Elizabeth Irungu, MBChB, MPH
Nominated From: University of Washington
Research Site: University of Nairobi, Kenya
Project: Evaluation of risk score to identify higher-risk HIV 1 serodiscordant couples for evaluation of an antiretroviral based HIV1 prevention intervention.
Primary Mentor: Jared Baeten, MD MPH (University of Washington)
Research Project Background
Recently, two randomized controlled trials (HPTN 052 and the Partners PrEP Study) demonstrated that antiretroviral-based HIV-1 prevention – including antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) – significantly reduced HIV-1 incidence among HIV-1 serodiscordant couples in Africa. Demonstration projects to establish the effectiveness and deliverability of antiretroviral-based prevention for serodiscordant couples are a priority. An important consideration for implementation of antiretrovirals for HIV-1 prevention is that these strategies are expensive and complex. Mathematical modeling studies have found that targeted delivery of antiretrovirals to those at highest risk of HIV-1 transmission, while also providing other available risk-reduction interventions to all couples, may be most cost-effective and would yield the greatest public health impact. Within recognized ‘high’ risk populations there are sub-populations of vulnerable groups who should be targeted for combination prevention. A standardized risk score developed from the Partners PrEP analysis, provides an opportunity to provide targeted HIV prevention to a sub-population of HIV- 1 serodiscordant couples who are at most risk for HIV infection. The risk score was developed and validated using data from three prospective studies of African HIV-1 serodiscordant couples (>8500 couples). This score uses a discrete combination of easily-available information (age, number of children, plasma HIV-1 levels in the HIV-1 infected partner, male circumcision status, condom use, marital status) to identify couples at highest risk for HIV- 1 transmission – i.e., with an incidence of ≥5% per year for those with a high score versus as low as <1% per year for those with lower scores. This risk score tool may be useful for targeted implementation of HIV-1 prevention, prioritized for those at greatest risk, as well as to optimize efficient recruitment for research studies of couples.
Through NIH funding (R01 MH095507, PI: Baeten), the University of Washington-Kenyatta National Hospital Partners PrEP Study site in Thika, Kenya has initiated an open-label pilot demonstration and evaluation project of antiretroviral-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples (The Partners PrEP Study Demonstration Project). This cohort provides a unique opportunity to evaluate the feasibility of use of the risk scoring tool to identify and enroll higher risk HIV-1 serodiscordant couples.