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.

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.

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.

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.

Who prefers what? Correlates of preferences for next-generation HIV prevention products among a national U.S. sample of young men who have sex with men.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) has been available for young people for over a decade, yet only ∼15% of young people in the United States with indications for PrEP have a prescription for it. Next-generation PrEP modalities may address some of the challenges of daily oral PrEP. However, preferences for these products are unknown. METHODS: From October 2020 to June 2021, we conducted an online survey of 737 cisgender, young men who have sex with men (age 15-24 years) without HIV across the United States who reported same-sex attraction or consensual sex with another man in the past 6 months. Participants completed a conjoint experiment comparing daily oral pills, event-driven oral pills, event-driven rectal douches, intramuscular injections, intravenous broadly neutralizing antibody (bnAb) infusions and subcutaneous implants. Participants ranked the products from most to least preferred. Exploded logit models examined the association between ranked preferences of PrEP modalities and socio-demographic and behavioural characteristics. RESULTS: Participants' mean age was 21 years (SD = 2.3), and 56% identified as White. Nineteen percent were currently taking daily oral PrEP, and another 9% had previously taken it. Participants prioritized efficacy, absence of side effects and costs in the conjoint analyses. Daily oral PrEP had the highest preference ranking, followed by event-driven oral (OR = 0.89, p = 0.058), injectable (OR = 0.83, p = 0.005), implant (OR = 0.48, p < 0.0001), bnAb infusions (OR = 0.38, p < 0.0001) and rectal douches (OR = 0.24, p < 0.0001). There were differences in PrEP preferences across age, insurance status, sexual behaviour, PrEP use history, HIV and sexually transmitted infection (STI) testing history, and STI diagnoses (omnibus tests: p < 0.05). Participants also provided reasons for selecting their top product choice: ease of use for those who chose daily oral (99%) and daily event-driven (98.5%); feel more protected against HIV for those who chose injectable (95.4%) and implants (100%); not worrying about forgetting to take it for those who chose bnAbs (93.8%); and being able to stop taking it when they want for those who chose rectal douche (90.9%). CONCLUSIONS: Next-generation modalities were less likely to be preferred over daily oral PrEP, with differences in the magnitude by socio-demographic and behavioural characteristics. Given the low uptake of daily oral PrEP, end-users' preferences for and concerns about PrEP products must be understood to ensure high acceptability and penetration.

Current and Future Perspectives of HIV Prevention Research Among Young Sexual Minority Men in South Korea.

Social stigma within Korean society hinders structural efforts to reduce HIV disparities among sexual minority men (SMM). To date, however, there have been limited intervention efforts to reduce HIV disparities among SMM in Korea. Therefore, the current mixed-methods study (n = 180) explored young Korean SMM's perspectives on the acceptability of HIV prevention mHealth interventions to inform effective strategies for future intervention studies. We then analyzed participants' comments and suggestions on HIV research and examined associations with the acceptability of mHealth interventions. Through our textual coding and analysis, we identified four primary themes for comments and suggestions for HIV research in Korea: the centrality of stigma, health service accessibility, informational accessibility, and cultural adaptation. Our study suggests culturally adapted HIV intervention addressing stigma, health service accessibility, and information accessibility and mHealth interventions disseminating information and resources for stigmatized young SMM in Korea.

Preferences Across Pre-Exposure Prophylaxis Modalities Among Young Men Who Have Sex with Men in the United States: A Latent Class Analysis Study.

Access to daily oral pre-exposure prophylaxis (PrEP) is suboptimal among young cisgender men who have sex with men (YMSM) in the United States. Next-generation modalities that do not involve daily oral regimens may mitigate some of the barriers to PrEP use. We identified latent classes of YMSM based on health care decision-making patterns and examined associations between latent classes and access to health care and PrEP modality preferences (i.e., daily and event-driven oral, rectal douches, broadly neutralizing antibodies, subcutaneous implants, and an injectable). Between October 2020 and June 2021, we administered an online survey to 737 YMSM. Latent class analysis (LCA) identified groups of YMSM based on communication with providers, stigma and mistrust in health care, and autonomy in sexual health decisions. Logistic regression examined associations between class membership and health care access, and exploded logit regression examined associations between class membership and ranked PrEP modality preferences. LCA identified three classes: shared decision-making (high communication with providers and high autonomy); provider-led decision-making (high communication and low autonomy); and patient-driven decision-making (low communication and high autonomy). Shared decision-making was associated with higher access to health care in comparison with the other classes. Across all classes, YMSM preferred daily oral PrEP over all next-generation PrEP modalities. Preferences for daily oral PrEP over next-generation PrEP modalities were particularly marked among the patient-driven decision-making class. Shared decision-making is associated with access to health care and HIV prevention and higher acceptability of next-generation PrEP modalities, and should be considered as part of future interventions to promote use of daily oral and next-generation PrEP.

Next Generation Pre-Exposure Prophylaxis for Young Men who have Sex with Men: Lessons from System and Provider-level barriers to oral PrEP.

Next generation pre-exposure prophylaxis (PrEP) modalities that do not require daily regimens may address some of the barriers to daily oral PrEP among young men who have sex with men (YMSM). We conducted online semi-structured interviews with 30 YMSM to examine experiences and preferences related to HIV prevention care that may inform implementation of next generation PrEP. Barriers to PrEP care included initiating conversations about sexuality with providers; confidentiality concerns regarding disclosure of sexual practices and PrEP use to family; gaps in access to healthcare; and limited availability of affordable health services. Future implementation of next generation PrEP may benefit from providers addressing confidentiality concerns when discussing PrEP with YMSM; PrEP programs accounting for discontinuities in healthcare access among YMSM while strengthening access to affordable services; and collaborations between generalist providers and specialized clinics and providers to address providers' education needs, which may increase as next generation PrEP becomes available. We have linked affiliation 9 to author name "Katie B. Biello". Please check and confirm. Okay!

RESUMEN: Las modalidades de próxima generación de la profilaxis pre-exposición (PrEP) que no requieren un régimen diario pueden disminuir las barreras de tomar la PrEP oral diariamente por hombres jóvenes que tienen sexo con hombres (YMSM). Llevamos a cabo entrevistas semiestructuradas en línea con 30 YMSM para entender sus experiencias y preferencias relacionadas con el cuidado de la prevención del VIH que puedan informar la implementación de la próxima generación de la PrEP. Las barreras al cuidado de la PrEP incluyeron tender conversaciones sobre la sexualidad con proveedores médicos; las preocupaciones de confidencialidad al divulgar información sobre las relaciones sexuales y el uso de la PrEP con la familia; las brechas en el acceso al cuidado médico; y la disponibilidad limitada de servicios de salud accesibles. La futura implementación de la próxima generación de la PrEP se puede beneficiar de proveedores que hablan sobre las preocupaciones de confidencialidad al discutir la PrEP con YMSM; los programas de la PrEP que tienen en cuenta las discontinuidades en el acceso de salud por YMSM mientras que fortalezcan acceso a servicios accesibles; y las colaboraciones entre proveedores de atención primaria y proveedores especializados para entender las necesidades educativas de proveedores, que puedan aumentar cuando la próxima generación esté disponible.

PrEParing for NextGen: Cognitive Interviews to Improve Next Generation PrEP Modality Descriptions for Young Men Who have Sex with Men.

Next generation PrEP formulations may circumvent factors that impede daily oral pre-exposure prophylaxis (PrEP) use among young men who have sex with men (YMSM). We conducted video-based cognitive interviews with 20 YMSM (age 16-24) recruited in the US Northeast to assess participants' attitudes and comprehension of written descriptions of next generation PrEP modalities. Participants were predominately racial/ethnic minorities and half used daily oral PrEP. We identified four main areas for improvement of descriptions: defining scientific terms and balancing medical jargon and casual language; referencing more established products to contextualize PrEP formulations (e.g., hormonal implants); ensuring clarity and reducing redundancy; and including imagery (e.g., rectal douche applicator). The refined descriptions serve as exemplar text that may be used in future studies examining YMSM's preferences across next generation PrEP modalities. Accurate descriptions of next generation PrEP products strengthen measurement accuracy and can help roll-out products that become approved for clinical use.

RESUMEN: Las formulaciones de próxima generación para la profilaxis pre-exposición (PrEP) pueden eludir los factores que impiden el uso diario del PrEP oral en hombres jóvenes que tienen relaciones sexuales con hombres (YMSM). Realizamos entrevistas cognitivas usando videoconferencia con 20 YMSM (de 16 a 24 años) reclutados del noreste de los Estados Unidos con el fin de evaluar sus actitudes y su comprensión de las definiciones desarrolladas para describir las modalidades de PrEP de próxima generación. Los participantes eran predominantemente minorías raciales/étnicas y la mitad usaba PrEP oral diariamente. Identificamos cuatro áreas principales para mejorar las descripciones: definir términos científicos y equilibrar la jerga médica y el lenguaje casual; hacer referencia a productos más establecidos para contextualizar las formulaciones de PrEP (por ejemplo, implantes hormonales); garantizar la claridad y reducir la redundancia; e incluir imágenes (por ejemplo, aplicador de duchas rectales). Las descripciones refinadas sirven como texto ejemplar y pueden usarse en estudios futuros que examinen las preferencias de modalidades de PrEP de próxima generación entre YMSM. Las descripciones precisas de los productos PrEP de próxima generación fortalecen la precisión de la medición y pueden ayudar a implementar productos que se aprueben para uso clínico.

COVID-19 Vaccine Acceptance among an Online Sample of Sexual and Gender Minority Men and Transgender Women.

Sexual and gender minority (SGM) populations are particularly vulnerable to poor COVID-19 outcomes and are more likely to experience stigma and medical mistrust that may impact COVID-19 vaccine acceptance. This study examined the prevalence of COVID testing and diagnosis and assessed COVID-19 vaccine acceptance among a large sample of SGM. Participants were recruited as part of an online cross-sectional study focused on an HIV biomedical prevention technology willingness in the United States at increased risk for HIV sero-conversion. Multivariate linear analysis was conducted to examine COVID-19 vaccine acceptance. The study sample included 1350 predominately gay (61.6%), Black (57.9%), cis-gender (95.7%) males with a mean age of 32.9 years. Medical mistrust and social concern regarding COVID-19 vaccine stigma were significantly associated with decreased COVID-19 vaccine acceptance, and altruism was significantly associated with increased vaccine acceptance. Black participants were significantly less likely to accept a COVID-19 vaccine, and Asian participants were significantly more likely to accept a vaccine, compared to White peers. As the planning of COVID-19 vaccine rollout efforts is conceptualized and designed, these data may inform equitable implementation strategies and prevent worsening health inequities among SGM populations.

Online recruitment of youth for mHealth studies.

BACKGROUND: Social networking sites and apps have emerged as an opportunity to engage in research young men who have sex with men (YMSM) at risk of HIV infection who may not be otherwise reached by in-person recruitment efforts. This paper highlights lessons learned, best practices and on-going recruitment challenges in the iTech network of the NIH Adolescent Trials Network for HIV Interventions. METHODS: Recruitment was conducted for four randomized controlled trials (RCTs) of mHealth HIV prevention interventions for YMSM living in 10 US cities. Advertising was purchased on Facebook, Instagram, Snapchat, Twitter and Grindr. Users who clicked on banner ads were taken directly to a study-specific eligibility screener and if eligible, were asked to provide contact information for follow-up by respective study site staff. Ad and screening metrics (impressions, clicks, cost per click (CPC), click-through rate (CTR), number screened, number eligible, number who provided contact information and cost per eligible contact) were compared across platforms, studies and geographic areas (where available). Screening metrics were also calculated for in-person recruitment efforts. RESULTS: Grindr and Snapchat ads produced the highest CTRs as compared to Facebook ads. However, these ads had the lowest proportions of users who initiated eligibility screeners and ultimately Facebook ads yielded the lowest cost per eligible contact across studies. Instagram ads yielded the highest proportions of eligible contacts who were racial/ethnic minorities and under the age of 18. Geographic variability in cost per eligible contact was observed for studies with identical eligibility criteria running concurrently in different regions, driven by both advertising costs and the screening and eligibility rates. Despite lower eligibility rates, the total numbers of eligible contacts were higher for online advertising campaigns, as compared to other recruitment efforts, for all studies except P3. Ads recruiting for P3 had the highest cost per eligible contact, likely due to this study having the most stringent eligibility criteria of the studies described. CONCLUSIONS: We implemented a successful online advertising strategy to recruit YMSM at high risk for HIV infection into four RCTs of mHealth interventions. This report provides a framework for evaluation of data from future online recruitment efforts across platforms and geographic areas, regardless of inevitable changes in the digital marketing space.

Testing the Testers: Are Young Men Who Have Sex With Men Receiving Adequate HIV Testing and Counseling Services?

BACKGROUND: The United States Centers for Disease Control and Prevention promote HIV testing every 6 months among young men who have sex with men (YMSM) to facilitate entry into the HIV prevention and care continuum. Willingness to be tested may be influenced by testing services' quality. Using a novel mystery shopper methodology, we assessed YMSM's testing experiences in 3 cities and recommend service delivery improvements. METHODS: We assessed YMSM's experiences at HIV testing sites in Philadelphia (n = 30), Atlanta (n = 17), and Houston (n = 19). YMSM (18-24) were trained as mystery shoppers and each site was visited twice. After each visit, shoppers completed a quality assurance survey to evaluate their experience. Data were pooled across sites, normed as percentages, and compared across cities. RESULTS: Across cites, visits averaged 30 minutes (SD = 25.5) and were perceived as welcoming and friendly (70.9%). YMSM perceived most sites respected their privacy and confidentiality (84.3%). YMSM noted deficiencies in providers' competencies with sexual minorities (63.4%) and comfort during the visit (65.7%). Sites underperformed on Lesbian, Gay, Bisexual, Transgender visibility (49.6%) and medical forms inclusivity (57.95%). Sites on average did not discuss YMSM's relationship context (49.8%) nor provide risk reduction counseling (56.8%) or safer sex education (24.3%). Sites delivered pre-exposure prophylaxis information and counseling inconsistently (58.8%). CONCLUSIONS: Testing sites' variable performance underscores the importance of improving HIV testing services for YMSM. Strategies are recommended for testing sites to promote cultural sensitivity: funding staff trainings, creating systems to assess adherence to testing guidelines and best practices, and implementing new service delivery models.