mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina

Felicia A Browne, Wendee M Wechsberg, Paul N Kizakevich, William A Zule, Courtney P Bonner, Ashton N Madison, Brittni N Howard, Leslie B Turner, Felicia A Browne, Wendee M Wechsberg, Paul N Kizakevich, William A Zule, Courtney P Bonner, Ashton N Madison, Brittni N Howard, Leslie B Turner

Abstract

Background: Disparities in the prevalence of HIV persist in the southern United States, and young African American women have a disproportionate burden of HIV as compared with young women of other racial/ethnic backgrounds. As a result, engaging young African American women in the HIV care continuum through HIV testing is imperative. This study is designed to reach this key population at risk for HIV. The study seeks to test the efficacy of two formats of a gender-focused, evidence-based, HIV-risk reduction intervention-the Young Women's CoOp (YWC)-relative to HIV counseling and testing (HCT) among young African American women between the ages of 18 and 25 who use substances and have not recently been tested for HIV.

Methods: Using a seek-and-test framework, this three-arm cross-over randomized trial is being conducted in three county health departments in North Carolina. Each county is assigned to one of three study arms in each cycle: in-person (face-to-face) YWC, mobile Health (mHealth) YWC, or HCT. At study enrollment, participants complete a risk behavior survey via audio computer-assisted self-interview, and drug, alcohol, and pregnancy screening tests, and are then referred to HIV, gonorrhea, and chlamydia testing through their respective health departments. Participants in either of the YWC arms are asked to return approximately 1 week later to either begin the first of two in-person individual intervention sessions or to pick up the mHealth intervention preloaded on a tablet after a brief introduction to using the app. Participants in all arms are asked to return for a 6-month follow-up and 12-month follow-up, and repeat the survey and biological testing from baseline.

Discussion: The findings from this study will demonstrate which delivery format (mHealth or face-to-face) is efficacious in reducing substance use and sexual risk behaviors. If found to be efficacious, the intervention has potential for wider dissemination and reach.

Trial registration: ClinicalTrials.gov: NCT02965014 . Registered November 16, 2016.

Keywords: Alcohol or other drugs (AOD); HIV testing; Health departments; Key population; Seek and test; Substance use; Young Women’s CoOp.

Conflict of interest statement

Author's information

Ashton N. Madison was a research intern contractor at RTI International when this manuscript was prepared.

Ethics approval and consent to participate

This study has been approved by the RTI Committee for the Protection of Human Subjects. In addition, research committees of Wake County Human Services and the Durham County Department of Public Health reviewed and approved the study. The Guilford County Department of Public Health Director granted approval in lieu of a formal review by a research committee. Written consent will be obtained from all participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 1
Study design

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