Multi-Disease Health Fairs, Universal “Test and Treat” Help East African Communities Achieve HIV Benchmarks

PEPFAR- and NIH-Supported Study Results Support Patient-Centered Approach to Care Delivery

People living with HIV in rural East African communities that hosted annual community health campaigns initiated antiretroviral therapy (ART) earlier and had higher levels of overall survival and viral suppression than communities receiving standard HIV care, according to study data presented today at a press conference at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam.

A SEARCH health educator in Kisoro, Uganda, sings about the need to be tested for HIV and start ART.

Communities with annual multi-disease health fairs, which delivered patient-centered, streamlined HIV care, also had fewer cases of tuberculosis (TB), better control of hypertension and approximately 30 percent fewer new HIV cases during the last year of the study compared to the first year.

The study, known as Sustainable East Africa Research in Community Health (SEARCH), is supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) and the National Institutes of Health (NIH).

SEARCH investigators randomly assigned 32 rural communities in Uganda and Kenya to receive either a multi-faceted intervention that integrated universal HIV testing and treatment into annual health screenings for multiple conditions or standard HIV care at HIV clinics, which consisted of baseline community-wide HIV testing and treatment with ART in accordance with national guidelines. In 2015, while the study was taking place, national guidelines in Uganda and Kenya shifted from a recommendation that individuals begin ART when CD4+ T cell levels—an indicator of immune system health—dipped below a certain threshold to a recommendation that all individuals living with HIV begin ART at the time of diagnosis.

In communities randomized to receive the intervention, the SEARCH team held annual community health campaigns, which began with a census and then engaged community members through two-week health fairs. Participants received health education; screenings for HIV hypertension, diabetes, and TB; and prompt care for any health conditions detected, including providing immediate ART for those who tested positive for HIV.

At the end of the three-year study, rates of deaths from any cause among people living with HIV in the intervention communities were 21 percent lower than in communities receiving standard care. People living with HIV in communities that received the intervention also experienced 59 percent fewer new TB cases compared with the standard care communities. TB, a bacterial infection that affects the lungs, is a leading cause of death among people living with HIV across the globe and is particularly endemic in East Africa.

Prior to the study, investigators found that nearly half of individuals living with HIV in the 32 rural communities in Uganda and Kenya were virally suppressed—consistent use of daily ART had reduced their HIV blood levels to undetectable by standard tests. HIV suppression both benefits the health of those living with HIV and prevents sexual transmission(link is external) of the virus. At the end of the three-year study, 80 percent of people living with HIV in communities randomized to the intervention were virally suppressed compared to 68 percent in communities that received standard HIV care.

“We know that the ability of antiretroviral therapy to suppress HIV to undetectable levels is not only life-saving for individuals, but also prevents sexual transmission of the virus,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, part of NIH. “Innovative implementation of antiretroviral therapy through community health initiatives may be one way to save lives and change the trajectories of even the most ingrained epidemics.”

The SEARCH study outcomes exceeded international HIV testing and treatment goals set by UNAIDS, which call for 90 percent of people living with HIV to be diagnosed, 90 percent of those diagnosed to be on ART, and 90 percent of those in treatment to be virally suppressed by 2020. If met, the 90-90-90 targets would result in 73 percent of people living with HIV being virally suppressed. At the start of the study, the SEARCH team tested about 90 percent of the population in communities set to receive either the intervention or standard care. Through repeated annual testing in intervention communities, more than 95 percent of the population received an HIV test. Those diagnosed through community health campaigns were more likely to start ART, and viral suppression increased dramatically among individuals taking ART in all communities. In intervention communities, population-level viral suppression was 80 percent, surpassing the 90-90-90 target of 73 percent. Standard care communities approached the target with 68 percent of community members living with HIV virally suppressed. The reduction in HIV infections over the course of the study was similar between intervention and standard care communities.

“Our team hypothesized that partnering with communities to deliver patient-centered care for a range of common diseases, including but not exclusively HIV, would reduce new HIV infections and improve community health,” said Diane Havlir, M.D., principal investigator of SEARCH, at the University of California, San Francisco.

Investigators found that annual community health campaigns and streamlined care delivery also had a positive impact on the burden of diseases other than HIV. Patient-centered health care in the intervention communities led to better control of hypertension and diabetes. Investigators observed 16 percent fewer cases of uncontrolled hypertension in intervention communities compared with standard care communities, where uncontrolled hypertension was common.

While men and youth have participated at lower rates in HIV testing and treatment programs in Sub-Saharan Africa, the SEARCH model resulted in 74 percent of men living with HIV in intervention communities achieving viral suppression by the end of the study. However, youth between the ages of 15 and 24 living with HIV were nearly 20 percent less likely to be virally suppressed compared with community members over age 24. Investigators also found that about two thirds of all study participants who acquired HIV during the study period were women, but that in Western Uganda, a higher proportion of people who acquired HIV during the study were young, single men of low social and economic status.

SEARCH is led by Dr. Havlir and by co-principal investigators Moses Kamya, M.B.Ch.B., Ph.D., at Makerere University in Uganda, and Maya Petersen, M.D., Ph.D., at the University of California, Berkeley.

Combination HIV prevention reduces new infections by 42 percent in Ugandan district

A study published today in the New England Journal of Medicine provides real-world evidence that implementing a combination of proven HIV prevention measures across communities can substantially reduce new HIV infections in a population.

 

A research assistant draws blood for HIV testing from a participant in the Rakai Community Cohort Study.Rakai Health Sciences Program

Investigators found that HIV incidence dropped by 42 percent among nearly 18,000 people in Rakai District, Uganda, during a seven-year period in which the rates of HIV treatment and voluntary medical male circumcision increased significantly.

 

The HIV prevention strategy whose impact was observed in the study is based on earlier findings by the National Institutes of Health and others demonstrating the protective effect of voluntary medical male circumcisionfor HIV-uninfected men and of HIV-suppressing antiretroviral therapy (ART) for halting sexual transmission of the virus to uninfected partners. The strategy is also based on studies showing that changes in sexual behavior, such as having only one sexual partner, can help prevent HIV infection.

“Before this study, we knew that these HIV prevention measures worked at an individual level, yet it was not clear that they would substantially reduce HIV incidence in a population — or even if it would be possible to get large numbers of people to adopt them,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. “This new analysis demonstrates that scaling up combination HIV prevention is possible and can turn the tide of the epidemic.”

NIAID co-funded the research, and NIAID investigators oversaw all laboratory operations. The President’s Emergency Plan for AIDS Relief (PEPFAR) funded the provision of combination HIV prevention, including ART and circumcision services, during the period observed in the study.

The newly reported research involved nearly 34,000 people ages 15 to 49 years residing in 30 communities that participate in the Rakai Community Cohort Study (RCCS) conducted by the Rakai Health Sciences Program in Uganda. With funding from NIH and others, this program promoted HIV testing, ART and voluntary medical male circumcision to study participants. Every one or two years from April 1999 until September 2016, participants were tested for HIV and surveyed about their sexual behavior, use of HIV treatment, and male circumcision status. The authors of the new paper analyzed these survey data under the leadership of M. Kate Grabowski, Ph.D., an assistant professor of pathology at the Johns Hopkins University School of Medicine in Baltimore and of epidemiology at the Johns Hopkins University Bloomberg School of Public Health, and an epidemiologist with the Rakai Health Sciences Program.

The investigators found that the proportion of study participants living with HIV who reported taking ART climbed from zero in 2003 to 69 percent in 2016. The proportion of male study participants who were voluntarily circumcised grew from 15 percent in 1999 to 59 percent in 2016. While levels of condom use with casual partners and the proportion of people reporting multiple sexual partners remained largely unchanged, the proportion of adolescents ages 15 to 19 who reported never having sex rose from 30 percent in 1999 to 55 percent in 2016.

As an apparent consequence of these increases, particularly in ART use and voluntary male circumcision, the annual number of new HIV infections in the cohort fell from 1.17 per 100 person-years in 2009 to 0.66 per 100 person-years in 2016, a 42 percent decrease. Person-years are the sum of the number of years that each cohort member participated in the study. The researchers calculated the annual number of new HIV infections using data from nearly 18,000 of the almost 34,000 total participants.

In addition, the proportion of cohort members living with HIV whose treatment suppressed the virus increased from 42 percent in 2009 to 75 percent in 2016, showing the feasibility of meeting the goal of the UNAIDS 90-90-90 initiative(link is external) to achieve 73 percent viral suppression.

“These findings are extremely encouraging and suggest that with sustained commitment to increase the number of people who use combination HIV prevention, it may be possible to achieve epidemic control and eventual elimination of HIV,” said David Serwadda, M.B.Ch.B., M.Med., M.P.H., co-founder of the Rakai Health Science Program and professor at Makerere University School of Public Health in Kampala, Uganda.

HIV incidence dropped the most — by 57­­ percent — among circumcised men, likely because both their own circumcision and ART taken by their female sexual partners living with HIV protected these men from the virus. HIV incidence declined by 54 percent among all men but by only 32 percent among all women. According to the investigators, this difference probably occurred because a greater percentage of women living with HIV than men living with HIV took ART, and because nearly two-thirds of men chose the extra preventive benefit of circumcision. The researchers suggest addressing this gender imbalance by influencing more men living with HIV to take ART and by giving HIV-uninfected women HIV prevention tools that they can control unilaterally, such as pre-exposure prophylaxis (PrEP). The scientists anticipate that the RCCS will add PrEP to its combination HIV prevention package as the study continues.

“We expect that this multifaceted approach to HIV prevention will work as well in other populations as it has in rural Uganda,” said Dr. Grabowski. “Our results make a strong case for further expanding ART and male circumcision for HIV prevention in Rakai District and beyond. Additional proven HIV prevention interventions, such as PrEP, should be added to the mix to reduce HIV infections in women and other high-risk groups.”

The Rakai Health Sciences Program is an independent research organization whose collaborators include the Uganda Virus Research Institute of the Ministry of Health in Kampala, the NIAID Division of Intramural Research-supported International Center for Excellence in Research in Rakai, the U.S. Centers for Disease Control and Prevention partnership with Uganda (CDC-Uganda), Makerere University and the Johns Hopkins University Bloomberg School of Public Health.

The RCCS and the new analysis were funded by NIAID, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH), all part of NIH; as well as by the World Bank, the Doris Duke Charitable Foundation, the Bill & Melinda Gates Foundation, the Johns Hopkins University Center for AIDS Research and PEPFAR.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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Reference

MK Grabowski, et al. Combination HIV prevention and HIV incidence in Uganda. NEJM DOI: 10.1056/NEJMoa1702150 (2017).