Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia

Abstract

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.

The Mortality After Release from Incarceration Consortium (MARIC): Protocol for a multi-national, individual participant data meta-analysis

“…With MARIC data stored and governed by data custodians across 11 countries, and ethical and cross-jurisdictional data-sharing restrictions preventing the direct sharing of individual-level data [ 43 ], the two-step IPDM-A methodology overcomes these barriers and permits data analysis across all data sources in the Consortium. To account for participant overlap between cohorts – for example, there is a small degree of overlap between the Rosen [ 34 ] and Ranapurwala [ 44 ] cohorts from the US, and also some overlap between the Dolan [ 24 ], Degenhardt [ 22 ] and Karaminia [ 29 ] cohorts from Australia – we will ensure that all participants, person-time and deaths are only included once prior to conducting any data analysis.…”

Factors associated with methadone maintenance therapy discontinuation among people who inject drugs

“…The association between incarceration and MMT discontinuation has also been well-described elsewhere, and qualitative studies suggest this may be due to barriers to MMT continuity during transitions between custodial and community settings (Small, Wood, Betteridge, Montaner, & Kerr, 2009). There remain significant barriers to initiating and accessing opioid agonist therapies in custodial settings, and previous research has shown that the majority of individuals with OUD do not have access to MMT while incarcerated (Larney & Dolan, 2009; Bazazi et al, 2017 ; Bozinoff, Small, Long, DeBeck & Fast, 2017). This is particularly concerning given that incarcerated individuals with OUD are at high risk for relapse and fatal overdose in the year post-release, especially in the first month after leaving an incarcerated setting (Binswanger et al, 2007 ; Kinlock et al, 2007 ;Krinsky, Lathrop, Brown, & Nolte, 2009).…”

A Moderated Mediation Model of HIV-Related Stigma, Depression, and Social Support on Health-Related Quality of Life among Incarcerated Malaysian Men with HIV and Opioid Dependence

“…Project Harapan was a 2×2 multi-factorial randomized controlled trial designed to evaluate and compare the relative effectiveness of a pre-release methadone maintenance program and an evidence-based behavioral intervention (Holistic Health Recovery Program, HHRP+) in terms of reducing HIV-related risk behaviors and illicit drug use for HIV-infected, opioid dependent prisoners in Malaysia [46]. …”