NCT03648931

Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa

Qualitative Assessment of Acceptability of Vaginal Ring (VR) and Oral Pre-exposure Prophylaxis (PrEP) Use During Pregnancy and Breastfeeding

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 232 (actual)
• Sponsor: Microbicide Trials Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The MTN-041 study is a multi-site exploratory study using focus group discussions (FGDs) and in-depth interviews (IDIs) to identify individual, interpersonal, social and cultural factors that may affect potential uptake of two safe and effective HIV prevention products, the monthly dapivirine (DPV) vaginal ring (VR) and daily oral pre-exposure prophylaxis (PrEP), by pregnant and breastfeeding women in Africa.

Detailed description

MTN-041 is an exploratory study primarily designed to identify individual, interpersonal, social and cultural factors that may affect potential uptake of two safe and effective HIV prevention products, the monthly DPV VR and daily oral PrEP, in a vulnerable yet seldom-studied population, pregnant and breastfeeding women. MTN-041 will utilize FGDs and IDIs to elicit community and health professional perceptions about vaginal practices, sexual activity, use of medicines, and HIV risk during pregnancy or breastfeeding, including how these perceptions may affect pregnant and breastfeeding women's acceptability of using intravaginal products and oral medications like the DPV VR and Truvada oral tablet. The MTN-041 study population will consist of HIV-uninfected women 18-40 years old who are currently or were recently (within two years) pregnant or breastfeeding, men aged 18 years or older whose partners are currently or were recently (within two years) pregnant or breastfeeding, grandmothers whose daughters or daughters-in-law are currently or were recently (within two years) pregnant or breastfeeding, and key informants (KIs), which include: health care professionals (HCPs), traditional birth attendants (TBAs), providers of family planning, antenatal, and traditional health services to women, providers of other social services to women, and community leaders. Up to 60 men and women will be selected at each site for participation in this study, for a maximum total of 240 study participants. This includes up to 50 FGD participants (currently or recently pregnant or breastfeeding women, male partners of women who are currently or were recently pregnant or breastfeeding, and grandmothers with currently or recently pregnant or breastfeeding daughters/daughters-in-law) and up to 10 KIs selected at each site, for a maximum total of 200 FGD participants and 40 KIs enrolled across all sites.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
BEHAVIORAL	Focus Group Discussion (FGD)	No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures. In particular, the FGDs will focus on: * Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding * Perceptions of HIV risk during pregnancy and breastfeeding * Perceived role of male partners during pregnancy and breastfeeding * Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding * Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding * Willingness to join a VR and/or oral PrEP study during pregnancy and breastfeeding
BEHAVIORAL	In-depth Interview (IDI)	No actual intervention is planned. A single in-depth interview (IDI) will be conducted to assess study outcome measures, focusing on the following topics: * Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding * Perceptions of HIV risk during pregnancy and breastfeeding * Perceived role of male partners during pregnancy and breastfeeding * Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding * Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding * How others in their professional and social networks and communities would view the VR and/or oral PrEP use by pregnant and breastfeeding women

Timeline

• Start date: 2018-05-31
• Primary completion: 2018-11-02
• Completion: 2018-11-02
• First posted: 2018-08-28
• Last updated: 2022-10-14

Locations

4 sites across 4 countries: Malawi, South Africa, Uganda, Zimbabwe