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Introduction: Women in sub-Saharan Africa spend a substantial portion of their reproductive lives pregnant and/or breastfeeding (P/BF), yet they have limited options to prevent HIV during these maternal stages. In preparation for phase 3b prevention trials in P/BF women, we explored attitudes about using a vaginal ring or oral pills for pre-exposure prophylaxis (PrEP), perceptions of HIV risk during P/BF and key influences on future PrEP use. Methods: In 2018, we conducted 16 single-sex focus group discussions (FGDs) with community- and clinic-recruited HIV-uninfected women, currently or recently P/BF, aged 18 to 40, and men with (currently or recently) P/BF partners, aged 18+. Participants completed a behavioural questionnaire, viewed an educational video and handled prototype placebo products. FGDs were conducted in local languages and transcribed, coded and analysed, using a socio-ecological framework, for key influences on willingness to use products, HIV risk perceptions and opinions on product attributes. Results: 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. Conclusions: Participants perceived pregnancy and breastfeeding as high HIV risk periods and valued new prevention options. HIV protection of the mother-child dyad, safety of the baby, and ultimately, health of the family were paramount. Endorsement by HCPs and support from partners were key to future product acceptance. Participants recommended involving partners and HCPs in sensitization efforts for future trials.
MTN‐041/MAMMA (Microbicide/PrEP Acceptability among Mothers and Male Partners in Africa), a multisite study in Blantyre, Malawi; Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, was conducted between May and November 2018. Sixteen single‐sex focus group discussions (FGDs) were conducted across all sites, with individuals independently recruited into the following groups: (a) self‐reported HIV‐uninfected women aged 18 to 40 who were currently or recently (in the past two years) P/BF; or (b) men aged 18+ with female partners who were currently or recently (in the past two years) P/BF. Participants were recruited from various community settings (e.g. street outreach, community advisory board members, word of mouth, construction sites (men only)), antenatal and postnatal clinics (women only)); 129 were screened and eligible and 128 joined the study. Placebo pills for daily oral PrEP (identical in appearance to Truvada, Gilead Sciences, Foster City, CA, USA) and a silicone elastomer placebo ring (identical in appearance to dapivirine vaginal ring, International Partnership for Microbicides, Silver Spring, MD, USA) were presented for handling during FGDs. Demographic and behavioural information were collected through interviewer‐administered questionnaires translated into local languages (Chichewa in Malawi, Zulu or English in South Africa, Luganda in Uganda and Shona in Zimbabwe). The decision‐making dominance subscale was adapted from Pulerwitz et al. [22]. The food insecurity item was based on the Household Food Insecurity Access Scale [23]. FGDs were conducted in these languages using semi‐structured guides by gender‐matched trained local social scientists. All site staff were fluent in the local language of their country, and FGD participants were required to speak and understand the language in order to participate. Topics discussed included HIV risk perceptions, health‐related decision making, key influencers, and interest in HIV prevention methods while P/BF. Just prior to discussing new HIV prevention options, participants viewed a brief educational video and handled prototype placebo products (Figure 1). FGDs were audio recorded, transcribed and translated into English. Interviewers completed a summary report after each FGD for rapid thematic analysis. Screenshots from educational video and demonstration placebo study products. The four‐minute educational video (https://vimeo.com/262813431/dd19ece7dc) was presented at midpoint into the FGD, just prior to moving to the section of the discussion on new prevention products. It described briefly the HIV prevention landscape and the two study products (daily oral pills and monthly vaginal ring), including mechanism of action and how each is to be used. Placebo products (as pictured) that were identical looking to the active dosage forms were passed along during the FGDs so participants could touch and feel both. FGDs, focus group discussions. Demographic and behavioural data on decision making, HIV prevention methods awareness/use and key influencers are presented descriptively in Tables 1 and and3.3. Differences by geographical site for women’s responses were calculated using Fisher’s exact tests (Table 3). Characteristics of sample by sex, country (alphabetically ordered) and overall P/BF, Pregnant and/or breastfeeding; PrEP, pre‐exposure prophylaxis. Women’s reported key influencers during pregnancy and breastfeeding, overall and by country Fisher’s Exact p‐value Fisher’s Exact p‐value At church they say that the head of the family is the man, so a woman may want [to use] but if the man doesn’t it cannot be possible. So, the first one to have the decision is the man. [Obama, 35, man, Blantyre] All sites research staff attended several analysis workshops and participated in a rapid preliminary analysis of the data they had collected [24]. The findings generated during the workshops directly informed the iterative development of the codebook, which in turn was used to systematically analyse all qualitative data. Transcripts were coded by four coders (Dedoose software, v7.0.23) using the codebook that followed a socio‐ecological framework (Figure 2). An acceptable level of intercoder reliability was set and maintained at approximately 80% agreement for 10 key codes representative of the main topics of interest. The analysis team met weekly to discuss coding questions, issues and emerging themes. Coded data reports were further summarized thematically into analytical memos that were reviewed by site teams. Pseudonyms are used in presenting quotes to protect the identity of participants. Socio‐ecological spheres of influences on future use of HIV prevention products during p/BF periods. Sphere of influence on future product use included the mother and baby dyad, the spouse (or male partner or father of the baby) at the closest interpersonal level, followed by family members (mostly grandmother of the baby, siblings and other family members). Institutionally, important stakeholder included health care providers (doctors, nurses, etc.) and religious leaders. At the socio‐structural level, salient influences included pregnant or breastfeeding‐related permissible or forbidden practices, community rumours that fuelled HIV stigma (influencing all levels from socio‐structural to their partner’s opinion of the products), fear of health innovations, such as PrEP, as a manifestation of general medical mistrust, and patriarchal gender norms favouring the sexual double standard. Salient health outcomes aligned with dyadic protection for efficacy, and with safety, for those exposed to PrEP and VR (the woman and the baby), as well as with the maternal stages of pregnancy and lactation. = perceived facilitators; = perceived barriers; = other topics of influence acting either as perceived facilitators or barriers. Pregnant and/or breastfeeding. All participants provided written informed consent prior to participation. The study protocol was approved by the Western Institutional Review Board and by local IRBs at each of the study sites and was overseen by the regulatory infrastructure of the U.S. National Institutes of Health and the Microbicide Trials Network.
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