Adolescent Medicine Trials Network for HIV/AIDS Interventions Data Harmonization: Rationale and Development of Guidelines

McCumber, Micah; Cain, Demetria; LeGrand, Sara; Mayer, Kenneth R.; Murphy, Debra A.; Psioda, Matthew A.; Seña, Arlene C.; Starks, Tyrel J.; Hudgens, Michael G.

doi:10.2196/11207

Cited by 17 publications

(8 citation statements)

References 30 publications

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“…This includes assessing willingness and intentions for PrEP uptake. The Motivational PrEP Cascade also assesses when participants begin and stop taking PrEP [65].…”

Section: Resultsmentioning

confidence: 99%

Clinic-Based Delivery of the Young Men’s Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial

et al. 2019

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Background Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men’s Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM. Objective This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Up program described in a recently published article by Naar et al. Methods This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats—clinic-based versus remote delivery—offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either CAS or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period. Results Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access. Conclusions We are conducting YMHP in 3 cities with high rates of YMSM at risk for HIV and STIs. When adapted for real-world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by the method of delivery. Trial Registration...

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“…This includes assessing willingness and intentions for PrEP uptake. The Motivational PrEP Cascade also assesses when participants begin and stop taking PrEP [65].…”

Section: Resultsmentioning

confidence: 99%

Clinic-Based Delivery of the Young Men’s Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial

et al. 2019

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“…Third, to support comparison across projects offering integrated services, we need outcome measures beyond the assessment of impact along the HIV continuum. Outcome measures and metrics that currently exist for HIV [ 51 ] should be expanded to capture services that impact other important domains such as sexual and reproductive health and mental health. Fourth, cost-effectiveness assessments should be incorporated as a key research component in all projects offering integrated services to adolescents so policy makers can identify the most efficient use of available resources.…”

Section: Discussionmentioning

confidence: 99%

Integrated Health Care Delivery for Adolescents Living with and at Risk of HIV Infection: A Review of Models and Actions for Implementation

et al. 2022

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Integrated service delivery, providing coordinated services in a convenient manner, is important in HIV prevention and treatment for adolescents as they have interconnected health care needs related to HIV care, sexual and reproductive health and disease prevention. This review aimed to (1) identify key components of adolescent-responsive integrated service delivery in low and middle-income countries, (2) describe projects that have implemented integrated models of HIV care for adolescents, and (3) develop action steps to support the implementation of sustainable integrated models. We developed an implementation science-informed conceptual framework for integrated delivery of HIV care to adolescents and applied the framework to summarize key data elements in ten studies or programs across seven countries. Key pillars of the framework included (1) the socioecological perspective, (2) community and health care system linkages, and (3) components of adolescent-focused care. The conceptual framework and action steps outlined can catalyze design, implementation, and optimization of HIV care for adolescents.

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“…Future work may include new therapies that are likely to be studied in the near future among YLWH, for example, long-acting ART [78]. The Modeling Core also collaborates with the ATN Data Harmonization Working Group to standardize the collection of resource utilization and cost data across all active ATN studies [79].…”

Section: Discussionmentioning

confidence: 99%

Model-Based Methods to Translate Adolescent Medicine Trials Network for HIV/AIDS Interventions Findings Into Policy Recommendations: Rationale and Protocol for a Modeling Core (ATN 161)

Neilan¹,

Patel²,

Agwu³

et al. 2019

JMIR Res Protoc

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Background The United States Centers for Disease Control and Prevention estimates that approximately 60,000 US youth are living with HIV. US youth living with HIV (YLWH) have poorer outcomes compared with adults, including lower rates of diagnosis, engagement, retention, and virologic suppression. With Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) support, new trials of youth-centered interventions to improve retention in care and medication adherence among YLWH are underway. Objective This study aimed to use a computer simulation model, the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Adolescent Model, to evaluate selected ongoing and forthcoming ATN interventions to improve viral load suppression among YLWH and to define the benchmarks for uptake, effectiveness, durability of effect, and cost that will make these interventions clinically beneficial and cost-effective. Methods This protocol, ATN 161, establishes the ATN Modeling Core. The Modeling Core leverages extensive data—already collected by successfully completed National Institutes of Health–supported studies—to develop novel approaches for modeling critical components of HIV disease and care in YLWH. As new data emerge from ongoing ATN trials during the award period about the effectiveness of novel interventions, the CEPAC-Adolescent simulation model will serve as a flexible tool to project their long-term clinical impact and cost-effectiveness. The Modeling Core will derive model input parameters and create a model structure that reflects key aspects of HIV acquisition, progression, and treatment in YLWH. The ATN Modeling Core Steering Committee, with guidance from ATN leadership and scientific experts, will select and prioritize specific model-based analyses as well as provide feedback on derivation of model input parameters and model assumptions. Project-specific teams will help frame research questions for model-based analyses as well as provide feedback regarding project-specific inputs, results, sensitivity analyses, and policy conclusions. Results This project was funded as of September 2017. Conclusions The ATN Modeling Core will provide critical information to guide the scale-up of ATN interventions and the translation of ATN data into policy recommendations for YLWH in the United States.

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Adolescent Medicine Trials Network for HIV/AIDS Interventions Data Harmonization: Rationale and Development of Guidelines

Cited by 17 publications

References 30 publications

Clinic-Based Delivery of the Young Men’s Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial

Clinic-Based Delivery of the Young Men’s Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial

Integrated Health Care Delivery for Adolescents Living with and at Risk of HIV Infection: A Review of Models and Actions for Implementation

Model-Based Methods to Translate Adolescent Medicine Trials Network for HIV/AIDS Interventions Findings Into Policy Recommendations: Rationale and Protocol for a Modeling Core (ATN 161)

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