The Role of Stigma and Resilience in Healthcare Engagement Among Transgender Latinas in the U.S. South: Baseline Findings from the ChiCAS Study.

Research demonstrates that stigma and resilience influence transgender peoples' healthcare use. Less is known about transgender Latinas in the U.S. South who face multilevel barriers to healthcare access. We used baseline data from the ChiCAS intervention study. Using logistic regression, we examined how stigma (perceived discrimination related to gender identity, race/ethnicity, sexual behavior and perceived documentation status and internalized transphobia), and resilience (ethnic group pride and social support) are associated with two healthcare outcomes (use of routine medical care and medically supervised gender-affirming hormones). We also explored barriers to accessing both types of care. After removing 13 participants with missing data, our sample size was 131 transgender Latinas in the U.S. South. Most participants (74.8%, n = 98) received routine medical care in the past year and 57.3% (n = 75) had ever received medically supervised gender-affirming hormones. Reports of discrimination were highest for gender identity and documentation status. Race/ethnicity-based discrimination was positively associated with accessing routine medical care in the past year (OR = 1.94, p = 0.048). Having more social support was positively associated with care (routine care: OR = 3.48, p = 0.002 and gender-affirming hormones: OR = 2.33, p = 0.003). The most commonly reported barriers to accessing both types of care included cost, insurance, and not knowing where to go. Findings highlight the importance of social support for healthcare use among transgender Latinas. Social support may be especially important when considering the unique experiences of discrimination faced by transgender Latinas in the U.S. South.

Understanding uptake of COVID-19 testing, vaccination, and boosters among Spanish-speaking Latines in the United States: Qualitative insights from Spanish speakers and key informants.

BACKGROUND: Latine communities in the United States have been disproportionately affected by COVID-19. It is critical to gain a better understanding of the sociocultural determinants that challenge and facilitate COVID-19 testing, vaccination, and booster uptake within these vulnerable communities to inform culturally congruent strategies and interventions. METHODS: In summer 2022, our community-based participatory research partnership conducted 30 key informant interviews and 7 focus groups with 64 Spanish-speaking Latine participants in North Carolina. Interviewees consisted of representatives from health and service organizations, most of whom were engaged with direct service to Spanish speakers. Interviews were conducted in either English or Spanish, depending on the preference of the participant; all focus groups were conducted in Spanish. Interviews and focus groups were conducted in person or by videoconference. RESULTS: Twenty themes emerged that we organize into four domains: general perceptions about COVID-19; barriers to COVID-19 testing, vaccination, and booster uptake; facilitators to COVID-19 testing, vaccination, and booster uptake; and recommendations to promote testing, vaccination, and booster uptake. DISCUSSION: Results underscore important sociocultural determinants of ongoing COVID-19 testing, vaccination, and booster uptake to consider in developing interventions for Spanish-speaking Latines in the United States. Based on this formative work, our partnership developed Nuestra Comunidad Saludable (Our Healthy Community). We are implementing the intervention to test whether trained peer navigators can increase COVID-19 testing, vaccination, and booster uptake among Spanish-speaking Latines through blending in-person interactions and mHealth (mobile health) strategies using social media.

Preexposure Prophylaxis Uptake Among Spanish-Speaking Transgender Women: A Randomized Controlled Trial in North and South Carolina, 2019-2022.

Objectives. To evaluate Chicas Creando Acceso a la Salud (Girls Creating Access to Health; ChiCAS), a Spanish-language, small-group intervention designed to increase preexposure prophylaxis (PrEP) use, consistent condom use, and medically supervised gender-affirming hormone therapy use among Spanish-speaking transgender Latinas who have sex with men. Methods. Participants were 144 HIV-negative Spanish-speaking transgender Latinas, aged 18 to 59 years, living in North and South Carolina. From July 2019 to July 2021, we screened, recruited, and randomized them to the 2-session ChiCAS intervention or the delayed-intervention waitlist control. Participants completed assessments at baseline and 6-month follow-up. Follow-up retention was 94.4%. Results. At follow-up, relative to control participants, ChiCAS participants reported increased PrEP use (adjusted odds ratio [AOR] = 4.64; 95% confidence interval [CI] = 1.57, 13.7; P < .006). However, ChiCAS participants did not report increased use of condoms or medically supervised gender-affirming hormone therapy. ChiCAS participants reported increases in knowledge of HIV (P < .001), sexually transmitted infections (P < .001), and gender-affirming hormone therapy (P = .01); PrEP awareness (P < .001), knowledge (P < .001), and readiness (P < .001); condom use skills (P < .001); and community attachment (P < .001). Conclusions. The ChiCAS intervention was efficacious in increasing PrEP use among Spanish-speaking, transgender Latinas in this trial. (Am J Public Health. 2024;114(1):68-78. https://doi.org/10.2105/AJPH.2023.307444).

Exploring Individual and Contextual Factors Associated With Sexual Risk and Substance Use Among Underserved GBQMSM and Transgender and Nonbinary Persons in South Central Appalachia.

Gay, bisexual, queer, and other men who have sex with men (GBQMSM) and transgender and nonbinary persons are at elevated risk for HIV, sexually transmitted infections (STIs), and hepatitis C (HCV); in Appalachia, these communities experience more disease burden. However, little is known about the factors influencing risk. Sixteen semistructured in-depth interviews were conducted examining factors influencing prevention and care. Data were analyzed using constant comparison methodology. Fifteen themes emerged within four domains: social environment (e.g., microaggressions across gender, sexual orientation, and racial identities), substance use (e.g., high prevalence, use as coping mechanism), sexual health (e.g., misinformation and denial of risk for HIV and STIs), and access to health care (e.g., cost and transportation barriers, lack of local respectful care). Findings highlighted salient barriers and assets influencing prevention and care and suggest that multilevel interventions are needed to improve access to and use of HIV, STI, and HCV prevention and care services.

Strategies to improve outcomes of youth experiencing healthcare transition from pediatric to adult HIV care in a large U.S. city.

BACKGROUND: The healthcare transition (HCT) from pediatric to adult HIV care can be disruptive to HIV care engagement and viral suppression for youth living with HIV (YLH). METHODS: We performed qualitative interviews with 20 YLH who experienced HCT and with 20 multidisciplinary pediatric and adult HIV clinicians to assess and rank barriers and facilitators to HCT and obtain their perspectives on strategies to improve the HCT process. We used the Exploration Preparation Implementation Sustainment Framework to guide this qualitative inquiry. RESULTS: The most impactful barriers identified by YLH and clinicians focused on issues affecting the patient-clinician relationship, including building trust, and accessibility of clinicians. Both groups reported that having to leave the pediatric team was a significant barrier (ranked #1 for clinicians and #2 for YLH). The most impactful facilitator included having a social worker or case manager to navigate the HCT (listed #1 by clinicians and #2 by YLH); case managers were also identified as the individual most suited to support HCT. While YLH reported difficulty building trust with their new clinician as their #1 barrier, they also ranked the trust they ultimately built with a new clinician as their #1 facilitator. Factors reported to bridge pediatric and adult care included providing a warm handoff, medical record transfer, developing relationships between pediatric clinics and a network of youth-friendly adult clinics, and having the pediatric case manager attend the first adult appointment. Longer new patient visits, increased health communication between YLH and clinicians and sharing vetted clinician profiles with YLH were identified as innovative strategies. CONCLUSION: In this multi-disciplinary contextual inquiry, we have identified several determinants that may be targeted to improve HCT for YLH.

Exploring the consequences of food insecurity and harnessing the power of peer navigation and mHealth to reduce food insecurity and cardiometabolic comorbidities among persons with HIV: protocol for development and implementation trial of weCare/Secure.

BACKGROUND: Food insecurity, or the lack of consistent access to nutritionally adequate and safe foods, effects up to 50% of people living with HIV (PWH) in the United States (US). PWH who are food insecure have lower antiretroviral adherence, are less likely to achieve viral suppression, and are at increased risk developing of serious illnesses, including cardiometabolic comorbidities. The objectives of this study are to better understand how food insecurity contributes to the development of cardiometabolic comorbidities among PWH and to test a novel bilingual peer navigation-mHealth intervention (weCare/Secure) designed to reduce these comorbidities in food-insecure PWH with prediabetes or Type 2 diabetes (T2DM). METHODS: In Aim 1, we will recruit a longitudinal cohort of 1800 adult (≥18 years) PWH from our clinic-based population to determine the difference in the prevalence and incidence of cardiometabolic comorbidities between food-secure and food-insecure PWH. Food insecurity screening, indicators of cardiometabolic comorbidities, and other characteristics documented in the electronic health record (EHR) will be collected annually for up to 3 years from this cohort. In Aim 2, we will conduct a randomized controlled trial among a sample of food-insecure PWH who have prediabetes or T2DM to compare changes in insulin sensitivity over 6 months between participants in weCare/Secure and participants receiving usual care. In Aim 3, we will conduct semi-structured individual in-depth interviews to explore the effect of the intervention among intervention participants with varying insulin sensitivity outcomes. TRIAL STATUS: Aim 1 (longitudinal cohort) recruitment began in May 2022 and is ongoing. Aim 2 (intervention) recruitment is planned for spring 2023 and is expected to be completed in spring 2024. Aim 3 (process evaluation) data collection will occur after sufficient completion of the 6-month assessment in Aim 2. Final results are anticipated in fall 2025. CONCLUSIONS: This research seeks to advance our understanding of how food insecurity impacts the development of cardiometabolic comorbidities among PWH and how food insecurity interventions may alleviate relevant comorbidities. Given the growing interest among health systems in addressing food insecurity, if the intervention is found to be efficacious, it could be broadly disseminated across HIV clinical care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04943861 . Registered on June 29, 2021.

Adapting a Group-Level PrEP Promotion Intervention Trial for Transgender Latinas During the COVID-19 Pandemic.

The COVID-19 pandemic has profoundly affected the conduct of community-based and community-engaged research. Prior to the pandemic, our community-based participatory research partnership was testing ChiCAS, an in-person, group-level behavioral intervention designed to promote uptake of pre-exposure prophylaxis (PrEP), condom use, and medically supervised gender-affirming hormone therapy among Spanish-speaking transgender Latinas. However, the pandemic required adaptations to ensure the safe conduct of the ChiCAS intervention trial. In this article, we describe adaptations to the trial within five domains. Transgender women are disproportionately affected by HIV, and it is essential to find ways to continue research designed to support their health within the context of the COVID-19 pandemic and future infectious disease outbreaks, epidemics, and pandemics. These adaptations offer guidance for ongoing and future community-based and community-engaged research during the COVID-19 pandemic and/or potential subsequent outbreaks (e.g., monkeypox), epidemics, and pandemics, particularly within under-served marginalized and minoritized communities.

Increasing COVID-19 testing and vaccination among Spanish speakers in the USA: protocol for the development and evaluation of the Nuestra Comunidad Saludable intervention using a group-randomised trial design.

INTRODUCTION: Our community-based participatory research partnership aims to expand understanding of the social, ethical and behavioural implications of COVID-19 testing and vaccination to inform the development of an integrated intervention that harnesses community-based peer navigation and mHealth strategies to improve COVID-19 testing and vaccination; test the intervention; and develop and disseminate practice, research and policy recommendations to further increase COVID-19 testing and vaccination among Spanish-speaking Latine communities in the USA. METHODS AND ANALYSIS: We will conduct 50 individual in-depth interviews with health providers, who have conducted COVID-19 testing and/or vaccination activities within Spanish-speaking communities, and with representatives from Latine-serving community-based organisations. We will also conduct six focus groups with 8-12 Spanish-speaking Latine community member participants each for a total number of about 60 focus group participants. Next, we will develop the Nuestra Comunidad Saludable intervention based on findings from interviews and focus groups and use a longitudinal group-randomised trial design with two arms (intervention and delayed intervention) to evaluate the impact of the intervention. We will recruit, enrol and collect baseline data from 20 community-based peer navigators (Navegantes) and their social network members (n=8 unique social network members per Navegante). Navegantes (coupled with their social networks) will be randomised to intervention or delayed intervention groups (10 Navegantes and 80 social network members per group). ETHICS AND DISSEMINATION: Ethical approval for data collection was granted by the Wake Forest University School of Medicine Institutional Review Board. Following the description of study procedures, we will obtain consent from all study participants. Study findings will be disseminated through an empowerment theory-based community forum, peer-reviewed publications and presentations at scientific meetings, and reports and briefs for lay, community and practitioner audiences. TRIAL REGISTRATION NUMBER: NCT05302908.

Outcomes From a Randomized Trial of a Bilingual mHealth Social Media Intervention to Increase Care Engagement Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Transgender Women With HIV.

BACKGROUND: The North Carolina Community Research Partnership developed, implemented, and tested weCare, a 12-month bilingual mHealth social media intervention designed to reduce missed HIV care appointments and increase viral suppression among racially/ethnically diverse gay, bisexual, and other men who have sex with men (GBMSM) and transgender women living with HIV by harnessing established social media platforms (i.e., Facebook, texting, and dating apps). METHODS: We randomized 198 GBMSM and transgender women (mean age = 26) living with HIV to the weCare intervention (n = 100) or usual-care (n = 98) group. Inclusion criteria included being newly diagnosed or not in care. Participants completed structured assessments at baseline and 6-month postintervention follow-up (18 months after baseline data collection). HIV care appointment and viral load data were abstracted from each participant's electronic health record at baseline and follow-up. Follow-up retention was 85.5%. RESULTS: Among participants, 94% self-identified as cisgender men, 6% as transgender, 64% as African American/Black, and 13% as Latine. Participants in both groups significantly reduced missed HIV care appointments and increased viral suppression at follow-up compared with baseline. However, there were no significant differences between weCare and usual-care participants for either outcome at follow-up. CONCLUSIONS: An intervention effect was not identified for our two primary outcomes. Several factors may have influenced the lack of significant differences between weCare and usual-care participants at follow-up, including intervention implementation (e.g., staffing changes and lack of fidelity to the intervention as originally designed by the partnership), data collection (e.g., data collection time points and retention strategies), and clinical (e.g., contamination) factors.

Black heterosexual college men's masculinity dimensions, protective behavioral intentions, and sexual risk behaviors.

OBJECTIVE: To examine the associations of dimensions of masculinity-respect/toughness and anti-femininity/hypersexuality-with sexual risk behaviors and protective behavioral intentions and the effects of awareness of anti-Blackness. PARTICIPANTS: 127 Black heterosexual men were recruited from four Historically Black Colleges and Universities and one Minority Serving Institution in the South. METHODS: Students completed an online survey as part of a pilot study to assess the sexual health needs of Black college students. RESULTS: Our results indicated that respect/toughness and anti-femininity/hypersexuality were significant correlates of protective behavioral intentions. After accounting for awareness of anti-Blackness and age, anti-femininity/hypersexuality was a significant correlate of sexual risk behaviors. CONCLUSIONS: Our study highlights the complex multi-dimensional construct of masculinity and how forms of anti-Blackness continue to influence HIV vulnerability. Therefore, there is a need to include structural factors within research to better understand behaviors among Black college men and incorporate dimensions of masculinity that promote healthy sexual behaviors in interventions and programming.

More than just oral PrEP: exploring interest in rectal douche, dissolvable implant, removable implant and injection HIV prevention approaches among racially diverse men who have sex with men in the Northeast Corridor.

OBJECTIVES: HIV scholars and practitioners have worked to expand strategies for prevention among marginalised populations who are disproportionately impacted by the epidemic, such as racial minority men who have sex with men (MSM). Given this urgency, the objective of this study was to assess interest in biomedical prevention strategies. METHODS: This exploratory and cross-sectional study investigated interest in four biomedical prevention tools-rectal douche, dissolvable implant, removable implant and injection-among a racially diverse sample of MSM from the Northeast Corridor region between Philadelphia and Trenton. Data were collected as part of screening for Connecting Latinos en Pareja, a couples-based HIV prevention intervention for Latino MSM and their partners. RESULTS: A total of 381 individuals participated in the screener and provided information about their interest in bio tools. Approximately 26% of participants identified as black, 28% as white and 42% as 'other' or multiracial; 49% identified as Latino. Majority (54%) reported some form of child sexual abuse. Of the participants who reported being in a primary relationship (n=217), two-thirds reported unprotected anal sex within that relationship over the past 90 days (n=138, 64%) and approximately half (n=117, 54%) reported unprotected anal sex outside of the relationship in this period. Majority of participants reported interest in all bio tools assessed, including dissolvable implants (60%), removable implants (64%), rectal douching (79%) and injection (79%). Although interest in bio tools was broadly unassociated with demographics and sexual risk behaviours, analyses revealed significant associations between reports of child sexual abuse and interest in implant and injection methods. CONCLUSIONS: The authors recommend investing in these prevention methods, particularly rectal douching and injection, as a means of preventing HIV among racial minority MSM. Given the interest in biomedical prevention tools, future studies should explore potential strategies for adherence.

Measuring anti-transgender stigma in low-income and middle-income countries: a scoping review protocol.

INTRODUCTION: Globally, transgender and other gender diverse (trans) people face pervasive stigma, which contributes to health inequities across multiple health outcomes. Stigma is a fundamental cause of health inequities because it simultaneously limits access to resources, contributes to systemic vulnerability and generates chronic stress. Anti-trans stigma occurs across multiple socioecological levels, resulting in multiple possible definitions and measurements of trans stigma. Understanding how trans stigma has been measured in low-income and middle-income countries (LMICs) is critical to health promotion efforts for trans communities. Accordingly, this scoping review will identify and examine how anti-trans stigma has been measured in existing LMIC-specific research to inform best practices for measurement of anti-trans stigma that includes consideration of local context. METHODS AND ANALYSIS: This is the protocol for a scoping review of anti-trans stigma in LMICs. We will search (from January 2001 to December 2021) PubMed, WHO Global Medicus and EBSCO. Study selection will conform to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist. Original studies in English, Spanish, Arabic or Russian will be included. Reviewers will independently screen all citations, full-text articles and abstract data. Data analysis will involve quantitative and qualitative methods. A narrative summary of findings will be conducted. ETHICS AND DISSEMINATION: As a scoping review (no direct interaction with participants), this study is exempt from human subjects oversight. Understanding context-specific ways to measure anti-trans stigma is urgently needed to support trans health globally. The planned scoping review will help to address this gap. Results of the review will be disseminated in a peer-reviewed journal and likely in other media such as conferences, seminars and symposia. PROTOCOL REGISTRATION NUMBER: osf.io/qcs2v.

PrEP Uptake in North Carolina: Innovative Strategies for Reducing Barriers.

Pre-exposure prophylaxis (PrEP) is a biomedical HIV innovation designed to reduce HIV transmission. Unfortunately, PrEP uptake is suboptimal within many communities in the US South. Innovative interventions that integrate evidence-based strategies (e.g., mHealth and peer navigation through cyber health educators) are needed to increase PrEP uptake in North Carolina.

Transgender women of color in the U.S. South: A qualitative study of social determinants of health and healthcare perspectives.

Background: Research has shown that transgender and nonbinary people experience health disparities. However, few studies have explored, in-depth, the health-related experiences, perceptions, needs, and priorities of transgender women of color living in the U.S. South, a region that poses unique challenges to achieving health for transgender people. Aims: This study explored the social determinants of health, healthcare experiences, and health-related priorities of transgender women of color living in the U.S. South. Methods: Using a community-based participatory research approach, we conducted iterative in-depth interviews with 15 African American/Black and Latinx transgender women in North Carolina in May-July 2019 for a total of 30 interviews. We analyzed interview data using constant comparison, an approach to grounded theory. Results: Participants' mean age was 34 (range 19-56) years. Twenty themes emerged that were categorized into three domains: (1) social determinants of health (family rejection; bullying, discrimination, and violence; isolation; policy barriers; mistrust in systems; employment obstacles; sex work; high cost of care; transportation barriers; church antagonism; and substance misuse), (2) healthcare experiences (emotional burden of healthcare interactions; name and gender misidentification; staff discomfort and insensitivity; sexual risk assumptions; and use of nonmedical or predatory providers), and (3) health-related priorities (understanding healthcare; respect at all levels of healthcare; inclusive gender-affirming care; and comprehensive resources). Discussion: Transgender women of color living in the U.S. South face profound health barriers compounded throughout the life course and have unmet healthcare needs. Participants faced multilayered minority stressors: racial discrimination from society at large and within the LGTBQ community; gender identity discrimination within their regional context and racial/ethnic communities; and exclusion from existing health equity movements for transgender women of color, which often are found in and focus on larger urban communities. Health interventions mindful of this intersection are needed, including antidiscrimination policies and increasing gender-affirming healthcare access.

Stigma, Social Support, and Substance Use in Diverse Men Who Have Sex With Men and Transgender Women Living with HIV in the US Southeast.

OBJECTIVES: Human immunodeficiency virus (HIV) rates in the southeast United States are high and substance use is common among people living with HIV (PLWH). This study used baseline data from the weCare intervention study to examine factors associated with the use of alcohol, tobacco, and marijuana among racially and ethnically diverse young gay, bisexual, and other men who have sex with men (GBMSM) and transgender women in the southeast who were newly diagnosed as having HIV, not linked to care, out of care, and/or not virally suppressed. METHODS: Self-reported data were collected from 196 GBMSM and transgender women living with HIV via Audio Computer-Assisted Self-Interview at enrollment. Measures assessed demographics; stigma; social support; basic and clinical service needs; HIV disclosure; social media use; and recent use of alcohol, tobacco, and marijuana. Logistic regression identified correlates of past 30-day substance use. RESULTS: In multivariable analysis, increased age and needing basic support services were associated with past 30-day tobacco, cigarette, electronic cigarette, and/or hookah use. Increased HIV-related stigma and needing basic support services were associated with past 30-day marijuana use. Being White and needing clinical support services were associated with infrequent or no past 30-day marijuana use. CONCLUSIONS: HIV-related stigma and needing basic support services were associated with substance use among GBMSM and transgender women living with HIV in the southeastern United States. Routine screening for basic needs could identify GBMSM and transgender women living with HIV at risk for substance use and offer insight into intervention leverage points.

itMatters: Optimization of an online intervention to prevent sexually transmitted infections in college students.

ObjectiveTo describe an iterative approach to developing an online intervention targeting the intersection of alcohol use and sexual behaviors among first year college students. Methods and Participants: Using the multiphase optimization strategy (MOST), we conducted two iterative optimization trials to: (1) identify candidate intervention components (i.e., descriptive norms, injunctive norms, outcome expectancies, perceived benefits of protective behavioral strategies, and self-efficacy to use strategies); (2) revise components; and (3) identify the optimized intervention. Participants were first year college students at six geographically diverse universities (optimization trial 1 N = 5,880; optimization trial 2 N = 3,551) Results: For both optimization trials, the results indicated that only descriptive and injunctive norms produced a significant effect (p<.05). Conclusions: The iterative process of MOST allowed us to develop an optimized intervention which is an essential tool to maximize intervention effectiveness and efficiency to improve uptake, sustainability, and public health impact.

Perceived HIV Invulnerability and PrEP Knowledge and Attitudes among Black Sexual Minority Women.

Black women have disproportionate rates of HIV compared to women of all other racial groups. The purpose of this analysis was to investigate perceived HIV risk, HIV and STI testing behaviors, and PrEP knowledge and attitudes among Black sexual minority women (SMW) and examine differences based on their history of male sex partners. Secondary data analysis was conducted using data from the Generations Study. This analysis used a sample of N=149 participants who identified as Black cisgender women. Results showed Black SMW with a history of male sex partners reported a higher perceived risk of contracting HIV and significantly more frequent HIV and STI testing than those without a history of male sex partners. Overall, most of the sample was not familiar with PrEP, but one-third had favorable attitudes towards it, and half felt like they did not know enough about PrEP to form an opinion. Implications for culturally relevant public health campaigns and comprehensive sexuality education that integrate PrEP are included.

Evaluating Locally Developed Interventions to Promote PrEP Among Racially/Ethnically Diverse Transgender Women in the United States: A Unique CDC Initiative.

In the United States, transgender women are disproportionately affected by HIV. However, few evidence-based prevention interventions exist for this key population. We describe two promising, locally developed interventions that are currently being implemented and evaluated through the Centers for Disease Control and Prevention Combination HIV Prevention for Transgender Women Project: (a) ChiCAS, designed to promote the uptake of pre-exposure prophylaxis (PrEP), condom use, and medically supervised hormone therapy among Spanish-speaking transgender Latinas, and (b) TransLife Care, designed to address the structural drivers of HIV risk through access to housing, employment, legal services, and medical services, including HIV preventive care (e.g., PrEP use) among racially/ethnically diverse urban transgender women. If the evaluation trials determine that these interventions are effective, they will be among the first such interventions for use with transgender women incorporating PrEP, thereby contributing to the evidence-based resources that may be used to reduce HIV risk among this population.

An Intervention for the Transition From Pediatric or Adolescent to Adult-Oriented HIV Care: Protocol for the Development and Pilot Implementation of iTransition.

BACKGROUND: In the United States, adolescents and young adults are disproportionately affected by HIV and have poorer HIV-related health outcomes than adults. Health care transition (HCT) from pediatric or adolescent to adult-oriented HIV care is associated with disruptions to youths' care retention, medication adherence, and viral suppression. However, no evidence-based interventions exist to improve HCT outcomes for youth living with HIV. OBJECTIVE: There are 2 phases of this project. Phase 1 involves the iterative development and usability testing of a Social Cognitive Theory-based mobile health (mHealth) HIV HCT intervention (iTransition). In phase 2, we will conduct a pilot implementation trial to assess iTransition's feasibility and acceptability and to establish preliminary efficacy among youth and provider participants. METHODS: The iterative phase 1 development process will involve in-person and virtual meetings and a design team comprising youth living with HIV and health care providers. The design team will both inform the content and provide feedback on the look, feel, and process of the iTransition intervention. In phase 2, we will recruit 100 transition-eligible youth across two clinical sites in Atlanta, Georgia, and Philadelphia, Pennsylvania, to participate in the historical control group (n=50; data collection only) or the intervention group (n=50) in a pilot implementation trial. We will also recruit 28 provider participants across the pediatric or adolescent and adult clinics at the two sites. Data collection will include electronic medical chart abstraction for clinical outcomes as well as surveys and interviews related to demographic and behavioral characteristics; Social Cognitive Theory constructs; and intervention feasibility, acceptability, and use. Analyses will compare historical control and intervention groups in terms of HCT outcomes, including adult care linkage (primary), care retention, and viral suppression (secondary). Interview data will be analyzed using content analysis to understand the experience with use and acceptability. RESULTS: Phase 1 (development) of iTransition research activities began in November 2019 and is ongoing. The data collection for the phase 2 pilot implementation trial is expected to be completed in January 2023. Final results are anticipated in summer 2023. CONCLUSIONS: The development and pilot implementation trial of the iTransition intervention will fill an important gap in understanding the role of mHealth interventions to support HCT outcomes for youth living with HIV. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24565.

A Hybrid Evaluation-Optimization Trial to Evaluate an Intervention Targeting the Intersection of Alcohol and Sex in College Students and Simultaneously Test an Additional Component Aimed at Preventing Sexual Violence.

BACKGROUND: Using the multiphase optimization strategy (MOST), we previously developed and optimized an online behavioral intervention, itMatters, aimed at reducing the risk of sexually transmitted infections (STI) among first-year college students by targeting the intersection of alcohol use and sexual behaviors. PURPOSE: We had two goals: (a) to evaluate the optimized itMatters intervention and (b) to determine whether the candidate sexual violence prevention (SVP) component (included at the request of participating universities) had a detectable effect and therefore should be added to create a new version of itMatters. We also describe the hybrid evaluation-optimization trial we conducted to accomplish these two goals in a single experiment. METHODS: First year college students (N = 3,098) at four universities in the USA were individually randomized in a hybrid evaluation-optimization 2 × 2 factorial trial. Data were analyzed using regression models, with pre-test outcome variables included as covariates in the models. Analyses were conducted separately with (a) immediate post-test scores and (b) 60-day follow-up scores as outcome variables. RESULTS: Experimental results indicated a significant effect of itMatters on targeted proximal outcomes (norms) and on one distal behavioral outcome (binge drinking). There were no significant effects on other behavioral outcomes, including the intersection of alcohol and sexual behaviors. In addition, there were mixed results (positive short-term effect; no effect at 60-day follow-up) of the SVP component on targeted proximal outcomes (students' self-efficacy to reduce/prevent sexual violence and perceived effectiveness of protective behavioral strategies). CONCLUSIONS: The hybrid evaluation-optimization trial enabled us to evaluate the individual and combined effectiveness of the optimized itMatters intervention and the SVP component in a single experiment, conserving resources and providing greatly improved efficiency. TRIAL REGISTRATION: NCT04095065.