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Current Research Studies

Learn more about the work of the Rakai Health Sciences Program.

Jump to these studies:

Rakai Community Cohort Study (RCCS)

RCCS team

The Rakai Community Cohort Study team. (Click for large version of photo.)

Since its inception in 1988, the core of the Rakai Health Sciences Program (RHSP) has been the Rakai Community Cohort Study (RCCS). The current 50-village cohort was established in 1994/95, based in part on an earlier smaller cohort study initiated in 1989. The cohort enrolls all resident, consenting adults aged 15-49. All participants are followed annually in the home, at which time they provide survey information and biological samples for detection of HIV, STDs, and other infections. This is an open cohort which enrolls new in-migrants and newly-age-eligible residents at each annual survey visit. The open cohort structure maintains the number of participants under surveillance at around 12,000 annually and prevents the cohort population becoming atypical due to attrition.

The RCCS provides a framework within which multiple sub-studies can be conducted at modest incremental cost. Building on the prospective cohort design, Rakai investigators have conducted large scale randomized trials; operations research; studies of molecular epidemiology, including the effects of HIV viral load and subtypes on dynamics of transmission; and observational studies on the links between male circumcision and HIV acquisition/transmission and on the socio-behavioral determinants of HIV risk. Other studies have examined the impact of HIV on demographic parameters, household composition, orphanhood, and marital stability. The cohort has also facilitated provisions and evaluation of voluntary HIV counseling and testing (VCT), prevention of mother-to-child HIV transmission, promotion of family planning, and screening for cervical cancer. More recently, we have introduced antiretroviral (ARV) therapy, and the cohort will provide a mechanism for evaluating the impact of ARVs on HIV epidemiology and risk behaviors at a population-level.

Male Circumcision for HIV Prevention (NIAID)
and
Randomized Trial of Male Circumcision, STD, HIV and Behavioral Effects in Men, Women and the Community (Bill and Melinda Gates Foundation)

Research by Rakai Health Sciences Program (RHSP) scientists and others suggested that male circumcision could reduce the risk of HIV acquisition in men and reduce transmission of HIV from infected men to their uninfected female partners (Gray et al 2000). On the basis of these findings, the RHSP has conducted two randomized trials of circumcision for HIV prevention in men and women.

One trial, supported by NIH, enrolled 5,000 HIV-negative men who agreed to learn their HIV results. This trial was designed to determine whether male circumcision could protect uninfected men from HIV. The other trial, supported by the Gates Foundation, enrolled 800 HIV+ and monitored HIV infection in around 7,000 female partners of men enrolled in either trial. This study was designed to determine whether male circumcision could protect uninfected women from HIV. 

In both studies, consenting men aged 15-49 were randomized to either receive circumcision immediately after enrollment (the intervention arm), or circumcision delayed for two years (the control arm). Participants were then followed up at 6, 12, and 24 months to determine rates of HIV infection. Other important trial objectives were to determine the safety of circumcision in HIV+ and HIV-negative men, the effects of circumcision on sexually transmitted infections, and to assess whether an exaggerated belief in the protective efficacy of circumcision might result in an increase in sexual risk behaviours (i.e., “risk compensation” or “behavioural disinhibition”).

HIV Incidence in Circumcised and Uncircumcised Men

The NIH trial of HIV-negative men was stopped on December 12, 2005, six months earlier than planned, because an interim analysis showed a 50 persent reduction of HIV infection in intervention arm compared to control arm. This is an “intent-to-treat” analysis which includes all men randomized to circumcision or to control the arm.  However, 6 percent of men randomized to circumcision changed their minds and did not receive surgery, and 1.3 percent of controls received surgery from other sources. When the analysis is restricted to men who actually received or did not receive surgery (called an “as treated” analysis), HIV incidence was reduced by 55 percent.

These findings are supported by two other trials, one in South Africa and the other in Kenya, which showed comparable protection of circumcision against HIV in young men aged 18-24. These three trials provide unequivocal evidence that circumcision can reduce the rates of HIV infection in men, and that provision of male circumcision to men and boys could play a major role in control of the HIV epidemic in sub-Saharan African countries where circumcision is infrequent and where heterosexual transmission is the primary mode of HIV infection. Such countries include much of Eastern and Southern Africa, where the HIV epidemic is most severe. 

These findings have been hailed as the most important advance in HIV control since the development of antiretroviral drugs in the mid 1990s, and model estimates suggest that male circumcision programs could significantly abate the epidemic over the next 10-20 years. The challenge is now to scale up circumcision services for the populations in need, and a meeting of international and national donor programs and foundations has been scheduled in Geneva in March, 2007, to plan the next steps in this innovative strategy.

ARV Effects on HIV Epidemiology and Behaviors (NICHD)
In front of the clinic

Patients wait in front of one of the RHSP clinics in Rakai District.

This study is nested within the Rakai Community Cohort Study. It examines epidemiological, socio-demographic (behavioral disinhibition, use of HIV counseling and testing, use of other prevention services, contraceptive use, mortality, fertility, marital stability and orphanhood), and virological effects of antiretroviral drugs (ARVs) in Rakai. The study will examine knowledge and attitude towards ARVs and the effect of stigma on ARV use. The study will provide unique data to guide HIV care in Africa and for projecting the course of the epidemic in the ARV era. This is a five-year study which will run up to 2010.

There are several studies which are nested within the ARV study:

  • ARV-Related Maternal Infant Study
    To assess the impact of HIV and antiretroviral use on the morbidity and mortality of women and children
  • ARV-Related Clinical Study
  • ARV-Related Qualitative Study
    To assess knowledge, attitudes, practices, and beliefs about HIV, HIV prevention and care, and antiretrovirals in Rakai communities.
  • Fever in Ugandan Outpatients: A Microbiological Survey of Causative Organisms and Clinical Determinants Study
    The aims of this study are to assess infectious causes of illness and their effects among clinic participants, including malaria, bacterial bloodstream infections, mycobacterial illnesses and others.
  • Morbidity/ Mortality and Disability in Children Study
    As part of the ARV-Related Maternal Infant Study, the aims of this study are to assess the effects of HIV infection in the child and/or the mother on birth outcomes (birth weight, gestational age), child health (morbidity), growth and development (anthropometry), neourodevelopmental disability (cognitive, motor and behavioral disorders), and mortality. The effects of antiretroviral therapy on each of these outcomes will also be assessed.

Impact of Peer Educators and Mobile Phones on HIV Care

Building on the experiance of previously assessed pilot study, we will conduct a three arm, cluster-randomized trial of the impact on HIV care of peer educators, with and without mobile phones (intervention arms A and B), compared to a control arm in rural Rakai District, Uganda. The peer educators will be supported with a Warmline toll free service staffed by clinicians experienced in HIV care. The primary endpoints will be virologic treatment failure and antiretroviral (ARV) adherence over one year. The hypotheses are that compared to control communities, peer educators will reduce treatment failures and improve ARV adherence, and mobile phones used by peer educators will more rapidly address adherence and clinical problems, resulting in lower treatment failures.

Assessing the Impact of a Community-Based Intervention Designed to Reduce Levels of Physical and Sexual Domestic Violence in Rakai District, Uganda 

This is an evaluation study to assess the effectiveness and impact of the first two years of the Safe Homes And Respect for Everyone (SHARE) Project, RHSP’s primary domestic violence prevention intervention.  The evaluation has a quasi experimental design. The primary research component will be quantitative survey questions nested into the 13th round of the Rakai Community Cohort Study (RCCS), beginning in early 2008. The secondary research component will be qualitative interviews and focus group discussions to collect in-depth information on attitudes about domestic violence, behaviors related to physical and sexual violence, factors that contribute to physical and sexual violence, accounts of the experience and perpetration of violence, accounts of the experience of violence prevention and intersections between domestic violence and HIV/AIDS.

Other studies include:
Epidemiology of Pneumocystis
Acyclovir Prophylaxid Study and Impact of Peer Educators

Voices from Rakai

David Serwadda

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[In Africa] we are truly at a crossroads. If we can invest in prevention, then we have a chance that we may actually reduce both incidence of the disease and make a dent in the epidemic. I really don't think we have invested in antiretroviral education in Africa the way we should have, and there isn't a good companion program at the moment in monitoring resistance. That is the capacity we're starting in Rakai...>

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David Serwadda
Founding Principal Investigator, Rakai Health Sciences Program

Center for Global Health

 

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Rakai Health Sciences Program

Johns Hopkins Bloomberg School of Public Health

Uganda Virus Research Institute

National Institute of Health