Lauren M. Hill

Patient-centered PrEP choice in antenatal care may promote effective use of PrEP to reduce the risk of maternal HIV acquisition. To inform patient-centered counseling, we sought to understand values that pregnant women considered in their PrEP decision-making and their relationship with PrEP use in the context of an adherence support trial in Lilongwe, Malawi. 200 women completed an enrollment survey reporting values (motivations and concerns) they considered when deciding to use PrEP. We examined the associations of these values with study retention and adherence to PrEP (pharmacologic assessment), at 3 and 6 months after enrollment by estimating probability differences (PD). Thirty women and 10 study staff also completed in-depth interviews on the influence of women’s values on PrEP adherence. We thematically analyzed interview transcripts through topical coding and summary matrices. Quantitatively, women reporting concerns related to PrEP disclosure and stigma were less likely to be retained. At 6 months, women concerned about partner disclosure (65.0% vs. 87.8%; PD: -22.8%, 95% CI: -44.2%, -1.3%) and family disclosure (68.2% vs. 87.6%; PD: -19.5%, 95% CI: -39.5%, -0.1%), and those who worried they would be perceived as living with HIV (74.5% vs. 88.9%; PD: -14.4%, 95% CI: -27.8%, -1.0%) were less likely to be retained than women without these concerns. Qualitatively, stigma-related concerns led women to avoid PrEP disclosure and conceal their PrEP use which made adherence difficult. Many missed early doses due to concerns about side effects and safety. Some who enrolled with an STI perceived less need for PrEP after their STI resolved. To address adherence barriers, counseling should address the difference between PrEP, ART, and STI treatments. Disclosure support and follow-up counseling to address side effects may also promote PrEP adherence.

Background: HIV preexposure prophylaxis (PrEP) has potential for preventing HIV during the perinatal period, but few strategies promote person-centered shared decision-making (SDM) about PrEP use in these contexts. The MyChoice study aims to evaluate the feasibility, acceptability, and appropriateness of an SDM approach to support pregnant and breastfeeding women in Lilongwe, Malawi, integrating PrEP into antenatal care to encourage consistent use. Objective: Two pilot studies will assess the feasibility, acceptability, and appropriateness of an SDM intervention to support pregnant and breastfeeding women in making informed HIV prevention choices. The intervention will also explore the perspectives of participants, their male partners, and implementers. Each study compares the MyChoice intervention to standard-of-care PrEP counseling, with different HIV prevention method choices available. Methods: We will conduct 2 pilot randomized trials to evaluate the MyChoice intervention, designed to support PrEP decision-making among pregnant women in Lilongwe. Both studies will compare the MyChoice intervention to standard-of-care PrEP counseling. Study 1 will include 100 participants who will be offered oral PrEP and condoms for 3 months. Study 2 will include 50 participants who will be offered oral PrEP or injectable long-acting cabotegravir and condoms for 2 months. The primary end points for MyChoice study 1 are intervention acceptability, intervention appropriateness, and intervention feasibility, whereas for MyChoice study 2 they are intervention acceptability and intervention appropriateness. The secondary end point for MyChoice study 1 is decisional conflict, and for MyChoice study 2, it is the feasibility of study procedures. Exploratory end points include PrEP uptake assessment and dried blood spot measurement of PrEP adherence for MyChoice study 1 and PrEP uptake assessment for MyChoice study 2. Results: Data collection started on July 30, 2024, for study 1 and on February 10, 2025, for study 2. A total of 100 participants were enrolled in MyChoice study 1, and 50 participants were enrolled in MyChoice study 2. Study follow-up has been completed. Data analysis is expected to be completed by November 2025. Conclusions: The MyChoice pilot studies will provide critical evidence on a novel intervention for PrEP decision-making during pregnancy and breastfeeding. If feasible and acceptable, these results will form the basis for larger efficacy trials to promote PrEP uptake during pregnancy. Trial Registration: ClinicalTrials.gov NCT06394323; https://clinicaltrials.gov/study/NCT06394323 and ClinicalTrials.gov NCT06397690; https://www.clinicaltrials.gov/study/NCT06397690 International Registered Report Identifier (IRRID): DERR1-10.2196/76442

Mother-to-child transmission (MTCT) of HIV remains a challenge in Eastern and Southern Africa. Oral pre-exposure prophylaxis (PrEP) is a powerful tool to reduce MTCT, but women face barriers to effective use including those related to inaccurate comprehension of PrEP To understand women’s misconceptions about PrEP and their potential impact on PrEP use, we conducted interviews with 33 pregnant and lactating women in Malawi using PrEP, and ten PrEP counselors and clinicians. The results indicate that, although pregnant women generally understood PrEP’s features and functions, many held misconceptions that persisted over the course of their PrEP use and impacted their perceptions and use of the medication. Some women erroneously believed that PrEP could treat and prevent sexually transmitted infections other than HIV, which motivated some to keep taking PrEP while motivating others to stop using PrEP once their STI had resolved. Some were confused about PrEP’s function, with some believing it was the same as antiretroviral therapy for HIV treatment, and others believing that PrEP could be used for overall enhancement of health. Rarer misconceptions included fears that PrEP was connected to satanic practices, could cause cancer, or was solely for individuals engaged in sex work. These misconceptions stemmed from a mix of prior knowledge, societal influences, and miscommunications during counseling sessions. Ensuring accurate knowledge and addressing common misconceptions head-on is crucial to promote continued PrEP use among women. Both clinic- and community-based communication efforts with a particular focus on the difference between PrEP, STI treatments, and ART are needed.

Women in low-income communities are disproportionately affected by HIV yet have been largely left out of efforts to raise awareness about pre-exposure prophylaxis (PrEP). To inform future awareness campaigns, we assessed women’s current knowledge of and attitudes toward PrEP. We surveyed 184 women living in public housing communities in North Carolina regarding PrEP knowledge, attitudes, and perceived norms, as well as reported HIV-associated factors and perceived HIV acquisition chances. 38 women participated in eight focus group discussions (FGDs) addressing personal and community PrEP perceptions. Survey participants were 46 years old on average, and 86% identified as Black/African American. Only 35% had heard of PrEP, yet, after being told what it was, 61% said they probably or definitely would take PrEP in the next 6 months. Most women believed that if they decided to take PrEP, their partner (72%) or their family (66%) would approve. When asked about the importance of factors influencing their interest in PrEP, women most frequently rated possible side effects as important or very important (76%), followed by cost considerations (67% for cost of PrEP, 74% for cost of clinic visits and labs). In the FGDs, women had limited PrEP knowledge, but several had heard of PrEP from television commercials, which gave them the impression that PrEP was only for men. Women were concerned about potential side effects, interactions with other medications, safety during pregnancy, and the burden of daily dosing. Most FGD participants expressed generally positive attitudes toward PrEP, but some thought other women would be uninterested due to low perceived chances of HIV acquisition. Overall, these results suggest that while few women had previously heard of PrEP, most were interested in PrEP after receiving information about it and perceived positive community attitudes toward PrEP. Our findings indicate the importance of community-based PrEP communication that speaks to cisgender women, provides information on side effects, and offers destigmatized messaging regarding reasons for HIV prevention for women to consider.

Oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy with high efficacy. An increased willingness to use PrEP among at-risk Indian men who have sex with men (MSM) population has been reported; however, little is known about their real experiences that guide their key motivators, facilitators, and barriers with using oral and Long-Acting (LA) Injectable PrEP. We recruited participants (n = 18) through active MSM social media networks. The interviews were conducted using teleconferencing software. Interview topics included participants’ sources of knowledge, experiences accessing daily PrEP, safe-sex behaviors while on PrEP, barriers and facilitators around PrEP, long-term goals with PrEP, perceptions around LA PrEP, and discussion around decision-making to switch from oral PrEP to LA PrEP. Transcripts were coded according to interview topics, and key themes were analyzed using a topical data analysis approach. Participants (median age 28 years, ranging from 18 to 40) reported a high perceived risk of HIV. This increased perceived risk was a key motivator for oral PrEP uptake. Most participants shared that they accessed PrEP through non-profit organizations serving the MSM community, where doctor consultations and medication were either free or subsidized. Even when participants reported high adherence to oral PrEP, they expressed discontent with the requirement to take it daily. High condom usage was reported concomitantly with PrEP use among most participants, except for a few who preferred bareback sex. Participants shared that they would prefer to continue PrEP until they are in a monogamous, exclusive relationship. The cost and affordability remained recurring themes, and while participants could afford oral PrEP, they wished it was cheaper, making it more accessible to the community at large. Most participants did not have prior knowledge of LA injectable PrEP but welcomed the intervention, alluding to cost and availability as the key decision-making factors affecting switching. MSM from India we interviewed adopted oral PrEP as an additional HIV prevention strategy to condoms through non-profit and private channels. Cost and broader access remains a concern among the MSM community. More acceptability research about long-acting PrEP is needed among MSM in the Indian context, and it is recommended for government interventions to include oral PrEP groups at higher risk of HIV acquisition.

Background: Adherence to antiretroviral (ARV) therapy is critical for achieving HIV RNA suppression in people living with HIV and for preventing HIV infection in uninfected individuals using preexposure prophylaxis. However, a high level of adherence can be challenging to achieve for people living with HIV on lifelong ARVs and for HIV-negative individuals using daily preexposure prophylaxis who are not at daily risk for HIV infection. Current biological measures of adherence are invasive and use bioanalytical methods that do not allow for real-time feedback during a clinic visit. This study was designed to test the feasibility and acceptability of using MedViewer, a novel, minimally invasive, hair-based assay that measures longitudinal ARV drug adherence in real time and provides an output for provider-patient discussion. Objective: The primary objectives were to investigate the feasibility of delivering the MedViewer results as planned, the acceptability of participation in a discussion of the MedViewer results, and the appropriateness of using MedViewer for adherence counseling. The secondary objectives were to investigate additional dimensions of feasibility, acceptability, and appropriateness of using the MedViewer test during a routine clinic visit for people with HIV. Methods: The proposed study was a single-arm cross-sectional study among patients receiving HIV care and providers of HIV care in a southeastern infectious disease clinic. The study originally planned to implement the MedViewer test with 50 eligible patients who were living with HIV across 2 viral load strata (undetectable or detectable plasma HIV RNA over the previous 2 years), administer brief visit-specific questionnaires to all patient and provider participants, and conduct qualitative in-depth interviews and quantitative end-line questionnaires with a subsample of patient participants (n=30) and all provider participants. Results: The Establishing Novel Antiretroviral Imaging for Hair to Elucidate Nonadherence study was funded by the National Institute of Allergy and Infectious Diseases and approved by the local institutional review board on November 4, 2019. Provider participant enrollment began on January 17, 2020, and patient participant enrollment began on January 22, 2020. Participant enrollment was halted on March 16, 2020, because of the COVID-19 pandemic (16 providers and 10 patients on study). Study activities resumed on February 2, 2021, with COVID-19 modifications approved by the local institutional review board. Participant enrollment closed on October 8, 2021, and data collection closed on November 15, 2021. In total, 36 unique patient participants, representing 37 samples, and 20 provider participants were enrolled. Data analysis and manuscript writing will take place throughout 2023. Conclusions: We anticipate that the data collected through this study will provide important insights regarding the feasibility, acceptability, and appropriateness of incorporating new real-time longitudinal, minimally invasive adherence tests into routine clinical care and identify potential barriers to medication adherence among patients. Trial Registration: ClinicalTrials.gov NCT04232540; https://clinicaltrials.gov/ct2/show/NCT04232540 International Registered Report Identifier (IRRID): RR1-10.2196/41188

Introduction: Pre‐exposure prophylaxis (PrEP) is a promising tool for HIV prevention during pregnancy. With increasing rollout in antenatal settings, counselling strategies to help pregnant women make appropriate decisions about PrEP use are needed. Understanding women's motivations and concerns for PrEP use—and how these inform their decision making and feelings about the decision to start PrEP—are critical to inform these strategies.Methods: We conducted a convergent mixed‐methods study from June 2020 to June 2021 in the context of a PrEP adherence support trial among HIV‐negative pregnant women in Lilongwe, Malawi. Two hundred women completed a survey reporting their motivations and concerns about PrEP use, and their feelings about the decision to start PrEP (Decisional Regret Scale). Thirty women completed in‐depth interviews to better understand the decision‐making process, including motivations and concerns weighed in women's decision to use PrEP. Analyses comprised descriptive and bivariate statistics, thematic qualitative analysis, and integration of quantitative and qualitative results.Results: Women initiating PrEP during pregnancy were highly motivated to obtain HIV protection for themselves and their unborn child, often due to perceived HIV risk connoted by a recent sexually transmitted infection and/or concerns about partner non‐monogamy. These motivations prevailed despite some concerns about safety and side effects, anticipated stigmatization, and concerns about adherence burden and pill attributes. Many women had informed their partner of their decision to use PrEP yet few felt their decision was contingent upon partner approval. Most women felt positively about the decision to start PrEP (mean decisional regret = 1.2 out of 5), but those with a greater number of concerns reported greater decisional regret (B = 0.036; p = 0.005). Furthermore, women who were specifically concerned about partner disclosure, who disliked pills or who had no perceived HIV risk reported greater decisional regret.Conclusions: Pregnant women were strongly motivated by the promise of HIV protection offered by PrEP and accepted it despite diverse concerns. A shared decision‐making approach that centres pregnant women and offers partner involvement may help identify and address initial concerns about PrEP use and support prevention‐effective use of PrEP during this important period.

BACKGROUND Adherence to antiretroviral (ARV) therapy is critical for achieving HIV RNA suppression in people living with HIV and for preventing HIV infection in uninfected individuals using preexposure prophylaxis. However, a high level of adherence can be challenging to achieve for people living with HIV on lifelong ARVs and for HIV-negative individuals using daily preexposure prophylaxis who are not at daily risk for HIV infection. Current biological measures of adherence are invasive and use bioanalytical methods that do not allow for real-time feedback during a clinic visit. This study was designed to test the feasibility and acceptability of using MedViewer, a novel, minimally invasive, hair-based assay that measures longitudinal ARV drug adherence in real time and provides an output for provider-patient discussion. OBJECTIVE The primary objectives were to investigate the feasibility of delivering the MedViewer results as planned, the acceptability of participation in a discussion of the MedViewer results, and the appropriateness of using MedViewer for adherence counseling. The secondary objectives were to investigate additional dimensions of feasibility, acceptability, and appropriateness of using the MedViewer test during a routine clinic visit for people with HIV. METHODS The proposed study was a single-arm cross-sectional study among patients receiving HIV care and providers of HIV care in a southeastern infectious disease clinic. The study originally planned to implement the MedViewer test with 50 eligible patients who were living with HIV across 2 viral load strata (undetectable or detectable plasma HIV RNA over the previous 2 years), administer brief visit-specific questionnaires to all patient and provider participants, and conduct qualitative in-depth interviews and quantitative end-line questionnaires with a subsample of patient participants (n=30) and all provider participants. RESULTS The Establishing Novel Antiretroviral Imaging for Hair to Elucidate Nonadherence study was funded by the National Institute of Allergy and Infectious Diseases and approved by the local institutional review board on November 4, 2019. Provider participant enrollment began on January 17, 2020, and patient participant enrollment began on January 22, 2020. Participant enrollment was halted on March 16, 2020, because of the COVID-19 pandemic (16 providers and 10 patients on study). Study activities resumed on February 2, 2021, with COVID-19 modifications approved by the local institutional review board. Participant enrollment closed on October 8, 2021, and data collection closed on November 15, 2021. In total, 36 unique patient participants, representing 37 samples, and 20 provider participants were enrolled. Data analysis and manuscript writing will take place throughout 2023. CONCLUSIONS We anticipate that the data collected through this study will provide important insights regarding the feasibility, acceptability, and appropriateness of incorporating new real-time longitudinal, minimally invasive adherence tests into routine clinical care and identify potential barriers to medication adherence among patients. CLINICALTRIAL ClinicalTrials.gov NCT04232540; https://clinicaltrials.gov/ct2/show/NCT04232540 INTERNATIONAL REGISTERED REPORT RR1-10.2196/41188

COVID-19 was the third leading cause of death in the United States in 2020. Prior to the wide dissemination of SARS-CoV-2 vaccines, individual prevention behaviors, such as wearing face masks, have been the primary non-pharmaceutical interventions to reduce infections. We surveyed 404 North Carolina residents recruited through Amazon MTurk in July 2020 to assess adherence to key prevention behaviors (6-foot distancing, mask wearing, and gathering limits) and barriers to and facilitators of adherence. Participants reported past 7-day prevention behaviors and behavioral barriers and facilitators informed by the Integrated Behavior Model and the Health Belief Model (perceived risk, perceived severity, behavioral attitudes, injunctive and descriptive norms, and personal agency). Reported adherence to each behavior in the past 7 days was generally high, with lower adherence to 6-foot distancing and mask wearing in the work context. The most commonly endorsed barriers to 6-foot distancing included physical impediments, forgetting, and unfavorable descriptive norms. For mask wearing, ability to keep a distance, discomfort/inconvenience, and forgetting were most commonly endorsed. In logistic regression models, injunctive social norms followed by perceived personal agency were the strongest independent correlates of 6-foot distancing. Behavioral attitudes and injunctive social norms were independently associated with mask wearing. For gathering size limit adherence, perceived personal agency was the strongest independent predictor followed by perceived severity of COVID-19. Messaging campaigns targeting these barriers and facilitators should be tested. Interventions improving the convenience and salience of physical distancing and mask wearing in high-density public places and places of work may also promote prevention behaviors.

To eliminate mother-to-child transmission of HIV (EMTCT), scalable strategies to enhance antiretroviral adherence for both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are needed as part of integrated HIV and maternal-child health services. We developedTonse Pamodzi(“all of us together”), an adaptable intervention integrating biomedical and behavioral components to support HIV treatment and prevention. We describe our intervention development process, which comprised formative qualitative research, a review of the literature, and technical input from stakeholders representing the community, health systems, and policymakers. The resulting intervention, described herein, integrates patient-centered counseling and engagement of a patient-selected adherence supporter for pregnant and breastfeeding women initiating ART or PrEP. Patients receiving the intervention engage in Integrated Next Step Counseling (iNSC) sessions delivered by trained counselors to build and maintain adherence skills. Each patient also has the option of selecting an adherence supporter (partner, family member, or friend) who may participate in iNSC sessions and provide adherence support outside of these sessions. This flexible intervention is adaptable not only to ART or PrEP use, but also to the needs and preferences of each woman and the clinical context. If shown to be acceptable and feasible, the Tonse Pamodzi intervention may be an important tool in continuing efforts for EMTCT.