Mental Health, Social Connectedness, and Fear During the COVID-19 Pandemic: A Qualitative Perspective from Older Women with HIV.

Older women with HIV (WWH) confront significant biopsychosocial challenges that may be exacerbated by the COVID-19 pandemic. Between May 2020 and April 2021, following a resiliency intervention conducted as part of a randomized parent trial, 24 cisgender WWH (M = 58 years old) completed quantitative assessments and qualitative interviews exploring the impact of COVID-19 on mental health. Qualitative data were analyzed via rapid analysis. Most participants were Black (62.5%) and non-Hispanic or Latina (87.5%). Emergent themes included (1) increased anxiety and depression; (2) a loss of social connectedness; (3) fear of unknown interactions among COVID-19, HIV, and other comorbidities; and (4) the use of largely adaptive strategies to cope with these issues. Findings suggest that older WWH face significant COVID-19-related mental health challenges, compounding existing stressors. As the pandemic persists, it will be important to assess the impact of these stressors on wellbeing, identify effective coping strategies, and provide increased support to mitigate COVID-19-related mental health issues over time. Trial Registration: ClinicalTrials.gov identifier: NCT03071887.

"I am scared, I do not want to lie": exploring the impacts of COVID-19 on engagement in care, perceived health, relationship dynamics, and parenting among postpartum women with HIV in South Africa.

BACKGROUND: COVID-19 and efforts to manage widespread infection may compromise HIV care engagement. The COVID-19-related factors linked to reduced HIV engagement have not been assessed among postpartum women with HIV, who are at heightened risk of attrition under non-pandemic circumstances. To mitigate the effects of the pandemic on care engagement and to prepare for future public health crises, it is critical to understand how COVID-19 has impacted (1) engagement in care and (2) factors that may act as barriers to care engagement. METHODS: A quantitative assessment of COVID-19-related experiences was added to a longitudinal cohort study assessing predictors of postpartum attrition from HIV care among women in South Africa. Participants (N = 266) completed the assessment at 6, 12, 18, or 24 months postpartum between June and November of 2020. Those who endorsed one or more challenge related to engagement in care (making or keeping HIV care appointments, procuring HIV medications, procuring contraception, and/or accessing immunization services for infants; n = 55) were invited to complete a brief qualitative interview, which explored the specific factors driving these challenges, as well as other impacts of COVID-19 on care engagement. Within this subset, 53 participants completed an interview; qualitative data were analyzed via rapid analysis. RESULTS: Participants described key challenges that reduced their engagement in HIV care and identified four other domains of COVID-19-related impacts: physical health, mental health, relationship with a partner or with the father of the baby, and motherhood/caring for the new baby. Within these domains, specific themes and subthemes emerged, with some positive impacts of COVID-19 also reported (e.g., increased quality time, improved communication with partner, HIV disclosure). Coping strategies for COVID-19-related challenges (e.g., acceptance, spirituality, distraction) were also discussed. CONCLUSIONS: About one in five participants reported challenges accessing HIV care, medications, or services, and they faced complex, multilayered barriers to remaining engaged. Physical health, mental health, relationships with partners, and ability to care for their infant were also affected. Given the dynamic nature of the pandemic and general uncertainty about its course, ongoing assessment of pandemic-related challenges among postpartum women is needed to avoid HIV care disruptions and to support wellbeing.

Optimizing PMTCT Adherence by Treating Depression in Perinatal Women with HIV in South Africa: A Pilot Randomized Controlled Trial.

BACKGROUND: South Africa (SA) has the greatest HIV prevalence in the world, with rates as high as 40% among pregnant women. Depression is a robust predictor of nonadherence to antiretroviral therapy (ART) and engagement in HIV care; perinatal depression may affect upwards of 47% of women in SA. Evidence-based, scalable approaches for depression treatment and ART adherence in this setting are lacking. METHOD: Twenty-three pregnant women with HIV (WWH), ages 18-45 and receiving ART, were randomized to a psychosocial depression and adherence intervention or treatment as usual (TAU) to evaluate intervention feasibility, acceptability, and preliminary effect on depressive symptoms and ART adherence. Assessments were conducted pre-, immediately post-, and 3 months post-treatment, and included a qualitative exit interview. RESULTS: Most (67.6%) eligible individuals enrolled; 71% completed at least 75% of sessions. Compared to TAU, intervention participants had significantly greater improvements in depressive symptoms at post-treatment, ß = - 11.1, t(24) = - 3.1, p < 0.005, 95% CI [- 18.41, - 3.83], and 3 months, ß = - 13.8, t(24) = - 3.3, p < 0.005, 95% CI [- 22.50, - 5.17]. No significant differences in ART adherence, social support, or stigma were found. Qualitatively, perceived improvements in social support, self-esteem, and problem-solving adherence barriers emerged as key benefits of the intervention; additional sessions were desired. CONCLUSION: A combined depression and ART adherence intervention appears feasible and acceptable, and demonstrated preliminary evidence of efficacy in a high-need population. Additional research is needed to confirm efficacy and identify dissemination strategies to optimize the health of WWH and their children. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03069417. Protocol available at https://clinicaltrials.gov/ct2/show/NCT03069417.

Adapting, testing, and refining a resilience intervention for older women with HIV: An open pilot study.

Half of persons with HIV in the United States (US), many of whom are women, are over age 50. Aging women with HIV (WWH) face unique biopsychosocial challenges, including stigma, the physiological effects of aging, and illness-associated stressors. Resilience interventions can build awareness of such stressors and aid in facilitating the relaxation response; however, no existing interventions specifically cater to the needs of older WWH. The content of the Relaxation Response Resiliency Program, which teaches positive psychology strategies, relaxation techniques, and cognitive behavioral skills, was adapted for older WWH. Thirteen WWH over 50 participated in an open pilot of the adapted intervention to iteratively refine the program and its procedures. Participants attended either 8 or 10 weekly group sessions; three groups were conducted in total. Pre- and post-intervention assessments and qualitative exit interviews were conducted. Among completers, an increase in resilience was observed. Though significance testing was not conducted, social support also increased, and depression, anxiety, and HIV stigma decreased from pre- to post-intervention. Over half of eligible women enrolled; completers reported high satisfaction with the program. However, retention was difficult; six participants withdrew or were lost to follow-up. Mean number of sessions attended was 3.5 in the 8-session group and 5 in the 10-session groups. In this small sample, the adapted intervention led to a clinically meaningful increase in resilience, though recruitment and retention were challenging. Further refinements to the intervention are needed to minimize attrition and increase acceptability before additional testing is initiated.

Preventing cardiovascular disease in midlife women with HIV: An examination of facilitators and barriers to heart health behaviors.

Midlife women with HIV (WWH) are disproportionately impacted by cardiovascular disease (CVD), yet little is known about perceptions of CVD risk and the factors that influence engagement in heart health behaviors in this population. Few (if any) studies have used a qualitative approach to examine these perceptions, which has important implications for minimizing the negative impact of HIV-related noncommunicable diseases, the risk for which increases after midlife. Eighteen midlife WWH (aged 40-59) in Boston, MA, completed semistructured interviews to explore perceptions of CVD, HIV, and barriers and facilitators to healthy lifestyle behaviors. Interviews were analyzed via thematic analysis. Participants viewed heart health as important but were unaware of HIV-associated CVD risk. Facilitators included family and generational influences, social support, and access to resources. Physical symptoms, menopause, mental health challenges, and limited financial resources were barriers. Midlife WWH may benefit from tailored CVD prevention interventions that target their unique motivations and barriers to healthy behaviors.

Ingestible Electronic Sensors for Monitoring Real-time Adherence to HIV Pre-exposure Prophylaxis and Antiretroviral Therapy.

PURPOSE OF REVIEW: This review summarizes the recent advancements and future directions of digital pill systems (DPS) - which utilize ingestible sensors to directly measure medication ingestion events in real-time - in the context of HIV prevention and treatment. RECENT FINDINGS: Two DPS are cleared by the US Food and Drug Administration. The bioequivalence and stability of digitized pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) have been established, and pilot studies have demonstrated the feasibility and acceptability of using DPS for PrEP and ART adherence measurement. Important bioethical and implementation considerations have been identified for future clinical trials. Continued technological advancement may reduce barriers to use, and integration of DPS into behavioral interventions may facilitate adherence improvement efforts. DPS represent an innovative tool for PrEP and ART adherence measurement. Future work will optimize the technology to reduce operational barriers. DPS have significant potential for expansion across a diverse array of diseases, though key bioethical considerations must be examined prior to large-scale implementation.

"I'd feel like someone was watchin' me watching for a good reason": perceptions of data privacy, access, and sharing in the context of real-time PrEP adherence monitoring among HIV-negative MSM with substance use.

Once-daily oral tenofovir/emtricitabine is highly effective as pre-exposure prophylaxis (PrEP) against HIV but is dependent on adherence, which may be challenging for men who have sex with men (MSM) and use substances. Digital pill systems (DPS) permit the direct, real-time measurement of adherence, though user perceptions of data privacy in this context are unknown. Thirty prospective DPS users - HIV-negative MSM with non-alcohol substance use - completed in-depth qualitative interviews exploring preferences around privacy, access, and sharing of DPS adherence data. Participants discussed some concerns about the impact of DPS use on personal privacy, and emphasized the need for robust data protections in the technology. Participants were interested in having on-demand access to their adherence data, and were most willing to share data with primary care providers and long-term relationship partners. Future investigations exploring bioethical frameworks around DPS use are warranted, and user preferences should inform best practices for protecting DPS data.

Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use.

Once-daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV transmission, but adherence can be challenging for men who have sex with men (MSM) who use substances. A novel method for directly measuring ingestion events is a digital pill system (DPS), which comprises an ingestible radiofrequency emitter that signals a wearable Reader device upon PrEP ingestion, relaying ingestion data to a wearable Reader device and then to a smartphone application. Qualitative interviews were conducted with 15 MSM with non-alcohol substance use following an open-label pilot demonstration trial involving use of the DPS to measure PrEP adherence for 90 days. The purpose of this qualitative investigation was to understand overall user experiences and potential barriers and facilitators to using the DPS to measure PrEP adherence among MSM. The DPS was largely perceived as acceptable, novel, and valuable, with most participants reporting that the system was easily integrated into their daily routines. Technological and design factors, especially related to the wearable Reader, impacted participants' interest in using the technology long-term; several suggested improvements were discussed.Trial Registration ClinicalTrials.gov: NCT03842436.

Formative acceptance of ingestible biosensors to measure adherence to TB medications.

BACKGROUND: Tuberculosis (TB) represents a significant public health threat in India. Adherence to antitubercular therapy (ATT) is the key to reducing the burden of this infectious disease. Suboptimal adherence to ATT and lack of demonstrated feasibility of current strategies for monitoring ATT adherence highlights the need for alternative adherence monitoring systems. METHODS: A quantitative survey was conducted to assess the acceptance of and willingness to use a digital pill system (DPS) as a tool for monitoring ATT adherence among stakeholders directly involved in the management of patients with TB in India. Participants reviewed a video explaining the DPS and completed a survey, which covered sociodemographics, degree of involvement with TB patients, initial impressions of the DPS, and perceived challenges for deploying the technology in India. Participants were also asked to interpret mock DPS adherence data. RESULTS: The mean age was 34.3 (SD = 7.3), and participants (N = 50) were predominantly male (70%). The sample comprised internists (52%) and pulmonologists (30%), with a median of 4 years' experience (IQR 3, 6) in the management of TB patients. No participants had previously used a DPS, but some reported prior awareness of the technology (22%). Most reported that they would recommend use of a DPS to patients on ATT (76%), and that they would use a DPS in both the intensive and continuation phases of TB management (64%). The majority viewed the DPS (82%) as a useful alternative to directly observed therapy-short course (DOTS), particularly given the ongoing COVID-19 pandemic. Participants reported that a DPS would be most effective in patients at risk of nonadherence (64%), as well as those with past nonadherence (64%). Perceived barriers to DPS implementation included lack of patient willingness (92%), cost (86%), and infrastructure constraints (66%). The majority of participants were able to accurately interpret patterns of adherence (80%), suboptimal adherence (90%), and frank nonadherence (82%) when provided with mock DPS data. CONCLUSIONS: DPS are viewed as an acceptable, feasible, and useful technology for monitoring ATT adherence by stakeholders directly involved in TB management. Future investigations should explore patient acceptance of DPS and pilot demonstration of the system in the TB context.

A resiliency intervention adapted for older women with HIV: Results from a pilot randomized controlled trial in the northeastern US.

Aging with HIV often results in psychosocial and health-related challenges for women; however, no resiliency interventions exist for older women with HIV (WWH). WWH aged ≥50 were randomized to 10 group sessions of an adapted resiliency intervention or time-matched supportive psychotherapy. Assessments were conducted at three timepoints. Feasibility and acceptability metrics were defined a priori; differences in resilience, stress coping, anxiety, and depression across timepoints were assessed. Overall, 44 WWH enrolled; participants were 58 years old on average, and 56.4% identified as Black/African American. Among those who attended any sessions, all feasibility metrics were met, and the intervention was acceptable. The interaction of study arm and time was associated with significant decreases in depression and a trend toward significant decreases in anxiety. The intervention was not associated with changes in resilience or stress coping. Adjusting delivery modality may further reduce barriers to attendance, improving feasibility and clinical outcomes.

Smartphone and Wearable Device-Based Digital Phenotyping to Understand Substance use and its Syndemics.

Digital phenotyping is a process that allows researchers to leverage smartphone and wearable data to explore how technology use relates to behavioral health outcomes. In this Research Concepts article, we provide background on prior research that has employed digital phenotyping; the fundamentals of how digital phenotyping works, using examples from participant data; the application of digital phenotyping in the context of substance use and its syndemics; and the ethical, legal and social implications of digital phenotyping. We discuss applications for digital phenotyping in medical toxicology, as well as potential uses for digital phenotyping in future research. We also highlight the importance of obtaining ground truth annotation in order to identify and establish digital phenotypes of key behaviors of interest. Finally, there are many potential roles for medical toxicologists to leverage digital phenotyping both in research and in the future as a clinical tool to better understand the contextual features associated with drug poisoning and overdose. This article demonstrates how medical toxicologists and researchers can progress through phases of a research trajectory using digital phenotyping to better understand behavior and its association with smartphone usage.

Real-World Implementation Challenges Associated with a Digital Pill System to Measure Adherence to HIV Pre-Exposure Prophylaxis from Two Studies of Men Who Have Sex With Men.

Once-daily oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but its efficacy is dependent on adherence, which can be challenging for men who have sex with men (MSM) with substance use. Digital pill systems (DPS) represent a novel tool for directly measuring adherence through ingestible radiofrequency sensors that confirm ingestions in real-time. We examined operational challenges across two studies involving DPS to measure PrEP adherence. While most participants successfully operated the system, a number of technological and sociobehavioral challenges requiring intervention were identified across both studies. Technological issues were both system- and participant-related, and were primarily addressed with technical updates and participant re-education, while sociobehavioral issues, including health and housing changes and issues with technology access, warranted innovative solutions. Future research leveraging DPS technology should develop robust supportive infrastructure and mitigation procedures to promptly identify and resolve operational issues to optimize the potential benefits of DPS use.

Formative Perceptions of a Digital Pill System to Measure Adherence to Heart Failure Pharmacotherapy: Mixed Methods Study.

BACKGROUND: Heart failure (HF) affects 6.2 million Americans and is a leading cause of hospitalization. The mainstay of the management of HF is adherence to pharmacotherapy. Despite the effectiveness of HF pharmacotherapy, effectiveness is closely linked to adherence. Measuring adherence to HF pharmacotherapy is difficult; most clinical measures use indirect strategies such as calculating pharmacy refill data or using self-report. While helpful in guiding treatment adjustments, indirect measures of adherence may miss the detection of suboptimal adherence and co-occurring structural barriers associated with nonadherence. Digital pill systems (DPSs), which use an ingestible radiofrequency emitter to directly measure medication ingestions in real-time, represent a strategy for measuring and responding to nonadherence in the context of HF pharmacotherapy. Previous work has demonstrated the feasibility of using DPSs to measure adherence in other chronic diseases, but this strategy has yet to be leveraged for individuals with HF. OBJECTIVE: We aim to explore through qualitative interviews the facilitators and barriers to using DPS technology to monitor pharmacotherapy adherence among patients with HF. METHODS: We conducted individual, semistructured qualitative interviews and quantitative assessments between April and August 2022. A total of 20 patients with HF who were admitted to the general medical or cardiology service at an urban quaternary care hospital participated in this study. Participants completed a qualitative interview exploring the overall acceptability of and willingness to use DPS technology for adherence monitoring and perceived barriers to DPS use. Quantitative assessments evaluated HF history, existing medication adherence strategies, and attitudes toward technology. We analyzed qualitative data using applied thematic analysis and NVivo software (QSR International). RESULTS: Most participants (12/20, 60%) in qualitative interviews reported a willingness to use the DPS to measure HF medication adherence. Overall, the DPS was viewed as useful for increasing accountability and reinforcing adherence behaviors. Perceived barriers included technological issues, a lack of need, additional costs, and privacy concerns. Most were open to sharing adherence data with providers to bolster clinical care and decision-making. Reminder messages following detected nonadherence were perceived as a key feature, and customization was desired. Suggested improvements are primarily related to the design and usability of the Reader (a wearable device). CONCLUSIONS: Overall, individuals with HF perceived the DPS to be an acceptable and useful tool for measuring medication adherence. Accurate, real-time ingestion data can guide adherence counseling to optimize adherence management and inform tailored behavioral interventions to support adherence among patients with HF.

Perceptions of and preferences for PrEP use among African American women and providers in the U.S. South: a qualitative study.

OBJECTIVE: African American (AA) women in the U.S. South experience significant HIV incidence, and efforts to support antiretroviral pre-exposure prophylaxis (PrEP) uptake and maintenance among this group have been insufficient. This study aimed to explore perceptions, attitudes, and implementation preferences surrounding PrEP use for AA women in the U.S. South. METHODS AND MEASURES: The study team conducted qualitative interviews with AA cisgender women clients (n = 21) and their providers (n = 20) in Federally Qualified Health Centers and HIV clinics in Alabama. The research team employed directed qualitative content analysis to analyze interview data. RESULTS: Five themes emerged: a) inconsistent access to PrEP and PrEP knowledge, b) need for improving low PrEP awareness, c) managing hesitancy to prescribe or use PrEP, d) perceived HIV vulnerability and inherent stigma, and e) normalizing PrEP as part of routine sexual healthcare to increase uptake and maintenance. Interviews revealed an openness towards PrEP as an HIV prevention strategy for AA, cisgender women in Alabama. CONCLUSION: Improving PrEP uptake and maintenance among AA women in the U.S. South must go beyond increasing awareness to improving PrEP access and trust through visibility of AA women's PrEP use and incorporating PrEP education and services into routine sexual healthcare.

Acceptance of digital phenotyping linked to a digital pill system to measure PrEP adherence among men who have sex with men with substance use.

Once-daily oral HIV pre-exposure prophylaxis (PrEP) is an effective strategy to prevent HIV, but is highly dependent on adherence. Men who have sex with men (MSM) who use substances face unique challenges maintaining PrEP adherence. Digital pill systems (DPS) allow for real-time adherence measurement through ingestible sensors. Integration of DPS technology with other digital health tools, such as digital phenotyping, may improve understanding of nonadherence triggers and development of personalized adherence interventions based on ingestion behavior. This study explored the willingness of MSM with substance use to share digital phenotypic data and interact with ancillary systems in the context of DPS-measured PrEP adherence. Adult MSM on PrEP with substance use were recruited through a social networking app. Participants were introduced to DPS technology and completed an assessment to measure willingness to participate in DPS-based PrEP adherence research, contribute digital phenotyping data, and interact with ancillary systems in the context of DPS-based research. Medical mistrust, daily worry about PrEP adherence, and substance use were also assessed. Participants who identified as cisgender male and were willing to participate in DPS-based research (N = 131) were included in this subsample analysis. Most were White (76.3%) and non-Hispanic (77.9%). Participants who reported daily PrEP adherence worry had 3.7 times greater odds (95% CI: 1.03, 13.4) of willingness to share biometric data via a wearable device paired to the DPS. Participants with daily PrEP adherence worry were more likely to be willing to share smartphone data (p = 0.006) and receive text messages surrounding their daily activities (p = 0.003), compared to those with less worry. MSM with substance use disorder, who worried about PrEP adherence, were willing to use DPS technology and share data required for digital phenotyping in the context of PrEP adherence measurement. Efforts to address medical mistrust can increase advantages of this technology for HIV prevention.

HPTN 083-02: factors influencing adherence to injectable PrEP and retention in an injectable PrEP study.

INTRODUCTION: HPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial. METHODS: Participants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non-adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis. RESULTS: Participants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules). CONCLUSIONS: Respondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non-judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.

"I am scared, I do not want to lie": Exploring the impacts of COVID-19 on engagement in care, perceived health, relationship dynamics, and parenting among postpartum women with HIV in South Africa.

Background COVID-19 and efforts to manage widespread infection may compromise HIV care engagement. The COVID-19-related factors linked to reduced HIV engagement have not been assessed among postpartum women with HIV, who are at heightened risk of attrition under non-pandemic circumstances. To mitigate the effects of the pandemic on care engagement and to prepare for future public health crises, it is critical to understand how COVID-19 has impacted (1) engagement in care and (2) factors that may act as barriers to care engagement. Methods A quantitative assessment of COVID-19-related experiences was added to a longitudinal cohort study assessing predictors of postpartum attrition from HIV care among women in South Africa. Participants (N = 266) completed the assessment at 6, 12, 18, or 24 months postpartum between June and November of 2020. Those who endorsed one or more challenge related to engagement in care (making or keeping HIV care appointments, procuring HIV medications, procuring contraception, and/or accessing immunization services for infants; n = 55) were invited to complete a brief qualitative interview, which explored the specific factors driving these challenges, as well as other impacts of COVID-19 on care engagement. Within this subset, 53 participants completed an interview; qualitative data were analyzed via rapid analysis. Results Participants described key challenges that reduced their engagement in HIV care and identified four other domains of COVID-19-related impacts: physical health, mental health, relationship with a partner or with the father of the baby, and motherhood/caring for the new baby. Within these domains, specific themes and subthemes emerged, with some positive impacts of COVID-19 also reported (e.g., increased quality time, improved communication with partner, HIV disclosure). Coping strategies for COVID-19-related challenges (e.g., acceptance, spirituality, distraction) were also discussed. Conclusions About one in five participants reported challenges accessing HIV care, medications, or services, and they faced complex, multilayered barriers to remaining engaged. Physical health, mental health, relationships with partners, and ability to care for their infant were also affected. Given the dynamic nature of the pandemic and general uncertainty about its course, ongoing assessment of pandemic-related challenges among postpartum women is needed to avoid HIV care disruptions and to support wellbeing.

Attitudes towards participating in research involving digital pill systems to measure oral HIV pre-exposure chemoprophylaxis: a cross-sectional study among men who have sex with men with substance use in the USA.

OBJECTIVES: This quantitative survey sought to understand, among men who have sex with men (MSM) with potentially problematic substance use, the attitudes towards participation in research involving digital pill systems (DPS) for HIV pre-exposure prophylaxis (PrEP) adherence measurement, and the barriers and facilitators to research participation. DESIGN: One-time, cross-sectional, online sampling-based survey. SETTING: US social networking app predominantly focused on MSM. PARTICIPANTS: MSM without HIV who reported current use of oral PrEP, potentially problematic substance use and sexual activity in the past 3 months. A total of 157 participants were eligible, passed validity checks and enrolled. OUTCOME MEASURES: Perceptions of DPS usefulness, accuracy and usability (System Usability Scale (SUS)); willingness and motivations to participate in DPS research; preferences for access to and feedback on DPS adherence data; data sharing considerations; and medical mistrust (Group-Based Medical Mistrust Scale (GBMMS)). RESULTS: Most of the sample (N=157) was white (n=119, 75.8%), gay (n=124, 79.0%) and cisgender (n=150, 95.5%). The median age was 33 years (IQR: 14). The mean GBMMS score was 13.5 (SD=5.2), and the median SUS score was 70 (IQR: 27.5). In the past 3 months, 36.3% (n=57) reported frequent use of substances before or during sex, and 62.4% (n=98) engaged in condomless sex. While most were adherent to PrEP, approximately 34.4% (n=54) expressed significant worry about daily adherence. Participants wished to monitor their PrEP adherence daily (n=66, 42.0%) and 52% (n=82) were very willing to participate in DPS-based research. The majority were minimally concerned about sharing DPS-detected adherence data with research teams (n=126, 80.3%), and were extremely willing to share these data with healthcare providers (n=109, 69.4%). CONCLUSIONS: In this sample, MSM without HIV who use substances reported willingness to use DPS to measure PrEP adherence in a research context, and identified benefits to accessing real-time, DPS-detected adherence data.

Diversity in Digital Pill Systems: Differences in Perceptions and Attitudes Towards Use of a Digital Pill System for HIV Pre-Exposure Prophylaxis Among Men Who Have Sex with Men with Diverse Racial and Ethnic Identities.

Nonadherence, particularly among men who have sex with men (MSM) with substance use disorders, increases the risk of HIV acquisition. Measuring adherence to HIV pre-exposure chemoprophylaxis (PrEP), and responding to suboptimal adherence or changes in adherence behavior remains a challenging public health problem. Despite the importance of accurate adherence measurement, there is no gold standard for detecting medication ingestion events in HIV research. Current adherence measures indirectly infer ingestion events or measure medication concentrations over time, yet such approaches fail to provide direct confirmation of ingestions and contextual information surrounding adherence and nonadherence. A digital pill system (DPS) - a novel tool that leverages ingestible radiofrequency sensors to measure actual ingestion events - may advance adherence measurement in HIV research. We examined and compared the willingness of MSM across racial and ethnic identities to operate a DPS in the context of PrEP adherence measurement and suggest potential future applications of this technology.

Protocol for WeExPAnd: a prospective, mixed-methods pilot demonstration study to increase access to pre-exposure prophylaxis among women vulnerable to HIV infection in the Southern USA.

INTRODUCTION: African American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may circumvent barriers to traditional HIV prevention tools, such as condom use; however, very little is known about how to improve PrEP access and uptake among AA women who may benefit from PrEP use. This project aims to understand how to increase PrEP access among AA women in the rural Southern USA, which may ultimately affect HIV incidence in this population. METHODS AND ANALYSIS: The goal of the current study is to systematically adapt a patient-provider communication tool to increase PrEP uptake among AA women receiving care at a federally qualified health centre in Alabama. We will use an iterative implementation process, by assessing the feasibility, acceptability and preliminary impact of the tool on PrEP uptake, using a pilot preintervention/postintervention design (N=125). We will evaluate women's reasons for declining a referral to a PrEP provider, reasons for incomplete referrals, reasons for not initiating PrEP after a successful referral and ongoing PrEP use at 3 and 12 months after PrEP initiation among our sample. The proposed work will significantly contribute to our understanding of factors impacting PrEP uptake and use among AA women, particularly in underserved areas in the Deep South that are heavily impacted by the HIV epidemic and experience worse HIV-related health outcomes relative to other areas in the USA. ETHICS AND DISSEMINATION: This protocol has been approved by the Institutional Review Board (IRB) at University of Alabama at Birmingham (Birmingham, AL; protocol 300004276). All participants will review a detailed informed consent form approved by the IRB and will provide written or verbal informed consent prior to enrolment. Results will be disseminated through peer-reviewed manuscripts, reports, and local, national and international presentations. TRIAL REGISTRATION NUMBER: NCT04373551.