Correction: Improving the Engagement of Underrepresented People in Health Research Through Equity-Centered Design Thinking: Qualitative Study and Process Evaluation for the Development of the Grounding Health Research in Design Toolkit.

[This corrects the article DOI: 10.2196/43101.].

A secondary gendered analysis of interviews with Latina cisgender women indicated for HIV pre-exposure prophylaxis.

HIV infections disproportionately impact Latinx populations in the United States, yet oral pre-exposure prophylaxis (PrEP) uptake is low. This study was a secondary gendered analysis of interviews with Latina cisgender women (n = 20) recruited from an urban safety net hospital inNew York City between August 2019 and October 2022. All women were indicated for PrEP by the provider. In-depth interviews were conducted with participants in English and Spanish and asked about social determinants of health, sexual partnerships and behaviors, and PrEP-specific enablers and barriers. Secondary thematic content analysis was conducted to identify gender-related factors influencing PrEP uptake. The following themes emerged from the data:structural factors (e.g., employment), partner-related factors, low sexual health knowledge, and resilience and empowerment. Partner-related factors were the most salient; partner infidelity served as reasons for initiating PrEP. Despite being constrained by low power in relationships, women made empowered choices to initiate PrEP and protect themselves. Findings indicated that the impact of gender inequity was an important factor in Latina women's PrEP decision making, pointing to a need to address partner-driven HIV risk, imbalance of power in relationships, and gender norms.

Individual and Collective Forms of Stigma Resistance: Pathways Between HIV and Sex Work Stigma and Viral Suppression Among Female Sex Workers in the Dominican Republic.

Intersecting forms of stigma including both HIV and sex work stigma have been known to impede HIV prevention and optimal treatment outcomes among FSW. Recent research has indicated that intersectional stigma can be resisted at the community and individual level. We assessed pathways between HIV stigma, sex work stigma, social cohesion and viral suppression among a cohort of 210 FSW living with HIV in the Dominican Republic. Through Poisson regression we explored the relationship between HIV outcomes and internalized, anticipated and enacted HIV and sex work stigma, and resisted sex work stigma. We employed structural equation modeling to explore the direct effect of various forms of stigma on HIV outcomes, and the mediating effects of multi-level stigma resistance including social cohesion at the community level and occupational dignity at the individual level. 76.2% of FSW were virally suppressed and 28.1% had stopped ART at least once in the last 6 months. ART interruption had a significant negative direct effect on viral suppression (OR = 0.26, p < 0.001, 95% CI: 0.13-0.51). Social cohesion had a significant positive direct effect on viral suppression (OR = 2.07, p = 0.046, 95% CI: 1.01-4.25). Anticipated HIV stigma had a significant negative effect on viral suppression (OR = 0.34, p = 0.055, 95% CI: 0.11-1.02). This effect was mediated by the interaction between cohesion and dignity which rendered the impact of HIV stigma on viral suppression not significant. Findings demonstrate that while HIV stigma has a negative impact on viral suppression among FSW, it can be resisted through individual and collective means. Results reinforce the importance of community-driven, multi-level interventions.

Improving the Engagement of Underrepresented People in Health Research Through Equity-Centered Design Thinking: Qualitative Study and Process Evaluation for the Development of the Grounding Health Research in Design Toolkit.

BACKGROUND: Health inequalities are rooted in historically unjust differences in economic opportunities, environment, access to health care services, and other social determinants. Owing to these health inequalities, the COVID-19 pandemic has disproportionately affected underserved populations, notably people of color, incarcerated and formerly incarcerated individuals, and those unable to physically distance themselves from others. However, people most strongly impacted by health disparities, and the pandemic, are not frequently engaged in research, either as researchers or as participants, resulting in slow progress toward improving health equity. Establishing ways to foster the engagement of historically excluded people is crucial to improving health equity through patient-centered health research. OBJECTIVE: This study aimed to assess the use of equity-centered design thinking (EDT) for engaging community members in research prioritization related to COVID-19. The co-design methods and subsequent production of a toolkit that can be used for engagement were assessed through process evaluation and qualitative methods. METHODS: Process evaluation and qualitative inquiry, using reflexive thematic analysis, were undertaken to examine the use of EDT. Patient community members and stakeholders remotely partnered with design and health researchers in a year-long digital process to cocreate capacity-building tools for setting agenda for research regarding the impact of COVID-19 on health outcomes. Through a series of 3 workshops, 5 community partners engaged in EDT activities to identify critical challenges for the health and well-being of their communities. The subsequent tools were tested with 10 health researchers who provided critical input over the course of 2 workshops. Interviews with co-designers, project materials, and feedback sessions were used in the process evaluation and finalization of an equity-centered toolkit for community engagement in research. Data from the co-design process, meetings, workshops, and interviews were analyzed using reflexive thematic analysis to identify salient themes. RESULTS: Process evaluation illustrated how the EDT co-design process offered an approach to engage patient partners and community stakeholders in health-related research around COVID-19. The participants expressed satisfaction with design thinking approaches, including creative activities and iterative co-design, as a means of working together. Thematic analysis identified 3 key themes: the value of authentic partnerships, building trust and empathy through design, and fostering candid dialogue around health and social issues impacting historically underrepresented and underinvested communities. CONCLUSIONS: The project addressed the need to test EDT strategies for fostering inclusive community engagement in health research agenda setting and provided an alternative to traditional top-down models. Despite the increasing use of human-centered design in health, few projects explicitly include equity in design thinking approaches. The use of methods and tools to intentionally engage underrepresented stakeholders in the process of research agenda setting and equitably sharing power between researchers and community members may improve health research, ultimately improving health equity.

Context and Considerations for the Development of Community-Informed Health Communication Messaging to Support Equitable Uptake of COVID-19 Vaccines Among Communities of Color in Washington, DC.

BACKGROUND: Communities of color have been disproportionately impacted by COVID-19. We explored barriers and facilitators to COVID-19 vaccine uptake among African American, Latinx, and African immigrant communities in Washington, DC. METHODS: A total of 76 individuals participated in qualitative interviews and focus groups, and 208 individuals from communities of color participated in an online crowdsourcing contest. RESULTS: Findings documented a lack of sufficient, accurate information about COVID-19 vaccines and questions about the science. African American and African immigrant participants spoke about the deeply rooted historical underpinnings to their community's vaccine hesitancy, citing the prior and ongoing mistreatment of people of color by the medical community. Latinx and African immigrant participants highlighted how limited accessibility played an important role in the slow uptake of COVID-19 vaccines in their communities. Connectedness and solidarity were found to be key assets that can be drawn upon through community-driven responses to address social-structural challenges to COVID-19 related vaccine uptake. CONCLUSIONS: The historic and ongoing socio-economic context and realities of communities of color must be understood and respected to inform community-based health communication messaging to support vaccine equity for COVID-19 and other infectious diseases.

Acceptability of multiple modalities of pre-exposure prophylaxis (PrEP) among female sex workers in Tanzania: a mixed-methods study.

OBJECTIVES: Modalities of pre-exposure prophylaxis (PrEP) for HIV prevention offer options to women at high risk including female sex workers (FSW). This study aimed to explore FSW's acceptability and preferences for oral pills, long-acting (LA) injectable and vaginal ring PrEP. DESIGN: Sequential, explanatory, mixed methods. SETTING: Iringa, Tanzania. PARTICIPANTS: FSW aged above 18 were recruited from sex work venues using time-location sampling (n=496); HIV-uninfected (n=293) were included in this analysis. Subsequently, survey participants were recruited for in-depth interviews (n=10) and two focus group discussions (n=20). PRIMARY OUTCOME MEASURES: (1) Acceptability of PrEP (Do you personally think it would be worth it to you to take ART if it could prevent HIV?: yes/no) and (2) preference for LA injectable versus oral pills (If you personally were going to take ART to prevent HIV infection, would you prefer to take it in the form of a daily pill or an injection once every 3 months? Injection/pill). RESULTS: Participants were (92%) unaware of PrEP but 58% thought it would be worth it to personally take PrEP. Acceptability of PrEP was significantly associated with higher social cohesion (aOR 2.12; 95% CI 1.29 to 3.50) and STI symptoms in the past 6 months (aOR 2.52; 95% CI 1.38 to 4.62). Most (88%) preferred LA vs oral PrEP. Qualitative findings revealed generally positive reactions to all types of PrEP, and they were viewed as a welcome backup to condoms. Participants had concerns about pills (burden of daily use, stigma from clients), and the vaginal ring (fear of client noticing and becoming suspicious, fear of infertility) and overall preferred LA-PrEP (less frequent use, easy to hide, belief in higher efficacy). CONCLUSIONS: Offering multiple formulations of PrEP within the context of community-driven HIV prevention interventions among FSW may facilitate increased uptake and adherence. LA injectable PrEP may be a particularly preferred formulation among FSW. TRIAL REGISTRATION NUMBER: NCT02281578.

Experiences of women raising children with congenital Zika syndrome along a trajectory of prevention, care and support in Brazil.

Social science research investigating the social dynamics of Zika and congenital Zika syndrome (CZS) is essential to inform future services related to Zika and other infectious diseases. We sought to understand lived experiences with Zika during pregnancy, birth, and post-partum by conducting in-depth interviews with a sample of 31 women infected with Zika during the 2015-16 outbreak who had a child with CZS in Pernambuco, Brazil. Transcripts were coded using thematic content analysis. Many women experienced shock when their children were born with CZS given the lack of information they were provided during the antenatal period. Stigma from loved ones and community members was a salient theme as were financial difficulties arising from women having to stop working to care for their child. While women experienced significant challenges caring for a child with CZS, they also exhibited resiliency in their ability to move from shock and sorrow to focusing on the needs of their child. While support services were generally available, they were often located at a significant distance. Results underscore the need for interventions to improve patient-provider communication, address socio-structural stressors, and support individual and collective resilience in women and families affected by Zika in lower resource settings.

"She is the one who knows": A qualitative exploration of oral and injectable PrEP as part of a community empowerment approach to HIV prevention among female sex workers in the Dominican Republic and Tanzania.

Despite documented interest among female sex workers (FSW), uptake of oral pre-exposure prophylaxis (PrEP) for HIV prevention has been low. Recent trials and regulatory approval of long-acting injectable (LAI) PrEP offer new hope for the potential of this biomedical intervention. We examined FSW's PrEP-related interest and preferences regarding both oral and LAI PrEP situating these dynamics within their specific social and occupational realities. We conducted this work using qualitative methods across two distinct contexts by conducting 40 in-depth interviews with FSW in Tanzania and the Dominican Republic. Textual data was coded using iterative thematic content analysis. Analytic summaries were developed and reviewed to identify recurring themes. We systematically organized themes within each country and then compared across settings. Women in both settings expressed strong interest in PrEP seeing it as an important option to protect themselves in their work. Most participants preferred LAI PrEP due to expectations of reduced stigma and concerns about daily pill adherence and side effects. Occupational factors such as alcohol use, overnight dates with clients, and fear of violence from clients were identified as barriers to daily oral PrEP. LAI PrEP was seen as having the potential to reduce stress related to oral PrEP. Women who preferred pills discussed fear of needles, skepticism about the injections, and others relayed that taking a daily pill would not be challenging for them. There was a pre-dominant sentiment that women know best whether they are better suited for oral or LAI PrEP. Participants stressed the importance of FSW understanding both options to ensure informed decision-making around PrEP and described community-led peer education as key to delivering trusted information. Community empowerment approaches led by FSW which address structural and psychosocial constraints and promote safe work environments may facilitate equitable access and uptake of PrEP among FSW across settings.

Acceptability and perceptions of HIV oral self-testing across settings: A comparative qualitative study among Dominican and Tanzanian female sex workers.

Rapid oral HIV self-tests (HIVST) have potential to increase the proportion of people who know their HIV status, especially among stigmatised populations. This study was embedded in two cohorts of female sex workers (FSW) in the Dominican Republic (DR) and Tanzania. Qualitative interviews with 40 FSW were conducted to explore perceived acceptability of HIVST. Interviews were analysed using inductive and deductive thematic coding. Emergent themes were organised by socio-ecological framework levels. FSW in both settings responded positively to the ease of use of HIVST but questioned test accuracy due to the use of saliva rather than blood. FSW in the DR had a more cautious response, while women in Tanzania had favourable perceptions expressing eagerness to use it. At the individual level, themes shaping participants' interest included autonomy, HIV risk perception, and emotional well-being for those with reactive test results, and self-efficacy. At the interpersonal level, privacy, confidentiality, sex work and HIV stigma and social support were salient. Structural level themes focused on health systems including linkages to HIV treatment, provider roles, and access (cost, travel, distribution). Understanding FSW's perceptions and acceptability of HIVST is essential to its integration into health systems and programmes using a community-driven approach.

Development of the Experiences of Sex Work Stigma Scale Using Item Response Theory: Implications for Research on the Social Determinants of HIV.

While HIV stigma has received significant attention, limited work has been conducted on the measurement of intersecting stigmas. We developed the Experiences of Sex Work Stigma (ESWS) scale in the Dominican Republic (DR) and Tanzania. We conducted in-depth interviews with 20 female sex workers (FSW) per country to identify scale domains followed by cognitive debriefing interviews to assess content validity. Items were administered in a survey to FSW in DR (n = 211) and Tanzania (n = 205). Factor analysis established four sex work stigma domains including: shame (internalized), dignity (resisted), silence (anticipated) and treatment (enacted). Reliability across domains ranged from 0.81 to 0.93. Using item response theory (IRT) we created context-specific domain scores accounting for differential item functioning between countries. ESWS domains were associated with internalized HIV stigma, depression, anxiety, sexual partner violence and social cohesion across contexts. The ESWS is the first reliable and valid scale to assess multiple domains of sex work stigma and can be used to examine the effects of this form of intersectional stigma on HIV-related outcomes across settings.

Multi-level considerations for optimal implementation of long-acting injectable antiretroviral therapy to treat people living with HIV: perspectives of health care providers participating in phase 3 trials.

BACKGROUND: Long-acting injectable antiretroviral therapy (LA ART) has been shown to be non-inferior to daily oral ART, with high patient satisfaction and preference to oral standard of care in research to date, and has recently been approved for use in the United States and Europe. This study examined the perspectives of health care providers participating in LA ART clinical trials on potential barriers and solutions to LA ART roll-out into real world settings. METHODS: This analysis draws on two data sources: (1) open-ended questions embedded in a structured online survey of 329 health care providers participating in the ATLAS-2 M trial across 13 countries; and (2) in-depth interviews with 14 providers participating in FLAIR/ ATLAS/ATLAS-2 M trials in the United States and Spain. Both assessments explored provider views and clinic dynamics related to the introduction of LA ART and were analyzed using thematic content analysis. The Consolidated Framework for Implementation Research (CFIR) was drawn on as the conceptual framework underpinning development of a model depicting study findings. RESULTS: Barriers and proposed solutions to LA ART implementation were identified at the individual, clinic and health system levels. Provider perceptions of patient level barriers included challenges with adhering to frequent injection appointments and injection tolerability. Proposed solutions included patient education, having designated staff for clinic visit retention, and clinic flexibility with appointment scheduling. The main provider concern was identifying appropriate candidates for LA ART; proposed solutions focused on patient provider communication and decision making. Clinic level barriers included the need for additional skilled individuals to administer injections, shifts in workflow as demand increases and the logistics of cold-chain storage. Proposed solutions included staff hiring and training, strategic planning around workflow and logistics, and the possibility of offering injections in other settings, including the home. Health system level barriers included cost and approvals from national regulatory bodies. Potential solutions included governments subsidizing treatment, ensuring cost is competitive with oral ART, and offering co-pay assistance. CONCLUSIONS: Results suggest the importance of multi-level support systems to optimize patient-provider communication and treatment decision-making; clinic staffing, workflow, logistics protocols and infrastructure; and cost-related factors within a given health system.

Mindfulness, Mental Health and HIV Outcomes Among Female Sex Workers in the Dominican Republic and Tanzania.

We examined the relationship between mindfulness, mental health and HIV outcomes among female sex workers (FSW) from the Dominican Republic (DR) (n = 201) and Tanzania (n = 208) using cross-sectional survey and biologic data. We employed stratified multivariate linear and logistic regression. Depression was associated with lower odds of ART adherence in the DR (AOR 0.25, 95% CI: 0.08-0.78) and of viral suppression in Tanzania (AOR 0.49, 95% CI: 0.24-0.97). In both countries, mindfulness was associated with lower odds of moderate to severe depression (AOR 0.82, 95% CI: 0.76-0.88 for the DR; AOR 0.85, 95% CI: 0.77-0.95 for Tanzania). In the DR, mindfulness was associated with lower odds of anxiety (AOR 0.83, 95% CI: 0.77-0.89), lower HIV stigma (ß = - 0.28 per unit change, 95% CI: - 0.37 to - 0.19) and greater odds of viral suppression (AOR 1.09, 95% CI: 1.02-1.15). Findings demonstrate the potential of tailored mindfulness interventions to improve mental health and HIV outcomes among FSW.

RESUMEN: Examinamos la relación entre la atención plena, la salud mental y los resultados del VIH entre las trabajadoras sexuales (TRSX) de la República Dominicana (RD) (n = 201) y Tanzania (n = 208) utilizando una encuesta transversal y datos biológicos. Empleamos regresión lineal multivariada estratificada y regresión logística. La depresión se asoció con menores probabilidades de adherencia al terapia antiretroviral (TAR) en la República Dominicana (AOR 0.25, IC del 95%: 0.08­0.78) y de supresión viral en Tanzania (AOR 0.49, IC del 95%: 0.24­0.97). En ambos países, la atención plena se asoció con menores probabilidades de depresión moderada a grave (AOR 0.82, IC del 95%: 0.76­0.88 para la República Dominicana; AOR 0.85, IC del 95%: 0.77­0.95 para Tanzania). En la República Dominicana, la atención plena se asoció con menores probabilidades de ansiedad (AOR 0.83, IC del 95%: 0.77­0.89), menor estigma del VIH (ß = − 0.28 por unidad de cambio, IC del 95%: − 0.37 to − 0.19) y mayores probabilidades de supresión viral (AOR 1.09, 95% CI: 1.02­1.15). Los hallazgos demuestran el potencial de las intervenciones de atención plena para mejorar la salud mental y los resultados del VIH entre las TRSX.

"I feel empowered": women's perspectives on and experiences with long-acting injectable antiretroviral therapy in the USA and Spain.

Long-acting injectable antiretroviral therapy has been shown to be non-inferior to daily oral antiretroviral therapy in clinical trials and may soon become part of clinical care. While most trial participants to date have been men, approximately one quarter of ongoing Phase 3 trial participants are women offering an important opportunity to understand how long-acting antiretroviral therapy is perceived and experienced by women. We conducted in-depth interviews with 80 people living with HIV participating in Phase 2 and 3 clinical trials of long-acting antiretroviral therapy in the USA and Spain. Fifteen percent (12/80) of trial participants interviewed were women. Interviews were audio-recorded, transcribed and coded using content analysis, focused on gender-specific themes. Women shared many of the positive perceptions expressed by men but also had unique perspectives, including finding that long-acting antiretroviral therapy addressed the challenge of remembering pills amidst busy day-to-day realities including multiple roles and responsibilities, is less time consuming and creates less stress compared to oral antiretroviral therapy, and is emotionally freeing and empowering. The gendered nature of women's lives shaped why and how they were satisfied with long-acting antiretroviral therapy. Findings can inform interventions and support systems to facilitate uptake of and adherence to long-acting antiretroviral therapy in women.

Feasibility of Implementing Long-Acting Injectable Antiretroviral Therapy to Treat HIV: A Survey of Health Providers from the 13 Countries Participating in the ATLAS-2M Trial.

Long-acting (LA) injectable antiretroviral therapy (ART) was found noninferior to daily oral ART in Phase 3 trials with high patient satisfaction. Limited information on provider experiences with LA ART exists, which is critical to inform real-world implementation. An online survey of health providers from the 13 countries participating in the Phase 3b ATLAS-2M trial was conducted. A total of 293 providers responded to questions on LA ART feasibility. Multivariable regression was utilized to identify factors related to the feasibility of LA ART every month and every 2 months within routine care such as the characteristics, experiences, and attitudes of providers, and perceptions of patient benefits and barriers. A majority of providers indicated that it would be very feasible (62.8%) or somewhat feasible (32.1%) to administer monthly LA ART. Feasibility scores were higher for delivering LA ART every 2 months versus monthly (mean 28.3 vs. 26.9; p value <.001). African providers had higher odds of perceived overall feasibility of monthly LA ART [adjusted odds ratio (aOR) 2.9, 95% confidence interval (CI) 1.9-4.4] versus those from other regions, as did providers reporting a greater number of benefits for patients (aOR 1.1, 95% CI 1.0-1.1) versus those reporting less. Providers reporting a greater number of patient barriers to adhere to clinic appointments had lower odds of perceived feasibility of monthly LA ART (aOR 0.8, 95% CI 0.7-1.0) versus those reporting less. Findings highlight the need for further implementation research regarding barriers, facilitators, and strategies to optimize the introduction of LA ART outside of clinical trials.

Identifying appropriate candidates for long-acting antiretroviral therapy: findings from a survey of health care providers in the ATLAS-2M trial.

INTRODUCTION: Recent results from Phase 3 clinical trials with cabotegravir (CAB) and rilpivirine (RPV) long-acting (LA) have shown that a monthly regimen is non-inferior to daily oral antiretroviral therapy (ART). Additional insights are necessary to prepare for LA ART roll-out, including identifying the appropriate patients. METHODS: Within the ATLAS-2M trial, an online survey was administered to 329 health care providers (HCPs) in 13 countries. Multivariate logistic regression was conducted to identify factors associated with providers considering a greater proportion of patients as appropriate LA ART candidates. RESULTS: Forty-seven percent of HCPs believed that "some" patients (25-50%) would be appropriate while nearly one-quarter of HCPs (23%) felt that "many" patients (more than 50%) would be appropriate candidates for LA ART. Providers in the African region had a greater odds of identifying a greater proportion of their patients as appropriate candidates (AOR 8.97; p < 0.001) vs. other regions. Nurses/physician assistants and research staff/pharmacists had a higher odds of perceiving a greater proportion of their patients as appropriate candidates vs. physicians, respectively (AOR 3.42 p < 0.001; AOR 2.48; p = 0.19). Providers who had experience transitioning patients from LA to oral ART had a higher odds of reporting that more of their patients would be appropriate candidates (AOR 1.64; p = 0.008) vs. those without experience. CONCLUSION: A significant proportion of providers reported that many of their patients would be appropriate candidates for LA ART. To optimize roll-out after regulatory approval, it is important to support providers with tools to help identify patients who would most benefit from this option.

Examining adherence barriers among women with HIV to tailor outreach for long-acting injectable antiretroviral therapy.

BACKGROUND: Long-acting (LA) injectable antiretroviral therapy (ART) has been found non-inferior to daily oral ART in Phase 3 trials. LA ART may address key barriers to oral ART adherence and be preferable to daily pills for some people living with HIV. To date, women have been less represented than men in LA ART research. Using longitudinal data from the Women's Interagency HIV Study (WIHS) cohort of women living with HIV in the United States, we examined barriers and facilitators of daily oral ART adherence that may be related to or addressed by LA ART. METHODS: We conducted a secondary analysis of WIHS cohort data from 1998 to 2017 among participants seen for at least 4 visits since 1998 who reported using ART at least once (n = 2601). Two dichotomous outcomes, patient-reported daily oral ART adherence and viral suppression were fit using generalized linear models, examining the role of socio-demographic and structural factors. RESULTS: At study enrollment, the median age was 40.5 years, 63% of participants were African American and 22% were Latina. The majority (82%) reported taking ART more than 75% of the time and 53% were virally suppressed. In multivariate analysis, several sub-groups of women had lower odds of reported adherence and viral suppression: 1) younger women (adherence aOR: 0.71; viral suppression aOR: 0.63); 2) women who inject drugs (adherence aOR: 0.38; viral suppression aOR: 0.50) and those with moderate (adherence aOR: 0.59; viral suppression aOR: 0.74) and heavy alcohol consumption (adherence aOR: 0.51; viral suppression aOR: 0.69); 3) those with depressive symptoms (adherence aOR: 0.61; viral suppression aOR: 0.76); and 4) those with a history of going on and off ART (adherence aOR: 0.62, viral suppression aOR: 0.38) or changing regimens (adherence aOR: 0.83, viral suppression aOR: 0.56). CONCLUSIONS: Current injectable contraceptive users (vs. non-users) had greater odds of oral ART adherence (aOR: 1.87) and viral suppression (aOR: 1.28). Findings identify profiles of women who may benefit from and be interested in LA ART. Further research is warranted focused on the uptake and utility of LA ART for such key subpopulations of women at high need for innovative approaches to achieve sustained viral suppression.

"A dream come true": Perspectives on long-acting injectable antiretroviral therapy among female sex workers living with HIV from the Dominican Republic and Tanzania.

BACKGROUND: Long-acting injectable antiretroviral therapy (LA ART) was found to be non-inferior to daily oral ART in Phase 3 clinical trials. LA ART may offer an important alternative for people living with HIV with challenges adhering to daily oral ART or preferences for non-pill-based regimens. METHODS: Using a mixed methods approach integrating survey, in-depth interview and biological data from female sex workers (FSW) living with HIV in Tanzania (N = 208) and the Dominican Republic (DR) (N = 201), we assessed factors associated with the potential likelihood of LA ART use if it were available. We conducted multivariate logistic regression and thematic content analysis. RESULTS: Likelihood of LA ART use was high with 84.92% of FSW from the DR and 92.27% of FSW from Tanzania reporting they would be "likely" or "very likely" to use LA ART if available (p = 0.02). In Tanzania better HIV-related patient-provider communication (AOR 4.58; 95% CI 1.90-11.05) and quality of HIV clinical care (AOR 3.68; 95% CI 1.05-12.86) were positively associated with the high likelihood of LA ART use. In the DR, easier clinic access was associated with a higher likelihood of LA ART use (AOR 3.04; 95% CI 1.41-6.56), as was greater monthly income from sex work (AOR 2.37; 95% CI 1.27-4.41). In both settings, years on ART was significantly associated with a strong likelihood of LA ART use (TZ: AOR 1.16 per year; 95% CI 1.00-1.34/DR: AOR 1.07 per year; 95% CI 1.00-1.14). Qualitative findings underscored enthusiasm for LA ART and reinforced its potential to address sex work-specific barriers to daily oral ART adherence including work-related schedules and substance use. CONCLUSIONS: We found a high likelihood of LA ART use if available among FSW in two diverse settings and documented barriers to future uptake. Community-driven approaches which include tailored health education and improved patient-provider communication and quality of care, as well as strategies to facilitate appointment adherence are needed to optimize LA ART use among FSW.

"It made me more confident that I have it under control": Patient and provider perspectives on moving to a two-drug ART regimen in the United States and Spain.

BACKGROUND: Two-drug regimens (2DR) to treat HIV infection have the potential to reduce long-term toxicity and increase therapeutic options for people living with HIV (PLHIV). Prior phase III trials, SWORD-1 and SWORD-2, as well as GEMINI-1 and GEMINI-2, have demonstrated that a dolutegravir-based 2DR is as effective as three- or four-drug regimens among virologically suppressed patients. Limited information exists, however, on patient and provider experiences with 2DR to inform roll-out and integration into routine clinical care. METHODS: We conducted 39 in-depth interviews with PLHIV currently on 2DR in the context of routine care and 8 of their clinical care providers in the United States (U.S.) and Spain. Participants included 33 male and 6 female PLHIV and 8 providers. Interview topics explored perceptions of and experiences with 2DR compared to prior anti-retroviral regimens (ARVs), side effects, patient satisfaction, and clinical performance. Interviews were audio-recorded, transcribed and analyzed using thematic content analysis. RESULTS: Participants viewed 2DR as a significant and positive advance, in terms of its ability to effectively treat HIV with reduced toxicity and essentially no reported side effects. Patients noted the central role providers played in the decision to switch to a 2DR regimen and, among U.S. participants, the importance of insurance coverage making this preferred option feasible. Patients and providers agreed that a 2DR regimen would be appropriate for any PLHIV regardless of whether they were treatment naïve or had significant experience with ARVs. CONCLUSIONS: Participants' experiences with a 2DR regimen were positive with no participants, reporting side effects and all reporting continued viral suppression. Providers valued the reduced toxicity offered by 2DR and served as the primary gateway to a transition to 2DR for patients in both settings. This study provides a foundation for further research on the transition to 2DR regimens in other populations and contexts including low- and middle-income settings.

Efficacy and Freedom: Patient Experiences with the Transition from Daily Oral to Long-Acting Injectable Antiretroviral Therapy to Treat HIV in the Context of Phase 3 Trials.

Long-acting injectable antiretroviral therapy (LA ART) may be an alternative for people living with HIV (PLHIV) with adherence challenges or who prefer not to take pills. Using in-depth interviews, this study sought to understand the experiences of PLHIV (n = 53) participating in Phase 3 LA ART trials in the United States and Spain. The most salient consideration when contemplating LA ART was its clinical efficacy; many participants reported wanting to ensure that it worked as well as daily oral ART, including with less frequent dosing (every 8 versus 4 weeks). While injection side effects were often reported, most participants felt that regimen benefits outweighed such drawbacks. Participants described the main benefit of LA ART as the "freedom" it afforded both logistically and psychosocially, including through reduced HIV stigma. Findings highlight the importance of patient-provider communication related to weighing potential benefits and side effects and the continued need to address HIV stigma.