The relationship between anti-LGBTQ+ legislation and HIV prevention among sexual and gender minoritized youth.

OBJECTIVE: Estimate the longitudinal associations of state-level anti-LGBTQ+ policies and county-level politics with individual HIV prevention outcomes among sexual and gender minoritized (SGM) youth. DESIGN: Keeping it LITE-1 prospectively enrolled 3,330 SGM youth and young adults (ages 13-34) at increased risk of HIV throughout the United States from 2017-2022. METHODS: Semiannual surveys collected self-reported HIV prevention measures (current PrEP use, weekly PrEP adherence, HIV/STI testing in the past 6 months). Geolocation was linked with state-level LGBTQ+ policy data and county-level election data. Generalized linear models with GEE estimated the single and joint longitudinal associations for 2 exposures [state-level policy climate (more discriminatory vs. less discriminatory) and county-level political majority (Democratic/swing vs. Republican)] with each outcome. RESULTS: Among participants living in a state with more discriminatory laws, those in a Democratic/swing county had a 6-percentage point increase in PrEP use (95% CI: 0.02, 0.09) compared to those in a Republican county. Those living in a Republican county but a state with less discriminatory laws saw a similar increase (0.05; -0.02,0.11). Residing in both a Democratic/swing county and a state with less discriminatory laws, relative to a Republican county and a state with more discriminatory laws, was associated with a 10-percentage point increase in PrEP use (0.10; 0.06,0.14) and a 5-percentage point increase in HIV/STI testing (0.05; 0.00,0.09). CONCLUSIONS: More progressive state and local policies were each associated with increased PrEP use, and together, doubled the magnitude of this association. PrEP is underutilized among SGM youth, and anti-LGBTQ+ policies may exacerbate this gap in coverage.

Paradata: Measuring Engagement in Digital HIV Interventions for Sexual and Gender Minorities.

PURPOSE OF REVIEW: The goal of this review was to examine online engagement using paradata (i.e., intervention usage metrics) as part of the reporting of online behavioral HIV prevention and care interventions' findings. We underscore the importance of these data in examining intervention engagement and effectiveness. RECENT FINDINGS: We focused on studies indexed in PubMed and published between April 1, 2017, and June 30, 2023, that reported the development and testing of online behavioral interventions for HIV prevention and/or care. Of the 689 extracted citations, 19 met the study criteria and provided engagement data - only six studies tested the association between engagement and intervention outcomes. Of these, four studies found a positive association between participants' engagement and improvements in HIV-related outcomes. Increasing attention is being paid to the collection and reporting of paradata within HIV online behavioral interventions. While the current evidence suggests a dose-response relationship due to user engagement on HIV outcomes, greater efforts to systematically collect, report, and analyze paradata are warranted.

A qualitative exploration of how to support PrEP adherence among young men who have sex with men.

New HIV infections disproportionately affect young men who have sex with men (YMSM). PrEP is effective in preventing HIV acquisition; however, adherence is critical and is often suboptimal among YMSM. Interventions addressing the unique PrEP adherence challenges faced by YMSM are needed. We conducted qualitative interviews with 20 HIV-negative, YMSM (ages 15-24) with a PrEP indication and 11 healthcare professionals to inform adaption of a PrEP adherence intervention (Life-Steps for PrEP) for YMSM. We explored environmental, healthcare, and individual factors influencing uptake, adherence, attitudes, and perspectives (including desired modifications) on the Life-Steps intervention. Interviews were analyzed using content analysis. Of YMSM study participants (mean age 21.6) 55% were White, 15% Hispanic, and 5% Black. Most YMSM were PrEP-experienced (70%). Healthcare professionals (6 prescribers, 1 nurse, 2 health educators, 2 other/unspecified) averaged 6.9 years of experience caring for YMSM. All described stigma as a barrier to PrEP; YMSM expressed concern around being perceived as "risky" and concern about inadvertent PrEP disclosure if family/friends found their medication, or if parental insurance was used. Difficulty with planning for potential adherence challenges were identified by both groups. YMSM highlighted benefits of a nurse-led intervention (i.e., adding "legitimacy"), but stressed need for nonjudgmental, "savvy" interventionists. YMSM expressed a desire for comprehensive YMSM-specific sexual health information. These findings informed modification and expansion of Life-Steps content. Results highlight key potential barriers, many of which center around privacy. Content that addresses PrEP stigma, disclosing PrEP use, navigating insurance, and planning ahead in a nonjudgmental environment by trusted providers emerged as important components of a YMSM-focused delivery of Life-Steps for PrEP.

Evaluating the Feasibility and Acceptability of a Digital Pre-Exposure Prophylaxis Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth (PrEPresent): Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: To end the HIV epidemic by 2030, we must double down on efforts to tailor prevention interventions to both young men who have sex with men and transgender and nonbinary youth. There is an urgent need for interventions that specifically focus on pre-exposure prophylaxis (PrEP) uptake in sexual and gender minority youth (SGMY) populations. There are several factors that impact the ability of SGMY to successfully engage in the HIV prevention continuum, including uptake of PrEP. Patient activation, having the knowledge, skills, and self-efficacy to manage one's health, is an important indicator of willingness and ability to manage one's own health and care autonomously. Patient navigation also plays an important role in helping SGMY access PrEP and PrEP care, as navigators help guide patients through the health care system, set up medical appointments, and get financial, legal, and social support. OBJECTIVE: This study aims to evaluate the feasibility and acceptability of a digital PrEP navigation and activation intervention among a racially and ethnically diverse sample of SGMY living in the Los Angeles area. METHODS: In phase 1, we will conduct formative research to inform the development of PrEPresent using qualitative data from key informant interviews involving PrEP care providers and navigators and working groups with SGMY. In phase 2, we will complete 2 rounds of usability testing of PrEPresent with 8-10 SGMY assessing both the intervention content and mobile health delivery platform to ensure features are usable and content is understood. In phase 3, we will conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of PrEPresent. We will randomize, 1:1, a racially and ethnically diverse sample of 150 SGMY aged 16-26 years living in the Los Angeles area and follow participants for 6 months. RESULTS: Phase 1 (formative work) was completed in April 2021. Usability testing was completed in December 2021. As of June 2023, 148 participants have been enrolled into the PrEPresent pilot randomized controlled trial (phase 3). Enrollment is expected to be completed in July 2023, with final results anticipated in December 2023. CONCLUSIONS: The PrEPresent intervention aims to bridge the gaps in PrEP eligibility and PrEP uptake among racially and ethnically diverse SGMY. By facilitating the delivery of PrEP navigation and focusing on improving patient activation, the PrEPresent intervention has the potential to positively impact the PrEP uptake cascade in the HIV care continuum as well as serve as a model for the tailoring of PrEP interventions based on behavior-based qualifications for PrEP instead of generalized gender-based eligibility. TRIAL REGISTRATION: ClinicalTrials.gov NCT05281393; https://clinicaltrials.gov/ct2/show/NCT05281393. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50866.

MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Adolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for "Let's empower each other and improve our health") is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. OBJECTIVE: The aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. METHODS: We will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. RESULTS: Study screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. CONCLUSIONS: There is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. TRIAL REGISTRATION: ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47137.

Cost of peer mystery shopping to increase cultural competency in community clinics offering HIV/STI testing to young men who have sex with men: results from the get connected trial.

INTRODUCTION: Cultural competency has been identified as a barrier to lesbian, gay, bisexual and transgender (LGBT) populations seeking care. Mystery shopping has been widely employed in the formal health care sector as a quality improvement (QI) tool to address specific client needs. The approach has had limited use in community-based organizations due in part to lack of knowledge and resource requirement concerns. Several mystery shopping initiatives are now being implemented which focus on the LGBT population with the goal of reducing barriers to accessing care. One subset targets men who have sex with men (MSM) to increase uptake of human immunodeficiency virus (HIV) testing. No study investigates the costs of these initiatives. Get Connected was a randomized control trial with the objective of increasing uptake of HIV-prevention services among young men who have sex with men (YMSM) through use of a resource-locator application (App). The initial phase of the trial employed peer-led mystery shopping to identify culturally competent HIV testing sites for inclusion in the App. The second phase of the trial randomized YMSM to test the efficacy of the App. Our objective was to determine the resource inputs and costs of peer-led mystery shopping to identify clinics for inclusion in the App as costs would be critical in informing possible adoption by organizations and sustainability of this model. METHODS: Through consultation with study staff, we created a resource inventory for undertaking the community-based, peer-led mystery shopping program. We used activity-based costing to price each of the inputs. We classified inputs as start-up and those for on-going implementation. We calculated costs for each category, total costs and cost per mystery shopper visit for the four-month trial and annually to reflect standard budgeting periods for data collected from September of 2019 through September of 2020. RESULTS: Recruitment and training of peer mystery shoppers were the most expensive tasks. Average start-up costs were $10,001 (SD $39.8). Four-month average implementation costs per visit were $228 (SD $1.97). Average annual implementation costs per visit were 33% lower at $151 (SD $5.60). CONCLUSIONS: Peer-led, mystery shopping of HIV-testing sites is feasible, and is likely affordable for medium to large public health departments.

Supporting Adolescents With HIV in South Africa Through an Adherence-Supporting App: Mixed Methods Beta-Testing Study.

BACKGROUND: Novel smartphone app-delivered interventions have the potential to improve HIV treatment adherence among adolescents with HIV, although such interventions are limited. Our team has developed Masakhane Siphucule Impilo Yethu (MASI; Xhosa for "Let's empower each other and improve our health"), a smartphone app-delivered intervention to improve treatment adherence among adolescents with HIV in South Africa. MASI was adapted to the South African cultural context using the HealthMpowerment platform, an evidence-based digital health intervention developed for and with youth in the United States. OBJECTIVE: We conducted this beta-testing study to (1) explore the initial usability of MASI, (2) examine engagement and experiences using MASI features, and (3) inform refinements to the app and intervention implementation plan prior to a subsequent pilot randomized controlled trial (RCT). METHODS: This study was conducted from August 2021 to December 2021 in Cape Town, South Africa. Beta-testing participants received access to MASI for 3 weeks. A mixed methods approach was used, with brief questionnaires and semistructured in-depth interviews conducted prior to app installation and after 1 week to 2 weeks of app testing. Engagement with MASI was measured through analysis of back-end app paradata, and follow-up in-depth interview guides were tailored to each participant based on their app use. RESULTS: Participants in the beta-testing study (6 male participants, 6 female participants; ages 16-19 years) collectively spent 4.3 hours in MASI, averaging 21.4 minutes per participant over the 3-week period (range 1-51.8 minutes). Participants logged into MASI an average of 24.1 (range 10-75) times during the study period. The mean System Usability Scale score was 69.5 (SD 18), which is considered slightly above average for digital health apps. Thematic analysis of qualitative results revealed generally positive experiences across MASI features, although opportunities to refine the app and intervention delivery were identified. CONCLUSIONS: Initial usability of MASI was high, and participants described having a generally positive experience across MASI features. Systematically analyzing paradata and using the interview findings to explore participant experiences allowed us to gain richer insights into patterns of participant engagement, enabling our team to further enhance MASI. The results from this study led to a few technological refinements to improve the user experience. Enhancements were also made to the intervention implementation plan in preparation for a pilot RCT. Lessons learned from the conduct of this beta-testing study may inform the development, implementation, and evaluation of similar app-delivered interventions in the future.

Prediction of Sex and the Potential Use of On-Demand PrEP Among Young Men Who Have Sex With Men in the United States.

BACKGROUND: On-demand dosing of preexposure prophylaxis (PrEP) requires accurate prediction of sex; however, prediction abilities among young men who have sex with men (YMSM) have not been characterized. SETTING: A nationally recruited prospective cohort of YMSM ages 16-24 years. METHODS: We followed 120 YMSM for 8 weeks using digital daily surveys (DDSs) to measure engagement in and prediction of anal sex over 24 hours, along with condom use and other encounter-level circumstances. Our main outcome, an "unpredicted spontaneous encounter," was defined as an anal sex encounter that occurred without sufficient prior knowledge to (hypothetically) enable protective on-demand PrEP use according to dosing guidelines. We operationalized this outcome as an anal sex encounter for which a participant indicated: (1) on the prior day's DDS that there was a low likelihood of sex occurring in the subsequent 24 hours (unpredicted) and (2) on the current day's DDS that he knew ≤2 hours in advance that the encounter would occur (spontaneous). RESULTS: Approximately one-third of all anal sex encounters during the study period were unpredicted and spontaneous and would not have been protected (hypothetically) by on-demand dosing. More than two-thirds of participants experienced such an encounter and almost three-quarters of all acts were condomless. CONCLUSIONS: On-demand PrEP to prevent HIV acquisition may be challenging for many YMSM. Clinical and public health approaches that account for patients' predictive abilities alongside their dosing preferences may help to optimize selection of and adherence to PrEP dosing strategies.

A Relationship-Focused HIV Prevention Intervention for Young Sexual Minority Men in the United States: A Pilot Randomized Controlled Trial of the We Prevent Intervention.

We Prevent is a virtual counseling intervention designed to improve communication as a mechanism for reducing HIV risk among young sexual minority men (SMM) in relationships. We evaluated the feasibility, acceptability, and preliminary efficacy of We Prevent in comparison to standard Counseling, Testing, and Referral among a national sample of 318 SMM ages 15-24 in a pilot randomized control trial. We found significant differences in condomless sex with outside partners; however, there were no differences in other sexual behaviors, sexual agreements, intimate partner violence (IPV), or communication between the conditions across the 9-month follow-ups. Stratified analyses found non-significant trends suggestive that We Prevent may reduce condomless sex for those ages 15-17 and for relationships over 1-year and may reduce IPV in relationships over 1-year. Though study retention was adequate, session attendance was low. Exit interviews participants reported benefits of We Prevent and provided insights into how to increase uptake.

Adolescents Living With or at Risk for HIV: A Pooled Descriptive Analysis of Studies From the Adolescent Medicine Trials Network for HIV/AIDS Interventions.

PURPOSE: This study aims to describe the cohort of Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) research program participants and evaluate whether the ATN's recently completed 5-year cycle recruited study participants who parallel the populations most impacted by HIV in the United States. METHODS: Harmonized measures across ATN studies collected at baseline were aggregated for participants aged 13-24 years. Pooled means and proportions stratified by HIV status (at risk for or living with HIV) were calculated using unweighted averages of study-specific aggregate data. Medians were estimated using a weighted median of medians method. Public use 2019 Centers for Disease Control and Prevention surveillance data for state-level new HIV diagnoses and HIV prevalence among US youth aged 13-24 years were obtained for use as reference populations for ATN at-risk youth and youth living with HIV (YLWH), respectively. RESULTS: Data from 3,185 youth at-risk for HIV and 542 YLWH were pooled from 21 ATN study phases conducted across the United States. Among ATN studies tailored to at-risk youth, a higher proportion of participants were White and a lower proportion were Black/African American and Hispanic/Latinx compared to youth newly diagnosed with HIV in the United States in 2019. Participants in ATN studies tailored to YLWH were demographically similar to YLWH in the United States. DISCUSSION: The development of data harmonization guidelines for ATN research activities facilitated this cross-network pooled analysis. These findings suggest the ATN's YLWH are representative, but that future studies of at-risk youth should prioritize recruitment strategies to enroll more participants from African American and Hispanic/Latinx populations.

Tough Talks COVID-19 Digital Health Intervention for Vaccine Hesitancy Among Black Young Adults: Protocol for a Hybrid Type 1 Effectiveness Implementation Randomized Controlled Trial.

BACKGROUND: Interventions for increasing the uptake of COVID-19 vaccination among Black young adults are central to ending the pandemic. Black young adults experience harms from structural forces, such as racism and stigma, that reduce receptivity to traditional public health messaging due to skepticism and distrust. As such, Black young adults continue to represent a priority population on which to focus efforts for promoting COVID-19 vaccine uptake. OBJECTIVE: In aims 1 and 2, the Tough Talks digital health intervention for HIV disclosure will be adapted to address COVID-19 vaccine hesitancy and tailored to the experiences of Black young adults in the southern United States (Tough Talks for COVID-19). In aim 3, the newly adapted Tough Talks for COVID-19 digital health intervention will be tested across the following three southern states: Alabama, Georgia, and North Carolina. METHODS: Our innovative digital health intervention study will include qualitative and quantitative assessments. A unique combination of methodological techniques, including web-based surveys, choose-your-own-adventures, digital storytelling, user acceptability testing, and community-based participatory approaches, will culminate in a 2-arm hybrid type 1 effectiveness implementation randomized controlled trial, wherein participants will be randomized to the Tough Talks for COVID-19 intervention arm or a standard-of-care control condition (N=360). Logistic regression will be used to determine the effect of the treatment arm on the probability of vaccination uptake (primary COVID-19 vaccine series or recommended boosters). Concurrently, the inner and outer contexts of implementation will be ascertained and catalogued to inform future scale-up. Florida State University's institutional review board approved the study (STUDY00003617). RESULTS: Our study was funded at the end of April 2021. Aim 1 data collection concluded in early 2022. The entire study is expected to conclude in January 2025. CONCLUSIONS: If effective, our digital health intervention will be poised for broad, rapid dissemination to reduce COVID-19 mortality among unvaccinated Black young adults in the southern United States. Our findings will have the potential to inform efforts that seek to address medical mistrust through participatory approaches. The lessons learned from the conduct of our study could be instrumental in improving health care engagement among Black young adults for several critical areas that disproportionately harm this community, such as tobacco control and diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05490329; https://clinicaltrials.gov/ct2/show/NCT05490329. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41240.

Development and Validation of the Youth Pre-Exposure Prophylaxis (PrEP) Stigma Scale.

To date, there are no established scales to assess PrEP stigma among youth. We validated the Youth PrEP Stigma Scale within the Adolescent Trials Network P3 study (2019-2021). Data from sexual and gender minority youth (16-24 years) who were prescribed PrEP across nine domestic sites were evaluated (N = 235). Descriptive statistics, exploratory factor analysis, and correlation coefficients are reported. Results yielded a three-factor solution (PrEP Disapproval by Others, Enacted PrEP Stigma, and PrEP User Stereotypes) with strong factor loadings and Cronbach's alphas ranging from 0.83 to 0.90, suggesting excellent internal consistency. Correlations between this Scale, anticipated HIV stigma, perceived HIV risk, and disclosure of sexual identity were significant, indicating potential for robust application. Given the persistence of HIV infections among youth, stigma as a barrier to prevention, and expansion of PrEP modalities, the Youth PrEP Stigma Scale could enhance intervention and mechanistic research among youth at elevated risk for HIV acquisition.

RESUMEN: Hasta la fecha, no existen escalas establecidas para evaluar el estigma de la PrEP entre los jóvenes. Validamos la Escala de estigma de la PrEP para jóvenes dentro del estudio P3 de la Red de ensayos para adolescentes (2019­2021). Se evaluaron los datos de jóvenes de minorías sexuales y de género (16­24 años) a quienes se les recetó PrEP en nueve sitios domésticos (N = 235). Se informan estadísticas descriptivas, análisis factorial exploratorio y coeficientes de correlación. Los resultados arrojaron una solución de tres factores (desaprobación de PrEP por parte de otros, estigma de PrEP promulgado y estereotipos de usuarios de PrEP) con fuertes cargas factoriales y alfas de Cronbach que oscilan entre 0.83 y 0.90, lo que sugiere una excelente consistencia interna. Las correlaciones entre esta Escala, el estigma anticipado del VIH, el riesgo percibido del VIH y la divulgación de la identidad sexual fueron significativas, lo que indica un potencial para una aplicación sólida. Dada la persistencia de las infecciones por el VIH entre los jóvenes, el estigma como una barrera para la prevención y la expansión de las modalidades de PrEP, la Escala de estigma de la PrEP para jóvenes podría mejorar la intervención y la investigación mecánica entre los jóvenes con un riesgo elevado de contraer el VIH.

Co-occurring Epidemic Conditions Among Southern U.S. Black Men Who Have Sex with Men in an Online eHealth Intervention.

Black men who have sex with men (BMSM) face disproportionately higher risks for adverse sexual health outcomes compared to their non-Hispanic White counterparts. This disparity can be attributable to overlapping and intersecting risk factors at the individual and structural levels and can be understood through syndemic theory. Using longitudinal data from the HealthMPowerment trial (n = 363), six conditions related to stigma syndemics were indexed as a cumulative risk score: high alcohol use, polydrug use, depression and anxiety symptomology, and experiences of racism and sexual minority stigma. Using Poisson regression, we found a positive association between baseline risk scores and sexual risk behavior (b: 0.32, SE: 0.03, p < 0.001). Using a Generalized Estimating Equation, we also found a 0.23 decrease in the within-participant risk scores at 3-month follow-up (SE: 0.10, p < 0.020). Future work examining how care and prevention trials improve health outcomes in this population is needed.

Using narratives to inform the development of a digital health intervention related to COVID-19 vaccination in Black young adults in Georgia, North Carolina and Alabama.

Interactive stories are a relatively newer form of storytelling with great potential to correct misinformation while increasing self-efficacy, which is crucial to vaccine acceptance. To address COVID-19 vaccine hesitancy and medical mistrust in young Black adults (BYA), we sought to adapt a pre-existing application ("app"; Tough Talks) designed to address HIV disclosure decision-making through choose-your-own adventure (CYOA) narratives and other activities. The adapted app (Tough Talks - COVID) uses a similar approach to situate COVID-19 vaccination decision-making within social contexts and to encourage greater deliberation about decisions. To inform content for the CYOA narratives, we conducted an online survey that was used to elicit the behavioral, cognitive, and environmental determinants influencing COVID-19 vaccine hesitancy among 150 BYA (ages 18-29) in Georgia, Alabama, and North Carolina. The survey included scenario questions that were developed with input from a youth advisory board to understand responses to peer and family influences. In two scenarios that involved discussions with family and friends about vaccination status, most respondents chose to be honest about their vaccination status. However, vaccinated individuals perceived more social pressure and stigma about not being vaccinated than unvaccinated respondents who were not as motivated by social pressure. Personal choice/agency in the face of perceived vaccine risks was a more common theme for unvaccinated respondents. Results suggest that relying on changing social norms alone may not impact barriers to vaccination in unvaccinated young adults without also addressing other barriers to vaccination such as concerns about autonomy and vaccine safety. Based on these findings, CYOA narratives in the app were adapted to include discussions with family and friends but also to touch on themes of personal choice as well as other topics that influence behaviors besides norms such as safety, side effects, and risk of COVID-19 in an evolving pandemic.

Validation of HIV Pre-Exposure Prophylaxis (PrEP) Medication Scales with Youth on PrEP: PrEP Confidence Scale and PrEP Difficulties Scale.

Pre-exposure prophylaxis (PrEP) is a lifesaving medical intervention that protects against human immunodeficiency virus (HIV), but to date, PrEP uptake has been limited. PrEP utilization and adherence among youth, including stigmatized and highly vulnerable young sexual and gender minorities, have been exceptionally low across all regions, leading to preventable HIV transmission. Considering the scientific value of measuring and understanding predictors or associations of PrEP adherence, our study team validated two scales: a PrEP Difficulties Scale and a PrEP Confidence Scale tested within the Adolescent Trials Network P3 study (2019-2021). Data from sexual and gender minorities who were prescribed PrEP across nine domestic sites were evaluated (N = 235). Descriptive statistics, exploratory factor analysis, and correlation coefficients are reported herein. Results for the PrEP Difficulties Scale yielded a four-factor solution (Disclosure, Health Effects, Logistics, and Cost), and results for the PrEP Confidence Scale produced a three-factor solution (Scheduling, Distraction, and Planning). Factor loadings and Cronbach's alphas suggested good internal consistency for both scales. PrEP Confidence Scale subscales were correlated with PrEP adherence, and subscales of both scales were associated with dimensions of social support and PrEP-related stigma. Given the persistence of preventable HIV infections among key populations, multi-level barriers and facilitators to medication adherence, and expansion of PrEP modalities, the PrEP Difficulties Scale and PrEP Confidence Scale have the potential to enhance intervention, exploratory, and mechanistic HIV prevention research. ClinicalTrials.gov Identifier: NCT03320512.

Tough Talks Virtual Simulation HIV Disclosure Intervention for Young Men Who Have Sex With Men: Development and Usability Testing.

BACKGROUND: HIV status disclosure is an important decision with barriers specific to young men who have sex with men (YMSM), who have the highest rates of new HIV infections in the United States. Behavioral and social determinants of the difficulty to disclose can include fear of rejection, stigma, loss of financial stability, and lack of communication skills. Once able to disclose, a person may have increased access to social support and improved informed risk reduction conversations and medication adherence. Despite the known challenges and advantages of disclosure, there are few effective tools supporting this behavior. OBJECTIVE: To address this gap in disclosure interventions, the Tough Talks (TT) app, an mHealth intervention using artificial intelligence (AI)-facilitated role-playing scenarios, was developed for YMSM. This paper reports stages of development of the integrated app and results of the usability testing. METHODS: Building on the successful development and testing of a stand-alone interactive dialogue feature in phases 1-3, we conducted additional formative research to further refine and enhance the disclosure scenarios and develop and situate them within the context of a comprehensive intervention app to support disclosure. We assessed the new iteration for acceptability and relevance in a usability study with 8 YMSM with HIV. Participants completed a presurvey, app modules, and a semistructured qualitative interview. RESULTS: TT content and activities were based on social cognitive theory and disclosure process model framework and expanded to a 4-module curriculum. The AI-facilitated scenarios used dialogue from an utterance database developed using language crowdsourced through a comic book contest. In usability testing, YMSM reported high satisfaction with TT, with 98% (31/33) of activities receiving positive ratings. Participants found the AI-facilitated scenarios and activities to be representative and relevant to their lived experiences, although they noted difficulty having nuanced disclosure conversations with the AI. CONCLUSIONS: TT was an engaging and practical intervention for self-disclosure among YMSM with HIV. Facilitating informed disclosure decisions has the potential to impact engagement in sexual risk behaviors and HIV care. More information is needed about the ideal environment, technical assistance, and clinical support for an mHealth disclosure intervention. TT is being tested as a scalable intervention in a multisite randomized controlled trial to address outstanding questions on accessibility and effect on viral suppression. TRIAL REGISTRATION: ClinicalTrials.gov NCT03414372; https://clinicaltrials.gov/ct2/show/NCT03414372.

Exploring Motivations for COVID-19 Vaccination Among Black Young Adults in 3 Southern US States: Cross-sectional Study.

BACKGROUND: Few studies have focused on attitudes toward COVID-19 vaccination among Black or African American young adults (BYA) in the Southern United States, despite high levels of infection in this population. OBJECTIVE: To understand this gap, we conducted an online survey to explore beliefs and experiences related to COVID-19 vaccination among BYA (aged 18-29 years) in 3 southern states. METHODS: We recruited 150 BYA to participate in an online survey as formative research for an intervention to address vaccine hesitancy in Alabama, Georgia, and North Carolina from September 22, 2021, to November 18, 2021. Participants were recruited through social media ads on Facebook, Twitter, Instagram, and YouTube. Additionally, we distributed information about the survey through organizations working with BYA in Alabama, Georgia, and North Carolina; our community partners; and network collaborations. We used measures that had been used and were previously validated in prior surveys, adapting them to the context of this study. RESULTS: Roughly 28 (19%) of the participants had not received any doses of the COVID-19 vaccine. Half of the unvaccinated respondents (n=14, 50%) reported they wanted to wait longer before getting vaccinated. Motivators to get vaccinated were similar between unvaccinated and vaccinated respondents (eg, if required, to protect the health of others), but the main motivator for those vaccinated was to protect one's own health. Among unvaccinated individuals, reasons for not receiving the COVID-19 vaccine included concern about vaccine side effects (n=15, 54%) and mistrust of vaccine safety (n=13, 46%), of effectiveness (n=12, 43%), and of the government's involvement with vaccines (n=12, 43%). Experiences of discrimination (n=60, 40%) and mistrust of vaccines (n=54, 36%) were common overall. Among all respondents, those who said they would be motivated to get vaccinated if it was required for school, work, or travel were more likely to endorse negative beliefs about vaccines compared to those motivated for other reasons. CONCLUSIONS: Mistrust in COVID-19 vaccine safety and efficacy is common among BYA in the Southern United States, irrespective of vaccination status. Other motivators, such as safety of family and community and vaccination requirements, may be able to tip the scales toward a decision to be vaccinated among those who are initially hesitant. However, it is unclear how vaccine requirements among BYA in the South affect trust in the government or health care in the long term. Interventions that include BYA in vaccination messaging and programs may more proactively build feelings of trust and combat misinformation.

Adapting a Motivational Interviewing Intervention to Improve HIV Prevention Among Young, Black, Sexual Minority Men in Alabama: Protocol for the Development of the Kings Digital Health Intervention.

BACKGROUND: African American or Black young men who have sex with men (BYMSM) are at a disproportionate risk for contracting HIV and have high rates of undiagnosed, and therefore untreated, HIV infection. In the southern United States, BYMSM face region-specific hurdles to HIV prevention, such as limited access to care and high levels of racism and intersectional stigma, necessitating HIV testing and pre-exposure prophylaxis interventions that address sociocultural and structural barriers while motivating BYMSM to engage in prevention. Brothers Saving Brothers (BSB) is a motivational interviewing behavioral intervention that successfully and simultaneously increased community-based HIV testing and prevention counseling and education among BYMSM in the midwestern United States. OBJECTIVE: The aim of this protocol is to detail the process for the adaption of the BSB intervention for midwestern BYMSM to the Kings intervention for southern BYMSM. During the adaptation process, the intervention will be modernized to include rapid HIV testing, as opposed to HIV testing that requires BYMSM to return for test results, pre-exposure prophylaxis, and the provision of structural supports, and for relevance in the southern United States. METHODS: Aim 1 is to gather qualitative data through focus groups and in-depth interviews with BYMSM aged 18 to 29 years in Alabama and in-depth interviews with prevention and outreach workers who routinely work with BYMSM in Alabama. NVivo qualitative software (QSR International) will be used for the coding and analysis of the transcripts via a thematic analysis approach. For aim 2, intervention mapping will guide the adaptation process, intervention content, components, and design. Both aims 1 and 2 will leverage the Exploration, Preparation, Implementation, Sustainment implementation science framework, with emphasis on the exploration and preparation phases of this model. By applying these frameworks, the original midwestern BSB intervention will be scientifically adapted to the southern BYMSM Kings intervention. RESULTS: This study is ongoing as of 2022 and is expected to conclude in 2024, with aims 1 and 2 being completed in 2023. Qualitative data will offer insight into the current real-world experiences and preferences of BYMSM in Alabama. Feedback will be collected through the adaptation process to inform intervention refinement. Institutional review board approvals have been received. CONCLUSIONS: The findings will inform next steps, that is, testing the Kings intervention for feasibility, acceptability, and preliminary effectiveness in a pilot hybrid type 1 effective-implementation randomized controlled trial. The study results will provide insights about important considerations for HIV prevention among BYMSM in the southern United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT03680729; https://clinicaltrials.gov/ct2/show/NCT03680729. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/36655.

"Do I want PrEP or do I want a roof?": Social determinants of health and HIV prevention in the southern United States.

Scaling up use of Pre-Exposure Prophylaxis (PrEP) among young men who have sex with men and transgender women (YMSM/TGW) is a critical part of the Ending the HIV Epidemic plan. This qualitative study contextualized the social determinants of health (SDOH) that can impede HIV prevention in rural North and South Carolina with 14 key informant interviews with stakeholders and 3 focus groups with YMSM/TGW (N = 23). A deductive-inductive approach with multiple coders was employed to identify themes related to SDOH in rural areas, including economic challenges (e.g., housing and food insecurity), neighborhood characteristics (e.g., lack of transportation), healthcare-related issues (e.g., provider shortages) and educational barriers (e.g., lack of comprehensive and inclusive sexual education). The socio-environmental context of the rural South and prioritization of local, community-based partnerships are necessary to reduce the burden of HIV.