Integrated Bio-behavioral Approach to Improve Adherence to Pre-exposure Prophylaxis and Reduce HIV Risk in People Who Use Drugs: A Pilot Feasibility Study.

This study reports the feasibility, acceptability, and preliminary efficacy of the bio-behavioral community-friendly health recovery program-an integrated, HIV prevention intervention to improve pre-exposure prophylaxis (PrEP) adherence and HIV-risk reduction behaviors among high-risk people who use drugs. We used a within-subjects, pretest-posttest follow-up design to recruit participants, who were HIV-uninfected, methadone-maintained and reported HIV-risk behaviors and had initiated PrEP (n = 40; males: 55%). Participants were assessed at baseline (T0), immediately post-intervention (4 weeks: T4) and 4 weeks post-intervention (T8). Immediately after completing the four weekly intervention groups, participants underwent a post-intervention assessment including in-depth qualitative interviews. Feasibility was high, assessed by participant willingness to enroll (90.1%) and retention (95%). Results showed that participants were highly satisfied and perceived the intervention as valuable and acceptable [mean: 81.3 (range 0-100)]. Significant enhancements in self-reported PrEP adherence [F(2,74) = 7.500, p = 0.001] and PrEP-related knowledge [F(2,74) = 3.828, p = 0.026] were observed. Drug-related (e.g., injection of drugs, sharing of injection equipment) and sex-related (e.g., number of sexual partners, condomless sex) risk behaviors were reduced, while information, motivation, and behavioral skills (IMB) constructs increased. The results support feasibility and high acceptability and support further examination of the efficacy of this combination bio-behavioral intervention in a prospective clinical trial.

RCT Entities:   Population Interventions Outcomes