History of Rectal Product Use and Country of Residence Influence Preference for Rectal Microbicide Dosage Forms Among Young Sexual and Gender Minorities: A Multi-country Trial Comparing Placebo Douche, Suppository, and Insert Products.

The DESIRE Study (MTN-035) explored product preference among three placebo rectal microbicide (RM) formulations, a rectal douche (RD), a suppository, and an insert, among 210 sexually active transgender people and men who have sex with men in five counties: the United States, Peru, Thailand, South Africa, and Malawi. Participants used each product prior to receptive anal sex (RAS) for 1 month, following a randomly assigned sequence, then selected their preferred product via computer assisted self-interview. In-depth interviews examined reasons for preference. We compared product preference and prior product use by country to explore whether geographic location and experience with the similar products impacted preference. A majority in the United States (56%) and Peru (58%) and nearly half in South Africa (48%) preferred the douche. Most in Malawi (59%) preferred the suppository, while half in Thailand (50%) and nearly half in South Africa (47%) preferred the insert. Participants who preferred the douche described it as quick and easy, already routinized, and serving a dual purpose of cleansing and protecting. Those who preferred the insert found it small, portable, discreet, with quick dissolution. Those who preferred the suppository found the size and shape acceptable and liked the added lubrication it provided. Experience with product use varied by country. Participants with RD experience were significantly more likely to prefer the douche (p = 0.03). Diversifying availability of multiple RM dosage forms can increase uptake and improve HIV prevention efforts globally.

RESUMEN: El estudio DESIRE (MTN-035) exploró la preferencia de producto entre tres formulaciones de microbicida rectal (MR) de placebo, una ducha rectal, un supositorio y un inserto, entre 210 personas transgénero y hombres que tienen sexo con hombres en cinco países: los Estados Unidos, Perú., Tailandia, Sudáfrica y Malawi. Los participantes utilizaron cada producto antes del sexo anal receptive (SAR) durante un mes, siguiendo una secuencia asignada al azar, luego seleccionaron su producto preferido mediante una autoentrevista asistida por computadora. Las entrevistas en profundidad examinaron los motivos de preferencia. Comparamos la preferencia de producto y el uso previo del producto por país para explorar si la ubicación geográfica y la experiencia con la forma farmacéutica impactaron la preferencia. Una mayoría en los Estados Unidos (56%) y Perú (58%) y casi la mitad en Sudáfrica (48%) prefirieron la ducha rectal. La mayoría en Malawi (59%) prefirió el supositorio, mientras que la mitad en Tailandia (50%) y casi la mitad en Sudáfrica (47%) prefirió el inserto. Los participantes que prefirieron la ducha rectal la describieron como rápida y fácil, ya parte de su rutina y que tenía el doble propósito de limpiar y proteger. Los que prefirieron el inserto lo consideraron pequeño, portátil, discreto y de rápida disolución. Los que prefirieron el supositorio encontraron que tenía un tamaño y forma aceptables y proveía lubricación adicional. La experiencia con el uso del producto varió según el país. Los participantes con experiencia con duchas rectales tenían significativamente más probabilidades de preferir la ducha rectal (p = 0,03). Diversificar la disponibilidad de múltiples formas farmacéuticas de MR puede aumentar la aceptación y mejorar los esfuerzos de prevención del VIH a nivel mundial.

Determining the Innovativeness of Nurses Who Engage in Activities That Encourage Innovative Behaviors.

BACKGROUND: We sought to understand the innovativeness of nurses engaging in innovative behaviors and quantify the associated characteristics that make nurses more able to innovate in practice. We first compared the innovativeness scores of our population; then we examined those who self-identified as an innovator versus those who did not to explore differences associated with innovativeness between these groups. METHODS: A cross-sectional survey study of nurses in the US engaging in innovative behaviors was performed. We performed an exploratory factor analysis (EFA) to determine the correlates of innovative behavior. RESULTS: Three-hundred and twenty-nine respondents completed the survey. Respondents who viewed themselves as innovators had greater exposure to HCD/DT workshops in the past year (55.8% vs. 36.6%, p = 0.02). The mean innovativeness score of our sample was 120.3 ± 11.2 out of a score of 140. The mean innovativeness score was higher for those who self-identified as an innovator compared with those who did not (121.3 ± 10.2 vs. 112.9 ± 14.8, p =< 0.001). The EFA created four factor groups: Factor 1 (risk aversion), Factor 2 (willingness to try new things), Factor 3 (creativity and originality) and Factor 4 (being challenged). CONCLUSION: Nurses who view themselves as innovators have higher innovativeness scores compared with those who do not. Multiple individual and organizational characteristics are associated with the innovativeness of nurses.

A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention.

BACKGROUND: On-demand topical products could be an important tool for HIV prevention. We evaluated the safety, pharmacokinetics, and ex vivo pharmacodynamics of a tenofovir alafenamide/elvitegravir (TAF/EVG; 16 mg/20 mg) insert administered rectally. METHODS: MTN-039 was a Phase 1, open-label, single-arm, 2-dose study. Blood, rectal fluid (RF), and rectal tissue (RT) were collected over 72 hours (hr) following rectal administration of one and two TAF/EVG inserts for each participant. ClinicalTrials.gov Identifier: NCT04047420. RESULTS: TAF/EVG inserts were safe and well tolerated. EVG and tenofovir (TFV) were detected in blood plasma at low concentrations: median peak concentrations after 2 inserts were EVG 2.4 ng/mL and TFV 4.4 ng/mL. RT EVG peaked at 2-hr (median 2 inserts= 9 ng/mg) but declined to BLQ in the majority of samples at 24-hr, whereas TFV-DP remained high >2,000 fmol/million cells for 72-hr with 2 inserts. Compared to baseline, median cumulative log10 HIV p24 antigen of ex vivo rectal tissue HIV infection was reduced at each timepoint for both 1 and 2 inserts (p<0.065 and p<0.039, respectively). DISCUSSION: Rectal administration of TAF/EVG inserts achieved high rectal tissue concentrations of EVG and TFV-DP with low systemic drug exposure and demonstrable ex vivo inhibition of HIV infection for 72 hours.

Health activism, vaccine, and mpox discourse: BERTopic based mixed-method analyses of tweets from sexual minority men and gender diverse (SMMGD) individuals in the U.S.

Objectives: To synthesize discussions among sexual minority men and gender diverse (SMMGD) individuals on mpox, given limited representation of SMMGD voices in existing mpox literature. Methods: BERTopic (a topic modeling technique) was employed with human validations to analyze mpox-related tweets (n = 8,688; October 2020-September 2022) from 2,326 self-identified SMMGD individuals in the U.S.; followed by content analysis and geographic analysis. Results: BERTopic identified 11 topics: health activism (29.81%); mpox vaccination (25.81%) and adverse events (0.98%); sarcasm, jokes, emotional expressions (14.04%); COVID-19 and mpox (7.32%); government/public health response (6.12%); mpox symptoms (2.74%); case reports (2.21%); puns on the virus' naming (i.e., monkeypox; 0.86%); media publicity (0.68%); mpox in children (0.67%). Mpox health activism negatively correlated with LGB social climate index at U.S. state level, ρ = -0.322, p = 0.031. Conclusions: SMMGD discussions on mpox encompassed utilitarian (e.g., vaccine access, case reports, mpox symptoms) and emotionally-charged themes-advocating against homophobia, misinformation, and stigma. Mpox health activism was more prevalent in states with lower LGB social acceptance. Public Health Implications: Findings illuminate SMMGD engagement with mpox discourse, underscoring the need for more inclusive health communication strategies in infectious disease outbreaks to control associated stigma.

Trust in federal COVID-19 vaccine oversight and parents' willingness to vaccinate their children against COVID-19: a cross-sectional study.

BACKGROUND: Over half of the youth population in the United States, aged 6 months to 17 years, have not received the Coronavirus Disease 2019 (COVID-19) vaccine. Given parents' central role in vaccinating their children, we examined associations between parents' trust of the federal oversight of COVID-19 vaccine safety and their willingness to vaccinate their children against COVID-19. METHODS: This cross-sectional study included 975 parents of minor children residing in Philadelphia who completed the online survey between September 2021 and February 2022. Trust was measured using a four-point Likert scale ranging from 'do not trust' to 'fully trust' for two variables: (1) trust in federal oversight of COVID-19 vaccine safety for children and (2) trust in federal oversight of COVID-19 vaccine safety for the general public. A multiple logistic regression evaluated associations between trust and parents' willingness to vaccinate their children, which was measured on a five-point Likert scale ranging from 'strongly disagree' to 'strongly agree.' The analysis was adjusted for race/ethnicity, age, sexual orientation, gender, education, insurance, and parents' vaccination status. RESULTS: Analyses included 975 parents whose children had not previously been vaccinated against COVID-19 (mean age 36.79, standard deviation 6.4; 42.1% racial/ethnic minorities; 93.2% heterosexual; and 73.7% with a college degree). Greater trust regarding federal oversight of COVID-19 vaccine safety for children [adjusted odds ratio (aOR) = 1.52, 95% confidence interval (CI): 1.13-2.04] and for the public (aOR = 1.58, 95% CI: 1.17-2.14) were each associated with increased willingness to have their child vaccinated against COVID-19. Unvaccinated parents had decreased willingness compared to parents who had received at least one dose of the vaccine (aOR = 0.14, 95% CI: 0.04-0.41). College-graduate parents exhibited increased willingness compared to those without a college degree (aOR = 2.07, 95% CI: 1.52-2.81). Non-heterosexual parents showed increased willingness compared to heterosexual parents (aOR = 2.30, 95% CI: 1.20-4.76). CONCLUSIONS: Trust in federal COVID-19 vaccine oversight was associated with parental willingness to vaccinate their children against COVID-19 among parents whose children have not yet been vaccinated. Identifying and addressing causes of mistrust are crucial next steps to promote child vaccination. Intervention efforts to address trust gaps should remain a public health priority.

Adolescent Preferences for a Pediatric Primary Care-based Sexually Transmitted Infection and HIV Prevention Intervention.

PURPOSE: We sought to elicit perspectives on HIV and sexually transmitted infection (STI) prevention among adolescents with recent STIs in primary care to optimize acceptability and effectiveness in designing a novel HIV/STI prevention intervention. METHODS: We enrolled 13-19 year-olds with recent gonorrhea, chlamydia, trichomonas, and/or syphilis in a multimethods cross-sectional study at two primary care clinics. Participants completed surveys and interviews. We used an integrated analytic approach deductively coding data using the Integrated Behavioral Model, then inductively coding to identify themes not represented in the Integrated Behavioral Model. RESULTS: Participants (n = 35) were 85% cisgender female, 14% cisgender male, 1% transgender female; 25% identified as lesbian, bisexual, or queer. Most (97%) identified as non-Latinx Black. None used condoms consistently, 26% were aware of pre-exposure prophylaxis (PrEP), and 31% were never HIV tested. Five key themes emerged. 1) Mental health was central to HIV prevention behavior uptake and coping with STI diagnosis. 2) Youth desired prevention counseling that allowed decisional autonomy and individualized goal setting. 3) Negative social norms around condoms and absent norms around HIV testing and PrEP limited method uptake. 4) Both confidence and concrete skills were needed to initiate prevention methods. 5) Youth desired education at the time of STI diagnosis to improve subsequent prevention decision making. DISCUSSION: Key intervention design considerations included 1) integrating mental health assessment and referral to services, 2) promoting individualized goal setting, 4) building communication skills, 4) providing navigation and material support for PrEP uptake and HIV testing, and 5) augmenting comprehensive STI and HIV prevention education.

A conjoint experiment of three placebo rectal products used with receptive anal sex: results from MTN-035.

INTRODUCTION: End-user perspectives are vital to the design of new biomedical HIV prevention products. Conjoint analysis can support the integration of end-user perspectives by examining their preferences of potential pre-exposure prophylaxis (PrEP) products. The Microbicides Trial Network (MTN) 035 protocol examined three placebo rectal dosage forms (insert, enema and suppository) that could deliver PrEP prior to receptive anal sex (RAS). METHODS: Between April 2019 and July 2020, we enrolled 217 HIV-negative, cisgender men who have sex with men (MSM; n = 172; 79.3%) and transgender people (n = 47; 20.7%) ages 18-35 into a randomized cross-over trial across Malawi, Peru, South Africa, Thailand and the United States. Participants used each product prior to RAS over 4-week periods. Participants completed a conjoint experiment where they selected between random profiles using seven features (dosage form, timing of use before sex, side effects, duration of protection, effectiveness, frequency of use and need for a prescription). RESULTS: Effectiveness was the strongest determinant of choice (30.4%), followed by modality (18.0%), potential side effects (17.2%), frequency of use (10.8%), duration of protection (10.4%), timing of use before sex (7.4%) and need for a prescription (5.9%). Relative utility scores indicated that the most desirable combination of attributes was a product with 95% efficacy, used 30 minutes before sex, offering a 3- to 5-day protection window, used weekly, having no side effects, in the form of an enema and available over-the-counter. CONCLUSIONS: Choice in next-generation PrEP products is highly desired by MSM and transgender people, as no one-size-fits-all approach satisfies all the preferences. MTN-035 participants weighed product features differently, recognizing the need for diverse, behaviourally congruent biomedical options that fit the needs of intended end-users.

Efficacy of a Digital Health Preventive Intervention for Adolescents With HIV or Sexually Transmitted Infections and Substance Use Disorder: Protocol for a Randomized Controlled Trial.

BACKGROUND: HIV or sexually transmitted infections remain a significant public health concern in the United States, with adolescents affected disproportionately. Adolescents engage in HIV/STI risk behaviors, including drug use and condomless sex, which increase the risk for HIV/STIs. At-risk adolescents, many of whom are racial minorities, experience HIV/STI disparities. Although at-risk adolescents are disproportionately affected by HIV/STI risk behaviors and infections and although the Centers for Disease Control and Prevention recommends routine HIV/STI testing for adolescents, relatively few adolescents report having ever been tested for HIV/STI. With expected increases in health clinic visits as a result of the Affordable Care Act combined with technological advances, health clinics and mobile health (mHealth), including apps, provide innovative contexts and tools to engage at-risk adolescents in HIV/STI prevention programs. Yet, there is a dearth of efficacious mHealth interventions in health clinics to prevent and reduce both condomless sex and drug use and increase HIV/STI testing for at-risk adolescents. OBJECTIVE: To address this gap in knowledge, we developed a theory-driven, culturally congruent mHealth intervention (hereon referred to as S4E [Storytelling 4 Empowerment]) that has demonstrated feasibility and acceptability in a clinical setting. The next step is to examine the preliminary efficacy of S4E on adolescent HIV/STI testing and risk behaviors. This goal will be accomplished by 2 aims: the first aim is to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both iOS and Android operating systems and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic, and the second aim is to evaluate the preliminary efficacy of S4E, relative to usual care control condition, in preventing or reducing drug use and condomless sex and increasing HIV/STI testing in a clinical sample of at-risk adolescents aged 14-21 years living in Southeast Michigan. METHODS: In this study, 100 adolescents recruited from a youth-centered community health clinic will be randomized via blocked randomization with random sequences of block sizes to one of the 2 conditions: S4E mHealth intervention or usual care. Theory-driven and culturally congruent, S4E is an mHealth adaptation of face-to-face storytelling for empowerment, which is registered with the Substance Abuse and Mental Health Services Administration's National Registry of Evidence-Based Programs and Practices. RESULTS: This paper describes the protocol of our study. The recruitment began on May 1, 2018. This study was registered on December 11, 2017, in ClinicalTrials.gov. All participants have been recruited. Data analysis will be complete by the end of March 2024, with study findings available by December 2024. CONCLUSIONS: This study has the potential to improve public health by preventing HIV/STI and substance use disorders. TRIAL REGISTRATION: ClinicalTrials.gov NCT03368456; https://clinicaltrials.gov/study/NCT03368456. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47216.

HIV pre-exposure prophylaxis programme preferences among sexually active HIV-negative transgender and gender diverse adults in the United States: a conjoint analysis.

INTRODUCTION: Current implementation efforts have failed to achieve equitable HIV pre-exposure prophylaxis (PrEP) provision for transgender and gender-diverse (trans) populations. We conducted a choice-based conjoint analysis to measure preferences for key attributes of hypothetical PrEP delivery programmes among a diverse online sample predominantly comprised of transmasculine and nonbinary individuals in the United States. METHODS: Between April 2022 and June 2022, a national online survey with an embedded conjoint analysis experiment was conducted among 304 trans individuals aged ≥18 years in the United States to assess five PrEP programme attributes: out-of-pocket cost; dispensing venue; frequency of visits for PrEP-related care; travel time to PrEP provider; and ability to bundle PrEP-related care with gender-affirming hormone therapy services. Participants responded to five questions, each of which presented two PrEP programme scenarios and one opt-out option per question and selected their preferred programme in each question. We used hierarchical Bayes estimation and multinomial logistic regression to measure part-worth utility scores for the total sample and by respondents' PrEP status. RESULTS: The median age was 24 years (range 18-56); 75% were assigned female sex at birth; 54% identified as transmasculine; 32% as nonbinary; 14% as transfeminine. Out-of-pocket cost had the highest attribute importance score (44.3%), followed by the ability to bundle with gender-affirming hormone therapy services (18.7%). Minimal cost-sharing ($0 out-of-pocket cost) most positively influenced the attribute importance of cost (average conjoint part-worth utility coefficient of 2.5 [95% CI 2.4-2.6]). PrEP-experienced respondents preferred PrEP delivery in primary care settings (relative utility score 4.7); however, PrEP-naïve respondents preferred pharmacies (relative utility score 5.1). CONCLUSIONS: Participants preferred programmes that offered PrEP services without cost-sharing and bundled with gender-affirming hormone therapy services. Bolstering federal regulations to cover PrEP services and prioritizing programmes to expand low-barrier PrEP provision are critical to achieving equitable PrEP provision. Community-engaged implementation research conducted by and in close collaboration with trans community stakeholders and researchers are needed to streamline the design of patient-centred PrEP programmes and develop implementation strategies that are salient to the diverse sexual health needs of trans patients.

Advancing the community plan to end the HIV Epidemic in Philadelphia: a qualitative descriptive evaluation of low-threshold PrEP services in sexual health clinics.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is an effective HIV prevention method and a key component of Philadelphia's Community Plan to End the HIV Epidemic (EHE). However, significant barriers to accessing PrEP exist among people at risk for HIV. Low-threshold models for PrEP services that minimize barriers to entry and service engagement could help bolster access to PrEP through community-based clinics. This study aimed to describe the initial implementation of low-threshold PrEP services in three sexual health clinics funded by the Philadelphia Department of Public Health and explore strategies for delivering low-threshold PrEP services. METHODS: We conducted three focus groups with staff (i.e., providers, prevention navigators, and administrative staff, N = 21) at each of three participating PDPH-funded sexual health clinics from November 2021 to January 2022. Discussion topics included details about the PrEP delivery process, clinic strengths and assets, resource gaps, and PrEP implementation goals. Follow-up interviews with staff members (N = 8) between March 2022 and May 2022 focused on identifying successful strategies for PrEP delivery and adaptations needed to optimize low-threshold PrEP service delivery. Rapid qualitative methods and the Consolidated Framework for Implementation Science were used to analyze data from focus groups and interviews. RESULTS: Participants collaborated to create process maps that visualized the steps involved in delivering PrEP services within their respective settings. These maps highlighted several stages in PrEP service delivery, such as connecting individuals to services, providing prevention navigation, conducting clinical encounters, and ensuring follow-up care. Participants described effective strategies for implementing PrEP, which included integrating and co-locating services on-site, strengthening staffing resources and capacity, and addressing barriers experienced by clients. CONCLUSIONS: Lessons from the implementation of low-threshold PrEP service delivery in Philadelphia can guide ongoing local adaptations and future scale-up of these models to improve access to PrEP and advance the goals of the EHE initiative.

Direct and Indirect Effects of Cannabis Risk Perceptions on Cannabis Use Frequency.

Background: Perceived risk of harm associated with cannabis use has decreased in recent decades, particularly among emerging adults who show the highest prevalence of use. Cannabis-related protective behavioral strategies (PBS) are associated with lower cannabis use and fewer consequences; however, individuals who perceive using cannabis as low risk may use cannabis PBS less often. Therefore, using cross-sectional data, we examined the associations between perceived risk of harm associated with cannabis use, cannabis PBS, and cannabis use frequency. Method: Participants were 146 emerging adults between the ages of 18-25 (56.2% female) who reported consuming cannabis at least 3 times/week and completed measures of past-month cannabis use, past three-month use of cannabis PBS, and perceived risk of harm associated with cannabis use. Path analyses examined direct and indirect effects of perceived risk of cannabis-related harm on cannabis frequency through cannabis PBS. Results: Most (66.4%) participants reported no perceived risk of harm associated with occasional cannabis use, whereas 30.1% reported no perceived risk of harm associated with regular cannabis use. Findings indicated a significant indirect effect between perceived risk of harm and cannabis use frequency through cannabis PBS, b = -10.23, SE = 3.80, 95% CI [-17.67, -2.80], p = .007. Conclusions: Among emerging adults who consume cannabis regularly, findings suggest that a greater perceived risk of cannabis-related harm is associated with decreased cannabis use frequency via increased use of cannabis PBS. Although future analyses evaluating causal mechanisms are needed, these findings have clinical implications for harm reduction interventions focused on cannabis use.

Assessing and Improving Data Integrity in Web-Based Surveys: Comparison of Fraud Detection Systems in a COVID-19 Study.

BACKGROUND: Web-based surveys increase access to study participation and improve opportunities to reach diverse populations. However, web-based surveys are vulnerable to data quality threats, including fraudulent entries from automated bots and duplicative submissions. Widely used proprietary tools to identify fraud offer little transparency about the methods used, effectiveness, or representativeness of resulting data sets. Robust, reproducible, and context-specific methods of accurately detecting fraudulent responses are needed to ensure integrity and maximize the value of web-based survey research. OBJECTIVE: This study aims to describe a multilayered fraud detection system implemented in a large web-based survey about COVID-19 attitudes, beliefs, and behaviors; examine the agreement between this fraud detection system and a proprietary fraud detection system; and compare the resulting study samples from each of the 2 fraud detection methods. METHODS: The PhillyCEAL Common Survey is a cross-sectional web-based survey that remotely enrolled residents ages 13 years and older to assess how the COVID-19 pandemic impacted individuals, neighborhoods, and communities in Philadelphia, Pennsylvania. Two fraud detection methods are described and compared: (1) a multilayer fraud detection strategy developed by the research team that combined automated validation of response data and real-time verification of study entries by study personnel and (2) the proprietary fraud detection system used by the Qualtrics (Qualtrics) survey platform. Descriptive statistics were computed for the full sample and for responses classified as valid by 2 different fraud detection methods, and classification tables were created to assess agreement between the methods. The impact of fraud detection methods on the distribution of vaccine confidence by racial or ethnic group was assessed. RESULTS: Of 7950 completed surveys, our multilayer fraud detection system identified 3228 (40.60%) cases as valid, while the Qualtrics fraud detection system identified 4389 (55.21%) cases as valid. The 2 methods showed only "fair" or "minimal" agreement in their classifications (κ=0.25; 95% CI 0.23-0.27). The choice of fraud detection method impacted the distribution of vaccine confidence by racial or ethnic group. CONCLUSIONS: The selection of a fraud detection method can affect the study's sample composition. The findings of this study, while not conclusive, suggest that a multilayered approach to fraud detection that includes conservative use of automated fraud detection and integration of human review of entries tailored to the study's specific context and its participants may be warranted for future survey research.

Patterns of engagement in digital mental health intervention for LGBTQ+ youth: a latent profile analysis.

Engagement is a key metric that researchers can use to assess whether participants received the intended dose of a digital health intervention. However, the prevailing approach has predominantly focused on individual paradata metrics, resulting in a fragmented understanding of overall engagement. To address this limitation, our study utilizes person-centered approaches that allow for the simultaneous capture of multiple engagement metrics within imi-a web application specifically designed to support the mental health of lesbian, gay, bisexual, transgender, queer, and other sexual and gender minority youth (LGBTQ+ youth). This person-centered approach enabled us to explore the association between engagement patterns and stress appraisal outcomes within the imi intervention arm. Utilizing latent profile analysis, we classified users into two engagement forms: overall engagement (total number of sessions, pages visited, and external links clicked and their cumulative time spent using imi) and content engagement (number of pages viewed across imi's four core guides: gender, stress, queerness, and stigma). We identified two profiles for each form: a "high engagement" profile and an "average engagement" profile, with the majority of participants assigned to the "average engagement" profile. Our analyses revealed a significant association between overall engagement profiles and stress appraisals, with the "high engagement" profile demonstrating higher challenge appraisals and marginal improvements in threat appraisals compared to the "average engagement" profile. However, no such associations were observed for content engagement profiles and stress appraisal outcomes. The two person-centered approaches used were consistent with prior results utilizing a variable-centered approach, indicating a stronger intervention effect among individuals who exhibit higher engagement in digital health interventions. Although both methods yielded comparable findings, the person-centered approach mitigates concerns related to multi-collinearity and adds additional nuance and context to the study of digital engagement.

A latent trajectory analysis of young sexual and gender minorities' adherence to three rectal microbicide placebo formulations (MTN-035; a randomized crossover trial).

BACKGROUND: Rectal microbicides (RM) are biomedical HIV prevention products that aim to prevent or reduce the transmission of HIV and other sexually transmitted infections (STIs). RM modalities may be beneficial for populations who have complex lifestyles, difficulties adhering to pre-exposure prophylaxis (PrEP) regimens, and/or have limited access to care. MTN-035 (DESIRE; Developing and Evaluating Short-Acting Innovations for Rectal Use), a randomized crossover trial, aimed to evaluate the safety and acceptability of, and adherence to, three placebo RM modalities (douche, insert, and suppository) prior to receptive anal intercourse. METHODS: We conducted latent trajectory analysis to identify clusters of individuals who shared similar trajectories in acceptability and adherence for each product (douche, insert, and suppository) over time. We analyzed weekly short messaging service (SMS) use reports for each modality as reported by enrolled sexual and gender minority (SGM) participants. RESULTS: Two trajectories for each product were identified: a "protocol compliant" trajectory (i.e., at least one product use occasion per week) and "high use" trajectory (i.e., more than three product use occasions per week). Participants with high use were more likely to lack access to PrEP and have higher intentions to utilize RM modalities compared to those who were protocol compliant. CONCLUSIONS: This study highlighted high adherence to RM modalities among SGM. As research into viable HIV prevention modalities continues to evolve, tailored intervention strategies are needed to support the uptake of and adherence to alternative prevention modalities that are behaviorally congruent with targeted users. TRIAL REGISTRATION: NCT03671239 (14/09/2018).

Psychosocial and structural stressors and engagement in medical care among young sexual minority men across racial identities.

Psychosocial and structural stressors and low engagement in medical care likely contribute to the disproportionate burden of chronic disease among sexual minority men (SMM) across the life course. However, how these stressors impact engagement in medical care among young SMM (YSMM) across racial identities remains understudied. The association of psychosocial and structural stressors with forgoing care among YSMM across racial identities was examined using race-stratified adjusted logistic regression of cross-sectional data. Among 737 HIV-negative SMM aged 16-24 years, nearly all (93%) experienced discrimination in their daily lives. Non-Hispanic/Latinx Black participants reported significantly higher levels of discrimination, exposure to community violence, and food insecurity. Medical mistrust and mental health were not significantly different across racial groups. In the full sample model, education, food insecurity, and discrimination were associated with forgoing care. Among the non-Hispanic/Latinx White sample, medical mistrust and discrimination were associated with forgoing care. Among the non-Hispanic/Latinx Black sample, discrimination was associated with forgoing care. Among the Hispanic/Latinx sample, food insecurity was associated with forgoing care. Psychosocial and structural stressors were common in this YSMM cohort, and significantly different across racial/ethnic identities. Race-stratified analysis revealed differences in the association of stressors with forgoing care among YSMM across racial identities, not appreciated in the analysis limited to the total study population. Our findings may support efforts to address health inequity and improve engagement in medical care among SMM.

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 Suicide Prevention Intervention for Emerging Adult Sexual and Gender Minority Groups: Protocol for a Pilot Hybrid Effectiveness Randomized Controlled Trial.

BACKGROUND: Suicide attempts and suicide death disproportionately affect sexual and gender minority emerging adults (age 18-24 years). However, suicide prevention strategies tailored for emerging adult sexual and gender minority (EA-SGM) groups are not widely available. The Safety Planning Intervention (SPI) has strong evidence for reducing the risk for suicide in the general population, but it is unclear how best to support EA-SGM groups in their use of a safety plan. Our intervention (Supporting Transitions to Adulthood and Reducing Suicide [STARS]) builds on content from an existing life skills mobile app for adolescent men who have sex with men (iREACH) and seeks to target core risk factors for suicide among EA-SGM groups, namely, positive affect, discrimination, and social disconnection. The mobile app is delivered to participants randomized to STARS alongside 6 peer mentoring sessions to support the use of the safety plan and other life skills from the app to ultimately reduce suicide risk. OBJECTIVE: We will pilot-test the combination of peer mentoring alongside an app-based intervention (STARS) designed to reduce suicidal ideation and behaviors. STARS will include suicide prevention content and will target positive affect, discrimination, and social support. After an in-person SPI with a clinician, STARS users can access content and activities to increase their intention to use SPI and overcome obstacles to its use. EA-SGM groups will be randomized to receive either SPI alone or STARS and will be assessed for 6 months. METHODS: Guided by the RE-AIM (reach, efficacy, adoption, implementation, and maintenance) framework, we will recruit and enroll a racially and ethnically diverse sample of 60 EA-SGM individuals reporting past-month suicidal ideation. Using a type-1 effectiveness-implementation hybrid design, participants will be randomized to receive SPI (control arm) or to receive SPI alongside STARS (intervention arm). We will follow the participants for 6 months, with evaluations at 2, 4, and 6 months. Preliminary effectiveness outcomes (suicidal ideation and behavior) and hypothesized mechanisms of change (positive affect, coping with discrimination, and social support) will serve as our primary outcomes. Secondary outcomes include key implementation indicators, including participants' willingness and adoption of SPI and STARS and staff's experiences with delivering the program. RESULTS: Study activities began in September 2021 and are ongoing. The study was approved by the institutional review board of the University of Pennsylvania (protocol number 849500). Study recruitment began on October 14, 2022. CONCLUSIONS: This project will be among the first tailored, mobile-based interventions for EA-SGM groups at risk for suicide. This project is responsive to the documented gaps for this population: approaches that address chosen family, focus on a life-course perspective, web approaches, and focus on health equity and provision of additional services relevant to sexual and gender minority youth. TRIAL REGISTRATION: ClinicalTrials.gov NCT05018143; https://classic.clinicaltrials.gov/ct2/show/NCT05018143. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48177.

Latent class analysis of substance use typologies associated with mental and sexual health outcomes among sexual and gender minority youth.

Little is known about sexual and gender minority youth (SGMY) who have sex with men's unique patterns of substance use, even though they are at risk for substance use and adverse mental and other health outcomes. We used latent class analysis to examine typologies of substance use and multinomial logistic regression to investigate mental health outcomes (depression and anxiety) and HIV/STI testing correlates associated with different classes of substance use in a sample of SGMY who have sex with men in the USA and use substances (n = 414) who participated in an online survey. The average age was 22.50 years old (SD = 3.22). A four-class solution was identified representing: 'depressant and stimulant use' (3.4%), 'high polysubstance use' (4.6%), 'low substance use with moderate cannabis use' (79.2%), and 'high cannabis, stimulant and alcohol use' (12.8%). Membership to a specified substance use class varied by age, previous arrest, gender identity, anxiety, and lifetime HIV testing. Multivariate logistic regression results indicated that participants in the high polysubstance use (AOR = 5.48, 95% CI 1.51, 19.97) and high cannabis use class (AOR = 3.87, 95% CI 1.25, 11.94) were significantly more likely than those in the low substance use with moderate cannabis use class to report previous arrest. Those in the high polysubstance use class were also significantly less likely to have been tested for HIV than those in the low substance use with moderate cannabis use class (AOR = 0.21, 95% CI 0.05, 0.93). Findings will guide the development and implementation of tailored approaches to addressing the intersection of substance use and HIV risk among SGMY.

Perspectives From Community-Based HIV Service Organization Leaders on Priorities in Serving Sexual and Gender Minority Populations.

Sexual and gender minority (SGM) populations experience discrimination and care-related barriers when seeking appropriate sexual health services. Using rapid assessment procedures we conducted site visits with 11 community-based HIV service agencies to identify priorities, assets, and needs related to serving SGM clients and assessed the alignment of these services with the city's local Ending the HIV Epidemic plan. We identified and mapped themes across agencies into the Consolidated Framework for Implementation Research domains of inner and outer settings: client-facing materials; priorities in serving SGM communities; SGM policies and protocols; collecting sexual orientation and gender identity data; training and education; and funding and scope of programs. Rapid assessment procedures can accelerate the collection and interpretation of data to help public health institutions and community partners make timely adaptations when implementing comprehensive and culturally humble sexual health services for SGM communities.