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.

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.

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.

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.

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.

"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.

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.

Patient and Provider Perspectives on HIV Stigma in Healthcare Settings in Underserved Areas of the US South: A Mixed Methods Study.

Stigma experienced in healthcare settings is a barrier to ending the HIV epidemic. Using a convergent parallel mixed methods approach, we collected qualitative data from 14 focus groups with People with HIV (PWH) and Healthcare workers (HCW) and quantitative survey data (N = 762 PWH and N = 192 HCW) from seven HIV healthcare clinics outside of major urban areas in the southeastern US. Four key themes emerged: (1) HIV-related stigma and discrimination in healthcare settings; (2) experiences of intersectional stigma; (3) disclosure concerns in healthcare settings; and (4) impact of stigma on HIV-related health behavior. Implications for future stigma interventions in healthcare settings include the importance of engaging PWH in the development of interventions, the need for interventions in settings that do not specialize in HIV care, and the importance of engaging all staff when addressing HIV-related stigma.

RESUMEN: El estigma experimentado en los entornos de atención médica es una barrera para poner fin a la epidemia del VIH. Utilizando un enfoque convergente de métodos mixtosparalelos, recopilamos datos cualitativos de 14 grupos focales con personas con VIH y trabajadores de la salud y datos de encuestas cuantitativas (N = 762 personas con VIH y N = 192 trabajadores de la salud) de siete clínicas de atención médica de VIH fuera de las principales áreas urbanas en el sureste de los Estados Unidos. Surgieron cuatro temas clave: (1) el estigma y la discriminación relacionados con el VIH en los entornos de atención médica; (2) experiencias de estigma interseccional; (3) preocupaciones de divulgación en entornos de atención médica; y (4) el impacto del estigma en el comportamiento de salud relacionado con el VIH. Las implicaciones para futuras intervenciones de estigma en entornos de atención médica incluyen la importancia de involucrar a las personas con VIH en el desarrollo de intervenciones, la necesidad de intervenciones en entornos que no se especializan en la atención del VIH y la importancia de involucrar a todo el personal al abordar el estigma relacionado con el VIH.

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.

HIV Prevention Trials Network 078: High Prevalence of Hepatitis C Virus Antibodies Among Urban US Men Who Have Sex With Men, Independent of Human Immunodeficiency Virus Status.

BACKGROUND: Sexual transmission of hepatitis C virus (HCV) is uncommon, yet documented among men who have sex with men (MSM), primarily among those with human immunodeficiency virus (HIV). METHODS: In the HIV Prevention Trials Network 078 study (HPTN 078), which assessed an integrated strategy to achieve HIV viral suppression, 1305 MSM were screened across 4 geographically diverse US cities. At screening, demographic/behavioral/psychosocial questionnaires were completed, along with HIV and HCV testing. Multivariable logistic regression was used to evaluate associations with HCV antibody positivity. RESULTS: Among the 1287 (99%) of the MSM with HCV antibody results, the median age was 41, 69% were black, 85% had a high school education or more, 35% were employed, 70% had HIV, and 21% had undergone substance use counseling. The median lifetime number of male sexual partners was 17 (interquartile range, 6-50), and 246 (19%) were HCV antibody positive. HCV antibody positivity was high in MSM with HIV (20%) and MSM without HIV (17%) (P = .12) and was higher in those receiving substance use counseling (36%) than in those who had not (15%) (P ≤ .01). Substance use counseling (odds ratio, 2.51; 95% confidence interval, 1.80-3.51) and unstable housing (2.16; 1.40-3.33) were associated with HCV antibody positivity. CONCLUSIONS: Nearly 1 in 5 MSM screened for HPTN 078 have been infected with HCV. The prevalence is high regardless of HIV status and is high even in those who did not undergo substance use counseling. In HIV burden networks, high HCV infection prevalence may occur in MSM without HIV. As implementation of preexposure prophylaxis expands and condom use declines, routine HCV counseling and screening among MSM are important.

Drug and alcohol use among people living with HIV in care in the United States by geographic region.

Substance use in the U.S. varies by geographic region. Opioid prescribing practices and marijuana, heroin, and methamphetamine availability are evolving differently across regions. We examined self-reported substance use among people living with HIV (PLWH) in care at seven sites from 2017-2019 to understand current regional substance use patterns. We calculated the percentage and standardized percentage of PLWH reporting current drug use and at-risk and binge alcohol use by U.S. Census Bureau geographic region and examined associations in adjusted logistic regression analyses. Among 7,686 PLWH, marijuana use was the most prevalent drug (30%), followed by methamphetamine/crystal (8%), cocaine/crack (7%), and illicit opioids (3%). One-third reported binge alcohol use (32%). Differences in percent of current use by region were seen for marijuana (24-41%) and methamphetamine/crystal (2-15%), with more use in the West and Northeast, and binge alcohol use (26-40%). In adjusted analyses, PLWH in the Midwest were significantly less likely to use methamphetamine/crystal (aOR: 0.13;0.06-0.25) or illicit opioids (aOR:0.16;0.05-0.53), and PLWH in the Northeast were more likely to use cocaine/crack (aOR:1.59;1.16-2.17), compared to PLWH in the West. Understanding differences in substance use patterns in the current era, as policies continue to evolve, will enable more targeted interventions in clinical settings among PLWH.

Performance of a high-throughput next-generation sequencing method for analysis of HIV drug resistance and viral load.

OBJECTIVES: To evaluate the performance of a high-throughput research assay for HIV drug resistance testing based on whole genome next-generation sequencing (NGS) that also quantifies HIV viral load. METHODS: Plasma samples (n = 145) were obtained from HIV-positive MSM (HPTN 078). Samples were analysed using clinical assays (the ViroSeq HIV-1 Genotyping System and the Abbott RealTime HIV-1 Viral Load assay) and a research assay based on whole-genome NGS (veSEQ-HIV). RESULTS: HIV protease and reverse transcriptase sequences (n = 142) and integrase sequences (n = 138) were obtained using ViroSeq. Sequences from all three regions were obtained for 100 (70.4%) of the 142 samples using veSEQ-HIV; results were obtained more frequently for samples with higher viral loads (93.5% for 93 samples with >5000 copies/mL; 50.0% for 26 samples with 1000-5000 copies/mL; 0% for 23 samples with <1000 copies/mL). For samples with results from both methods, drug resistance mutations (DRMs) were detected in 33 samples using ViroSeq and 42 samples using veSEQ-HIV (detection threshold: 5.0%). Overall, 146 major DRMs were detected; 107 were detected by both methods, 37 were detected by veSEQ-HIV only (frequency range: 5.0%-30.6%) and two were detected by ViroSeq only. HIV viral loads estimated by veSEQ-HIV strongly correlated with results from the Abbott RealTime Viral Load assay (R2 = 0.85; n = 142). CONCLUSIONS: The NGS-based veSEQ-HIV method provided results for most samples with higher viral loads, was accurate for detecting major DRMs, and detected mutations at lower levels compared with a method based on population sequencing. The veSEQ-HIV method also provided HIV viral load data.

Are missed- and kept-visit measures capturing different aspects of retention in HIV primary care?

The literature recognizes six measures of retention in care, an integral component of the HIV Continuum of Care. Given prior research showing that different retention measures are differentially associated with HIV health outcomes (e.g., CD4 count and viral suppression), we hypothesized that different groups of people living with HIV (PLWH) would also have differential retention outcomes based on the retention measure applied. We conducted a cross-sectional analysis of multisite patient-level medical record data (n = 10,053) from six academically-affiliated HIV clinics using six different measures of retention. Principal component analysis indicated two distinct retention constructs: kept-visit-measures and missed-visit measures. Although black (compared to white) PLWH had significantly poorer retention on the three missed-visit measures, race was not significantly associated with any of the three kept-visit measures. Males performed significantly worse than females on all kept-visit measures, but sex differences were not observed for any missed-visit retention measures. IDU risk transmission group and younger age were associated with poorer retention on both missed- and kept-visit retention measures. Missed- and kept-visit measures may capture different aspects of retention, as indicated in the observed differential associations among race, sex, age, and risk transmission group. Multiple measures are needed to effectively assess retention across patient subgroups.

Awareness, Willingness, and Perceived Efficacy of Pre-exposure Prophylaxis among Adolescent Sexual Minority Males.

Despite the approval of PrEP for adolescents by the FDA in 2018, little is known about the awareness and attitudes about PrEP use among adolescent sexual minority males, who are at the greatest risk for HIV. We analyzed baseline data from the MyPEEPS Mobile study, a multi-site randomized controlled trial evaluating the effectiveness of a mobile behavioral HIV prevention intervention. A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV. On the other hand, only about one third (34.6%) of participants indicated that taking a daily HIV pill would be "very" or "completely" effective in preventing HIV when having sex without a condom. These findings suggest that high awareness and willingness to use PrEP across various adolescent subgroups present opportunities for increased PrEP advocacy among this young age group.

Protocol of a randomized controlled trial to test the effects of client-centered Representative Payee Services on antiretroviral therapy adherence among marginalized people living with HIV.

BACKGROUND: Client-Centered Representative Payee (CCRP) is an intervention modifying implementation of a current policy of the US Social Security Administration, which appoints organizations to serve as financial payees on behalf of vulnerable individuals receiving Social Security benefits. By ensuring beneficiaries' bills are paid while supporting their self-determination, this structural intervention may mitigate the effects of economic disadvantage to improve housing and financial stability, enabling self-efficacy for health outcomes and improved antiretroviral therapy adherence. This randomized controlled trial will test the impact of CCRP on marginalized people living with HIV (PLWH). We hypothesize that helping participants to pay their rent and other bills on time will improve housing stability and decrease financial stress. METHODS: PLWH (n = 160) receiving services at community-based organizations will be randomly assigned to the CCRP intervention or the standard of care for 12 months. Fifty additional participants will be enrolled into a non-randomized ("choice") study allowing participant selection of the CCRP intervention or control. The primary outcome is HIV medication adherence, assessed via the CASE adherence index, viral load, and CD4 counts. Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months. Viral load, CD4, and appointment adherence data will be collected at baseline, 6, 12, 18, and 24 months from medical records. Outcomes will be compared by treatment group in the randomized trial, in the non-randomized cohort, and in the combined cohort. Qualitative data will be collected from study participants, eligible non-participants, and providers to explore underlying mechanisms of adherence, subjective responses to the intervention, and implementation barriers and facilitators. DISCUSSION: The aim of this study is to determine if CCRP improves health outcomes for vulnerable PLWH. Study outcomes may provide information about supports needed to help economically fragile PLWH improve health outcomes and ultimately improve HIV health disparities. In addition, findings may help to refine service delivery including the provision of representative payee to this often-marginalized population. This protocol was prospectively registered on May 22, 2018 with ClinicalTrials.gov (NCT03561103) .

A randomized controlled efficacy trial of an mHealth HIV prevention intervention for sexual minority young men: MyPEEPS mobile study protocol.

BACKGROUND: Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group. METHODS: This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up. DISCUSSION: Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.