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

BMC Public Health. 2018 Aug 6;18(1):982. doi: 10.1186/s12889-018-5796-8.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • African Americans*
  • Counseling / methods*
  • Female
  • HIV Infections / diagnosis
  • HIV Infections / ethnology
  • HIV Infections / prevention & control*
  • Health Promotion / methods*
  • Humans
  • Mass Screening
  • North Carolina / ethnology
  • Pregnancy
  • Pregnancy Tests
  • Research Design
  • Risk-Taking*
  • Sexual Behavior*
  • Sexually Transmitted Diseases
  • Substance-Related Disorders / diagnosis
  • Substance-Related Disorders / ethnology
  • Substance-Related Disorders / prevention & control
  • Telemedicine / methods*
  • Women's Health
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT02965014