Long-Acting Injectable Antiretrovirals for HIV Treatment: A Multi-Site Qualitative Study of Clinic-Level Barriers to Implementation in the United States.

Long-acting injectable antiretroviral therapy (LAI ART) has the potential to address adherence obstacles associated with daily oral ART, leading to enhanced treatment uptake, adherence, and viral suppression among people living with HIV (PLWH). Yet, its potential may be limited due to ongoing disparities in availability and accessibility. We need a better understanding of the organizational context surrounding the implementation of LAI ART, and to inform its widespread rollout, we conducted 38 in-depth interviews with medical and social service providers who offer HIV care at private and hospital-based clinics across six US cities. Our findings highlight real-world implementation barriers outside of clinical trial settings. Providers described ongoing and anticipated barriers across three stages of LAI ART implementation: (1) Patient enrollment (challenges registering patients and limited insurance coverage), (2) medication delivery (insufficient personnel and resources), and (3) leadership and management (lack of interprofessional coordination and a lack of programming guidelines). Providers described how these barriers would have a disproportionate impact on under-resourced clinics, potentially exacerbating existing disparities in LAI ART access and adherence. Our findings suggest strategies that clinic leadership, policymakers, and other stakeholders can pursue to promote rapid and equitable LAI ART implementation in clinics across the United States. Resource and staffing investments could support clinics to begin, sustain, and scale up LAI ART delivery; additionally, the establishment of guidelines and tools could facilitate wider adoption of LAI ART across clinical settings. These efforts are crucial to promote resourced, standardized, and equitable implementation of LAI ART and maximize its potential to help end the HIV epidemic.

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.

"What Is the Benefit?": Perceptions and Preferences for Long-Acting Injectable Antiretroviral Therapy Among People Living With HIV.

Long-acting injectable antiretroviral therapy (LA-ART) expands treatment options for people living with HIV (PLWH). This qualitative study characterizes LA-ART awareness, perceptions, and preferences among PLWH engaged in HIV care. From 2019 through 2021, we conducted semistructured in-depth interviews with 71 PLWH sampled from three clinics in three U.S. settings (North Carolina, Washington, DC, Massachusetts). Transcripts were analyzed using narrative and thematic techniques. Participant mean age was 46 years (range 24-72); most were cisgender men (55%) and virally suppressed (73%). Most participants had not heard of LA-ART and reacted with a mix of excitement and cautiousness. Potential LA-ART benefits included easier adherence, privacy, and effectiveness; concerns included effectiveness, side effects, costs, and increased clinic visits. Participants appreciated that LA-ART could support achieving and sustaining viral suppression. To inform their decision, participants wanted more information and convenient access and administration. Findings indicated that a shared decision-making approach and economic and logistical support for PLWH could facilitate LA-ART uptake.

Reducing HIV-associated post-hospital mortality through home-based care in South Africa: a randomized controlled trial.

BACKGROUND: Twenty-three percent of people with HIV (PWH) die within 6-months of hospital discharge. We tested the hypothesis whether a series of structured home visits could reduce mortality. METHODS: We designed a disease neutral home visit package with up to 6 home visits starting 1-week post-hospitalization and every 2 weeks thereafter. The home visit team used a structured assessment algorithm to evaluate and triage social and medical needs of the participant and provide nutritional support. We compared all-cause mortality 6-months following discharge for the intervention compared to usual care in a pilot randomized trial conducted in South Africa. To inform potential scale-up we also included and separately analyzed a group of people without HIV (PWOH). RESULTS: We enrolled 125 people with HIV and randomized them 1:1 to the home visit intervention or usual care. Fourteen were late exclusions because of death prior to discharge or delayed discharge leaving 111 for analysis. The median age was 39 years, 31% were men; and 70% had advanced HIV disease. At six months among PWH 4 (7.3%) in the home visit arm and 10 (17.9%) in the usual care arm (p = 0.09) had died. Among the 70 PWOH enrolled overall 6-month mortality was 10.1%. Of those in the home visit arm, 91% received at least one home visit. CONCLUSIONS: We demonstrated feasibility of delivering post-hospital home visits and demonstrated preliminary efficacy among PWH with a substantial, but not statistically significant, effect size (59% reduction in mortality). COVID-19 related challenges resulted in under-enrollment.

Adapting a community-based intervention to address social determinants of health influencing pre-exposure prophylaxis services for Black adults in Washington, District of Columbia: A study protocol.

Community-based HIV treatment initiation and continuation helps to address social determinants of health (SDOH) barriers to care and increase antiretroviral therapy (ART) uptake and adherence. Similarly, community-based pre-exposure prophylaxis (cbPrEP) services can help address SDOH barriers such as transportation costs and stigma. However, few studies have examined cbPrEP programming in the Washington, District of Columbia (DC) area where more Blacks are disproportionately affected by HIV and have low PrEP uptake. This study aims to adapt and pilot a community-based ART intervention (cbART) intervention for cbPrEP service delivery for Black adults in the Washington, DC area. The adaptation of the cbART intervention will be informed by the ADAPT-ITT framework and the Consolidated Framework for Implementation Research. For Aim 1, in-depth and key informant interviews will be conducted with PrEP program managers at community-based organizations (N = 10), DC health department representatives (N = 8), PrEP providers (N = 10) and current and potential Black PrEP users (n = 24). The interviews will provide an initial assessment of barriers and facilitators to PrEP services and inform the decisions on how to adapt the cbART intervention for cbPrEP services. In Aim 2, we will train and pilot test the cbPrEP intervention for acceptability, feasibility, and appropriateness with Black adults (n = 60). Enrolled participants will complete a survey at baseline and at 45 days post-enrollment. In-depth interviews will be conducted with a subset (N = 16) of participants, those who did not enroll (N = 10) and providers implementing the cbPrEP intervention (N = 8). Alternative strategies to PrEP service delivery are needed to increase PrEP uptake among those most in need in the DC area. If cbPrEP delivery is found to be acceptable, feasible, and appropriate, it could have a significant impact on DC's Ending the HIV Epidemic efforts and will inform future efforts to investigate the intervention's efficacy on PrEP uptake and continuation among Black adults in DC.

Comparing typologies of violence exposure and associations with syndemic health outcomes among cisgender and transgender female sex workers living with HIV in the Dominican Republic.

Violence against women research largely excludes transgender women's experiences and violence from perpetrators other than intimate partners. This study compares patterns of violence exposure among cisgender and transgender female sex workers (FSWs) and the associations with syndemic health outcomes. We used cross-sectional surveys from samples of cisgender and transgender FSWs living with HIV in the Dominican Republic (N = 211 and 100, respectively). We used latent class analysis to identify patterns of emotional, physical, and sexual violence and harassment by partners, clients, and police. We assessed sociodemographic and occupational predictors in relation to class membership, and class membership in relation to health (HIV continuum of care outcomes, mental health, substance use), using logistic regression. Two classes were identified in cisgender sample: Low Reported Violence Exposure (Class 1) and Sex Work-related Police Harassment (Class 2). Class 2 participants had greater odds of scoring abnormal or borderline abnormal anxiety on the Hospital Anxiety and Depression Scale (HADS-A) (adjusted OR = 3.97, p<0.01), moderate-to-severe depression per the Patient Health Questionnaire-9 (PHQ-9) (aOR = 5.74, p<0.01), and any illicit drug use in the past six months (aOR = 3.06, p<0.05), compared to Class 1. The transgender sample produced three classes: Low Reported Violence Exposure (Class 1); Sex Work-related Police Harassment (Class 2); and Sex Work-related Violence and Harassment (Class 3). Class 3 participants had greater odds of having anxiety (aOR = 6.65, p<0.01) and depression (aOR = 4.45, p<0.05), while Class 2 participants had greater odds of perfect ART adherence during the previous four days (aOR = 2.78, p<0.05), compared to Class 1. The more diverse and extreme violence patterns uncovered for the transgender sample show this group's heightened risk, while similar patterns across groups regarding police abuse highlight a need for police-focused violence prevention interventions. Each sample's highest violence class was associated with poor mental health, underscoring the need for mental health interventions for all FSWs.

Beyond a deficit-based approach: Characterizing typologies of assets for cisgender and transgender female sex workers and their relationship with syndemic health outcomes.

Female sex workers (FSWs) live and work at the intersection of multiple marginalized identities that place them at greater risk for various negative health outcomes. Resilience theory asserts that an individual or community needs assets from which they can draw in response to stressors, such as chronic discrimination and abuse. This study characterizes and compares patterns of assets among cisgender and transgender FSWs living with HIV in the Dominican Republic and their relations with syndemic health outcomes. With Latent Class Analysis, we used companion cross-sectional datasets comprised of cisgender and transgender FSWs (N = 211 and 100, respectively) to estimate typologies of interpersonal, community, and institutional assets. We used multivariate logistic regression to model the relationship between class membership and HIV care and treatment, mental health, violence exposure, and substance use outcomes, respectively. Among cisgender FSWs, we identified three classes: Internal and External Multilevel Assets (Class 1); External Institutional Assets (Class 2); and Low Reported Assets (Class 3). Compared to Class 3, Class 1 membership among cisgender FSWs was significantly associated with ART adherence and marginally associated with viral suppression, and Class 2 membership was marginally associated with currently taking ART. We identified two classes in the transgender sample: Internal and External Multilevel Assets (Class 1) and External Institutional Assets (Class 2). Class 1 membership among transgender FSWs was significantly associated with ART adherence and marginally associated with current ART use and physical or sexual violence, compared to Class 2. Having a variety of assets may explain the ability of some FSWs to more effectively engage with healthcare and maintain their HIV medication regimen. Future interventions should seek to expand FSWs' interpersonal and community assets, both from within and outside of the sex worker community, to bolster their ability to care for themselves and their community.

Rationale, formative research, and protocol for Calma, Conversa, y Cría: A pilot mindful parenting intervention with Latina women.

Background: Latina mothers' stress is associated with their children's health behaviors and risk for obesity; however, existing pediatric health promotion programs have not focused on maternal stress reduction. Methods: Herein we describe a study design that will examine the acceptability and feasibility of Calma, Conversa, y Cría (CCC) a 6-week mindful parenting intervention designed to reduce stress. We present the results of qualitative research with Latina mothers and experts in Latinx health and mindfulness who provided culturally-relevant feedback on existing mindful parenting strategies to inform the development of CCC. Fifty Latina mothers of children ages 3-11 years will be randomly assigned to CCC or an enhanced usual care health education intervention. Acceptability will be assessed through participant satisfaction surveys and exit interviews. Feasibility will be determined through detailed tracking of recruitment, retention, and attendance rates. A signal regarding any group differences in maternal stress, health-related parenting practices, child diet, child physical activity, and child quality of life will be explored. Discussion: The development of interventions that can reduce maternal stress and risk for obesity in Latinx children is critical to significantly reduce negative health impacts in this underserved population. Our approach includes the identification of effective cultural adaptations that should improve the feasibility and acceptability of mindful parenting strategies in Latinx families, ideally reducing maternal stress and improving parenting behaviors related to child health. If successful, CCC will be examined in a larger efficacy trial involving the measurement of objective biomarkers of children's chronic disease risk.

Exploring the dynamics of the quality of HIV care experienced by female sex workers living in the Dominican Republic.

Despite increased attention and efforts to improve HIV care among female sex workers (FSWs), they continue to have suboptimal HIV outcomes. Exploring the socio-structural dynamics related to the quality of HIV care received by FSWs is critical to further strengthen interventions to improve their HIV care continuum outcomes. In this study, we conducted two rounds of qualitative in-depth interviews with 20 FSWs living with HIV in the Dominican Republic to explore how healthcare experiences contributed to their quality of HIV care. Data was analyzed using a thematic analytic approach exploring diverse structural and relational aspects of the quality of HIV care affecting FSWs as they navigate the clinic environment. Results indicated that quality of HIV care was influenced by both structural and relational factors within clinics. At the structural level, insufficient stock of antiretroviral therapy and the financial burden created by HIV care related costs hindered FSWs' satisfaction with their current HIV care and presented a barrier in FSWs' ability to access HIV care services. Quality of care was also closely linked to relational aspects of the HIV care environment, including FSWs' relationship and communication with their clinical providers, as FSWs often expressed their satisfaction with HIV care experiences based on these interpersonal factors. Lastly, personal agency emerged as an important factor contributing to the quality of HIV care, specifically as FSWs' treatment literacy resulted in greater advocacy and demands for quality care. Programmatic efforts should be directed to improving the quality of HIV care experiences of FSWs in the clinic environment. These include addressing resource shortages, promoting positive and effective patient-provider relationships, and facilitating HIV treatment education opportunities for FSWs.

Contextualizing and optimizing novel strategies to improve the latent TB continuum of care: Insights from people living with HIV and health care providers in Brazil.

Tuberculosis (TB) causes 1 in 3 deaths among people living with HIV (PLHIV). Diagnosing and treating latent tuberculosis infection (LTBI) is critical to reducing TB incidence and mortality. Blood-based screening tests (e.g., QuantiFERON-TB Gold Plus (QFT+)) and shorter-course TB preventive therapy (TPT) regimens such as 3HP (3 months weekly isoniazid-rifapentine) hold significant promise to improve TB outcomes. We qualitatively explored barriers and solutions to optimizing QFT+ and 3HP among PLHIV in three cities in Brazil. We conducted 110 in-depth interviews with PLHIV, health care providers (HCP) and key informants (KI). Content analysis was conducted including the use of case summaries and comparison of themes across populations and contexts. LTBI screening and treatment practices were dependent on HCP's perceptions of whether they were critical to improving TB outcomes. Many HCP lacked a strong understanding of LTBI and perceived the current TPT regimen as complicated. HCP reported that LTBI screening and treatment were constrained by clinic staffing challenges. While PLHIV generally expressed willingness to consider any test or treatment that doctors recommended, they indicated HCP rarely discussed LTBI and TPT. TB testing and treatment requests were constrained by structural factors including financial and food insecurity, difficulties leaving work for appointments, stigma and family responsibilities. QFT+ and 3HP were viewed by all participants as tools that could significantly improve the LTBI cascade by avoiding complexities of TB skin tests and longer LTBI treatment courses. QFT+ and 3HP were perceived to have challenges, including the potential to increase workload on over-burdened health systems if not implemented alongside improved supply chains, staffing, and training, and follow-up initiatives. Multi-level interventions that increase understanding of the importance of LTBI and TPT among HCP, improve patient-provider communication, and streamline clinic-level operations related to QFT+ and 3HP are needed to optimize their impact among PLHIV and reduce TB mortality.

Stigma and HIV Treatment Outcomes Among Transgender Women Sex Workers in the Dominican Republic.

Trans women experience multiple forms of intersecting stigma due to trans identity, HIV, and sex work, which can negatively affect their health. There is limited understanding of the relationships between stigma and HIV care and treatment outcomes. We assessed associations between multiple forms and types of stigma and HIV treatment outcomes among trans women who conduct sex work in Santo Domingo, Dominican Republic using cross-sectional survey data. Most participants had received HIV care (91%) and were currently taking anti-retroviral therapy (ART) (84%). Only 64% were virally suppressed. Nearly one-third (32%) had interrupted ART at some point; those who had never interrupted ART were more likely to be suppressed. Drug use was associated with ART interruption. Higher enacted HIV stigma was associated with current ART use. Higher enacted HIV stigma and higher anticipated sex work stigma were associated with ART adherence. Higher trans stigma was associated with being virally suppressed. Findings highlight the importance of addressing multiple forms of stigma at the individual and clinic levels to improve and sustain viral suppression. Future research is needed to assess if unexpected associations between stigma and HIV outcomes reflect processes of resilience. Future research is also needed to assess the pathways between drug use, ART interruption, and viral suppression among trans women.

Trajectories of HIV management among virally suppressed and unsuppressed female sex workers in the Dominican Republic: A comparative qualitative analysis.

PURPOSE: Despite suboptimal HIV outcomes among female sex workers (FSW), limited research has been conducted on factors that impact viral suppression among this population. Examining narratives of HIV management, we examined how experiences of diagnosis, treatment initiation, and ongoing care behaviours shaped viral suppression outcomes over time. METHODS: We conducted 20 in-depth interviews with FSW in Santo Domingo, Dominican Republic. Using narrative and thematic qualitative approaches, we developed analytic summaries and matrices to compare trajectories of managing HIV between suppressed and unsuppressed participants. RESULTS: Regardless of suppression status, participants described similar narratives of overcoming initial challenges to HIV management through personal resilience and social support. Unsuppressed participants identified more delays in initiating antiretroviral therapy and more lapses in adherence due to less active acceptance of their HIV status and more persistent experiences of economic hardship and HIV stigma. CONCLUSIONS: We found that individual, interpersonal and structural factors, including stigma and economic precarity, differentiated trajectories towards viral suppression among FSW indicating the importance of multilevel interventions. Improved access to mental health services and social support could promote greater early acceptance of HIV status and progress towards viral suppression among FSW.

Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial.

Cabotegravir and rilpivirine long-acting (LA) antiretroviral therapy (ART) demonstrated similar safety and efficacy in maintaining viral suppression among participants switching from daily oral to LA ART in the Extension Phase of the FLAIR trial. The Phase IIIb SOLAR study comparing efficacy and safety of daily oral versus LA ART every 2 months allowed participants and health care providers (HCPs) to choose an oral lead-in (OLI) before LA initiation or proceed by immediately starting with injections (SWI). We conducted an online survey among SOLAR HCPs (n = 110) in 13 countries to assess reasons for choosing OLI versus SWI. Logistic regression was used to identify factors influencing this decision. Thirty-two percent of HCPs reported a future preference to use OLI, whereas 54% reported a future preference for SWI. HCPs had greater odds of reporting future intentions for SWI if they were from Continental Europe versus North America [adjusted odds ratio (aOR): 3.83, p < 0.05], from sites with a greater number of participants who initiated LA ART without OLI (aOR: 1.56, p < 0.01), and those who reported comfort with the medication safety profile (aOR: 6.39, p < 0.01). HCPs who participated in LA ART trials before SOLAR had decreased odds of reporting a preference for SWI compared to those with no prior LA ART trial experience (aOR: 0.11; p < 0.01). Results indicated higher intentions to SWI over OLI among HCPs initiating participants on LA ART. A major factor associated with SWI was provider comfort with safety data, reinforcing the role of continued training regarding an SWI approach.

Relationships Between Stigma and Intimate Partner Violence Among Female Sex Workers Living With HIV: Social and Economic Exclusion.

Violence against female sex workers (FSWs) perpetrated by their intimate (i.e., non-commercial) partners, particularly against FSWs living with HIV, is understudied. Stigma can deplete the economic resources, social relationships, and mental well-being of stigmatized people, which may increase their intimate partner violence (IPV) risk. We quantitatively assessed relationships between HIV stigma and sex work stigma and IPV victimization among FSWs living with HIV in the Dominican Republic (n = 266). Enacted HIV stigma, in the form of job loss, and anticipated HIV stigma, in the form of fear of exclusion by family, were associated with increased IPV risk. Potential association mechanisms, including increased economic vulnerability and social isolation, and programmatic responses are discussed.

Substance Use and Depression Impede ART Adherence Among Female Sex Workers Living with HIV in the Dominican Republic.

Female sex workers (FSW) have worse HIV outcomes in part due to lower anti-retroviral therapy (ART) adherence. Substance use and depression are important barriers to ART adherence, yet few studies have assessed these relationships among FSW in longitudinal studies. Cross-Lagged Panel Models and autoregressive mediation analyses assessed substance use (illicit drug use and alcohol use disorders) in relation to ART non-adherence and the mediation role of depressive symptoms among 240 FSW living with HIV in the Dominican Republic. In annual visits (T1, T2, T3), the majority (70%, 66%, and 53%) reported at-risk drinking and 15%, 13% and 9% used illicit drug during the past 6 months. Most FSW (70%, 62% and 46%) had mild-to-severe depression. Illicit drug use predicted later ART non-adherence. This relationship was not mediated via depressive symptoms. Integrated substance use and HIV care interventions are needed to promote ART adherence and viral suppression among FSW.

RESUMEN: Las trabajadoras sexuales (TRSX) tienen peores resultados de VIH debido en parte a la menor adherencia a la terapia antirretroviral (TAR). El uso de sustancias y la depresión son barreras importantes para la adherencia; sin embargo, pocos estudios longitudinales han evaluado estas relaciones entre las TRSX. Utilizamos modelos de panel y análisis de mediación para evaluar el uso de sustancias en relación a la falta de adherencia al TAR y el papel de mediación de los síntomas depresivos entre 240 TRSX con VIH en la República Dominicana. En visitas anuales (T1, T2, T3), la mayoría (70%, 66%, and 53%) reportó consumo riesgoso de alcohol y 15%, 13% y 9% consumieron alguna droga ilícita durante los últimos 6 meses. La mayoría (70%, 62% y 46%) tenían depresión leve a grave. El uso de drogas ilícitas predijo la falta de adherencia al TAR. Esta relación no fue mediada por síntomas depresivos. Se necesitan intervenciones integradas de atención del VIH y el uso de sustancias para promover la adherencia al TAR y la supresión viral entre TRSX.

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.

A Patient Decision Aid (i.ARTs) to Facilitate Women's Choice Between Oral and Long-Acting Injectable Antiretroviral Treatment for HIV: Protocols for its Development and Randomized Controlled Pilot Trial.

BACKGROUND: Many women with HIV (WWH) have suboptimal adherence to oral antiretroviral therapy (ART) due to multilevel barriers to HIV care access and retention. A long-acting injectable (LAI) version of ART was approved by the US Food and Drug Administration in January 2021 and has the potential to overcome many of these barriers by eliminating the need for daily pill taking. However, it may not be optimal for all WWH. It is critical to develop tools that facilitate patient-provider shared decision making about oral versus LAI ART modalities to promote women's adherence and long-term HIV outcomes. OBJECTIVE: This study will develop and pilot test a web-based patient decision aid called i.ART+support (i.ARTs). This decision aid aims to support shared decision making between WWH and their providers, and help women choose between oral and LAI HIV treatment. METHODS: The study will occur in 3 phases. In phase 1, we will utilize a mixed methods approach to collect data from WWH and medical and social service providers to inform i.ARTs content. During phase 2, we will conduct focus groups with WWH and providers to refine i.ARTs content and develop the web-based decision aid. In phase 3, i.ARTs will be tested in a randomized controlled trial with 180 women in Miami, Florida, and assessed for feasibility, usability, and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART pharmacy refills, and clinic attendance. RESULTS: This study was funded in March 2021. Columbia University's IRB approved the study protocols (approval number IRB-AAAT5314). Protocols for phase 1 interviews have been developed and interviews with service providers started in September 2021. We will apply for Clinicaltrials.gov registration prior to phase 3, which is when our first participant will be enrolled in the randomized controlled trial. This is anticipated to occur in April 2023. CONCLUSIONS: This study is the first to develop a web-based patient decision aid to support WWH choices between oral and LAI ART. Its strengths include the incorporation of both patient and provider perspectives, a mixed methods design, and implementation in a real-world clinical setting. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35646.

Mindfulness instruction for medication adherence among adolescents and young adults living with HIV: a randomized controlled trial.

Adolescents and young adults (AYA) 13-24 years old make up a disproportionate 21% of new HIV diagnoses. Unfortunately, they are less likely to treat HIV effectively, with only 30% achieving viral suppression, limiting efforts to interrupt HIV transmission. Previous work with mindfulness-based stress reduction (MBSR) has shown promise for improving treatment in AYA living with HIV (AYALH). This randomized controlled trial compared MBSR with general health education (HT). Seventy-four 13-24-year-old AYALH conducted baseline data collection and were randomized to nine sessions of MBSR or HT. Data were collected at baseline, post-program (3 months), 6 and 12 months on mindfulness and HIV management [medication adherence (MA), HIV viral load (HIV VL), and CD4]. Longitudinal analyses were conducted. The MBSR arm reported higher mindfulness at baseline. Participants were average 20.5 years old, 92% non-Hispanic Black, 51% male, 46% female, and 3% transgender. Post-program, MBSR participants had greater increases than HT in MA (p = 0.001) and decreased HIV VL (p = 0.052). MBSR participants showed decreased mindfulness at follow-up. Given the significant challenges related to HIV treatment in AYALH, these findings suggest that MBSR may play a role in improving HIV MA and decreasing HIV VL. Additional research is merited to investigate MBSR further for this important population.