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Cisgender women, particularly pregnant and postpartum women in Eastern and Southern Africa, face an unacceptably high risk of HIV acquisition. Oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention intervention that can reduce HIV acquisition and vertical transmission. In this qualitative study, we interviewed 21 postpartum women from Cape Town, South Africa who initiated PrEP during pregnancy and who self-reported low PrEP adherence or missed > 1 PrEP follow-up collection. We identified multiple overlapping barriers to PrEP continuation and/or adherence. Individual factors included forgetting to take PrEP daily, being away from home when PrEP should be taken, anticipated stigma and limited disclosure of PrEP use. Women also reported pill-related factors such as side effects and having to take PrEP in addition to other tablets during pregnancy and the postpartum period. Facility-related barriers included logistics around PrEP collection especially when not in antenatal care, as well as transport and financial barriers.
We nested a qualitative study within the larger PrEP in pregnancy and postpartum (PrEP-PP) study ({“type”:”clinical-trial”,”attrs”:{“text”:”NCT03902418″,”term_id”:”NCT03902418″}}NCT03902418). The PrEP-PP study is a prospective cohort study being conducted at a single primary health care, public clinic in Cape Town, South Africa to assess PrEP initiation, continuation and adherence in a cohort of pregnant and breastfeeding women. PrEP-PP began enrolling pregnant and breastfeeding women in August 2019 and follow-up was ongoing as of March, 2022. Women who attend antenatal care and are HIV-negative, pregnant, aged ≥ 16 years, and have no medical contraindications to PrEP are eligible for the parent study. Women enrolled in the study are counselled on the risks of HIV acquisition during pregnancy and postpartum and offered oral daily PrEP from pregnancy until 12-months postpartum. Women can start or stop PrEP at any time in the study. PrEP is integrated into antenatal care and offered from the first antenatal visit onward. Women who agree to initiate PrEP are given a monthly supply of Truvada® (tenofovir disoproxil fumarate/emtricitabine). Study visits are conducted at 1-month after PrEP initiation, then 2-months after, then every 3-months up to 12-months post-partum. PrEP providers are trained staff including a trained nurse practitioner, PrEP counsellors and study interviewers. For this qualitative sub-study, we purposively recruited women from the PrEP-PP cohort to participate in a one-time in-depth interview. We invited women who reported poor PrEP adherence (either missed a PrEP refill or used PrEP intermittently [n = 13, 62%]) or discontinued PrEP during pregnancy or postpartum (n = 8, 38%). Eligibility criteria for the sub-study included being enrolled in PrEP-PP for a minimum of 6 months, being postpartum with a live birth at the time of recruitment for the sub-study, and self-reported low adherence to PrEP during pregnancy and/or postpartum (defined as missing ≥ 6 doses of PrEP within the last 30 days), and/or missing > 1 follow-up PrEP distribution appointment (missed ≥ 14 days visit measured through study file review). Study staff invited women to participate in in-depth interviews between August and October 2020. Study staff reviewed study files to identify individuals who were eligible. These individuals were recruited via phone and in person during routine facility visits until we reached thematic saturation during data analysis (until no new themes emerged in five or more interviews) [18]. The interview guide explored reasons for study participation and initiating PrEP, experiences with PrEP, including disclosure of PrEP use, and factors that influenced adherence to PrEP. The interview guide was developed, and pre-tested prior to the sub-study. Interviews were conducted in-person when participants were already in the facility for study follow-up or by telephone due to the COVID-19 lockdown and associated restrictions. Where interviews were conducted in-person, a private room at the facility was used to ensure confidentiality. For telephone interviews, participants were asked to sit in a private space to ensure confidentiality. Interviews lasted approximately 30–40 min. Interviews were conducted in isiXhosa (local language) by a single female, native isiXhosa speaking interviewer (NT). The interviewer has extensive experience conducting qualitative interviews, was not part of the PrEP-PP study, and had no contact with the study participants prior to the interview. All interviews were audio-recorded, transcribed, and translated into English. Field notes were also recorded. Interviews were transcribed by a trained research staff (YM). All transcriptions were then reviewed by the interviewer for accuracy and necessary corrections were made. We used a thematic approach for coding and analysis of the interviews [19]. Interviews were coded and analysed using Nvivo 12 (QSR International, Victoria, Australia) [20]. A code list was developed by three trained research assistants (YG, JMM, NT) and led by the study principal investigator (DJD). The coding (within transcripts) was reviewed and revised by IB. Themes were developed a priori based on existing literature on HIV adherence and continuation during pregnancy and inductively during the process of coding. The codebook was also guided from quantitative data (self-reported barriers to PrEP use) from baseline and quarterly participant surveys from the PrEP-PP parent study. The analysis integrated memo writing and concept mapping to refine understandings of PrEP adherence and develop themes that were associated with low adherence to PrEP [18]. We selected quotes from women and present with their participant identification (PID) and maternal age. We used The Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist for analysis and reporting [21]. We adapted Ickovics’ and Meisler’s conceptual framework for the analysis that evaluates factors affecting treatment adherence in HIV clinical trials [22] to assess factors associated with poor continuation and low adherence to PrEP in pregnant and postpartum women. The framework posits that adherence is affected by factors across five levels including: (1) Individual (internal motivation; biofeedback), (2) Treatment regimen (daily oral PrEP), (3) Patient-provider relationship, (4) Facility setting, and (5) Disease (HIV and HIV risk in self and partner). In our analysis, we considered the following factors for PrEP adherence and continuation: (1) individual-level factors (e.g., relationship status and communication, disclosure of PrEP use and anticipated or experienced stigma); (2) pill-related factors (e.g., side effects, pill burden); (3) clinical setting/facility-level factors (e.g., access to PrEP, transport and financial barriers to care). Ethical approval was obtained from the University of Cape Town (#297/2018) and the UCLA Institutional Review Board (IRB#18-001622). Written informed consent was obtained from all women to participate in the interviews. Women who were interviewed were reimbursed R120 (approximately $8 USD) in grocery vouchers for their time and transport costs.
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