BackgroundYouth living with HIV (YLH) aged 13 to 24 years made up over a fifth (21%) of new HIV diagnoses in 2016, yet only 27% of YLH are virally suppressed. YLH have been shown to be poorly adherent to antiretroviral therapy (ART); however, there has been limited research investigating how to increase adherence in YLH. Mobile health (mHealth) interventions may be one promising way to do this.ObjectiveThis study (ATN [Adolescent Trials Network] 144 SMART) aimed to compare adaptive interventions that could increase ART adherence in YLH aged 15 to 24 years. This includes mHealth initiatives, the tapering of interventions, and the use of incentives. Cost-effectiveness of sequencing the interventions without incentives before providing incentives and the savings on societal costs due to suppressed viral loads will be determined. This protocol is part of the ATN Scale It Up program described in this issue by Naar et al.MethodsThis study uses a Sequential Multiple Assignment Randomized Trial design. Approximately 190 participants are being recruited, enrolled, and randomized to either cell phone support or text message support. Both intervention groups receive 3 months of intervention, followed by a second randomization based on response to the intervention. Responders test tapering their intervention, and nonresponders test receiving incentives.ResultsData collection for this study is projected to begin in August 2018 and last until June 2020.ConclusionsThis is an innovative study, particularly in terms of population, intervention types, focus on cost-effectiveness, and recruitment. This study could be particularly effective in improving adherence in YLH while reducing long-term individual and societal costs.Trial RegistrationClinicalTrials.gov NCT03535337; https://clinicaltrials.gov/ct2/show/NCT03535337 (Archived by WebCite at http://www.webcitation.org/74alXb92z)International Registered Report Identifier (IRRID)PRR1-10.2196/11183

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Background Young men who have sex with men (YMSM), particularly those who are partnered, are at unique risk for HIV. YMSM are among those at highest risk for HIV. Meanwhile, despite the fact that primary partners account for many—possibly most—new HIV infections, partnered men who have sex with men perceive themselves to be at much lower risk for HIV infection and therefore test less often than single men. In response to the risk of primary partner HIV transmission, couples HIV testing and counseling (CHTC) procedures have been developed for use in adult populations. Although promising, YMSM couples may require additional support to complete CHTC given their developmental context in which sexual and romantic relationships are relatively new, and communication skills are emergent. Objective The aim of this study was to test the additive benefit of adjunct treatment components tailored for YMSM, which enhance communication skills before the completion of CHTC. The intervention tests a continuum of prevention packages including assertive communication training videos and motivational interviewing focused on assisting with identification and development (MI-AID) before entering into the dyadic intervention components. This protocol is part of the Adolescent Medicine Trials Network (ATN) Scale It Up program described in this issue. Methods This is a comparative effectiveness trial that will be executed in 3 phases. Phase 1 will gather qualitative data related to intervention development and implementation from partnered YMSM at 4 subject recruitment venues (SRVs). Phase 2 will compare a continuum of these interventions in a pilot randomized controlled trial (RCT) at 2 SRVs. Phase 3 will compare the most successful adapted intervention package from phase 2 to CHTC as usual in a larger RCT at 4 SRVs. This phase is focused on implementation and sustainment phases of the Exploration, Preparation, Implementation, and Sustainment framework. Results Phase 1 data will be drawn from qualitative interviews with partnered YMSM (n=24) and staff from ATN sites (n=20). Baseline enrollment for phase 2 is expected to begin across 2 SRVs in June 2018 (n couples =36). In phase 2, survey data collection along with HIV and sexually transmitted infection (STI) testing will occur at baseline, and 1- and 3-month (postintervention) follow-ups. Phase 3 will begin enrollment across 4 SRVs in September 2019 (n couples =144) and follow-ups will occur at 1, 3, 6, and 9 months postintervention. Conclusions Although MI-AID, video-based assertive communication training, and CHTC have established efficacy when administered on their own, this study will be the first to evaluate the strongest adjunctive version of these interventions to address the specific developmental needs of partnered YMSM. Trial Registration ClinicalTrials.gov NCT03386...

Background Past research shows that youth living with HIV (YLH) are not as engaged in the HIV treatment cascade as other HIV-positive populations. To achieve the health benefits of rapid and widespread testing and advanced pharmacologic treatment, YLH must be fully engaged in every stage of the treatment cascade. Cascade monitoring provides an opportunity to assess the youth care cascade, including engagement in care and when youth commonly drop out of care, across 10 clinical sites in the United States. Collecting electronic health record (EHR) data for prevention and care across participant recruitment venues within the Adolescent Medicine Trials Network (ATN) allows for monitoring of the prevention and care cascades within the ATN, for comparing the ATN population to large-scale surveillance, for future integration of technology-based interventions into EHRs, and for informing ATN strategic planning. Objective The aim of this protocol study is to examine the trends in treatment cascade, including whether patients are receiving antiretroviral therapy, adhering to regimens, attending care appointments, and maintaining suppressed viral loads, to guide new protocol development and to facilitate community engagement. This protocol is part of the ATN Scale It Up (SIU) program described in this issue. Methods Deidentified EHR data of YLH, aged 15 to 24 years, will be collected annually (2017 to 2022) from 10 ATN clinical sites, resulting in patient data from 2016 to 2021. These data will be transferred and stored using Dropbox Business, a Health Insurance Portability and Accountability Act–compliant site and then analyzed by the SIU analytic core. Results This study was launched in December 2017 in 10 clinical sites, with 2016’s EHR data due on January 31, 2017. All 10 sites electronically uploaded their EHR data. The mandatory variables requested to monitor cascade of care include date of visit, age, gender, height, weight, race, ethnicity, viral load, and International Classification of Diseases codes for other diagnosis. In total, 70% of the sites provided data for all mandatory variables. The remaining mandatory variables were manually extracted. Conclusions This study will provide a platform to determine how YLH across the nation progress through or drop out of the HIV treatment cascade. It will also provide a foundation for assessing impact of SIU projects on treatment cascade outcomes. International Registered Report Identifier (IRRID) DERR1-10.2196/11185