MTN HIV-1 Seroconverter Study

An Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials

Short Title: MTN HIV-1 Seroconverter Study

Rationele

Evaluation of the effect of microbicides or oral PrEP use on the natural history of HIV-1 infection is essential for the development of guidance for the use of these products in populations at risk of HIV-1 infection. At this time, no data are available to predict the likelihood of either risk or benefit among MTN study participants who become HIV-infected during product use. Careful monitoring of microbicide and oral PrEP study participants who acquire HIV-1 infection during product usage will provide critical knowledge to inform the field.

In MTN Phase II, IIB, and III trials, participants are monitored routinely for HIV-1 seroconversion (typically every 1-3 months). For the purposes of MTN-015, HIV Prevention Trials Network (HPTN) 035, MTN-003, MTN-020 and other trials of efficacy are considered MTN studies from which participants may be drawn. In addition, studies investigating both microbicides and oral PrEP will be considered studies from which participants in MTN-015 may be drawn.

MTN-015 will routinely collect and monitor laboratory and clinical data from participants who become HIV-1 infected during microbicide trials to characterize the natural history of infection and eventually the response to antiretroviral therapy in this population. To provide adequate comparison group(s) for specific analyses of interest, all participants with seroconversion during parent study participation will be eligible for enrolment into this protocol regardless of the specific product or placebo or the route of administration.

Individuals recently HIV infected often have high viral loads and may be highly infectious. Risky sexual behaviour soon after infection therefore carries high potential for HIV transmission to others. Upon becoming aware of recent HIV infection, some but not all individuals change behaviours to reduce their risks of transmitting HIV. Possible mediators of such behaviour change include dynamics of partnerships and disclosure. Observation of individuals with recent HIV-1 infection over time can provide information critical to secondary prevention. Many HIV positive individuals in Africa do disclose their status, with rates as high as 92% reported in one South African study. Conversely, there is evidence that disclosure is less common; for example in another South African study 42% of HIV-positive people reported not disclosing their status to a partner with whom they have had recent sexual intercourse, with a high percent of these acts unprotected. Participants of microbicides trials may have different responses to disclosure as their trial participation may have been known by a partner. The pattern of behaviour change in this unique situation to reduce transmission is important to describe and may help future counselling programs for HIV positive individuals in developing countries. Describing the pattern of behaviour change among newly HIV infected individuals in comparison to those who are negative or chronically infected (from HPTN 035 and other datasets), will inform counselling strategies to reduce further HIV infection.

Primary Objectives

To compare HIV disease progression 12 months post seroconversion among participants assigned to an active agent compared to placebo/control participants.

Study Population

Participants who have HIV-1 seroconversion during participation in microbicide trials

Invetigators

  • Prof Helen Rees, National Principal Investigator
  • Dr. Thesla Palanee-Phillips, Site Principal Investigator
  • Dr. Yuthika Naidoo, Sub-Investigator
  • Dr. Eleanor Matta, Sub-Investigator

Donors

  • Division of AIDS, US National Institute of Allergy and Infectious Diseases US
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development
  • US National Institute of Mental Health
  • US National Institutes of Health

Latest Update: 15 February 2021

For more about MTN HIV-1 Seroconverter Study please email rhicomms@wrhi.ac.za