Of the 53, 6 (with 2% of global burden) were high quality, using standard surveillance methods to derive an overall denominator and program data from national cohorts for estimating steps in the continuum. Only nine countries in sub-Saharan Africa had care continua with viral suppression estimates. Of the 53 countries, the average proportion of the aggregate of PLHIV from all countries on ART was 48%, and the proportion of PLHIV who were virally suppressed was 40%. Seven countries (Sweden, Cambodia, United Kingdom, Switzerland, Denmark, Rwanda, and Namibia) were within 12% and 10% of achieving the 90-90-90 target for “on ART” and for “viral suppression,” respectively. The limitations to consider when interpreting the results include significant variation in methods used to determine national continua and the possibility that complete continua were not available through our comprehensive search of the public domain.ConclusionsRelatively few complete national continua of care are available in the public domain, and there is considerable variation in the methods for determining progress towards the 90-90-90 target. Despite bearing the highest HIV burden, national care continua from sub-Saharan Africa were less likely to be in the public domain. A standardized monitoring and evaluation approach could improve the use of scarce resources to achieve 90-90-90 through improved transparency, accountability, and efficiency.

Alex Coutinho: transforming HIV care in Africa

The President's Emergency Plan for AIDS Relief (PEPFAR) has been the largest funder of abstinence and faithfulness programming in sub-Saharan Africa, with a cumulative investment of over US $1.4billion in the period 2004-13. We examined whether PEPFAR funding for abstinence and faithfulness programs, which aimed to reduce the risk of HIV transmission, was associated with a relative change in five outcomes indicative of high-risk sexual behavior: number of sexual partners in the past twelve months for men and for women, age at first sexual intercourse for men and for women, and teenage pregnancies. Using nationally representative surveys from twenty-two sub-Saharan African countries, we compared trends between people living in countries that received PEPFAR abstinence and faithfulness funding and those living in countries that did not in the period 1998-2013. We found no evidence to suggest that PEPFAR funding was associated with population-level reductions in any of the five outcomes. These results suggest that alternative funding priorities for HIV prevention may yield greater health benefits.

The US Food and Drug Administration (FDA) program to review antiretroviral drugs for use in low-resource settings via the US President's Emergency Plan for AIDS Relief (PEPFAR) now supports treatment of more than 14 million patients with HIV. However, an in-depth evaluation of the program has not been undertaken. To conduct a quantitative analysis of the FDA-reviewed antiretroviral drug applications in order to assess the contributions of PEPFAR and to identify areas for improvement. A cross-sectional study was conducted of all PEPFAR applications submitted to the FDA from December 1, 2004, to May 31, 2018. The analyses were conducted between October 2018 and February 2019. Numbers and types of applications reviewed, how long it took for applications to obtain approval or tentative approval (time to registration), how often the FDA issued a complete response letter (CRL) identifying deficiencies precluding application approval or tentative approval and their reasons, and the association between CRLs and time to registration. Overall, 260 PEPFAR applications for 327 antiretroviral therapies were reviewed by FDA, of which 216 applications (83%) for 272 drugs were authorized for use. Of the 216 authorized applications, 184 applications for 231 drugs remain in active status and, thus, are available for use. Twenty-six percent (56 of 216) of the applications were for pediatric-specific formulations or strengths; the remainder were for adults. For all 216 applications, the median (interquartile range) time to registration was 10.0 (7.0-17.5) months. Thirty-seven percent (95 of 260) of the applications received 1 or more CRLs, resulting in a total of 172 CRLs; most applications received 1 CRL, whereas some were issued up to 6 CRLs. Among all CRLs, 264 deficiency reasons were identified; the most common deficiencies were associated with manufacturing processes (155 [44%]), followed by product labeling (62 [23%]), and failing facility inspections (54 [20%]). Complete response letters were associated with an increased time to registration. Applications without CRLs had a median (interquartile range) time to registration of 9.0 (5.5-12.0) months, whereas those with at least 1 CRL took a median (interquartile range) of 22.0 (14.0-38.0) months (P < .001). The FDA's PEPFAR program has made many antiretroviral drugs available for global use. However, FDA and the pharmaceutical companies could take steps to improve the quality of applications submitted to prevent avoidable deficiencies in manufacturing processes and labeling. Further efforts to develop better, easier to use pediatric-specific therapies are needed.

The President's Emergency Plan for AIDS Relief (PEPFAR), which began in 2003, initially responded to the global AIDS epidemic by applying lessons learned in treating the disease in the United States to addressing the emergency abroad. As the program expanded, it evolved to support interventions increasingly tailored to local needs in countries receiving PEPFAR assistance. This global experience has created a knowledge base of how to provide HIV/AIDS prevention, care, and treatment services in low-resource settings. It underscored the importance of treatment adherence, family-centered care, and integration of HIV into broader health care delivery systems. Applying these lessons can help US policy makers address existing gaps in HIV care in the United States, where the availability of HIV treatment has at times masked the continued need for testing, early diagnosis, targeted prevention for key populations, and a solid array of social services for people living with HIV/AIDS and their families. This article identifies PEPFAR practices that merit further exploration for adoption in the United States, including strategies to increase adherence to drug treatment regimens and to ensure that HIV services are broadly integrated with other aspects of health care.