Facilitators and Barriers to Implementing HIV Testing and Pre-Exposure Prophylaxis in Substance Use Treatment Programs: Perspectives of Non-medical Staff.

BACKGROUND: People with substance use disorder (SUD) are at increased risk of HIV infection. HIV testing and pre-exposure prophylaxis (PrEP) are evidence-based practices to prevent HIV infection, yet these approaches are not regularly provided in SUD treatment programs. To address this evidence-to-practice gap, this study aimed to identify facilitators and barriers to implementing PrEP services in SUD treatment programs from the perspective of non-medical staff and administrators. METHODS: Semi-structured interviews were conducted from February to June 2022 with non-medical staff (N = 10) and administrators (N = 11) from 3 academic and 8 community-based SUD treatment programs in Philadelphia. Interview guides were developed using the Consolidated Framework for Implementation Research (CFIR). Qualitative descriptive techniques were used to examine interview data and identify key facilitators and barriers, which were grouped within CFIR domains and constructs. RESULTS: Of the 11 SUD treatment programs, 5 provided PrEP services. Most interviewees at programs without PrEP services reported high levels of receptivity to implementing PrEP and identified leadership engagement as a key determinant, but several lacked comfort with PrEP counseling. Inner setting facilitators included compatibility with workflows (eg, intake assessments), alignment with cultures of holistic care, and programs' longstanding community trust. Inner setting barriers included limited time to discuss PrEP, insufficient resources and staff (eg, phlebotomy), perception of clients' HIV risk, and lower prioritization of HIV prevention versus other services. Intervention facilitators included robust evidence and addressing costs through grants and drug pricing programs, and barriers included the time needed to initiate PrEP, loss to follow-up, and HIV stigma. CONCLUSIONS: Successful implementation of HIV testing and PrEP in SUD treatment programs requires addressing multi-level barriers. Including perspectives of non-medical staff and administrators is important for implementation. Potential strategies include supporting organizational networks, leveraging peer specialists' expertise, and packaging PrEP to better meet client priorities and needs.

Provider Factors Likely to Impact Access and Uptake of Long-Acting Injectable Cabotegravir for Transgender Women in the United States: Results of a Qualitative Study.

ABSTRACT: Long-acting injectable cabotegravir (CAB-LA) was US Food and Drug Administration-approved in 2021. However, little is known about providers' CAB-LA knowledge, attitudes, challenges, and prescribing preferences for transgender women patients. Understanding this is critical to developing new pre-exposure prophylaxis (PrEP) interventions tailored to transgender women. We conducted 45-min, in-depth Zoom interviews (IDIs) with United States-based health care providers who prescribe PrEP to transgender women. IDIs focused on providers' CAB-LA knowledge/acceptability, willingness to prescribe CAB-LA to transgender women, potential challenges, and solutions to mitigate challenges. Providers ( N = 17) had a mean age of 43 years, and 35.4% ( n = 6) identified as people of color. Most ( n = 12) had basic knowledge of CAB-LA but wanted additional training. All participants found CAB-LA acceptable and were willing to prescribe. Most ( n = 11) anticipated minimal challenges to implementation. Others ( n = 4) reported potential issues, including logistical/scheduling concerns that impede CAB-LA integration and staffing concerns. Many providers expressed support for self-injection ( n = 13) and injections at "drop-in" clinics ( n = 8) to overcome challenges.

Mpox Discourse on Twitter by Sexual Minority Men and Gender-Diverse Individuals: Infodemiological Study Using BERTopic.

BACKGROUND: The mpox outbreak resulted in 32,063 cases and 58 deaths in the United States and 95,912 cases worldwide from May 2022 to March 2024 according to the US Centers for Disease Control and Prevention (CDC). Like other disease outbreaks (eg, HIV) with perceived community associations, mpox can create the risk of stigma, exacerbate homophobia, and potentially hinder health care access and social equity. However, the existing literature on mpox has limited representation of the perspective of sexual minority men and gender-diverse (SMMGD) individuals. OBJECTIVE: To fill this gap, this study aimed to synthesize themes of discussions among SMMGD individuals and listen to SMMGD voices for identifying problems in current public health communication surrounding mpox to improve inclusivity, equity, and justice. METHODS: We analyzed mpox-related posts (N=8688) posted between October 2020 and September 2022 by 2326 users who self-identified on Twitter/X as SMMGD and were geolocated in the United States. We applied BERTopic (a topic-modeling technique) on the tweets, validated the machine-generated topics through human labeling and annotations, and conducted content analysis of the tweets in each topic. Geographic analysis was performed on the size of the most prominent topic across US states in relation to the University of California, Los Angeles (UCLA) lesbian, gay, and bisexual (LGB) social climate index. RESULTS: BERTopic identified 11 topics, which annotators labeled as mpox health activism (n=2590, 29.81%), mpox vaccination (n=2242, 25.81%), and adverse events (n=85, 0.98%); sarcasm, jokes, and emotional expressions (n=1220, 14.04%); COVID-19 and mpox (n=636, 7.32%); government or public health response (n=532, 6.12%); mpox symptoms (n=238, 2.74%); case reports (n=192, 2.21%); puns on the naming of the virus (ie, mpox; n=75, 0.86%); media publicity (n=59, 0.68%); and mpox in children (n=58, 0.67%). Spearman rank correlation indicated significant negative correlation (ρ=-0.322, P=.03) between the topic size of health activism and the UCLA LGB social climate index at the US state level. CONCLUSIONS: Discussions among SMMGD individuals on mpox encompass both utilitarian (eg, vaccine access, case reports, and mpox symptoms) and emotionally charged (ie, promoting awareness, advocating against homophobia, misinformation/disinformation, and health stigma) themes. Mpox health activism is more prevalent in US states with lower LGB social acceptance, suggesting a resilient communicative pattern among SMMGD individuals in the face of public health oppression. Our method for social listening could facilitate future public health efforts, providing a cost-effective way to capture the perspective of impacted populations. This study illuminates SMMGD engagement with the mpox discourse, underscoring the need for more inclusive public health programming. Findings also highlight the social impact of mpox: health stigma. Our findings could inform interventions to optimize the delivery of informational and tangible health resources leveraging computational mixed-method analyses (eg, BERTopic) and big data.

Using wiki surveys to rapidly test messages promoting COVID-19 vaccination boosters and child vaccination among Philadelphia residents.

Formative research is an important component of health communication campaign development. Rapid message testing approaches are useful for testing new messaging quickly and efficiently during public health emergencies, such as COVID-19, when guidance and recommendations are rapidly changing. Wiki surveys simultaneously collect quantitative message testing data and qualitative feedback on potential social media campaign messages. Philly CEAL used wiki surveys to test messages about COVID-19 vaccinations for dissemination on social media. A cross-sectional survey of Philadelphia residents (N = 199) was conducted between January and March 2023. Wiki surveys were used to assess the perceived effectiveness of messages promoting the updated COVID-19 booster and child vaccination. In each wiki survey, participants were presented with two messages and asked to select the one that they perceived as most effective. Participants could alternatively select "can't decide" or submit their own message. A score estimating the probability of selection was calculated for each message. Participant-generated messages were routinely reviewed and incorporated into the message pool. Participants cast a total of 32,281 votes on messages seeded by the research team (n = 20) and participants (n = 43). The highest scoring messages were those that were generated by participants and spoke to getting your child vaccinated to protect them against serious illness and getting the booster to protect your health and that of your community. These messages were incorporated into social media posts disseminated by Philly CEAL's social media accounts. Wiki surveys are a feasible and efficient method of rapid message testing for social media campaigns.

The relationship between trust in federal oversight of vaccine safety and willingness to participate in COVID-19 clinical trials: a repeated measures study of Philadelphia residents (September 2021 - March 2023).

BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic precipitated an urgent need for clinical trials to discover safe and efficacious treatments. We examined how COVID-19 experiences, clinical trial awareness, and trust in the vaccine safety process were associated with willingness to participate in COVID-19 clinical trials. The objective was to investigate the relationship between trust in federal oversight of vaccine safety and willingness to participate in clinical trials for COVID-19 treatment across four distinct time points over an 18-month period during the COVID-19 pandemic. METHODS: We used four waves of data collected from September 2021 to March 2023 among 582 Philadelphia residents (with a missing data rate of 0.9%). Generalized estimating equations estimated the association between willingness to participate in COVID-19 clinical trials and participants' trust in the federal government's oversight of COVID-19 vaccine safety, COVID-19-related variables (COVID-19 related health challenges, history of COVID-19 infection), awareness of clinical trials and how to enroll in them, and sociodemographic characteristics (age, race/ethnicity, sexual orientation, gender, parental status, education, and insurance). RESULTS: On average, willingness to participate in a COVID-19 clinical trial was positively associated with greater trust in the federal government's oversight of vaccine safety [ß = 0.34, 95% confidence interval (CI): 0.15-0.53], having COVID-19 (ß = 0.40, 95% CI: 0.08-0.73), awareness of clinical trials (ß = 0.38, 95% CI: 0.04-0.73), and knowledge of how to enroll (ß = 0.83, 95% CI: 0.44-1.23). Among sociodemographic characteristics, race/ethnicity (p = 0.001) and gender (p = 0.018) were identified as predictors for COVID-19 trial willingness. CONCLUSION: Willingness to participate in clinical trials may be bolstered by strengthening the public's trust in the federal government's role within vaccine safety oversight, increasing the perceived relevance of clinical trials to individuals' health and well-being, and offering tailored information to educate diverse communities about ongoing trials and how to enroll in them.

Factors associated with the COVID-19 booster vaccine intentions of young adults in the United States.

Young adults experience high coronavirus disease 2019 (COVID-19) incidence yet have the lowest vaccination and booster rates among adults. Understanding the factors influencing their intentions regarding boosters is essential for crafting effective public health strategies. We examined the psychosocial factors (attitudes, norms, perceived behavioral control) associated with their intentions to receive a COVID-19 booster. This cross-sectional study included 292 young adults aged 18-25 residing in Philadelphia who completed an online survey from September 2021 and February 2022 (mean age 21.98, standard deviation 2.25; 51% racial/ethnic minorities). The survey included measures of attitudes, norms, and perceived behavioral control related to COVID-19 vaccination. We employed structural equation modeling analysis to examine the intention of young adults to receive the COVID-19 booster and their vaccine-related attitudes, norms, and perceived behavioral control. Covariates included race/ethnicity and gender. Subjective norms were significantly associated with the intention to receive a COVID-19 booster (standardized ß̂ = 0.685, p = .018). Attitudes and perceived behavioral control showed no significant association with intention. Subgroup analyses based on race/ethnicity revealed that attitudes (standardized ß̂ = 0.488, p = .004) and subjective norms (standardized ß̂ = 0.451, p = .050) were predictors among young adults from racial and ethnic minority backgrounds, while only subjective norms (standardized ß̂ = 1.104, p = .002) were significant for non-Hispanic White young adults. Public health efforts should prioritize engaging healthcare providers and peer groups in order to influence subjective norms and promote collective responsibility and acceptance for vaccination. Tailored interventions and diverse communication strategies targeting specific subgroups of young adults may be useful to ensure comprehensive and effective vaccination initiatives.

Psychosocial correlates of parents' willingness to vaccinate their children against COVID-19.

BACKGROUND: Public health guidance recommended that children who are 6 months or older be vaccinated against COVID-19 in June of 2022. In the U.S., 56% of children under 17 had not received the COVID-19 vaccination in 2023. We examine parents' willingness to vaccinate their children against COVID-19 using the theory of planned behavior in order to design effective strategies to promote vaccine uptake. METHODS: The Philadelphia Community Engagement Alliance is part of an NIH community-engaged consortium focused on addressing COVID-19 disparities across the U.S. We surveyed 1,008 Philadelphia parents (mean age 36.86, SD 6.55; 42.3% racial/ethnic minorities) between September 2021 and February 2022, a period when guidance for child vaccination was anticipated. Structural Equation Modeling analysis examined associations between parental willingness and vaccine-related attitudes, norms, and perceived control. Covariates included parents' COVID-19 vaccination status, race/ethnicity, gender, and survey completion post-CDC pediatric COVID-19 vaccination guidelines. Subgroup analyses by race/ethnicity and gender were conducted. RESULTS: Our model demonstrated good fit (χ2 = 907.37, df = 419, p<0.001; comparative fit index [CFI] = 0.951; non-normed fit index [NNFI] = 0.946; root mean square error of approximation [RMSEA] = 0.034 with 95% CI = 0.030-0.038). Attitudes ([Formula: see text] = 0.447, p<0.001) and subjective norms ([Formula: see text] = 0.309, p = 0.002) were predictors of intention. Racial/ethnic minority parents exhibited weaker vaccination intentions ([Formula: see text] = -0.053, p = 0.028) than non-Hispanic White parents. CONCLUSIONS: Parents' attitudes and norms influence their vaccination intentions. Despite the survey predating widespread child vaccine availability, findings are pertinent given the need to increase and sustain pediatric vaccinations against COVID-19. Interventions promoting positive vaccine attitudes and prosocial norms are warranted. Tailored interventions and diverse communication strategies for parental subgroups may be useful to ensure comprehensive and effective vaccination initiatives.

Engaging Trusted Messengers to Increase COVID-19 Pediatric Vaccine Uptake in Philadelphia: Lessons from the VaxUpPhillyFamilies program.

INTRODUCTION: Communities of color had higher rates of Coronavirus (COVID-19) infection and lower rates of COVID-19 vaccination during the pandemic. Parental concern about the safety and necessity of pediatric COVID-19 vaccines contribute to low childhood vaccination. Enlisting parents and caregivers as trusted messengers is an evidence-based approach to mitigate this challenge. VaxUpPhillyFamilies was formed to engage parents and caregivers as vaccine ambassadors to increase vaccination rates in children of color. This study aimed to understand the key benefits, challenges, and lessons learned from the VaxUpPhillyFamilies program. METHODS: Three online debriefing sessions with ambassadors were conducted between September 7 and October 24, 2022, to share best practices, address challenges, receive emerging vaccine information, and provide support. Thematic analysis was utilized to develop broad themes and subthemes. RESULTS: Four themes with corresponding subthemes were identified: 1) Motivations to Become an Ambassador: a) improving the health of the community and b) personal satisfaction; 2) Defining Success: a) community interactions and b) influencing opinions; 3) Best Approaches: a) being mentally prepared with facts, b) addressing community health needs beyond COVID-19, c) demonstrating empathy, d) "meeting them where they're at" by motivational interviewing, and e) building trust and connection; 4) Challenges: a) changes in vaccine guidelines, b) vaccine misinformation, c) varied perceptions of severity of COVID-19 illness and benefits of the vaccine, d) breakdown of communication from trusted sources, and e) structural barriers to engagement. CONCLUSION: Parents and caregivers were a resource for delivering evidence-based messaging about COVID-19 and other health challenges. To effectively equip parents and caregivers as public health ambassadors, it is critical to offer training in engagement strategies, to identify and combat misinformation, and to provide support in navigating challenges. VaxUpPhillyFamilies program is a model for future public health campaigns.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.