Monthly Archives: May 2017

To date, HIV prevention efforts have largely relied on singular strategies (e.g., behavioral or biomedical approaches alone) with modest HIV risk-reduction outcomes for people who use drugs (PWUD), many of whom experience a wide range of neurocognitive impairments (NCI). We report on the process and outcome of our formative research aimed at developing an integrated biobehavioral approach that incorporates innovative strategies to address the HIV prevention and cognitive needs of high-risk PWUD in drug treatment. Our formative work involved first adapting an evidence-based behavioral intervention—guided by the Assessment–Decision–Administration–Production–Topical experts–Integration–Training–Testing model—and then combining the behavioral intervention with an evidence-based biomedical intervention for implementation among the target population. This process involved eliciting data through structured focus groups (FGs) with key stakeholders—members of the target population (n = 20) and treatment providers (n = 10). Analysis of FG data followed a thematic analysis approach utilizing several qualitative data analysis techniques, including inductive analysis and cross-case analysis. Based on all information, we integrated the adapted community-friendly health recovery program—a brief evidence-based HIV prevention behavioral intervention—with the evidence-based biomedical component [i.e., preexposure prophylaxis (PrEP)], an approach that incorporates innovative strategies to accommodate individuals with NCI. This combination approach—now called the biobehavioral community-friendly health recovery program—is designed to address HIV-related risk behaviors and PrEP uptake and adherence as experienced by many PWUD in treatment. This study provides a complete example of the process of selecting, adapting, and integrating the evidence-based interventions—taking into account both empirical evidence and input from target population members and target organization stakeholders. The resultant brief evidence-based biobehavioral approach could significantly advance primary prevention science by cost-effectively optimizing PrEP adherence and HIV risk reduction within common drug treatment settings.

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12 months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2 × 2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed.