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

Structural and Psychosocial Impacts of the COVID-19 Pandemic on HIV Care and Treatment Outcomes Among Female Sex Workers in the Dominican Republic

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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

The Experience and Perceptions of Sexual Harassment Against Women in Public Transportation: The Case of Mexico City

Background: A recent poll placed Mexico City as the second most unsafe city for female passengers. Evidence suggests that 65% of women in Mexico City experience gender-based violence (GBV) while traveling in the public transportation system. Methods: In December 2014, as part of a pilot evaluation of an intervention, “Hazme el Paro”, seeking to promote safer environments and reduce the incidence of GBV for women traveling by bus, we surveyed 1,509 randomly selected women and men on two of the city’s busiest bus routes. Results: Our findings indicate that, while traveling by bus, 58% of women have experienced GBV whereas 67% of men reported having witnessed GBV against women. Moreover, 18% of passengers reported believing that it is dangerous for women to travel alone. Among women, factors that significantly predicted perceived risk of traveling alone include personal experience with GBV (OR=1.92, 95% CI=1.12-3.31), having observed GBV against other women (OR=1.64, 95% CI=1.10-2.47) and the belief that women are personally responsible for their experience of GBV (victim blaming) (OR=1.80, 95% CI=1.15-2.84). For men, having observed GBV against women (OR=6.41, 95% CI=3.41-12.04) was the only predictor significantly associated with perceived risk for women traveling alone. Conclusion: To improve the safety of women traveling in public transportation and reduce the incidence of GBV among female passengers in Mexico City, efforts should be targeted towards changing the social norms that sanction aggression towards women, specifically reducing victim blaming as this behavior inhibits reporting, encouraging effective nonviolent intervention by drivers and passengers, and improving the mechanisms for reporting perpetrators

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 \u3c 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

Nurse versus physician-provision of early medical abortion in Mexico: a randomized controlled non-inferiority trial

Objective To examine the effectiveness, safety, and acceptability of nurse provision of early medical abortion compared to physicians at three facilities in Mexico City. Methods We conducted a randomized non-inferiority trial on the provision of medical abortion and contraceptive counselling by physicians or nurses. The participants were pregnant women seeking abortion at a gestational duration of 70 days or less. The medical abortion regimen was 200 mg of oral mifepristone taken on-site followed by 800 μg of misoprostol self–administered buccally at home 24 hours later. Women were instructed to return to the clinic for follow-up 7–15 days later. We did an intention-to-treat analysis for risk differences between physicians’ and nurses’ provision for completion and the need for surgical intervention. Findings Of 1017 eligible women, 884 women were included in the intention-to-treat analysis, 450 in the physician-provision arm and 434 in the nurse-provision arm. Women who completed medical abortion, without the need for surgical intervention, were 98.4% (443/450) for physicians’ provision and 97.9% (425/434) for nurses’ provision. The risk difference between the group was 0.5% (95% confidence interval, CI: −1.2% to 2.3%). There were no differences between providers for examined gestational duration or women’s contraceptive method uptake. Both types of providers were rated by the women as highly acceptable. Conclusion Nurses’ provision of medical abortion is as safe, acceptable and effective as provision by physicians in this setting. Authorizing nurses to provide medical abortion can help to meet the demand for safe abortion services

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 (β=−0.28 per unit change, 95% CI: −0.37- −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

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

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

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