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Background: The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women’s views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population. Methods: We conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women’s perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach. Results: A majority of women accepted participation in all trials. Women’s views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation – principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions. Conclusions: The majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.
The data for this analysis were collected in partnership with UNC Project Malawi and as part of a larger project, Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES). We conducted qualitative, in-depth interviews using a semi-structured guide to assess the views of women who might be eligible to participate in HIV research during pregnancy about (1) their experiences with research; (2) selected rules governing the intersection of research and reproduction; and (3) their responses to theoretical vignettes describing research during pregnancy. The latter are reported here. Participants included in this analysis were all HIV-negative, and purposively sampled to capture a range of experience with research during pregnancy. UNC Project Malawi in Lilongwe is a study site for U.S. National Institute of Allergy and Infectious Diseases (NIAID) HIV/AIDS Clinical Trials Network studies, many of which involve women of reproductive age. Just over half of the sample (see Table 2) were either: (1) women who had previously participated in a biomedical HIV prevention trial during pregnancy, or (2) women who were denied enrollment in a biomedical HIV prevention trial due to pregnancy; women meeting either criterion are described here as “research experienced”. Research experienced participants were identified by Malawi based research outreach staff through existing trial participation records at UNC Project Malawi. For this purposively selected research experienced subsample, current pregnancy status was not an eligibility requirement. Outreach staff contacted the women by phone, provided a brief description of the study, and invited them to participate. Those who indicated interest were scheduled for an interview appointment in a private office used for research administration. Participant characteristics The remaining participants were a convenience sample of women who were currently pregnant, recruited from a local antenatal care clinic. Interviewers approached women at the clinic and provided a brief explanation of the study. If the woman expressed interest, she was given the options of either reviewing the informed consent information and completing the interview after her clinic appointment in a private, adjacent room, or scheduling a more convenient time to return. Recruitment was designed around clinic flow and based on the limited availability of the interviewers. As such, an overall response rate was not calculated. As previously described [27], our objective in utilizing this sampling methodology was not to approximate a representative sample, but rather to surface and explore the range of issues and concrete considerations relevant to women who might be eligible to participate in studies while pregnant, that should inform discussions surrounding policy and best practices regarding the inclusion of pregnant women in clinical HIV prevention trials. Data for this analysis are based on 35 in-depth interviews conducted with reproductive-aged women at risk for HIV in Lilongwe, Malawi. In-depth interviews were utilized instead of focus groups because the topic—considerations regarding participation in HIV-related clinical trials during pregnancy—is highly personal and potentially sensitive, and we wanted to deeply explore women’s considerations about participating in such research. Interviews were conducted in Chichewa by two trained, bilingual, local social behavioral scientists both experienced in qualitative HIV research (TW and CZ), using a semi-structured guide between August 2016 and April 2017 [27]. Female interviewers were purposefully selected to encourage the comfort and candor of participants. Written informed consent was obtained prior to the interview, and women consented to being audio-recorded. Women also answered demographic questions and questions assessing their current pregnancy status, pregnancy history, and HIV testing/treatment history. Interviews lasted approximately 45–60 min. In line with recommendations by the National Health Science Research Committee of Malawi (NHSRC) at the time, participants were reimbursed 3500 Malawi Kwacha, the equivalent of $5 USD, for costs associated with participation (i.e., transportation). In the consent process, we described efforts to protect confidentiality, and assured participants that names and other identifying information would not be linked to their direct quotes in publications. The research was approved by the institutional review boards at the University of North Carolina (UNC) at Chapel Hill, Johns Hopkins University (JHU), and the National Health Science Research Committee of Malawi. Interview guide development was informed by a review of the scholarly literature on women’s participation in research during pregnancy, interviews with HIV investigators exploring barriers to and facilitators of including pregnant women in clinical trials [28], and consultations with researchers and healthcare providers in the U.S. and Malawi. The interview guide was developed in English, and then translated into Chichewa by TW and CZ. It was then used in preliminary interviews, and revised to enhance cultural appropriateness, clarity, and flow. As part of the interviews, we elicited women’s responses to the prospect of participating while pregnant in any of three hypothetical HIV prevention clinical trial vignettes, testing: (1) oral PrEP, (2) the vaginal ring, and (3) a randomized trial comparing the two (see Table 1). The use of succinct, standardized vignettes and subsequent probes allowed us to surface women’s initial receptiveness and considerations regarding participation within and across the trio of hypothetical HIV prevention research scenarios. The vignettes were read aloud to participants and consisted of a brief introductory overview of the purpose, design, participant requirements, and known safety data during pregnancy. Women were also provided a simple visual aid for each scenario. HIV biomedical prevention trial vignettes After each vignette was read, the interviewer would answer any questions the participant had about the scenario before proceeding. We then asked if women would participate in each vignette, and what was most important to them in making this decision. Additionally, participants were then told that, “Some people think about specific risks and benefits when they decide about participating in a study,” and asked if they thought about it this way. If participants responded affirmatively, we then probed specific risks and benefits to the baby and to the women themselves that they had considered. Interviews were audio recorded. After each interview, the interviewer wrote a summary and recorded her impressions. Trained, local bilingual research staff experienced in transcription and translation both transcribed the Chichewa audio recordings following a standardized protocol, and then translated the transcripts into English. The interviewer reviewed the Chichewa transcript for accuracy prior to translation, and again after they were translated into English. Additionally, the US-based Project Director (KS) reviewed the interview summaries and English transcripts as they were produced and provided feedback to the interviewers. English transcripts were uploaded into NVivo 11 for analysis. Codebook development was a collaborative process within the cross-cultural analytic team (KS, TW, EJ, and CZ) that began when the first 15 interviews were completed. Thematic analysis informed the analytic approach [29]. We familiarized ourselves with the data by reading and rereading the transcripts and summaries, and making notes of our impressions. Structural codes were first applied to organize the data by question and response. Content coding was then developed, with initial codes modified as we worked through the coding process with our research question in mind, and transcripts recoded as necessary. Throughout the coding process, the cross-cultural analysis team had extensive discussions about cultural and other meanings of responses. To enhance the cultural integrity and overall validity of the analysis, all transcripts were coded by at least one local researcher (TM, CZ). Additionally, to ensure intercoder reliability, 20% of the data were double coded, and any discrepancies were discussed until consensus was reached through re-coding or revising our understandings of the codes. With NVivo 11 software, we extracted the text for the interview sections of interest, and utilized data display matrices to make comparisons within and across respondents and identify thematically and conceptually overarching themes. Sub-themes were grouped into themes based on thematic similarities, and the dataset was analyzed for the prevalence and breadth of identified themes. Summaries of each theme including exemplary quotes are presented. Data saturation was assessed and confirmed as coding progressed and no new themes were found in subsequent transcripts [30]. Demographics were self-reported by participants. Of note, the cultural concept of marriage in Malawi extends beyond the legal definition and includes co-habitating couples jointly raising children. Methods are also described in detail elsewhere [27].
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