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.

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.

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.

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.

Measuring quality STI care among adolescent female primary care patients in Philadelphia.

OBJECTIVES: Engagement in guideline-recommended sexually transmitted infection (STI) care is fundamental to ending the STI epidemic in the USA. However, the US 2021-2025 STI National Strategic Plan and STI surveillance reports do not include a framework to measure quality STI care delivery. This study developed and applied an STI Care Continuum that can be used across settings to improve STI care quality, assess adherence to guideline-recommended care and standardise the measurement of progress towards National Strategic goals. METHODS: Review of the Centers for Disease Control and Prevention STI Treatment guidelines identified seven distinct steps of STI care for gonorrhoea, chlamydia and syphilis: (1) STI testing indication, (2) STI test completion, (3) HIV testing, (4) STI diagnosis, (5) partner services, (6) STI treatment and (7) STI retesting. Steps 1-4, 6 and 7 for gonorrhoea and/or chlamydia (GC/CT) were measured among females aged 16-17 years with a clinic visit at an academic paediatric primary care network in 2019. We used Youth Risk Behavior Surveillance Survey data to estimate step 1, and electronic health record data for steps 2, 3, 4, 6 and 7. RESULTS: Among 5484 female patients aged 16-17 years, an estimated 44% had an STI testing indication. Among those patients, 17% were tested for HIV, of whom none tested positive, and 43% were tested for GC/CT, 19% of whom were diagnosed with GC/CT. Of these patients, 91% received treatment within 2 weeks and 67% were retested within 6 weeks to 1 year after diagnosis. On retesting, 40% were diagnosed with recurrent GC/CT. CONCLUSIONS: Local application of an STI Care Continuum identified STI testing, retesting and HIV testing as areas for improvement. The development of an STI Care Continuum identified novel measures for monitoring progress towards National Strategic indicators. Similar methods can be applied across jurisdictions to target resources, standardise data collection and reporting and improve STI care quality.

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.

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

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

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.

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).

Risky Drinking in Adolescents and Emerging Adults: Differences between Individuals Using Alcohol Only versus Polysubstances.

BACKGROUND: Factors related to risky drinking (e.g., motives, protective behavioral strategies [PBS]) may vary between youth who engage in polysubstance use compared to those who consume alcohol only. We examined differences in factors among youth who consume alcohol only compared to alcohol with other substances (i.e., polysubstance use), and correlates associated with risky drinking between the groups. METHODS: Participants (N = 955; ages 16-24; 54.5% female) who reported recent risky drinking completed measures of alcohol/substance use, alcohol-related consequences, drinking motives, alcohol PBS, mental health symptoms, and emotion dysregulation. Participants were in the polysubstance group if they reported using at least one other substance (e.g., cannabis, stimulants) in addition to alcohol in the past three months. Chi-square and t-tests examined differences between the two groups and multiple regression analyses examined correlates of risky drinking. RESULTS: Most participants (70.4%, n = 672) reported polysubstance use; these individuals engaged in riskier patterns of drinking, experienced more alcohol-related consequences, used fewer PBS, had stronger drinking motives (enhancement, social, coping), endorsed more mental health symptoms, and reported more emotion dysregulation. Regression models showed that emotion dysregulation significantly associated with risky drinking in the alcohol-only group; conformity and coping motives, alcohol PBS, and anxiety symptoms significantly associated with risky drinking in the polysubstance group. CONCLUSIONS: Among risky drinking youth, results indicated youth engaging in polysubstance use have greater comorbidities and individual-level factors associated with risky drinking than youth who consume alcohol only. These findings may inform the tailoring of interventions for individuals who engage in risky drinking and polysubstance use.

LGBTQ + cultural competency training for health professionals: a systematic review.

BACKGROUND: Health disparities experienced by LGBTQ + individuals have been partially attributed to health professionals' lack of cultural competence to work with them. Cultural competence, the intricate integration of knowledge, skills, attitudes, and behaviors that improve cross-cultural communication and interpersonal relationships, has been used as a training framework to enhance interactions between LGBTQ + patients and health professionals. Despite multiple published LGBTQ + cultural competency trainings, there has been no quantitative appraisal and synthesis of them. This systematic review assessed articles evaluating the design and effectiveness of these trainings and examined the magnitude of their effect on cultural competence outcomes. METHODS: Included studies quantitatively examined the effectiveness of LGBTQ + cultural competency trainings for health professionals across all disciplines in various healthcare settings. 2,069 citations were retrieved from five electronic databases with 44 articles meeting inclusion criteria. The risk of bias in the included studies was assessed by two authors utilizing the Joanna Briggs Institute critical appraisal checklists. Data extracted included study design, country/region, sample characteristic, training setting, theoretical framework, training topic, modality, duration, trainer, training target, measurement instrument, effect size and key findings. This review followed the PRISMA statement and checklist to ensure proper reporting. RESULTS: 75% of the studies were published between 2017 and 2023. Four study designs were used: randomized controlled trial (n = 1), quasi-experimental pretest-posttest without control (n = 39), posttest only with control (n = 1) and posttest only without control (n = 3). Training modalities were multiple modalities with (n = 9) and without simulation (n = 25); single modality with simulation (n = 1); and with didactic lectures (n = 9). Trainings averaged 3.2 h. Ten studies employed LGBTQ + trainers. The training sessions resulted in statistically significant improvements in the following cultural competence constructs: (1) knowledge of LGBTQ + culture and health (n = 28, effect size range = 0.28 - 1.49), (2) skills to work with LGBTQ + clients (n = 8, effect size range = 0.12 - 1.12), (3) attitudes toward LGBTQ + individuals (n = 14, effect size range = 0.19 - 1.03), and (4) behaviors toward LGBTQ + affirming practices (n = 7, effect size range = 0.51 - 1.11). CONCLUSIONS: The findings of this review highlight the potential of LGBTQ + cultural competency training to enhance cultural competence constructs, including (1) knowledge of LGBTQ + culture and health, (2) skills to work with LGBTQ + clients, (3) attitudes toward LGBTQ + individuals, and (4) behaviors toward LGBTQ + affirming practices, through an interdisciplinary and multi-modal approach. Despite the promising results of LGBTQ + cultural competency training in improving health professionals' cultural competence, there are limitations in study designs, sample sizes, theoretical framing, and the absence of longitudinal assessments and patient-reported outcomes, which call for more rigorous research. Moreover, the increasing number of state and federal policies that restrict LGBTQ + health services highlight the urgency of equipping health professionals with culturally responsive training. Organizations and health systems must prioritize organizational-level changes that support LGBTQ + inclusive practices to provide access to safe and affirming healthcare services for LGBTQ + individuals.

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.

MTN-033: a Phase 1 Study Comparing Applicator versus "as Lubricant" Delivery of Rectal Dapivirine Gel.

Data to inform behaviorally congruent delivery of rectal microbicides as lubricants are scant. Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor which has been demonstrated to be well-tolerated and efficacious in multiple clinical trials when used in a vaginal ring formulation. DPV gel administered rectally with an applicator was found to be well-tolerated in a phase 1 clinical trial. MTN-033, a single site, open label, sequence randomized, crossover study, enrolled HIV-negative men to receive 0.05% DPV gel intrarectally using an applicator (2.5 g) and self-administered on an artificial phallus as lubricant (up to 10 g). The study evaluated the pharmacokinetics (in plasma, rectal fluid, and mucosal rectal tissue), safety, acceptability, and pharmacodynamics of DPV gel when applied rectally. Statistical comparisons between methods of application were performed using mixed effects models or Wilcoxon's signed rank tests. Sixteen participants used DPV gel by applicator and 15/16 participants used gel as lubricant (mean, 1.8 g; SD, 0.8). DPV plasma AUC0-24h after use as lubricant was estimated to be 0.41 times the AUC0-24h (95% CI 0.24, 0.88) after use with applicator. While DPV was quantifiable in plasma and luminal fluid, it was not quantifiable in tissue for both applicator and as lubricant administration. No related adverse events (AE) were reported, and 15/15 participants felt the gel was easy to use. Evidence of local delivery and systemic absorption of DPV when dosed as an anal lubricant supports the feasibility and potential for development of lubricant-delivered rectal microbicides. There were no safety concerns associated with use of DPV gel and participants reported finding it easy to use. However, lower DPV exposure in plasma and lack of quantifiable DPV in rectal tissue indicate that higher potency, concentration, and longer half-life antiretrovirals with optimized formulations will be needed to achieve protective tissue concentrations.

Methods in HIV-Related Intersectional Stigma Research: Core Elements and Opportunities.

Researchers are increasingly recognizing the importance of studying and addressing intersectional stigma within the field of HIV. Yet, researchers have, arguably, struggled to operationalize intersectional stigma. To ensure that future research and methodological innovation is guided by frameworks from which this area of inquiry has arisen, we propose a series of core elements for future HIV-related intersectional stigma research. These core elements include multidimensional, multilevel, multidirectional, and action-oriented methods that sharpen focus on, and aim to transform, interlocking and reinforcing systems of oppression. We further identify opportunities for advancing HIV-related intersectional stigma research, including reducing barriers to and strengthening investments in resources, building capacity to engage in research and implementation of interventions, and creating meaningful pathways for HIV-related intersectional stigma research to produce structural change. Ultimately, the expected payoff for incorporating these core elements is a body of HIV-related intersectional stigma research that is both better aligned with the transformative potential of intersectionality and better positioned to achieve the goals of Ending the HIV Epidemic in the United States and globally. (Am J Public Health. 2022;112(S4):S413-S419. https://doi.org/10.2105/AJPH.2021.306710).

A Latent Profile Analysis of Online Dating Patterns Among Single Young Men Who Have Sex with Men.

Despite the increased use of geosocial networking applications for finding sexual partners among young men who have sex with men (YMSM), few studies have examined the intricate patterns of online dating behaviors. In order to advance understanding of online dating patterns among YMSM, various factors, including how frequently and how much time is spent within partner-seeking sites, need to be examined concurrently. Therefore, we used latent profile analysis to identify online dating patterns and logistic regressions to examine their associations with sexual behaviors and relationship characteristics among single YMSM (N = 180; ages 18-24). We found three online dating patterns: discouraged users (N = 93, 52%), date seekers (N = 67, 37%), and instant lovers (N = 20, 11%). Discouraged users were less likely to seek sexual sensational activities, while date seekers were more likely to seek sexual sensational activities. Moreover, instant lovers were less likely to pursue committed romantic relationships, while they reported a higher number of condomless anal intercourse. Given that online dating patterns are not homogeneous, HIV prevention interventions may benefit from tailored approaches based on YMSM's different online dating profiles.

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.

Characterizing the PrEP Continuum for Black and Latinx Sexual and Gender Minority Youth.

Pre-exposure prophylaxis (PrEP) rollout efforts thus far have inadequately reached young people from underrepresented backgrounds. This study explores PrEP engagement among young Black and Latinx men who have sex with men, transgender women, and gender diverse individuals in three U.S. cities using an adapted PrEP continuum measure. We analyze data from the recruitment phase of an ongoing PrEP engagement intervention (n = 319) using partial proportional odds logistic regression. Participants reported high willingness and intention to use PrEP, yet most (82%) were not currently taking PrEP. Being insured (aOR = 2.95, 95%-CI = 1.60-5.49), having one or more PrEP users in one's sexual network (aOR = 4.19, 95%-CI = 2.61-6.79), and higher individual HIV risk scores (aOR = 1.62, 95%-CI = 1.34-1.97) were each associated with being further along the PrEP continuum. Strategies are needed to address barriers to healthcare access and leverage connections within social and sexual networks in order to bolster PrEP engagement among marginalized young people from diverse backgrounds.

RESUMEN: Los esfuerzos de dar a conocer la profilaxis prexposición (PrEP) hasta el momento han llegado de forma inadecuada a los jóvenes de entornos desfavorecidos. Este estudio explora en tres ciudades de los EE. UU. el compromiso con la PrEP entre los jóvenes de raza negra y latino quienes son minorías sexuales o de género, utilizando una medida de seguimiento de la PrEP adaptada. Analizamos los datos de la fase de reclutamiento de una participación en la PrEP en curso (n = 319) utilizando una regresión logística parcial de probabilidades proporcionales. Los participantes manifestaron una alta disposición e intención de utilizar la PrEP, aunque la mayoría (82%) no tomaba actualmente la PrEP. Estar asegurado (aOR = 2,95, 95%-CI = 1,60­5,49), tener uno o más usuarios de la PrEP en su red sexual (aOR = 4,19, 95%-CI = 2,61­6,79), y mayores puntuaciones individuales de riesgo de VIH (aOR = 1,62, 95%-CI = 1,34­1,97) se asociaron con el hecho de llevar un seguimiento estrecho con la PrEP. Se necesitan estrategias para abordar las barreras de acceso a la atención médica y aprovechar las conexiones entre las redes sociales y las de carácter sexual, con el fin de reforzar el compromiso con la PrEP entre los jóvenes marginados de diversas procedencias.

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.

Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026).

This study describes the acceptability of a rectal microbicide gel formulation using dapivirine (DPV) among men and women from two countries (United States and Thailand) participating in the Microbicide Trials Network-026 trial. We evaluated participants' acceptability of a rectal DPV/placebo gel as part of a Phase I trial (N = 26; 18 male, 8 female). Participants reported favorable acceptability of the study gel, with most participants reporting that they liked the gel the same (n = 14; 53.8%) or more (n = 11; 42.4%) than when they started the trial. Over half of participants noted that they would prefer the gel over condoms (n = 13; 50%) or that they liked condoms and the gel equally (n = 8; 30.8%). Side effects across products included leakage (n = 8; 30.8%), diarrhea (n = 4; 15.4%), or soiling (n = 1; 3.8%). The high acceptability of a rectal gel underscores its promise as a short-acting biomedical prevention, warranting future research for HIV prevention.Trial Registration: NCT03239483.

RESUMEN: Este estudio describe la aceptabilidad de un microbicida rectal (RM) con dapivirina (DPV) formulado como un gel por hombres y mujeres de dos países (Estados Unidos y Tailandia) que participaron como parte del Microbicide Trials Network (MTN)-026. Evaluamos la aceptabilidad de un gel rectal de DPV y un placebo como parte de un estudio de Fase I (N = 26; 18 hombres, 8 mujeres). Los participants informaron una aceptabilidad favorable sobre el gel del estudio; la mayoría de los participantes informaron que les gustó el gel igual (n = 14; 53.8%) o más (n = 11; 42.4%) que cuando comenzaron el estudio. Más de la mitad de los participantes señalaron que preferirían el gel sobre los condones (n = 13; 50%) o que les gustaban los condones y el gel por igual (n = 8; 30,8%). Los efectos de los productos incluyeron fugas (n = 8; 30,8%), diarrea (n = 4; 15,4%) o ensuciamiento (n = 1; 3,8%). La alta aceptabilidad de un gel rectal enfatiza su promesa para la prevención biomédica de acción corta y justifica futuras investigaciones para la prevención del VIH.

Social identity support, descriptive norms, and economic instability in PrEP engagement for emerging adult MSM in the United States.

Rates of pre-exposure prophylaxis (PrEP) uptake for HIV prevention continue to increase rapidly among men who have sex with men (MSM) in the United States (U.S.); however, these increases have been slower among young MSM. Emerging adulthood (ages 18-25) is a time of transitions and social development, resulting in increased vulnerability to HIV. Analyzing data from a cross-sectional survey of emerging adult MSM (ages 18-25 years; n = 281) in the Mid-Atlantic urban metropolitan region of the U.S., we examined how social identity support, descriptive PrEP norms, and economic instability were related to PrEP engagement. In structural equation models, PrEP norms were directly associated with PrEP engagement (ß = 0.29, 95% CI = [0.12,0.46]) and social identity support was indirectly associated with PrEP engagement through its association with descriptive PrEP norms (ß = 0.18, 95% CI = [0.09,0.28]). Economic instability was not significantly associated with PrEP engagement, although a negative trend was present (ß = -0.19, 95% CI = [-0.39,0.02]). Our results suggest that an integrative socioecological model is appropriate for the study of PrEP engagement among emerging adult MSM. Efforts to increase PrEP engagement should support community capacity building, amplify positive descriptive PrEP norms, and address unmet economic needs.