Protocol for an Adolescent and Young Adult HIV/STI and Substance Use Disorder Digital Health Preventive Intervention (Preprint)

Author:

Cordova DavidORCID,Bauermeister José AORCID,Warner SydniORCID,Wells Patricia,MacLeod JenniferORCID,Neilands Torsten BORCID,Lua Frania MendozaORCID,Delva JorgeORCID,Fessler Kathryn BORCID,Smith Jr VersellORCID,Boyer CherrieORCID,

Abstract

BACKGROUND

HIV/STI remain significant public health concerns in the United States and adolescents are disproportionately affected. Adolescents engage in HIV/STI risk behaviors, including drug use and condomless sex, which increases risk for HIV/STI infection. At-risk adolescents, many of whom are racial minorities, experience HIV/STI disparities. Despite the facts that: (a) At-risk adolescents are disproportionately affected by HIV/STI risk behaviors, and infections, and (b) while CDC recommends routine HIV/STI testing in adolescents, relatively few adolescents report having ever been tested for HIV/STI. With expected increases in health clinic visits as a result of the Affordable Care Act, combined with technological advances, health clinics and mobile-health (mHealth), including apps, provide innovative contexts and tools to engage at-risk adolescents in HIV/STI prevention programs. Yet, a dearth of efficacious mHealth interventions delivered in health clinics to prevent/reduce both condomless sex and drug use and increase HIV/STI testing in at-risk adolescents exists.

OBJECTIVE

To address this gap in knowledge, we developed a theory-driven, culturally congruent mHealth intervention (hereon referred to as S4E) that has demonstrated feasibility and acceptability in a clinic setting. A next important step is to examine the preliminary efficacy of S4E on adolescent HIV/STI testing and risk behaviors. This goal will be accomplished by two aims: AIM 1 is to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both IOS and Android operating systems, and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic, and AIM 2 is to evaluate the preliminary efficacy of S4E, relative to Usual Care control condition, in preventing/reducing drug use and condomless sex, and increasing HIV/STI testing in a clinic sample of at-risk adolescents aged 14 – 21 living in Southeast Michigan.

METHODS

One-hundred adolescents recruited from a youth-centered community health clinic will be randomized via a blocked randomization with random sequence of block sizes to one of two conditions: S4E mHealth intervention or Usual Care. Theory-driven and culturally-congruent, S4E is a mHealth adaptation of the face-to-face Storytelling for Empowerment, which is registered with the Substance Abuse and Mental Health Services Administration National Registry of Evidence Based Programs and Practices.

RESULTS

This paper describes the protocol of the study. The recruitment began May 1, 2018. This study was registered on December 11, 2017, on ClinicalTrials.gov (Registry ID: NCT03368456). All participants have been recruited. Data analysis will be complete by the end of March 2023, with study findings available by the end of 2023.

CONCLUSIONS

This study has the potential to improve public health by preventing HIV/STI and substance use disorders.

Publisher

JMIR Publications Inc.

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