The trial, conducted in 48 communities in Africa and Thailand among roughly 920,900 people, was funded by NIMH, the National Institute of Allergy and Infectious Diseases (NIAID), and the Office of AIDS Research, all part of the National Institutes of Health.
These results are encouraging,” said NIMH Director Thomas Insel, M.D. “They demonstrate the value of community-based interventions for both treatment and prevention.”
“This study shows that community-based approaches can encourage more people, especially those at high risk, to get tested,” said NIAID Director Anthony S. Fauci, M.D. “Additionally, the new methods to determine HIV incidence that were assessed within this study provide important tools to measure the impact of interventions in future studies.”
Globally, 34 million people are living with HIV infection, and a majority of infected individuals do not know they are infected. In the United States, people aged 13 to 24 account for more than a quarter of the 50,000 new HIV infections each year, and 60 percent of these young people have no idea they are infected, according to the U.S. Centers for Disease Control and Prevention. As a result, these individuals are at greater risk of transmitting the virus to their sexual partners. In many countries, HIV testing is not widely available or accessed when available. Further, the stigma associated with testing positive for HIV infection is also a primary driver for low HIV testing rates. Many existing HIV prevention programs, especially in sub-Saharan Africa, have reported difficulty in reaching men.
NIMH Project Accept, which launched in 2003, was a Phase III community randomized trial. Its goal was to test whether a community-based HIV prevention program could reduce the rate of new HIV infections, increase HIV testing rates, and reduce high-risk sexual behaviors in comparison to standard HIV testing and counseling provided in the clinic setting.
The study, which had four major intervention strategies, measured HIV incidence through a randomly selected sample of the population regardless of whether they participated in the study’s interventions to assess the effect. The four strategies included mobilizing communities through stakeholder meetings, HIV education, and outreach to change community norms about HIV awareness, particularly the benefit of knowing one’s HIV status.
Increasing access to voluntary testing and counseling through free rapid testing in mobile vans providing post-test support services such as workshops on stigma reduction and support groups for infected individuals providing feedback to researchers in real-time as a way to rapidly assess how the interventions were working.
The researchers found that the incidence measurements used in this study helped to accurately assess HIV incidence in an easier way than had been done in previous studies.
The study was led by study chair Thomas Coates, Ph.D., director of the Center for World Health at the University of California, Los Angeles. Researchers conducted the study in 16 communities in South Africa, 10 communities in Tanzania, eight communities in Zimbabwe, and 14 communities in Thailand—all areas where the rate of new HIV infections is high. For three years, individuals in all 48 communities received either the community-based interventions (intervention) or standard clinic-based voluntary testing and counseling (control). Outcomes were evaluated among a population-based sample of 54,326 community residents ages 18 to 32, not only those in the community who participated in the intervention.
The researchers found that HIV testing increased by 45 percent among men and 15 percent among women who received the community-based intervention, as compared to individuals who received the control intervention. Based on this increased testing, the community intervention group experienced an almost four-fold increase in the detection of new HIV cases at three sites. Compared with HIV-infected participants in the control communities, HIV-infected participants in the intervention communities reported 18 percent fewer sexual partners (multiple sexual partners, but the relationships do not overlap). They also reported 30 percent fewer concurrent sexual partners (steady sexual relations with more than one person during the same period of time). This effect was greatest among HIV-infected men.
Overall, the study did not have a statistically significant effect on HIV incidence. However, it provided a trend to suggest that the community-based intervention could potentially reduce the number of HIV infections compared to the clinic-based approach. On an individual level, this trend towards reduction was greatest among those ages 25 to 32 (25.4 percent) in comparison to 18 to 24-year olds (1.5 percent).
The study also found that a community-based HIV testing intervention did not trigger negative life events, such as the break-up of a marriage or sexual relationship, physical abuse by a sexual partner, neglect by family, rejection by peers, or being discriminated against by providers or employers.
Study participants who learned that they were HIV-infected were directed to post-test services, which included counseling, referrals to health care, and social services assistance. Participants who tested negative for HIV infection were also directed to post-test services for further counseling and support in staying uninfected. Local health authorities for each of the sites were thoroughly briefed on the study intervention strategy and encouraged to continue implementation efforts or adopt the intervention strategy after NIMH Project Accept concluded.
“NIMH Project Accept starts a new era of HIV prevention research,” said Dr. Coates. “We now have to see whether or not the strategies, proven effective in other controlled clinical trials, can work at the level of the entire community. Controlling HIV means bringing down transmission in entire communities, not just in selected cohorts. This is the first study to tackle this question and demonstrate progress.”
Results from the study will help inform other research as well, including the Population Effects of Antiretroviral Therapy to Reduce HIV Transmission study, set to launch this spring. The study, which is being funded by the President’s Emergency Plan for AIDS Relief and NIAID, is designed to determine the impact of several combination prevention packages, including universal HIV testing and intensified access to antiretroviral therapy, on HIV incidence in Africa.
The HIV Prevention Trials Network (HTPN) conducted NIMH Project Accept under grant 5U01MH066701-08.The network is largely funded by NIAID with additional funding from the NIMH and the National Institute on Drug Abuse, also part of NIH.