Connecting youth and young adults to optimize antiretroviral therapy adherence (youthrive): Protocol for a randomized controlled trial

K. J. Horvath, R. F. MacLehose, A. Martinka, J. DeWitt, L. Hightow-Weidman, P. Sullivan, K. R. Amico

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Despite intensive efforts to engage people living with HIV in the United States, less than half of the youth aged 13 to 24 years achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. Objective: There are 3 phases of this project. Phase 1 involves conducting focus groups to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YT intervention among youth living with HIV (YLWH). Methods: In phase 1, we will conduct 6 focus groups with approximately 8 youths (aged 15-19 years) and young adults (aged 20-24 years), each in 3 US cities to obtain (1) feedback from YLWH about the look and feel and content of an existing adult-focused Web-based ART adherence intervention and (2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve updating the existing intervention to include features and functionality recommended by YLWH in phase 1; it will conclude with beta testing with 12 participants to gain feedback on the overall design and ensure proper functionality and ease of navigation. For phase 3, we will enroll 300 YLWH in 6 US cities (Atlanta, Chicago, Houston, New York City, Philadelphia, and Tampa) into a 2-arm prospective RCT. Participants will be randomized 1:1 to YT intervention or control group. The randomization sequence will be stratified by city and use random permuted blocks of sizes 2 and 4. Participants randomized to the control condition will view a weekly email newsletter on topics related to HIV, with the exception of ART adherence, for 5 months. Participants randomized to the YT intervention condition will be given access to the YT site for 5 months. Study assessments will occur at enrollment and 5, 8, and 11 months post enrollment. The primary outcome that will be assessed is sustained viral load (VL), defined as the proportion of participants in each study arm who have suppressed VL at both the 5-and 11-month assessment; the secondary outcome that will be assessed is suppressed VL at both the 5-and 11-month assessment between drug-using and nondrug-using participants assigned to the YT intervention arm. Results: Participant recruitment began in May 2017 for phase 1 of the study. The data collection for aim 3 is anticipated to end in April 2020. Conclusions: The efficacy trial of the YT intervention will help to fill gaps in understanding the efficacy of mobile interventions to improve ART adherence among at-risk populations.

Original languageEnglish (US)
Article numbere11502
JournalJMIR Research Protocols
Volume8
Issue number7
DOIs
StatePublished - Jul 1 2019

Bibliographical note

Funding Information:
This work was supported by the National Institutes of Health Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN 138; MPI: Horvath & Amico) as part of and the UNC/Emory Center for Innovative Technology (iTech; principal investigators: Dr Hightow-Weidman/Sullivan, 1U19HD089881). The content is solely the responsibility of the authors and does not represent the official views of the funding agencies. The authors would like to thank Adi Ferrara, MS, ELS, for help in the preparation of this study.

Publisher Copyright:
© 2019 Geoff McCombe, Aine Harrold, Katherine Brown, Liam Hennessy, Mary Clarke, David Hanlon, Sinead O'Brien, John Lyne, Ciaran Corcoran, Patrick McGorry, Walter Cullen.

Keywords

  • Adolescent
  • Antiretroviral therapy
  • HIV
  • Mobile apps
  • Mobile phone
  • Treatment adherence

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