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MTN-041 is a multi-site qualitative acceptability study that will utilize focus group discussions (FGDs) and in-depth interviews (IDIs) to explore the attitudes of community members and key informants (KI) from the community about the use of a VR or oral PrEP during pregnancy and lactation. Up to 200 healthy, HIV-uninfected men and women who are 18-40 years of age and who are (or whose partner is) currently pregnant or breastfeeding, and up to 28 KIs (e.g., health providers, midwives, social service providers, local leaders, etc.) will be enrolled in MTN-041. It is anticipated that this study will take approximately 3-6 months to enroll the target sample size. A single FGD (or IDI if unable to schedule an FGD) will be conducted with men and women, and a single IDI will be conducted with KIs, to explore topics such as:

  • Use of oral medications and/or vaginal microbicides by pregnant and lactating women
  • VR and oral PrEP uptake, marketing and other product roll-out issues among pregnant and lactating women
  • HIV risk during pregnancy and lactation
  • Sexual activity among pregnant and lactating women
  • Vaginal practices during pregnancy and lactation
Protocol Chair(s)
Musara, Petina (Protocol Co-Chair)
van der Straten, Ariane (Protocol Chair)
Protocol Title
Qualitative Assessment of Acceptability of Vaginal Ring (VR) and Oral Pre-exposure Prophylaxis (PrEP) Use during Pregnancy and Breastfeeding
DAIDS Protocol ID
Participants off Study and Primary Analysis Completed
Oral Tablet
Vaginal Ring
Study Focus/Product Administration
Study Type
South Africa
Women (cisgender women, non‐transgender women)
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