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.
HIV prevention HIV risk Pre-exposure prophylaxis People who use drugs Substance abuse Methadone maintenance program
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This work was supported by grants from the National Institute on Drug Abuse for research (R01 DA032290 to MMC) and for career development (K24 DA017072 to FLA; K02 DA033139 to MMC).
Compliance with Ethical Standards
Conflict of interest
The authors have no conflicts of interest to disclose.
The study protocol was approved by the Institutional Review Board (IRB) at the University of Connecticut and received board approval from APT Foundation Inc. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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