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MTN-041 was a multi-site qualitative acceptability study that utilized 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 breastfeeding.

196 participants were enrolled in FGDs within the following three groups: 

  • HIV-uninfected women aged 18-40 who were pregnant or breastfeeding, or who had been pregnant or breastfeeding within the previous two years;
  • Men aged 18 or older whose partners were pregnant or breastfeeding, or whose partners had been pregnant or breastfeeding within the previous two years; and
  • Maternal and paternal grandmothers whose daughters or daughters-in-law were pregnant or breastfeeding, or had been pregnant or breastfeeding within the previous two years

Additionally, MTN-041 enrolled 36 KIs (e.g., health providers, midwives, social service providers, local leaders, etc.) to participate in IDIs. A single FGD was conducted with men and women, and a single IDI was conducted with KIs, to explore topics such as:

  • Use of oral medications and/or vaginal microbicides by pregnant and breastfeeding women
  • VR and oral PrEP uptake, marketing and other product roll-out issues among pregnant and breastfeeding women
  • HIV risk during pregnancy and breastfeeding
  • Sexual activity among pregnant and breastfeeding women
  • Vaginal practices during pregnancy and lactation

The study completed follow-up on November 2, 2018. Preliminary results were presented at the 10th International AIDS Society (IAS) Conference on HIV Science held on July 21-24, 2019 in Mexico City, Mexico. The first primary manuscript was published in Journal of the International AIDS society (JIAS) in June 2020. The second primary manuscript is under review at AIDS Education and Prevention.

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
38161
Status
Participants off Study and Primary Analysis Completed
Formulation
Oral Tablet
Vaginal Ring
Study Focus/Product Administration
Oral
Vaginal
Study Type
Behavioral
Countries
Malawi
South Africa
Uganda
Zimbabwe
Population
Lactating  
Pregnant  
Women (cisgender women, non‐transgender women)
Funder(s)
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