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.

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.

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).

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.

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.

The impact of stigma on HIV testing decisions for gay, bisexual, queer and other men who have sex with men: a qualitative study.

BACKGROUND: Stigmatization may prompt gay, bisexual, queer and other men who have sex with men (GBQMSM) to avoid or delay HIV testing. There has been little attention to GBQMSMs' perspectives about how stigma may influence their decisions about whether, where, and how often to get tested for HIV. METHODS: We conducted nine focus groups with 64 adult GBQMSM in Metropolitan Detroit, including HIV-negative men and people living with HIV (PLWH). Data were thematically analyzed deductively and inductively in three rounds. RESULTS: Three themes emerged regarding whether to get tested: (1) Perceived promiscuity, risk perceptions and HIV testing; (2) Fearing sexual rejection; and (3) Fearing friend and family member distancing and rejection. Themes concerning where to get tested included: (4) Conflating HIV testing and diagnosis; and (5) Seeking privacy and safety at specialized services. As for how often to get tested, themes included: (6) Reducing contact with healthcare providers due to intersectional stigma; (7) Responsibility and regular testing; and (8) HIV stigma and testing as routine care. Black participants articulated themes (3), (4), and (6) with greater frequency than other participants. Framing HIV testing as a personal responsibility may have created a "new stigma," with unintended consequences not observed with "routine healthcare" messaging. CONCLUSIONS: GBQMSMs' perspectives indicate the potential for new foci for HIV testing promotion interventions based on stigma-related issues that they deem important. There is a need for interventions to challenge the "promiscuity" stereotype, and to reduce the sexual stigmatization of GBQMSM living with HIV/AIDS-especially online. Provider stigma requires both intervention and continued availability of specialized services. Future stigma-reduction interventions for Black GBQMSM could focus on building family support/acceptance, awareness of multiple testing options, and integrating LGBTQ-related issues into initiatives for racial justice in health care.

Media representation, perception and stigmatisation of race, sexuality and HIV among young black gay and bisexual men.

Young Black gay and bisexual men who have sex with men experience stigma related to race, gender expression, sexuality and HIV status. Stigma impacts access to HIV care and prevention as well as interactions with healthcare providers. The amplification of stigma through popular media is under-researched in the health sciences. HealthMpowerment is a mobile phone optimised intervention to reduce sexual risk and support community-building for young Black gay and bisexual men (age 18-30). We analysed Forum conversations from 48 participants, 45.8% living with HIV. Of 322 stigma-relevant conversations, 18.9% referenced the media (e.g. television, news, social media) as a source of stigma. Forum conversations covered media representations of Black gay and bisexual men, media's influence on identity, and the creation of stigma by association with media representations. Cultural messages embedded in the media may accentuate stereotypes that influence perceptions of Black gay and bisexual men and disregard intersectional identities. HealthMpowerment provided a space to challenge stigmatising representations. Participants used HealthMpowerment to garner social support and celebrate positive media representations. Interventions for young Black gay and bisexual men should consider the influential role of media and include spaces for participants to process and address stigma.

Behavioral Efficacy of a Sexual Health Mobile App for Men Who Have Sex With Men: Randomized Controlled Trial of Mobile Messaging for Men.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) face the highest burden of HIV in the United States, and there is a paucity of efficacious mobile health (mHealth) HIV prevention and care interventions tailored specifically for GBMSM. We tested a mobile app combining prevention messages and access to core prevention services for GBMSM. OBJECTIVE: This study aims to measure the efficacy of the Mobile Messaging for Men (M-cubed) app and related services to increase HIV prevention and care behaviors in diverse US GBMSM. METHODS: We conducted a randomized open-label study with a waitlist control group among GBMSM in 3 groups (low-risk HIV-negative group, high-risk HIV-negative group, and living-with-HIV [LWH] group) recruited online and in venues in Atlanta, Detroit, and New York City. Participants were randomly assigned to receive access to the app immediately or at 9 months after randomization. The app provided prevention messages in 6 domains of sexual health and offered ordering of at-home HIV and sexually transmitted infection test kits, receiving preexposure prophylaxis (PrEP) evaluations and navigation, and service locators. Serostatus- and risk-specific prevention outcomes were evaluated at baseline, at the end of the intervention period, and at 3, 6, and 9 months after the intervention period. RESULTS: In total, 1226 GBMSM were enrolled and randomized; of these 611 (49.84%) were assigned to the intervention group and 608 (99.51%) were analyzed, while 615 (50.16%) were assigned to the control group and 612 (99.51%) were analyzed. For high-risk GBMSM, allocation to the intervention arm was associated with higher odds of HIV testing during the intervention period (adjusted odds ratio [aOR] 2.02, 95% CI 1.11-3.66) and with higher odds of using PrEP in the 3 months after the intervention period (aOR 2.41, 95% CI 1.00-5.76, P<.05). No changes in HIV prevention or care were associated with allocation to the intervention arm for the low-risk HIV-negative and LWH groups. CONCLUSIONS: Access to the M-cubed app was associated with increased HIV testing and PrEP use among high-risk HIV-negative GBMSM in 3 US cities. The app could be made available through funded HIV prevention providers; additional efforts are needed to understand optimal strategies to implement the app outside of the research setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/16439.

High-intensity drinking among adolescent and emerging adult risky drinkers.

Background: High-intensity drinking (HID; 8+ U.S. standard drinks for women, 10+ men) is initiated during adolescence/emerging adulthood, increasing risk for negative outcomes, including blackouts. We examined baseline data from a study of risky drinking youth to identify factors associated with HID. Methods: Risky drinkers (ages 16-24) were recruited online (positive 3-month AUDIT-C score) as part of a larger study to examine social media interventions for risky drinking. We used baseline survey data to examine HID in relation to demographics, substance use-related variables, and individual and social factors. Results: Among 931 risky drinkers, 29.8% reported past-month HID, and those with HID reported greater substance use and consequences. In multivariable analysis, HID was associated with male sex; greater social motives, impulsivity, and motivation; lower self-efficacy; and greater likelihood of not living with parents, drinking with important peers, and parental disapproval of posting drinking pictures. When examining age group interactions (16-20; 21-24), underage drinkers with high sensation-seeking scores and lower parental disapproval of posting drinking pictures on social media reported greater HID. Conclusions: Among risky drinking youth, male sex, social motives, impulsivity, higher motivation to and lower-self-efficacy to reduce drinking, living away from parents, more frequent drinking with important peers, and lower parental disapproval of posting drinking pictures on social media were positively associated with HID. Further, HID was associated with greater health consequences, underscoring the need for HID interventions. Such interventions may benefit from enhancing motivation and self-efficacy, particularly in social contexts, as well as increasing positive peer and leisure activities to reduce HID.

Patterns of same-day alcohol and cannabis use in adolescents and young adults with risky alcohol use.

Same-day alcohol and cannabis use is relatively common in adolescents and young adults, constituting a higher-risk behavior relative to single-substance use. However, the association between quantity of alcohol and cannabis use on co-use days is understudied. We examined the association between the quantity of alcohol and same-day cannabis use with a multilevel regression analysis in a sample of youth (16-24 years old) with risky alcohol use. Participants reported one or more days of alcohol and cannabis over the past month (N = 468). Quantity of cannabis use was highest on heavy drinking days [M = 0.91 grams, SD = 0.68] followed by moderate drinking days (M = 0.78 grams, SD = 0.63), and lowest on days without alcohol use (M = 0.74 grams, SD = 0.64, p < 0.001). In multilevel modeling analyses, adjusted for clustering within individuals, greater quantity of drinking on a given day was associated with greater cannabis use (estimate = 0.03, p < 0.001). When using alcohol and cannabis on the same day, greater alcohol use was associated with greater cannabis use. Preventing days of heavy use of multiple substances, particularly among at-risk drinkers, may complement interventions addressing co-use generally to prevent substance-related consequences.

Approaches to Promoting Linkage to and Retention in HIV Care in the United States: a Scoping Review.

PURPOSE OF REVIEW: Linkage to and retention in HIV care, as conceptualized in the HIV care continuum, remain critical steps towards achieving and maintaining viral suppression. We evaluated recently published (Jan 2018-Nov 2020) peer-reviewed clinical trials of linkage to and retention in care outcomes in the United States. RECENT FINDINGS: We identified 12 trials evaluating linkage to and retention in care outcomes in the United States. Most trials did not adhere to standardized definitions or metrics for linkage to or retention in HIV care, hindering comparisons between studies. Four interventions indicated improvements on linkage to or retention in HIV care at follow-up, relying on behavioral incentives and/or case management as key intervention strategies. We recommend the adoption standardize metrics across linkage and retention trials, and the future use of implementation science frameworks to identify implementation facilitators and barriers, and evaluate key strategies associated with improvements in linkage to and retention in care.

Assessing the Role of Gay Community Attachment, Stigma, and PrEP Stereotypes on Young Men Who Have Sex with Men's PrEP Uptake.

Negative stereotypes about pre-exposure prophylaxis (PrEP) hinder PrEP uptake among young men who have sex with men (YMSM). Prior research suggests community homophobia may be linked to negative PrEP attitudes. Conversely, individuals with high gay community attachments (GCA) may have more access to credible PrEP information/resources. Among 285 YMSM recruited online, we estimated structural equation models to test competing conceptual models that inform pathways from perceived stigmas, GCA, and negative PrEP stereotype endorsements to PrEP uptake. In Model A, perceived stigma was directly associated with PrEP uptake, partially mediated by stereotype endorsement (ß = - 0.05; 95% CI [- 0.09, - 0.01]) and GCA (ß = - 0.06; 95% CI [- 0.11, 0.02]). In Model B, perceived stigma was associated with PrEP uptake (ß = - 0.07; 95% CI [- 0.14, - 0.01]) through stereotype endorsement among high GCA YMSM. Complemented by anti-stigma initiatives, PrEP outreach for YMSM should utilize sex-positive messaging and disentangle negative PrEP stereotypes within gay-centric social spaces.

RESUMEN: Los estereotipos negativos sobre la profilaxis pre-exposición (PrEP) dificultan su uso entre hombres jóvenes que tienen sexo con otros hombres (YMSM). Investigaciones anteriores sugieren que la homofobia comunitaria puede estar relacionada a las actitudes negativas sobre PrEP. En cambio, personas con alto apego a la comunidad gay (GCA) pueden tener más acceso a información y recursos creíbles sobre PrEP. Entre los 285 YMSM reclutados en línea, estimamos varios modelos de ecuaciones estructurales para contrastar las asociaciones entre los estigmas percibidos, la GCA, los estereotipos negativos sobre PrEP, y el uso de PrEP entre diversos modelos conceptuales. En el Modelo A, el estigma percibido se asoció directamente con el uso de PrEP, siendo parcialmente mediado por el endoso a estereotipos (ß = − 0.05; IC del 95% [− 0.09, − 0.01]) y GCA (ß = − 0.06; IC del 95% [− 0.11, 0.02]). En el Modelo B, el estigma percibido se asoció con el uso de PrEP (ß = − 0.07; IC del 95% [− 0.14, − 0.01]) a través de los estereotipos entre YMSM con puntajes altos en GCA. Complementado con iniciativas contra el estigma, el alcance de la PrEP para YMSM debe utilizar mensajes de sexo positivo y desenredar los estereotipos negativos de PrEP dentro de los espacios sociales centrados en la comunidad gay.

Getting Clear About Rectal Douching Among Men Who Have Sex With Men.

Receptive anal sex is the primary means through which HIV is transmitted among men who have sex with men (MSM). Recently, researchers have begun investigating the role that rectal douching may play in amplifying risk for transmission. Yet, there is limited research on the frequency with which MSM douche, the products they use, and how this may vary across sociodemographic characteristics. A U.S. national sample of 4745 MSM completed an online survey that assessed their douching behavior, demographic characteristics, sexual behavior, and their anal sexual positioning (i.e., top, bottom, versatile). Nearly two-thirds (65.8%) had engaged in rectal douching in the last three months. Among those who douched, water was commonly reported (84.2%) and 20.1% reported using commercial enemas (e.g., Fleet), as well as water and soap (15.0%)-numbers exceed 100% as some participants reported more than one. Men who douched reported significantly more receptive and insertive condomless anal sex acts in the prior 3 months. One-in-ten men reported rectal bleeding after douching. Compared to HIV-negative participants who had not taken PrEP, participants had higher odds of reporting douching in the past 3 months if they were HIV-negative and currently on PrEP (AOR = 1.82), HIV-negative and previously used PrEP (AOR = 1.58), and HIV-positive (AOR = 1.83). Douching was common in this sample. Given that douching could amplify risk for HIV transmission, healthcare providers should discuss douching safety with their patients, with a focus on harm reduction (e.g., reduce risk of bleeding, as opposed to abstinence from douching).