Performance of the Applied Biosystems HIV-1 Genotyping Kit with Integrase.

HIV genotyping is used to assess HIV susceptibility to antiretroviral drugs. The Applied Biosystems HIV-1 Genotyping Kit with Integrase (AB kit, Thermo Fisher Scientific) detects resistance-associated mutations (RAMs) in HIV protease (PR), reverse transcriptase (RT), and integrase (IN). We compared results from the AB kit with results obtained previously with the ViroSeq HIV-1 Genotyping System. DNA amplicons from the AB kit were also analyzed using next-generation sequencing (NGS). HIV RNA was extracted using the MagNA Pure 24 instrument (Roche Diagnostics; 96 plasma samples, HIV subtype B, viral load range: 530-737,741 copies/mL). FASTA files were generated from AB kit data using Exatype (Hyrax Biosciences). DNA amplicons from the AB kit were also analyzed by NGS using the Nextera XT kit (Illumina). Drug resistance was predicted using the Stanford HIV Drug Resistance Database. The mean genetic distance for sequences from ViroSeq and the AB kit was 0.02% for PR/RT and 0.04% for IN; 103 major RAMs were detected by both methods. Four additional major RAMs were detected by the AB kit only. These four major RAMs were also detected by NGS (detected in 18.1%-38.2% of NGS reads). NGS detected 27 major RAMs that were not detected with either of the Sanger sequencing-based kits. All major RAMs detected with ViroSeq were detected with the AB kit; additional RAMs were detected with the AB kit only. DNA amplicons from the AB kit can be used for NGS for more sensitive detection of RAMs.

Social Marketing Perspective on Participant Recruitment in Informatics-Based Intervention Studies.

Effective recruitment strategies are pivotal for informatics-based intervention trials success, particularly for people living with HIV (PLWH), where engagement can be challenging. Although informatics interventions are recognized for improving health outcomes, the effectiveness of their recruitment strategies remains unclear. We investigated the application of a social marketing framework in navigating the nuances of recruitment for informatics-based intervention trials for PLWH by examining participant experiences and perceptions. We used qualitative descriptive methodology to conduct semi-structured interviews with 90 research participants from four informatics-based intervention trials. Directed inductive and deductive content analyses were guided by Howcutt et al.'s social marketing framework on applying the decision-making process to research recruitment. The majority were male (86.7%), living in the Northeast United States (56%), and identified as Black (32%) or White (32%). Most participants (60%) completed the interview remotely. Sixteen subthemes emerged from five themes: motivation, perception, attitude formation, integration, and learning. Findings from our interview data suggest that concepts from Howcutt et al.'s framework informed participants' decisions to participate in an informatics-based intervention trial. We found that the participants' perceptions of trust in the research process were integral to the participants across the four trials. However, the recruitment approach and communication medium preferences varied between older and younger age groups. Social marketing framework can provide insight into improving the research recruitment process. Future work should delve into the complex interplay between the type of informatics-based interventions, trust in the research process, and communication preferences, and how these factors collectively influence participants' willingness to engage.

Symptomatology and Quality of Life of Older People With HIV and Comorbid Chronic Obstructive Pulmonary Diseases From an HIV Clinic in Birmingham, Alabama.

ABSTRACT: Psychological symptomatology and quality of life (QoL) have been studied in older people with HIV (PWH) and those with chronic obstructive pulmonary disease (COPD), respectively, but there is a dearth of studies in older PWH with COPD. Our study compared depressive symptoms, anxiety, and QoL between older PWH with and without COPD using data from an HIV clinic in Birmingham, Alabama, from January 2018 to February 2020. Data on depressive symptoms (Patient Health Questionnaire-9), anxiety (Patient Health Questionnaire-5 Anxiety), and QoL (EuroQoL-5 Dimension) were analyzed. Among 690 PWH aged 50 years or older, 102 individuals (14.8%) had COPD. Significant differences were found between the two groups in depressive symptoms and components of QoL (e.g., mobility, self-care, usual activities, and pain/discomfort), but not in anxiety and general health. Experiencing COPD may worsen depressive symptomatology and QoL in older PWH, highlighting the need for tailored health care and research for this population.

Identifying Key Factors to PrEP Initiation and Persistence Among YMSM Through Focus Groups and Surveys in Two High-Priority Settings.

Cisgender men are diagnosed with HIV at a rate four times greater than cisgender women, with 71% of infections attributed to male-male sexual contact. Despite expanding accessibility, pre-exposure prophylaxis (PrEP) for HIV prevention is initiated by only 30% of people with PrEP indications. Five focus groups with 42 young men who have sex with men from New York and Alabama were conducted to identify key factors to PrEP initiation and persistence. Thirty focus group participants completed a survey on demographics, PrEP choices and health care attitudes. Findings suggest provider competency significantly influences PrEP use due to stigmatization in medical settings. Participants noted benefits of PrEP including HIV protection and sexual empowerment, yet barriers like cost and side effects were prevalent. Our findings outline barriers and facilitators to PrEP use among young men who have sex with men in two high priority settings that will inform PrEP care updates in participating clinics.

Alcohol use and the longitudinal HIV care continuum for people with HIV who enrolled in care between 2011 and 2019.

PURPOSE: We described the impact of alcohol use on longitudinal engagement in HIV care including loss to follow-up, durability of viral suppression, and death. METHODS: We followed a cohort of 1781 people with HIV from enrolled in care at one of seven US clinics, 2011-2019 through 102 months. We used a multistate, time-varying Markov process and restricted mean time to summarize engagement in HIV care over follow-up according to baseline self-reported alcohol use (none, moderate, or unhealthy). RESULTS: Our sample (86% male, 54% White) had median age of 35 years. Over 102 months, people with no, moderate, and unhealthy alcohol use averaged 62.3, 61.1, and 59.5 months virally suppressed, respectively. People who reported unhealthy or moderate alcohol use spent 5.1 (95% confidence intervals (CI): 0.8, 9.3) and 7.6 (95%CI: 3.1, 11.7) more months lost to care than nondrinkers. Compared to no use, unhealthy alcohol use was associated with 3.4 (95%CI: -5.6, -1.6) fewer months in care, not virally suppressed. There were no statistically significant differences after adjustment for demographic and clinical characteristics. CONCLUSIONS: Moderate or unhealthy drinking at enrollment in HIV care was associated with poor retention in care. Alcohol use was not associated with time spent virally suppressed.

Development and Preliminary Validation of the PrEP Empowerment Scale.

Informed by the Health Care Empowerment Model, a measure of PrEP Empowerment was developed and assessed for preliminary reliability and validity. Participants (N = 100) were invited to complete a survey during regular clinic visits. A subset (n = 84) volunteered to provide blood samples to assess plasma tenofovir (TFV) levels for recent PrEP adherence. A five-factor measure explained 70% of the total variance. Associations with internalized PrEP stigma, PrEP adherence self-efficacy, and plasma TFV were assessed. Results supported the multidimensional nature of PrEP Empowerment and reliability and validity. Additional research is needed in populations with varying PrEP experience and greater gender and ethnic representation.

RESUMEN: Basado en el modelo de empoderamiento de atención médica, se desarrolló y evaluó una medida de empoderamiento de la PrEP para determinar su confiabilidad y validez preliminares. Se invitó a los participantes (N = 100) a completar una encuesta durante las visitas regulares a la clínica. Un subconjunto (n = 84) se ofreció como voluntario para proporcionar muestras de sangre para evaluar los niveles de tenofovir (TFV) en plasma para la adherencia reciente a la PrEP. Una medida de cinco factores explicó el 70% de la varianza total. Se evaluaron las asociaciones con el estigma internalizado de la PrEP, la autoeficacia de la PrEP y el TFV plasmático. Los resultados respaldaron la naturaleza multidimensional de PrEP Empowerment y la confiabilidad y validez. Se necesita investigación adicional en poblaciones con diferentes experiencias de PrEP y una mayor representación étnica y de género.

Multilevel Stigma and Its Associations with Medical Care Ratings Among Men Who Have Sex With Men in HPTN 078.

INTRODUCTION: Our research assessed associations between stigma-related variables and medical care ratings among clients with HIV in HIV Prevention Trials Network (HPTN) 078 who were men who have sex with men (MSM). METHODS: Logistic regression explored care ratings, stigma, socio-demographics (N = 637). Qualitative thematic coding and themes explored stigmatizing experiences in different settings (N = 111). RESULTS: Whites were twice as likely as African-Americans to report high care ratings (P < .05). Clients who reported familial exclusion due to having sex with men were 40% less likely to report high medical care ratings (P < .05). Clients who agreed healthcare providers think people with HIV "sleep around" were half as likely to report high care ratings (P < .08). Stigmatization included "treating me like they'll catch HIV from my hand," and care avoidance so others didn't "know I was having sex with men". CONCLUSIONS: Providers can promote African American MSM client retention with more affirming healthcare provision, namely minimizing assumptions and addressing identities and client needs beyond just HIV care.

A Cross-sectional Study of Perceived Stress and Racial Discrimination Among a National Sample of Young Men Who Have Sex With Men.

ABSTRACT: Research regarding the impact of racism on stress among young men who have sex with men (YMSM) is sparse. Secondary data were assessed from a 2018-2020 national mHealth prevention trial for YMSM aged 13-18 years (N = 542). Linear regression models examined associations between perceived stress and interpersonal and vicarious racism, adjusting for covariates. Stratified models by race/ethnicity were included. A subanalysis (n = 288) examined associations between nine interpersonal racial discriminatory events and perceived stress. Over 50% of participants experienced racial discrimination. In the multivariable models, exposure to interpersonal (ß = 1.43, p-value: .038) and vicarious (ß = 1.77, p-value: .008) racism was associated with perceived stress because there were four interpersonal racial discriminatory events. Stratified analysis by race/ethnicity found significant associations between interpersonal and vicarious racism and perceived stress among some racial/ethnic groups. Racial discrimination was common among YMSM, making them susceptible to the possible effects of vicarious and interpersonal racism on stress.

A community health worker and mobile health app intervention to improve adherence to HIV medication among persons with HIV: the CHAMPS study protocol.

BACKGROUND: Persons with HIV (PWH) can now achieve a near-normal life expectancy due to antiretroviral therapy (ART). Despite widespread availability of ART in the United States (US), many of the country's approximate 1.1 million PWH are not achieving viral suppression due to poor ART adherence. Viral suppression rates are particularly low in Alabama (AL, 62%) and New York City (NYC, 67%). There is mixed evidence on the efficacy of community health workers (CHW) and mHealth interventions for improving ART adherence and viral suppression in PWH thus, we sought to combine these interventions and test the efficacy for improving health outcomes in PWH. METHODS: The CHAMPS study is a two-arm randomized controlled trial among 300 PWH with suboptimal primary care appointment adherence (n = 150 in AL and 150 in NYC) over the course of 12 months. Participants are randomly assigned to CHAMPS (intervention) or a standard-of-care (control) arm. Participants in the intervention arm are given a CleverCap pill bottle that syncs to the WiseApp to track medication adherence, reminds users to take their medication at a set time, and enables communication with CHW. All participants complete baseline, 6-month, and 12-month follow-up visits where surveys are administered and, CD4 and HIV-1 viral load are obtained through blood draw. DISCUSSION: Maintaining ART adherence has significant implications in HIV management and transmission. mHealth technologies have been shown to optimize the provision of health services, produce positive changes in health behavior, and significantly improve health outcomes. CHW interventions also provide personal support to PWH. The combination of these strategies may provide the necessary intensity to increase ART adherence and clinic attendance among PWH at highest risk for low engagement. Delivering care remotely enables CHW to contact, assess, and support numerous participants throughout the day, reducing burden on CHW and potentially improving intervention durability for PWH. The adoption of the WiseApp coupled with community health worker sessions in the CHAMPS study has the potential to improve HIV health outcomes, and will add to the growing knowledge of mHealth and CHW efforts to improve PWH medication adherence and viral suppression. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov (NCT04562649) on 9/24/20.

Development and implementation of a distributed data network between an academic institution and state health departments to investigate variation in time to HIV viral suppression in the Deep South.

BACKGROUND: Achieving early and sustained viral suppression (VS) following diagnosis of HIV infection is critical to improving outcomes for persons with HIV (PWH). The Deep South of the United States (US) is a region that is disproportionately impacted by the domestic HIV epidemic. Time to VS, defined as time from diagnosis to initial VS, is substantially longer in the South than other regions of the US. We describe the development and implementation of a distributed data network between an academic institution and state health departments to investigate variation in time to VS in the Deep South. METHODS: Representatives of state health departments, the Centers for Disease Control and Prevention (CDC), and the academic partner met to establish core objectives and procedures at the beginning of the project. Importantly, this project used the CDC-developed Enhanced HIV/AIDS Reporting System (eHARS) through a distributed data network model that maintained the confidentiality and integrity of the data. Software programs to build datasets and calculate time to VS were written by the academic partner and shared with each public health partner. To develop spatial elements of the eHARS data, health departments geocoded residential addresses of each newly diagnosed individual in eHARS between 2012-2019, supported by the academic partner. Health departments conducted all analyses within their own systems. Aggregate results were combined across states using meta-analysis techniques. Additionally, we created a synthetic eHARS data set for code development and testing. RESULTS: The collaborative structure and distributed data network have allowed us to refine the study questions and analytic plans to conduct investigations into variation in time to VS for both research and public health practice. Additionally, a synthetic eHARS data set has been created and is publicly available for researchers and public health practitioners. CONCLUSIONS: These efforts have leveraged the practice expertise and surveillance data within state health departments and the analytic and methodologic expertise of the academic partner. This study could serve as an illustrative example of effective collaboration between academic institutions and public health agencies and provides resources to facilitate future use of the US HIV surveillance system for research and public health practice.

Role of Visit Modality in the HIV-Related No-Shows During the COVID-19 Pandemic: A Multisite Retrospective Cohort Study.

The emergence of the COVID-19 pandemic necessitated rapid expansion of telehealth as part of healthcare delivery. This study compared HIV-related no-shows by visit type (in-person; video; telephone) during the COVID-19 pandemic (April 2020-September 2021) from the Data for Care Alabama project. Using all primary care provider visits, each visit's outcome was categorized as no-show or arrived. A logistic regression model using generalized estimating equations accounting for repeat measures in individuals and within sites calculated odds ratios (OR) and their accompanying 95% confidence interval (CI) for no-shows by visit modality. The multivariable models adjusted for sociodemographic factors. In-person versus telephone visits [OR (95% CI) 1.64 (1.48-1.82)] and in-person versus video visits [OR (95% CI) 1.53 (1.25-1.85)] had higher odds of being a no-show. In-person versus telephone and video no-shows were significantly higher. This may suggest success of telehealth visits as a method for HIV care delivery even beyond COVID-19.

HTPN 078: an enhanced case management study to achieve viral suppression among viremic HIV-positive men who have sex with men in the United States.

OBJECTIVES: After identifying and recruiting men who have sex with men living with HIV and virally unsuppressed, this study attempted to enhance treatment and care via case management to increase the proportion who achieved viral suppression. DESIGN: Participants were randomized into one of two study arms: standard of care (SOC) or enhanced case management (CM) intervention. Participants were followed for 12 months with quarterly study assessments, with blood collected for CD4+ cell count testing, HIV viral load testing (primary prespecified outcome), and plasma storage. METHODS: Participants identified via respondent-driven sampling and direct recruitment and were invited to participate in the randomized controlled trial. The CM intervention provided a wide range of support services including, health education, clinical care coordination, medication adherence support, and social service assistance. The month-12 assessment included questions about healthcare utilization, stigma, substance use, and mental health. RESULTS: Among the 144 participants virally unsuppressed at baseline, most had had a previous positive HIV test result; were Black, non-Hispanic, gay and bisexual men, aged 22-50. Among the 128 participants at the last study visit, 68 were virally suppressed, with no statistically significant difference between the CM and SOC arms (viral suppression 42% and 53%, respectively; adjusted odds ratio = 0.62 [P = 0.15; 95% confidence interval: 0.32, 1.2]). CONCLUSIONS: Reaching targets of at least 90% sustained viral suppression among all people with HIV will likely require more than an individual-level CM approach that addresses barriers to optimal care and treatment at multiple levels.

"If I have to drive 100 miles, I'll drive 100 miles to get it": a qualitative exploration of HIV care travel behavior.

ABSTRACTAlabama depends heavily on Ryan White HIV/AIDS Program (RWHAP) funding, yet patient enrollment at one large, RWHAP-funded, academically-affiliated HIV clinic in Alabama has steadily increased each year, with approximately 20% bypassing more proximal RWHAP clinics. To understand reasons why patients travel long distances and bypass closer clinics to receive care, we conducted eight focus groups over Zoom, each containing between 2-3 participants (n = 18) and applied thematic analysis to code the data. Primary themes included: (1) Reasons for Traveling Long Distances to Receive HIV Medical Care, (2) Experiences with HIV Medical Care during the COVID-19 Pandemic, and (3) Travel Challenges. Some participants were attracted by the clinic's one-stop-shop model, while others eschewed local clinics to avoid status disclosure. An overarching travel challenge was lack of transportation, yet most participants favored in-person appointments over telehealth despite driving long distances. Future research should explore patient attitudes towards telehealth in greater depth.

Assessing the Impact of COVID-19 on Retention in HIV Primary Care: A Longitudinal Multisite Analysis.

We compared retention in care outcomes between a pre-COVID-19 (Apr19-Mar20) and an early-COVID-19 (Apr20-Mar21) period to determine whether the pandemic had a significant impact on these outcomes and assessed the role of patient sociodemographics in both periods in individuals enrolled in the Data for Care Alabama project (n = 6461). Using scheduled HIV primary care provider visits, we calculated a kept-visit measure and a missed-visit measure and compared them among the pre-COVID-19 and early-COVID-19 periods. We used logistic regression models to calculated odds ratios (OR) and accompanying 95% confidence intervals (CI). Overall, individuals had lowers odds of high visit constancy [OR (95% CI): 0.85 (0.79, 0.92)] and higher odds of no-shows [OR (95% CI): 1.27 (1.19, 1.35)] during the early-COVID-19 period. Compared to white patients, Black patients were more likely to miss an appointment and transgender people versus cisgender women had lower visit constancy in the early-COVID-19 period.

Structural violence within communities and its impact on the well-being of people with HIV (PWH).

Structural violence (SV) is the concept that there are often invisible and intangible structures in place, whether political, economic, legal, cultural, religious, or social, that can inhibit individuals from reaching their full potential. There is a need to better understand the influence of SV on the well-being of people with HIV (PWH) in the Deep South. To address this gap in the literature, we interpreted data using a Structural Violence framework. In this community-based participatory research, in-depth interviews (n = 40) were conducted with PWH who previously established HIV medical care. In our study, we found that SV can have a widespread impact in communities, negatively impacting access to key tangible and emotional resources. SV themes included community crime and instability, financial insecurity, and disparate access to numerous resources known to influence health. Structures exacerbating unequal access to resources appear engrained within communities and often went unrecognized by participants as disadvantageous to achieving optimal HIV health. Greater effort is necessary to elucidate the influence and role of violent structures on access to key resources for and by PWH. A clearer understanding of SV's influence on HIV health can inform changes addressing these structural barriers to HIV health.

Partnership status and retention in care among cisgender heterosexual newly diagnosed people with HIV: a cohort study.

This study examined the role of partnership status (married, unmarried-partnered, and unpartnered) on retention in care among newly diagnosed (2013-2017), cisgender heterosexual people with HIV in Birmingham, Alabama (n = 152). This study evaluated all scheduled HIV primary care provider visits for two years following diagnosis date. A kept-visit measure was calculated such that, if an individual attended ≥1 visit in each of the four 6-month intervals, they were considered to have high visit constancy. A missed-visit measure was categorized as ≥1 no-show vs. 0 no-show for first and second year after diagnosis. Odds ratios (OR) and 95% confidence intervals (CI) were calculated using logistic regression models. Models were adjusted for confounding sociodemographic and clinical characteristics. The study population was 76% Black, 57% male, median age of 37 years. Overall, 65% had high visit consistency and 34.5% had ≥1 no-show in both years. Compared to unpartnered, married individuals had higher visit constancy [AOR (95% CI): 2.88 (1.02, 8.16)]; no differences were observed among unmarried-partnered individuals. No differences in having ≥1 no-show among partnership status groups were observed for either year. These findings suggest potential success of interventions involving a social confidant in optimizing retention in care among newly diagnosed, heterosexual PWH.

Changes in high-risk sexual behavior, HIV and other STI testing, and PrEP use during the COVID-19 pandemic in a longitudinal cohort of adolescent men who have sex with men 13 to 18 years old in the United States.

The COVID-19 pandemic has disrupted sexual health services among those most vulnerable to HIV acquisition, such as adolescent men who have sex with men (AMSM). We sought to characterize the changes in sexual-risk behaviors, HIV and other STI testing, and pre-exposure prophylaxis (PrEP) use among a longitudinal cohort of AMSM aged 13 to 18 years before and during the COVID-19 pandemic. We observed a significant decline in HIV testing and a marginal decrease in other STI testing since the pandemic began in March 2020. Outreach efforts and innovative remote delivery of sexual health services are needed to support access to healthcare services among AMSM as the pandemic persists.

RESUMEN: La pandemia de COVID-19 ha afectado la prestación de servicios de salud sexual para los más vulnerables, tales como los hombres adolescentes que tienen relaciones sexuales con hombres (AMSM; por sus siglas en ingles). En una cohorte longitudinal de AMSM de 13 a 18 años, examinamos los cambios en comportamientos sexuales de alto riesgo, la prueba de VIH, las pruebas de otras enfermedades de transmisión sexual, y el uso de Profilaxis Preexposición (PrEP) para el VIH antes y durante la pandemia. Desde el inicio de la pandemia en marzo de 2020, observamos una disminución significativa en la frecuencia de pruebas de VIH y una disminución marginal en la frecuencia de pruebas de otras enfermedades de transmisión sexual. Mientras persista la pandemia, serán necesarios más esfuerzos de divulgación e innovaciones en la prestación remota de servicios de salud sexual para apoyar el acceso a dichos servicios por parte de AMSM.

Addressing HIV and Homelessness During COVID-19: A Community-Based Demonstration Project.

People experiencing homelessness are at increased risk for HIV, and people with HIV (PWH) experiencing homelessness are more likely to experience suboptimal HIV health outcomes than PWH with stable housing. Within Alabama, a state prioritized in the Ending the HIV Epidemic initiative, Jefferson County consistently has the highest number of new HIV diagnoses as well as a high percentage of the state's homeless population. To address the twin epidemics of both HIV and homelessness within the high-priority setting of Jefferson County, Alabama, this 1-year community-based project, Ending the HIV Epidemic: Addressing HIV Health and Homelessness (AH3), sought to increase HIV testing and linkage to care among this population by placing a full-time case manager trained in HIV testing and case management at a homeless shelter. Results demonstrated that HIV testing was highly acceptable: 733 individuals were offered a test, and only 2.7% (n = 20) declined. Nine previously diagnosed, out of care PWH and one newly diagnosed PWH were identified through AH3 testing efforts. Of these, five (50%) were linked to care at a local HIV clinic. The remaining five PWH left the shelter before they could be linked to care. Just 10 shelter guests expressed interest in taking PrEP (just 1.4% of guests who tested negative for HIV), and only one of these linked to PrEP care. Future health promotion programs are needed to address mental health and other ancillary needs among this population, as well as programs that provide access to PrEP and other HIV prevention services.

Impact of harm reduction care in HIV clinical settings on stigma and health outcomes for people with HIV who use drugs: study protocol for a mixed-methods, multisite, observational study.

INTRODUCTION: Our previous pilot work suggests relational harm reduction strengthens relationships between people with HIV (PWH) who use drugs and their healthcare providers and improves HIV health outcomes. However, there is limited research examining ways that structural (eg, strategies like syringe service programmes) and/or relational (patient-provider relationship) harm reduction approaches in HIV clinical settings can mitigate experiences of stigma, affect patient-provider relationships and improve outcomes for PWH who use drugs. Our mixed methods, multisite, observational study aims to fill this knowledge gap and develop an intervention to operationalise harm reduction care for PWH who use drugs in HIV clinical settings. METHODS AND ANALYSIS: Aim 1 will explore the relationship between healthcare providers' stigmatising attitudes towards working with PWH who use drugs and providers' acceptance and practice of structural and relational harm reduction through surveys (n=125) and interviews (n=20) with providers. Aim 2 will explore the interplay between patient-perceived harm reduction, intersectional stigma and clinical outcomes related to HIV, hepatitis C (if applicable) and substance use-related outcomes through surveys (n=500) and focus groups (k=6, total n=36) with PWH who use drugs. We will also psychometrically evaluate a 25-item scale we previously developed to assess relational harm reduction, the Patient Assessment of Provider Harm Reduction Scale. Aim 3 will use human-centred design approaches to develop and pretest an intervention to operationalise harm reduction care for PWH who use drugs in HIV clinical settings. ETHICS AND DISSEMINATION: This study was approved via expedited review by the University of Pittsburgh Institutional Review Board (STUDY21090002). Study findings will be presented in peer-reviewed journals and public health conferences as well as shared with patient participants, community advisory boards and harm reduction organisations. TRIAL REGISTRATION NUMBER: NCT05404750.

Efficacy of MyPEEPS Mobile, an HIV Prevention Intervention Using Mobile Technology, on Reducing Sexual Risk Among Same-Sex Attracted Adolescent Males: A Randomized Clinical Trial.

Importance: HIV transmission rates in the United States have increased among men who have sex with men. However, there are no published randomized trials examining interventions to reduce sexual risk for HIV acquisition in males younger than 18 years. Objective: To determine the efficacy of MyPEEPS Mobile, a mobile-delivered HIV prevention intervention, to reduce sexual risk behavior in same-sex attracted young males. Design, Setting, and Participants: This was a national randomized clinical trial of the efficacy MyPEEPS Mobile vs a delayed intervention among males aged 13 to 18 years to prevent or reduce sexual risk for HIV acquisition. Study activities were completed through 4 study sites in Birmingham, Alabama; New York, New York; Seattle, Washington; and Chicago, Illinois. Study staff at each site met with participants in person or via video conferencing. Data were collected from June 1, 2018, to April 7, 2020, and analyzed from July to October 2021. Interventions: The MyPEEPS Mobile intervention contains 21 online psychoeducational and skill-building modules, which participants completed over a 3-month period. Participants randomized to the intervention group received access to MyPEEPS Mobile for the first 3 months, while those randomized to the delayed intervention group received access at their 9-month visit after data for the primary efficacy analysis had been collected. Main Outcomes and Measures: The self-reported primary outcome was change in the number of condomless anal sex acts between study conditions. Secondary outcomes were change in the number of sex partners, number of condomless anal sex partners, the number of sex acts while under the influence of substances, preexposure prophylactic uptake, nonoccupational postexposure prophylaxis use, and HIV and sexually transmitted infection testing. Results: In the analytic sample of 763 racially and ethnically diverse study participants, the mean (SD) age was 16.2 (1.4) years; 736 participants (97%) were male, 13 (2%) nonbinary; and 6 (1%) genderqueer; 158 (21%) were Black or African American, 311 (41%) were Hispanic or Latino, and 284 (37%) were White. Overall, 382 were randomized to the intervention group and 381 to the delayed intervention group. At 3-month follow-up, there was a significant reduction in the number of condomless anal sex acts in the intervention group compared with the delayed intervention group (incidence rate ratio [IRR], 0.56; 95% CI, 0.32-0.99); however, there was no significant difference between groups at 6 or 9 months. In subgroup analyses, the intervention effect was pronounced among Black non-Hispanic participants at 3-month follow-up (IRR, 0.19; 95% CI, 0.04-0.94) and 6-month follow-up (IRR, 0.15; 95% CI, 0.03-0.78) compared with the delayed intervention group. There were no significant differences in the change in the number of sex partners, number of condomless anal sex partners, the number of sex acts while under the influence of substances, preexposure prophylactic uptake, nonoccupational postexposure prophylaxis use, and HIV and sexually transmitted infection testing between the intervention and delayed intervention groups. Conclusions and Relevance: In this study, the MyPEEPS Mobile intervention demonstrated a 44% overall reduction in condomless anal sex at 3-month follow-up compared with the delayed intervention group, but not at 6 or 9 months. To our knowledge, MyPEEPS Mobile is the first intervention to demonstrate evidence of short-term efficacy for reducing sexual risk among same-sex attracted young males. Trial Registration: ClinicalTrials.gov Identifier: NCT03167606.