HIV self-testing and STI self-collection via mobile apps: experiences from two pilot randomized controlled trials of young men who have sex with men.

BACKGROUND: Young men who have sex with men (YMSM) are disproportionately impacted by HIV and other sexually transmitted infections (STIs) in the United States (US) and have low rates of HIV/STI testing. Provision of HIV self-testing and STI self-collection can increase testing rates, and access to these kits through mobile applications (apps) could help facilitate YMSM using HIV self-testing and STI self-collection. METHODS: Data for this study comes from two pilot randomized controlled trials (RCTs) of mobile apps within the Adolescent Trials Network-LYNX and MyChoices-aimed to increase HIV/STI testing among YMSM (age 15-24) who had not recently tested for HIV and were at high risk for HIV acquisition across five US cities. Both apps include the ability to order a HIV self-test with rapid results and a kit for STI self-collection and mailing of samples for syphilis, gonorrhea and chlamydia to a lab for testing. Using assessments of app users (n=80) at pre-randomization and at 3- and 6-months post-randomization and online interview data from a purposive sample of app users (n=37), we report on experiences and lessons learned with HIV self-testing and STI self-collection kits ordered via the apps. RESULTS: Participants were on average 20.7 years of age (SD =2.4), and 49% were non-White or multiple race/ethnicity. Sixty-three percent had a prior HIV test. Over half (58%) had a prior STI test, but only 3% had tested within the past 3 months. Nearly two-thirds ordered an HIV self-testing kit; of whom, 75% reported using at least one self-test kit over the study period. STI self-collection kit ordering rates were also high (54%); however, STI self-collection kit return rates were lower (13%), but with a high positivity rate (5.3%). Both HIV self-testing and STI self-collection kits were highly acceptable, and 87% reported that it was extremely/very helpful to be able to order these kits through the apps. The most common reason for not ordering the HIV/STI kits was preferring to test at a clinic. In interviews, participants expressed feeling empowered by being able to test at home; however, they also raised concerns around STI sample collection. CONCLUSIONS: HIV self-testing and STI self-collection kit ordering via mobile apps is feasible, acceptable and may show promise in increasing testing rates among YMSM. The LYNX and MyChoices apps are currently being tested in a full-scale efficacy trial, and if successful, these innovative mobile apps could be scaled up to efficiently increase HIV/STI testing among youth across the US.

A Measure to Assess HIV Treatment Readiness among Adolescents and Young Adults.

HIV infections among adolescents and young adults continue to grow and clinical guidelines recommend the immediate start of life-saving antiretroviral therapy (ART). Unfortunately, suboptimal medication adherence among youth is common and can lead to poorer health outcomes as well as onward transmission of HIV to sexual partners. Clinical tools to assess treatment readiness are needed and can assist with adherence intervention strategies for youth. An assessment tool that we previously developed, the HIV Treatment Readiness Measure (HTRM), was administered to 595 HIV-positive youth ages 13-24 recruited from adolescent medicine clinics in the United States. Participants were followed for a minimum of 6 months and had to have at least one viral load test completed to be included in this analysis. The HTRM demonstrated high internal consistency (Chronbach's alpha = 0.86). For participants currently on ART at study entry, higher overall treatment readiness scores predicted future viral suppression (OR 1.52). Individual scores on three of the measure's factors (Psychosocial Issues, Connection with Care, and HIV Medication Beliefs) were also significant predictors of viral suppression. For those participants not on ART at study entry, the HIV Medication Beliefs factor significantly predicted who would eventually start ART (OR 2.26) but overall treatment readiness scores did not predict viral suppression in that group.

Developing a Mobile App (LYNX) to Support Linkage to HIV/Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis for Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

BACKGROUND: Young men who have sex with men (YMSM) in the United States have among the highest incidence of HIV and sexually transmitted infection (STI) and the lowest uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP). Nearly universal mobile phone ownership among youth provides an opportunity to leverage mobile health apps to increase HIV/STI testing and PrEP uptake among YMSM. OBJECTIVE: The goals of this project are to develop and refine LYNX, a novel mobile app to support linkage to HIV/STIs testing and PrEP services among YMSM in the United States, and to evaluate the acceptability and feasibility of LYNX in a pilot randomized controlled trial (RCT). METHODS: This research protocol will be conducted in 3 phases: an iterative development phase with a series of 3 focus groups among 20 YMSM to refine the LYNX app; an open technical pilot among 15 YMSM to optimize usability of the app; and then a 6-month pilot RCT among 60 HIV-uninfected YMSM at risk for HIV acquisition. Developed using the Information, Motivation, and Behavioral skills theoretical model, the LYNX app includes an electronic diary to track sexual behaviors (information), a personalized risk score to promote accurate risk perception (information/motivation), testing reminders (motivation/behavioral skills), and access to home-based HIV/STI testing options and geospatial-based HIV/STI testing care sites (behavioral skills). Feasibility and acceptability will be assessed through app analytics of usage patterns and acceptability scales administered via computer-assisted self-interview at 3 and 6 months. We will also evaluate preliminary efficacy by comparing the proportion of YMSM who test at least once during the 6-month pilot and the proportion who successfully link to a PrEP provider in the intervention versus control groups. RESULTS: Formative work is currently underway. The LYNX pilot RCT will begin enrollment in October 2018, with study results available in 2019. CONCLUSIONS: The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM. As low-perceived risk is a barrier to HIV/STI testing and PrEP use among youth, the personalized risk assessment and interactive sexual diary in LYNX could assist YMSM in better understanding their HIV risk and providing motivation to test for HIV/STIs and initiate PrEP. Coupled with community-based recruitment, this novel mobile app has great potential to reach and engage YMSM not currently involved in care and increase rates of HIV/STI testing and PrEP uptake in this vulnerable population. TRIAL REGISTRATION: ClinicalTrials.gov NCT03177512; https://clinicaltrials.gov/ct2/show/NCT03177512 (Archived by WebCite at http://www.webcitation.org/73c917wAw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10659.

Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States.

Importance: Adolescents represent a key population for implementing preexposure prophylaxis (PrEP) interventions worldwide, yet tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for PrEP is only licensed for adults. Objective: To examine the safety of and adherence to PrEP along with changes in sexual risk behavior among adolescent men who have sex with men (MSM). Design, Setting, and Participants: Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 (Project PrEPare) was a PrEP demonstration project that evaluated the safety, tolerability, and acceptability of TDF/FTC and patterns of use, rates of adherence, and patterns of sexual risk behavior among healthy young MSM aged 15 to 17 years. Participants were recruited from adolescent medicine clinics and their community partners in 6 US cities, had negative test results for human immunodeficiency virus (HIV) but were at high risk for acquiring an infection, and were willing to participate in a behavioral intervention and accept TDF/FTC as PrEP. Exposures: All participants completed an individualized evidence-based behavioral intervention and were provided with daily TDF/FTC as PrEP for 48 weeks. Main Outcomes and Measures: The main objectives were to: (1) provide additional safety data regarding TDF/FTC use among young MSM who had negative test results for HIV; (2) examine the acceptability, patterns of use, rates of adherence, and measured levels of tenofovir diphosphate in dried blood spots; and (3) examine patterns of risk behavior when young MSM were provided with a behavioral intervention in conjunction with open-label TDF/FTC. Results: Among 2864 individuals screened (from August 2013 to September 2014), 260 were eligible and 78 were enrolled (mean [SD] age, 16.5 [0.73] years), of whom 2 (3%) were Asian/Pacific Islander, 23 (29%) were black/African American, 11 (14%) were white, 16 (21%) were white Hispanic, and 26 (33%) were other/mixed race/ethnicity. Over 48 weeks of PrEP use, 23 sexually transmitted infections were diagnosed in 12 participants. The HIV seroconversion rate was 6.4 (95% CI: 1.3-18.7) per 100 person-years. Tenofovir diphosphate levels consistent with a high degree of anti-HIV protection (>700 fmol/punch) were found in 42 (54%), 37 (47%), 38 (49%), 22 (28%), 13 (17%), and 17 (22%) participants at weeks 4, 8, 12, 24, 36, and 48, respectively. Conclusions and Relevance: Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 enrolled a diverse sample of adolescent MSM at risk for HIV who consented to study participation. Approximately half achieved protective drug levels during the monthly visits, but adherence decreased with quarterly visits. Youth may need additional contact with clinical staff members to maintain high adherence. Trial Registration: clinicaltrials.gov Identifier: NCT01769456.

The impact of stigma on medication adherence among HIV-positive adolescent and young adult females and the moderating effects of coping and satisfaction with health care.

To explore whether HIV stigma negatively impacts adherence to antiviral medications in HIV-infected adolescent women, moderational analysis was conducted and factors identified that could alter said relationship. Study participants were 178 adolescent females age 15-24, enrolled between 2003-2005, from 5 different cities and 60 provided adherence information. Findings reported by this cohort of 60 adolescent women included: medication adherence, 64.3% reporting adherence at baseline and 45.0% at 12 months; HIV stigma score of 57.60 (standard deviation [SD], 11.83; range, 25-86). HIV stigma was not found to be a significant predictor when binary logit regression was run with medication adherence at 1 year. Using moderational analysis, factors that could moderate stigma's effect on medication adherence was still pursued and identified the following to be significant at 12 months: health care satisfaction (B = -0.020, standard error [SE] = 0.010, p < .05); and Coping (proactive coping strategies [B = 0.012, SE = 0.005, p < .05]; turning to family [B = 0.012, SE = 0.016, p < 0.05]; spiritual coping [B = 0.021, SE = 0.010, p < 0.05]; professional help [B = 0.021, SE = 0.010, p < 0.05]; physical diversions [B = 0.016, SE = 0.007, p < 0.05]). Factors that had no significant moderating effects included: social support measures (mean = 74.9; median = 74.0) and depression score greater than 16 = 43%. We conclude that HIV-infected adolescent women experience HIV stigma and poor adherence over time. Factors like health care satisfaction and coping may minimize stigma's effect on medication adherence. Our findings are tempered by a small sample size and lack of a direct relationship between stigma and adherence on binary logit regression analysis.

Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens.

BACKGROUND: HIV-infected youth are at risk of hepatitis B infection and should be vaccinated. Previous reports suggest reduced response to standard hepatitis B vaccine regimens. METHODS: HIV-infected youth, aged 12 to younger than 25 years, were randomly assigned to one of three treatment arms: Arm 1: Engerix B, 20 µg HBsAg; Arm 2: Engerix B (GlaxoSmithKline, Rixensart, Belgium), 40 µg; and Arm 3: Twinrix (GlaxoSmithKline, Rixensart, Belgium), 20 µg HBsAg combined with 720 ELU hepatitis A antigen. Vaccines were administered at Weeks 0, 4, and 24. RESULTS: Characteristics of evaluable patients (n = 336) at entry were similar in the study arms. At enrollment, median CD4+ T-cell count was 460 cells/mm3 (interquartile range, 305-668); 13% were less than 200 cells/mm3. Among Engerix B, 20-µg recipients, 60.4% responded to vaccine (HBsAb 10 IU/mL or greater at Week 28). Improved vaccine response was seen in recipients of Engerix B, 40 µg (73.2% versus Arm 1, P = 0.04) and Twinrix (75.4% versus Arm 1, P = 0.02). In multivariate analysis, only baseline CD4+ T-cell count and study arm were independent predictors of vaccine response. CONCLUSIONS: In HIV-infected youth, a three-dose vaccination regimen with Engerix B, 40 µg, or Twinrix and higher baseline CD4+ T-cell counts were independently associated with improved vaccine response.