HPTN 082 is a sub-Saharan-based research study designed to assess the number of and characteristics of young women who accept versus decline pre-exposure prophylaxis (PrEP) at enrollment. The study will also compare adherence to PrEP between women who are randomized to receive standard adherence support and those receiving enhanced adherence support.
Protocol Based Projects
HPTN 067, also known as the ADAPT Study, was designed to assess whether non-daily use of oral FTC/TDF as pre-exposure prophylaxis (PrEP), compared with daily use, would demonstrate equivalent coverage of sex acts, lower number of pills needed for coverage and decreased self-reported drug side effects over 24 weeks. The study also evaluated self-reported adherence and analyzed drug levels in the blood of participants.
HPTN 065, also known as the Test, Link-to-Care Plus Treat (TLC-Plus) study, was a three-year research study evaluating the feasibility of a community-focused strategy to expand HIV testing, diagnose HIV infection, link HIV-positive individuals to medical care, initiate treatment according to current guidelines and ensure that patients adhere to their treatment regimens. This continuum, which begins with HIV testing and ends with viral suppression, is essential for a successful community-wide strategy centered on the use of antiretroviral therapy for HIV prevention. HPTN 065 (TLC-Plus) was designed with the aim to increase testing, linkage and viral suppression, key steps of the continuum.
HPTN 078 is a US-based research study designed to develop and determine the effectiveness of a combined HIV prevention strategy that includes a method to identify, recruit, and link MSM to HIV care and an intervention to help HIV-infected MSM achieve and maintain viral suppression (low level of HIV in the body).
Non Protocol Based Projects
Women constitute about 25% of new HIV infections in the US with about 66% of these infections occurring among black women, even if black women only represent 14% of the US female population. We also know that young women at particularly vulnerable to HIV and that receptive anal intercourse (RAI) is more efficient than receptive vaginal intercourse (RVI) at transmitting HIV, but its contribution to heterosexually-acquired HIV infections among at-risk women in the US is unclear. It is therefore important to gain a better understanding of the contribution of RAI to the number of new HIV infections acquired in a year among heterosexual women, black ad young women in order to inform data needs, HIV prevention and product development.
Understanding the impact of past interventions and the vulnerability of specific key population to acquire and transmit HIV infection and how it affected transmission dynamics is the first key step to guiding prevention efforts in Ivory Coast and elsewhere. In particular, current evidence suggests that anal intercourse (AI) during sex work is common in sub-Saharan Africa, but very few studies have assessed the contribution of heterosexual AI on the human immunodeficiency virus (HIV) epidemics. With the aim of cutting HIV transmission substantially in a near future, the Joint United Nations Programme on HIV/AIDS (UNAIDS) has set ambitious targets of scaling HIV treatment worldwide such that 90% of HIV-positive individuals are aware of their status, 90% of those aware receive antiretroviral therapy (ART), and 90% of those on treatment have a suppressed viral load by 2020, with each individual target reaching 95% by 2030. Thus, in many settings national responses will need to be markedly accelerated to achieve the ambitious UNAIDS targets. It is therefore important to determine the gaps to UNAIDS targets and the likely impact and cost of meeting these target on time or meeting them late.
New biomedical modalities for HIV prevention are currently undergoing testing in randomized controlled trials (RCTs) among individuals believed to be at-risk of HIV. The design of these RCTs typically assumes a common effectiveness at all levels of HIV acquisition risk, irrespective of exposure level. However, if participants with low or no HIV exposure are enrolled—a group in which an effective intervention cannot demonstrate an effect—then attenuation of observed treatment efficacy and hereby reduced efficiency of RCTs will occur. Here, we explore the extent to which enrolling large fractions of participants rom populations with consistently high exposure to HIV, such as female sex workers (FSWs), may improve the efficiency of an RCT and more accurately estimate product efficacy in future HIV prevention trials.
The effectiveness of male circumcision (MC) as an HIV prevention measure among heterosexual men has been definitively demonstrated in three groundbreaking trials. The individual efficacy and population-level effectiveness of MC as an HIV prevention measure among men who have sex with men (MSM) remains untested in clinical trials but results from observational studies suggest that it varies by behavioural and demographic differences observed in populations of MSM worldwide. Models are used to understand in which setting the scale up of circumcision could be useful worldwide and if a clinical trial could be warranted.