Development and Pilot Testing of an Addiction Clinic-Based PrEP Uptake and Adherence Intervention for Women with Substance Use Disorders: A Protocol for a Pilot Randomized Trial (Preprint)

Abstract

Black/African American and Hispanic/Latina cisgender women in the United States continue to bear disproportionate incidence of HIV related to sexual transmission and injection drug use. Specifically, women with substance use disorders (SUD) are more likely to engage in vaginal or anal condomless sex associated with HIV transmission. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool but is not widely used by racial/ethnic minority women. Effective interventions for engaging women with SUD in HIV prevention interventions that are culturally tailored and, therefore, more appealing to racial/ethnic minority women with SUD are critically needed.

This study will assess the initial efficacy, feasibility, and acceptability of an integrated SUD treatment and PrEP services intervention to increase the uptake and adherence to PrEP among racial/ethnic minority cisgender women.

A three-phased mixed methods research design will involve formative qualitative methods to design the intervention (Phase 1), theatre testing to adapt and refine the intervention (Phase 2), and randomized controlled trial (RCT) methods to pilot test the intervention for efficacy, feasibility, and acceptability (Phase 3). The pilot RCT will enroll and randomize 60 women to either the standard SUD treatment program or SUD treatment integrated with PrEP services. The integrated intervention will include four motivational counseling sessions guided by the Information-Motivation-Behavioral (IMB) Skills Model to increase the uptake of PrEP. A mobile health app will be used to engage participants with the intention of motivating PrEP initiation and supporting adherence to PrEP.

Findings from individual qualitative interviews informed the development of the integrated intervention. Study recruitment for the randomized pilot (Phase 3) launched in May 2024. Additional statistical analyses will be performed upon completion of the study.

This addiction-clinic based behavioral intervention aims to increase PrEP uptake and adherence among racial/ethnic minority cisgender women who engage in sexual and substance use behaviors associated with increased susceptibility to HIV transmission. The integrated intervention has the potential to reduce HIV-related disparities among Black and Hispanic/Latina cisgender women with SUD. Findings from this study will provide a foundation for future HIV prevention interventions for racial/ethnic minority cisgender women with SUD.

This study is registered on ClinicalTrials.gov (NCT06158607).