Transitional community adherence support for people leaving incarceration in South Africa: a pragmatic, open-label, randomised controlled trial

Background: People released from correctional facilities face multifactorial barriers to continuing HIV treatment. We hypothesised that barriers faced in the first 6 months of community re-entry would be decreased by a multilevel group-based and peer-led intervention, the Transitional Community Adherence Club (TCAC). Methods: We did a pragmatic, open-label, individually randomised controlled trial in five correctional facilities in Gauteng, South Africa. Participants aged 18 years and older and receiving antiretroviral therapy (ART) in correctional facilities were enrolled before release and randomly assigned (1:2) to either passive referral (usual care) or TCACs. TCACs followed a 12-session curriculum over 6 months and were facilitated by trained peer and social workers. Participants were followed up by telephone and in person to assess the primary outcome: post-release enrolment in HIV treatment services at 6 months from the date of release. We did an intention-to-treat analysis to determine the effectiveness of TCACs compared with usual care. The trial was registered with the South African National Clinical Trials Register (DOH-27–0419–605) and ClinicalTrials.gov (NCT03340428). This study is completed and is listed as such on ClinicalTrials.gov. Findings: From March 1, to Dec 13, 2019, we screened 222 individuals and enrolled 176 participants who were randomly assigned 1:2 to the usual care group (n=59) or TCACs (n=117). 175 participants were included in the final analysis. In the usual care group, 21 (36%) of 59 participants had enrolled in HIV treatment services at 6 months, compared with 71 (61%) of 116 in the TCAC group (risk ratio 1·7, 95% CI 1·2–2·5; p=0·0010). No adverse events were reported. Interpretation: We found strong evidence that a differentiated service delivery model with curriculum and peer support designed specifically to address the needs of people with HIV returning from incarceration improved the primary outcome of enrolment in HIV treatment services. Our approach is a reasonable model to build further HIV treatment continuity interventions for individuals in the criminal justice system in South Africa and elsewhere. Funding: National Institute of Mental Health.