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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.

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.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.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;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.

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.

PURPOSE OF REVIEW: This review describes social determinants of HIV in two geographic and epidemic settings, the Dominican Republic (DR) and Tanzania, among female sex workers (FSW), their influence on HIV outcomes including 90-90-90 goals, and the development and impact of tailored, context driven, community empowerment-based responses in each setting. RECENT FINDINGS: Our review documents the significance of social determinants of HIV including sex work-related stigma, discrimination and violence and the impact of community empowerment-based approaches on HIV incidence in Tanzania and other HIV prevention, treatment and care outcomes, including care engagement and adherence, in the DR and Tanzania. SUMMARY: Community empowerment approaches where FSW drive the response to HIV and strategically engage partners to target socio-structural and environmental factors can have a demonstrable impact on HIV prevention, treatment and care outcomes. Such approaches can also support further gains towards reaching the 90-90-90 across geographies and types of epidemics.

The COVID-19 pandemic and its associated socioeconomic disruptions have disproportionally affected marginalized populations, including people living with HIV. Little is known about how the pandemic has affected populations experiencing multiple forms of stigma, discrimination, and violence, such as female sex workers (FSW) living with HIV.We conducted a cross-sectional survey between August and December 2020 among 187 FSW living with HIV in the Dominican Republic to examine the impact of COVID-19. Using multivariable logistic regression, we examined associations between COVID-19-related financial concerns, mental health, substance use, and partner abuse on engagement in HIV care and antiretroviral therapy adherence. We conducted mediation analysis to assess whether mental health challenges mediated the impact of partner abuse or substance use on HIV outcomes.Most participants reported no income (72%) or a substantial decline in income (25%) since the COVID-19 pandemic. Approximately one-third of the participants (34%) reported COVID-19 had an impact on their HIV care and treatment. Greater COVID-19 financial concerns (adjusted odds ratio [aOR] = 1.14, 95% CI: 1.02 to 1.27), mental health challenges (aOR = 1.38, 95% CI: 1.06 to 1.79), and partner emotional abuse (aOR = 2.62, 95% CI: 1.01 to 6.79) were associated with higher odds of negatively affected HIV care, respectively. The relationship between increased emotional partner abuse and negatively affected HIV care was mediated by greater COVID-19-related mental health challenges.FSW living with HIV in the Dominican Republic have been significantly affected by the COVID-19 pandemic. Targeted interventions that address structural (financial security and partner abuse) and psychosocial (mental health) factors are needed to sustain HIV outcomes and well-being.

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.

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 (β = - 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.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%: 0.08–0.78) y de supresión viral en Tanzania (AOR 0.49, IC del 95%: 0.24–0.97). En ambos países, la atención plena se asoció con menores probabilidades de depresión moderada a grave (AOR 0.82, IC del 95%: 0.76–0.88 para la República Dominicana; AOR 0.85, IC del 95%: 0.77–0.95 para Tanzania). En la República Dominicana, la atención plena se asoció con menores probabilidades de ansiedad (AOR 0.83, IC del 95%: 0.77–0.89), menor estigma del VIH (β = − 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: 1.02–1.15). Los hallazgos demuestran el potencial de las intervenciones de atención plena para mejorar la salud mental y los resultados del VIH entre las TRSX.

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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

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.

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.

BackgroundLong-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.MethodsUsing 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.ResultsLikelihood 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.ConclusionsWe 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.

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 aynd providers agreed that a 2DR regimen would be appropriate for any PLHIV regardless of whether they were treatment naive 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., This study was funded by ViiV Healthcare (www.viivhealthcare.com) and ViiV Healthcare was involved in the study design, decision to publish, and preparation of the manuscript. Additional support was provided by ViiV Healthcare in the form of a contract to the American University which supported a portion of salaries for WD,AM, TK, and DK.

A correction to this paper has been published: https://doi.org/10.1007/s10461-021-03298-6

Background Adherence to antiretroviral therapy (ART) to treat HIV remains a critical global health challenge given its relationship with individual health outcomes and population-level transmission. Given barriers associated with oral ART adherence, and considerations of patients’ preferences, long-acting injectable (LA) ART (cabotegravir + rilpivirine) is under development and has been shown to be non-inferior to daily oral ART in Phase III trials. While most of the trial participants have been men, as LA ART gets closer to becoming available for routine clinical use, it is critical to understand how this option is perceived by women. Methods We conducted in-depth interviews with 67 individuals, 53 people living with HIV (PLHIV) and 14 healthcare providers, in 11 sites in the United States and Spain participating in Phase III LA ART trials (ATLAS, ATLAS 2-M and FLAIR). Twenty percent (10/53) of trial participants interviewed were women. Interviews explored patient and provider perspectives and experiences with LA ART, and appropriate candidates and recommendations to support use. Interviews were audio-recorded, transcribed and coded using thematic content analysis. Results Overall, several salient themes emerged regarding participant’s generally positive experiences transitioning from daily oral ART to injectable ART including: the importance of the clinical efficacy of LA ART, the ability to learn to manage injection side-effects over time, and the “freedom” reportedly afforded by LA ART logistically and psychosocially. Women interviewed shared many of the aforementioned positive perceptions of LA ART but also had some unique perspectives. Female participants discussed how LA ART was easier to integrate into their daily lives including managing their multiple roles and responsibilities, which often involved working full-time and taking care of themselves as well as their family and children. Conclusion Similar to all participants, female participants had generally positive views of LA ART. However, the gendered nature of their daily lives also led to some unique perspectives on why and how they were satisfied with LA ART that merits further exploration in future research. Disclosures All authors: No reported disclosures.

The south of Mexico has traditionally faced disproportionate social, health and economic disadvantage relative to the rest of the country, due in part to lower levels of economic and human development, and barriers faced by Indigenous populations. The state of Oaxaca, in particular, has one of the highest proportions of Indigenous people and consistently displays high rates of maternal mortality, sexually transmitted infections and teenage pregnancy. This study examines how social values and norms surrounding sexuality have changed between two generations of women living in Indigenous communities in Oaxaca. We conducted semi-structured in-depth interviews with 19 women from two generational cohorts in 12 communities. Comparison views of these two cohorts suggest that cultural gender norms continue to govern how women express and experience their sexuality. In particular, feelings of shame and fear permeate the expression of sexuality, virginity continues be a determinant of a woman's worth and motherhood remains the key attribute to womanhood. Evidence points to a transformation of norms, and access to information and services related to sexual health is increasing. Nonetheless, there is still a need for culturally appropriate sex education programmes focused on female empowerment, increased access to sexual health services, and a reduction in the stigma surrounding women's expressions of sexuality.

Objective In Mexico, abortion stigma in the general population is largely unexplored. We developed a scale to measure abortion stigma at the community level, examine its prevalence and explore factors associated with abortion stigma in a nationally representative sample. Study design Following intensive qualitative work to identify dimensions of the stigma construct, we developed a comprehensive list of statements that were cognitively tested and reduced to 33 to form a scale. We piloted the scale in a nationally and subregionally representative household public opinion survey administered to 5600 Mexican residents. Results Factor analysis tested the internal consistency and reliability of five previously hypothesized dimensions of abortion stigma: secrecy, religion, autonomy, discrimination and guilt/shame. Under the assumption that these dimensions were independent, confirmatory factor analysis indicated that each of these dimensions functioned as independent subscales. However, to test this assumption, we conducted exploratory factor analysis that revealed a strong codependence between discrimination, guilt/shame and religion statements, resulting in a 23-item four-factor model of abortion stigma and the elimination of the guilt/shame dimension. Both methods revealed a full scale and subscales with Cronbach's alphas between 0.80 and 0.90. Regression analyses suggested that older, less educated individuals living in the north of Mexico report higher levels of stigma, especially related to discrimination and religion. Conclusions This community-level abortion stigma scale is the first to be developed and tested in Mexico. This tool may be used in Mexico and other similar country settings to document the prevalence of community-level abortion stigma, identify associated factors and test interventions aimed at reducing abortion stigma. Implications Abortion stigma prevents women from accessing safe abortion services. Measuring community-level abortion stigma is key to documenting its pervasiveness, testing interventions aimed at reducing it and understanding associated factors. This scale may be useful in countries similar to Mexico to support policymakers, practitioners and advocates in upholding women's reproductive rights.