Barriers to Oral HIV Pre-exposure Prophylaxis (PrEP) Adherence Among Pregnant and Post-partum Women from Cape Town, South Africa

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Study Justification:
This study aimed to investigate the barriers to oral HIV pre-exposure prophylaxis (PrEP) adherence among pregnant and post-partum women in Cape Town, South Africa. The justification for this study is that cisgender women, particularly those who are pregnant or post-partum in Eastern and Southern Africa, face a high risk of HIV acquisition. Oral PrEP is an effective intervention for preventing HIV transmission, but there are challenges to its adherence. Understanding these barriers is crucial for improving PrEP continuation and adherence among this population.
Study Highlights:
– The study interviewed 21 postpartum women from Cape Town who initiated PrEP during pregnancy but reported low adherence or missed follow-up collections.
– Multiple overlapping barriers to PrEP continuation and adherence were identified, including individual factors (forgetting to take PrEP, being away from home), pill-related factors (side effects, taking multiple tablets), and facility-related barriers (logistics of PrEP collection, transport, and financial barriers).
– The study used a qualitative approach, conducting in-depth interviews to explore reasons for study participation, experiences with PrEP, and factors influencing adherence.
– The study integrated existing literature and a conceptual framework to analyze the factors affecting PrEP adherence and continuation in pregnant and postpartum women.
Recommendations:
Based on the findings of this study, the following recommendations can be made:
1. Improve education and counseling: Provide comprehensive education and counseling to pregnant and postpartum women about the importance of PrEP adherence, potential side effects, and strategies to overcome barriers.
2. Enhance support systems: Develop support systems that address individual-level factors, such as relationship status and communication, and provide strategies for disclosure of PrEP use to reduce anticipated or experienced stigma.
3. Simplify pill regimen: Explore options to simplify the pill regimen for pregnant and postpartum women, considering the pill burden and potential side effects.
4. Strengthen healthcare facilities: Address facility-level barriers by improving access to PrEP, streamlining logistics of PrEP collection, and addressing transport and financial barriers to care.
Key Role Players:
To address the recommendations, the following key role players are needed:
1. Healthcare providers: Trained staff, including nurse practitioners, PrEP counselors, and study interviewers, who can provide comprehensive education, counseling, and support to pregnant and postpartum women.
2. Policy makers: Government officials and policymakers who can develop and implement policies to improve access to PrEP, streamline logistics, and address financial barriers.
3. Community organizations: Organizations that can provide additional support, education, and resources to pregnant and postpartum women, including peer support groups and community health workers.
Cost Items for Planning Recommendations:
While the actual cost will vary depending on the context and implementation strategy, the following cost items should be considered in planning the recommendations:
1. Training and capacity building for healthcare providers: This includes training healthcare staff on PrEP counseling, adherence support, and addressing stigma. It may also involve ongoing supervision and mentorship.
2. Educational materials and resources: Develop and distribute educational materials, such as brochures and posters, to raise awareness about PrEP and provide information on adherence strategies.
3. Support systems: Allocate resources for the establishment and maintenance of support systems, such as peer support groups or hotlines, to provide ongoing support and guidance to pregnant and postpartum women.
4. Facility improvements: Invest in improving healthcare facilities to ensure easy access to PrEP, streamline logistics of PrEP collection, and address transport and financial barriers. This may include infrastructure upgrades, transportation services, and financial assistance programs.
Please note that the above cost items are estimates and should be further refined based on the specific context and resources available.

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong because it is based on a qualitative study that interviewed postpartum women from Cape Town, South Africa who initiated PrEP during pregnancy. The study identified multiple barriers to PrEP continuation and adherence, including individual factors, pill-related factors, and facility-related barriers. The study is nested within a larger prospective cohort study, which adds to its credibility. To improve the evidence, it would be beneficial to include information on the sample size and demographics of the participants, as well as the specific methods used for data collection and analysis.

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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Based on the provided information, here are some potential innovations that could improve access to maternal health:

1. Mobile Health (mHealth) Solutions: Develop mobile applications or SMS-based platforms to send reminders and educational messages about PrEP adherence to pregnant and postpartum women. These platforms can also provide information on nearby clinics, transportation options, and financial assistance programs.

2. Community Health Workers (CHWs): Train and deploy CHWs to provide personalized support and counseling to pregnant and postpartum women regarding PrEP adherence. CHWs can conduct home visits, offer reminders, and address any concerns or barriers faced by women in accessing and adhering to PrEP.

3. Integrated Care: Integrate PrEP services into existing antenatal care programs to ensure that pregnant women have easy access to PrEP. This can include training healthcare providers on PrEP counseling and provision, as well as streamlining the process of PrEP collection and distribution within antenatal care visits.

4. Peer Support Groups: Establish peer support groups for pregnant and postpartum women who are taking PrEP. These groups can provide a safe space for women to share their experiences, receive emotional support, and learn from each other’s strategies for adherence.

5. Telemedicine: Implement telemedicine services to provide remote consultations and follow-up visits for pregnant and postpartum women on PrEP. This can help overcome transportation and financial barriers by reducing the need for in-person clinic visits.

6. Addressing Stigma: Develop targeted interventions to address anticipated and experienced stigma related to PrEP use during pregnancy and postpartum. This can involve community education campaigns, sensitization of healthcare providers, and creating supportive environments for women to openly discuss and disclose their PrEP use.

7. Simplified Regimens: Explore the feasibility of simplified PrEP regimens, such as long-acting injectable formulations, to reduce the pill burden and improve adherence among pregnant and postpartum women.

8. Financial Support: Establish financial assistance programs to alleviate the financial barriers associated with PrEP access, including transportation costs and the cost of PrEP medications.

These innovations aim to address the identified barriers to PrEP continuation and adherence among pregnant and postpartum women in Cape Town, South Africa. Implementing these strategies can help improve access to maternal health and reduce the risk of HIV acquisition and transmission in this population.
AI Innovations Description
Based on the information provided, here is a recommendation that can be developed into an innovation to improve access to maternal health:

Develop a mobile application that provides reminders and support for pregnant and postpartum women taking oral pre-exposure prophylaxis (PrEP) for HIV prevention. The app can send daily reminders to take the medication, provide information about the importance of adherence, and offer resources for addressing barriers to adherence such as side effects and stigma. Additionally, the app can include features for tracking medication refills and scheduling follow-up appointments, as well as providing information on nearby clinics and transportation options. This innovation would help address individual-level factors (forgetting to take PrEP daily, being away from home when PrEP should be taken, anticipated stigma and limited disclosure of PrEP use), pill-related factors (side effects and having to take PrEP in addition to other tablets during pregnancy and the postpartum period), and facility-related barriers (logistics around PrEP collection, transport, and financial barriers). By improving adherence to PrEP, this innovation can contribute to reducing HIV acquisition and vertical transmission among pregnant and postpartum women, ultimately improving maternal health outcomes.
AI Innovations Methodology
Based on the provided information, here are some potential recommendations to improve access to maternal health:

1. Mobile Health (mHealth) Interventions: Develop and implement mobile health applications or text messaging services to provide reminders and educational information about PrEP adherence. These interventions can help address barriers such as forgetting to take PrEP daily and being away from home when PrEP should be taken.

2. Peer Support Programs: Establish peer support programs where pregnant and postpartum women who are using PrEP can connect with and receive support from other women who have successfully adhered to PrEP. Peer support can help address concerns about stigma and limited disclosure of PrEP use.

3. Simplified Regimens: Explore the possibility of simplifying the PrEP regimen by combining it with other necessary medications during pregnancy and the postpartum period. This can help reduce the pill burden and make it easier for women to adhere to PrEP.

4. Integration of PrEP into Antenatal Care: Strengthen the integration of PrEP into antenatal care services to ensure that women have easy access to PrEP throughout their pregnancy and postpartum period. This can include training healthcare providers, streamlining logistics around PrEP collection, and addressing transport and financial barriers.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could be developed as follows:

1. Define the Outcome Measures: Determine the specific outcome measures that will be used to assess the impact of the recommendations. This could include indicators such as PrEP adherence rates, rates of HIV acquisition, and rates of vertical transmission.

2. Collect Baseline Data: Gather baseline data on the current access to maternal health and PrEP adherence rates among pregnant and postpartum women in the target population. This can be done through surveys, interviews, or data analysis from existing sources.

3. Develop a Simulation Model: Create a simulation model that incorporates the potential recommendations and their expected impact on access to maternal health. This model should consider factors such as the population size, the implementation timeline, and the expected uptake of the recommendations.

4. Input Data and Run Simulations: Input the baseline data into the simulation model and run multiple simulations to estimate the potential impact of the recommendations on improving access to maternal health. This can be done by varying the parameters of the model, such as the effectiveness of the interventions and the coverage rates.

5. Analyze Results: Analyze the results of the simulations to determine the potential impact of the recommendations on improving access to maternal health. This can include assessing changes in PrEP adherence rates, rates of HIV acquisition, and rates of vertical transmission.

6. Validate and Refine the Model: Validate the simulation model by comparing the simulated results with real-world data, if available. Refine the model based on the validation results and incorporate any feedback or additional data.

7. Communicate Findings: Present the findings of the simulation study, including the estimated impact of the recommendations on improving access to maternal health. This can be done through reports, presentations, or other communication channels to relevant stakeholders and decision-makers.

By following this methodology, it is possible to simulate the potential impact of the recommendations on improving access to maternal health and inform decision-making processes for implementing these innovations.

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