The landscape for HIV pre-exposure prophylaxis during pregnancy and breastfeeding in Malawi and Zambia: A qualitative study

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Study Justification:
– High HIV incidence rates among pregnant and breastfeeding women in sub-Saharan Africa
– Limited understanding of the acceptability and feasibility of pre-exposure prophylaxis (PrEP) in these populations
– Need to address the gap in knowledge to design effective HIV prevention programs
Study Highlights:
– Conducted in-depth interviews with 90 participants in Malawi and Zambia
– Participants included HIV-negative pregnant/breastfeeding women, male partners, healthcare workers, and policymakers
– PrEP was not well-known among patients and healthcare workers, but most expressed positive views when it was described
– Concerns about safety and adherence were raised, highlighting the need for community outreach
– Feasibility of introducing PrEP into antenatal services was a concern, given strained health systems
– Support for PrEP varied among policymakers in Malawi and Zambia, reflecting ongoing policy discussions
Study Recommendations:
– Address barriers at the individual, facility, and policy levels to implement PrEP during pregnancy and breastfeeding
– Consider multilevel approaches in the design of new PrEP programs for antenatal and postpartum populations
Key Role Players:
– HIV-negative pregnant/breastfeeding women
– Male partners
– Healthcare workers
– Policymakers
– Ministries of Health
– National AIDS commissions
– Partner implementing organizations
– Donor agencies
Cost Items for Planning Recommendations:
– Community outreach programs
– Training and education for healthcare workers
– Integration of PrEP into existing antenatal services
– Policy development and implementation support
– Monitoring and evaluation of PrEP programs

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong, but there are a few areas for improvement. The study design is clearly described, and the sample size is adequate. The qualitative approach allows for in-depth understanding of participants’ views. The inclusion criteria are well-defined, and the interviews were conducted in a private setting. However, there are a few areas that could be improved. First, the abstract does not mention how participants were selected for the study, which could affect the generalizability of the findings. Second, the abstract does not provide information on the data analysis process, such as how themes were identified and how data were verified. Including these details would strengthen the evidence. Finally, the abstract does not mention any limitations of the study, which would be helpful for interpreting the findings. To improve the evidence, the authors could provide more information on participant selection, data analysis, and study limitations in the abstract.

High HIV incidence rates have been observed among pregnant and breastfeeding women in sub-Saharan Africa. Oral pre-exposure prophylaxis (PrEP) can effectively reduce HIV acquisition in women during these periods; however, understanding of its acceptability and feasibility in antenatal and postpartum populations remains limited. To address this gap, we conducted in-depth interviews with 90 study participants in Malawi and Zambia: 39 HIV-negative pregnant/breastfeeding women, 14 male partners, 19 healthcare workers, and 18 policymakers. Inductive and deductive approaches were used to identify themes related to PrEP. As a public health intervention, PrEP was not well-known among patients and healthcare workers; however, when it was described to participants, most expressed positive views. Concerns about safety and adherence were raised, highlighting two critical areas for community outreach. The feasibility of introducing PrEP into antenatal services was also a concern, especially if introduced within already strained health systems. Support for PrEP varied among policymakers in Malawi and Zambia, reflecting the ongoing policy discussions in their respective countries. Implementing PrEP during the pregnancy and breastfeeding periods will require addressing barriers at the individual, facility, and policy levels. Multilevel approaches should be considered in the design of new PrEP programs for antenatal and postpartum populations.

This qualitative study was part of a larger effort to design and evaluate a combination HIV prevention package for pregnant and breastfeeding women and their partners [3]. This formative work was conducted in Malawi and Zambia, where the parent study will be implemented. In both countries, population-based surveys have reported high rates of annual HIV incidence among women of reproductive age (0.46%, 95%CI: 0.18–0.75% in Malawi and 1.10%, 95%CI: 0.72–1.48% in Zambia) [18, 19]. Although data are not available to describe population-level HIV incidence during pregnancy and breastfeeding, prior studies from Malawi and Zambia indicate substantially higher rates during these periods [20–23]. In addition, estimates from the 2018 UNAIDS Spectrum model suggest that new maternal HIV infections—acquired during pregnancy and breastfeeding—may contribute to as high as 40–45% of new infant infections in these countries [2]. We used a qualitative descriptive approach in the design, data collection and analysis of this formative study [24, 25]. Our goal was to provide accurate accounting of events—and their meaning—from the individuals interviewed [24]. We drew from the basic tenets of naturalistic inquiry, with no specific commitment to a pre-defined theoretical framework [26]. We recruited participants from four populations: HIV-negative pregnant or breastfeeding women seeking care, their male partners, healthcare workers (HCWs), and policymakers. The first three groups were enrolled from Bwaila District Hospital (Lilongwe, Malawi), the University Teaching Hospital (Lusaka, Zambia), and Kamwala Health Centre (Lusaka, Zambia). Policymakers from both Malawi and Zambia were identified through existing governmental technical working groups. Female participants were recruited from maternal and child health care units (i.e., antenatal, postnatal, family planning, and well child clinics) at these hospitals via convenience sampling. All participants were aged 18 years or above and resided near the study sites. The inclusion criteria for pregnant/breastfeeding women were: confirmed pregnancy or reported delivery with continued breastfeeding, access of maternal-child health care services at one of the study sites, documented HIV-negative status, and report of a male sexual partner. Male partners of participating pregnant or breastfeeding women were eligible for this study. These individuals were only recruited after we received permission from the index pregnant or breastfeeding participant. HCWs were eligible to participate if they worked at the maternal and child health care units within the targeted study health facilities. Policymakers were recruited from the Ministries of Health, national AIDS commissions, partner implementing organizations, and donor agencies. All participated on governmental HIV technical working groups. Our target accrual was: 40 HIV-negative pregnant/breastfeeding women, 40 male partners, 20 HCWs, and 20 policymakers. This sample size was divided equally between the two countries. We conducted in-depth interviews to better understand the role of PrEP in HIV prevention among pregnant and breastfeeding women. Women, male partners, HCW, and policymakers were all asked about their knowledge of PrEP, overall opinion/acceptability of PrEP, and perceived challenges for implementing PrEP in pregnant/breastfeeding women in Malawi and Zambia. Sociodemographic data for pregnant/breastfeeding women and male partners were collected using a separate form. We did not collect analogous information from HCWs and policymakers for reasons of confidentiality. Researchers and research assistants trained in qualitative methods conducted the in-depth interviews to capture participant views on PrEP use during pregnancy and breastfeeding. All interviewers were local; they spoke the language of the participants and were familiar with the local context and culture. They used semi-structured interview guides developed by members of the study team. Prior to implementation, these interview guides were field tested at participating health facilities to assess content and ensure meaning. All interviews with pregnant/breastfeeding women, male partners, and HCWs were conducted in private rooms within study site facilities. Policymakers were typically interviewed at a private venue of their choosing. Interviews were conducted either in English or in local languages (e.g., Chichewa, Nyanja, or Bemba) depending on the participant’s choice. Each interview lasted approximately one hour. All in-depth interviews were audio-recorded, transcribed verbatim, and translated into English by bilingual study personnel. These were then verified for clarity and completeness by an independent reviewer who was part of the qualitative team but not involved in transcription and translation. Members of the study team developed a central codebook that was used in both countries. We used NVivo12 Version 10 (QSR International, Pty Ltd.; Doncaster, Victoria, Australia) to organize and code data. Initial inductive codes were derived from the interview guides and additional deductive codes were added as themes emerged. This information was then used to create summaries and matrices to compare participant views. We received ethical approval from the University of North Carolina at Chapel Hill Institutional Review Board (Chapel Hill, NC, USA), the National Health Science Research Committee of Malawi (Lilongwe, Malawi), and the University of Zambia Biomedical Research Ethics Committee (Lusaka, Zambia) to conduct this study. All participants provided written informed consent prior to initiating study activities.

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

1. Increase awareness and education about pre-exposure prophylaxis (PrEP) for HIV prevention during pregnancy and breastfeeding. This could involve targeted campaigns, community outreach programs, and informational materials to ensure that pregnant and breastfeeding women, as well as their partners, are aware of the benefits and availability of PrEP.

2. Address concerns about safety and adherence to PrEP. Develop strategies to address these concerns, such as providing clear information about the safety and effectiveness of PrEP during pregnancy and breastfeeding, and implementing support systems to help women adhere to the medication regimen.

3. Improve the feasibility of introducing PrEP into antenatal services. This could involve training healthcare workers on the use of PrEP, integrating PrEP services into existing antenatal care programs, and ensuring that health systems have the capacity to provide PrEP to pregnant and breastfeeding women.

4. Engage policymakers in discussions about the implementation of PrEP for pregnant and breastfeeding women. Advocate for the inclusion of PrEP in national guidelines and policies, and work towards securing funding and resources to support the integration of PrEP into maternal health services.

5. Take a multilevel approach to designing new PrEP programs for antenatal and postpartum populations. This could involve collaboration between healthcare providers, policymakers, community organizations, and researchers to ensure that PrEP programs are comprehensive, culturally appropriate, and address the specific needs of pregnant and breastfeeding women.

These innovations aim to improve access to maternal health by increasing awareness, addressing concerns, improving feasibility, engaging policymakers, and taking a multilevel approach to the implementation of PrEP for pregnant and breastfeeding women.
AI Innovations Description
The recommendation that can be developed into an innovation to improve access to maternal health is the implementation of oral pre-exposure prophylaxis (PrEP) during pregnancy and breastfeeding. This recommendation is based on a qualitative study conducted in Malawi and Zambia, which found that PrEP was not well-known among patients and healthcare workers, but when described, most participants expressed positive views.

To address the barriers to implementing PrEP, the following recommendations can be considered:

1. Community Outreach: Conduct community outreach programs to raise awareness about PrEP among pregnant and breastfeeding women, their partners, and healthcare workers. This can include educational campaigns, workshops, and training sessions to ensure that accurate information about PrEP is disseminated.

2. Safety and Adherence: Address concerns about safety and adherence by providing comprehensive counseling and support services. This can include regular follow-up visits, reminders for medication adherence, and addressing any misconceptions or fears about the use of PrEP.

3. Integration into Antenatal Services: Ensure the feasibility of introducing PrEP into antenatal services by addressing the strain on already limited health systems. This can be achieved by training healthcare workers on PrEP provision, streamlining service delivery, and integrating PrEP into existing maternal health programs.

4. Policy Support: Advocate for policy support for the implementation of PrEP during pregnancy and breastfeeding. Engage policymakers in discussions and provide evidence-based recommendations to facilitate policy changes that prioritize maternal health and HIV prevention.

By implementing these recommendations, it is possible to improve access to maternal health by introducing PrEP as an effective HIV prevention strategy during pregnancy and breastfeeding. This innovation can contribute to reducing HIV incidence rates among pregnant and breastfeeding women in sub-Saharan Africa.
AI Innovations Methodology
Based on the provided description, here are some potential recommendations to improve access to maternal health:

1. Increase awareness and education: Develop comprehensive public health campaigns to raise awareness about maternal health, including the importance of HIV prevention during pregnancy and breastfeeding. This can be done through various channels such as community outreach programs, mass media campaigns, and targeted messaging in healthcare facilities.

2. Strengthen healthcare systems: Invest in improving the capacity and resources of healthcare facilities to provide comprehensive maternal health services, including HIV prevention and treatment. This may involve training healthcare workers, ensuring the availability of necessary medications and supplies, and improving infrastructure to accommodate increased demand.

3. Integrate services: Implement integrated healthcare models that combine maternal health services with HIV prevention and treatment. This can help streamline care and ensure that pregnant and breastfeeding women receive comprehensive services in a convenient and accessible manner.

4. Address barriers to access: Identify and address barriers that prevent pregnant and breastfeeding women from accessing maternal health services, such as stigma, discrimination, transportation issues, and financial constraints. This may involve providing financial support, improving transportation options, and implementing strategies to reduce stigma and discrimination.

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

1. Define the indicators: Identify specific indicators that can measure the impact of the recommendations on access to maternal health. This may include indicators such as the number of pregnant and breastfeeding women receiving HIV prevention services, the percentage of women aware of the importance of HIV prevention during pregnancy and breastfeeding, and the reduction in new maternal HIV infections.

2. Collect baseline data: Gather baseline data on the current status of access to maternal health services, including HIV prevention, in the target population. This can be done through surveys, interviews, and data analysis of existing health records.

3. Develop a simulation model: Create a simulation model that incorporates the identified recommendations and their potential impact on access to maternal health. This model should consider factors such as population size, healthcare infrastructure, resource availability, and the effectiveness of the interventions.

4. Run the simulation: Use the simulation model to project the potential impact of the recommendations over a specified time period. This can be done by adjusting the input parameters of the model based on the expected implementation of the recommendations and running multiple iterations to account for different scenarios.

5. Analyze the results: Analyze the simulation results to assess the potential impact of the recommendations on improving access to maternal health. This may involve comparing the projected outcomes with the baseline data and identifying key areas of improvement.

6. Refine and validate the model: Continuously refine and validate the simulation model based on new data and feedback from stakeholders. This will help ensure the accuracy and reliability of the model in predicting the impact of the recommendations.

7. Communicate the findings: Present the findings of the simulation study to relevant stakeholders, including policymakers, healthcare providers, and community members. This can help inform decision-making and guide the implementation of interventions to improve access to maternal health.

It is important to note that the methodology for simulating the impact of recommendations may vary depending on the specific context and available data. The steps outlined above provide a general framework for conducting such a simulation study.

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