MTN-041

Primary Objectives

• To explore attitudes about use of a vaginal ring (VR) during pregnancy and breastfeeding, including participants’ willingness to use or recommend/support use of a VR during pregnancy and breastfeeding
• To explore attitudes about use of oral PrEP during pregnancy and breastfeeding, including participants’ willingness to use or recommend/support use of oral PrEP during pregnancy and breastfeeding

Study Summary
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 was submitted to African Journal of AIDS Research. A total of five papers have been published from the study.  

Primary Results
Sixteen single-sex focus group discussions were conducted. Of the 128 participants (65 women, 63 men) 75% lived with their partner and 84% had a child. Women reported the most important influencers when P/BF were partners, and all stated that health decisions when P/BF are typically made jointly (e.g., medication use; ante/postnatal and baby care). There was consensus that P/BF women are at high risk for HIV, primarily because of their partner's infidelities, and new prevention options were welcomed. Participants valued multiple options and stated that woman's personal preference would be key to product choice. Anticipated concerns about products included risk of miscarriage, impact on infant development, complications during delivery and adequate production or taste of breastmilk. Specific perceived disadvantages emerged for the ring (e.g., vaginal discomfort, difficulty inserting/removing) and for pills (e.g., nausea/vomiting) that may be exacerbated during pregnancy. Health care providers' (HCPs) knowledge and approval of product use during P/BF was needed to mitigate anticipated fears.

As for men’s influence on women’s interest in biomedical HIV prevention during pregnancy and breastfeeding, they were depicted by most participants as family heads, breadwinners and protectors of the household, decision makers and in control of women’s use of HIV prevention. Cultural and religious norms were cited to legitimize men’s authority. All groups recommended male partner education and engagement to garner their support in women’s HIV prevention. This study elucidated how P/BF women’s ability to prevent HIV is shaped by traditional gender norms. Findings may aid intervention design to engage men for P/BF women’s effective use of HIV prevention.