Virologic outcomes after early referral of stable HIV-positive adults initiating ART to community-based adherence clubs in Cape Town, South Africa: A randomised controlled trial

BACKGROUND: Differentiated service delivery (DSD) models are recommended for stable people living with HIV on antiretroviral therapy (ART) but there are few rigorous evaluations of patient outcomes. METHODS: Adherence clubs (ACs) are a form of DSD run by community health workers at community venues with 2–4 monthly ART refills and annual nurse assessments). Clinic-based care involves 2-monthly ART refills and 4-monthly nurse/doctor assessments. We compared virologic outcomes in stable adults randomised to ACs at four months post-ART initiation to those randomised to primary health care (PHC) ART clinics through 12 months on ART in Cape Town, South Africa (NCT03199027). We hypothesised that adults randomised to ACs would be more likely to be virally suppressed at 12 months post-ART initiation, versus adults randomised to continued PHC care. We enrolled consecutive adults on ART for 3–5 months who met local DSD [‘adherence clubs’ (AC)] eligibility (clinically stable, VL<400 copies/mL). The primary outcome was VL<400 copies/mL at 12 months on ART. RESULTS: Between January 2017 and April 2018, 220 adults were randomised (mean age 35 years; 67% female; median ART duration 18 weeks); 85% and 94% of participants randomised to ACs and PHCs attended their first service visit on schedule respectively. By 12 months on ART, 91% and 93% randomised to ACs and PHCs had a VL<400 copies/mL, respectively. In a binomial model adjusted for age, gender, previous ART use and nadir CD4 cell count, there was no evidence of superiority of ACs compared to clinic-based care (RD, -2.42%; 95% CI, -11.23 to 6.38). Findings were consistent when examining the outcome at a threshold of VL <1000 copies/mL. CONCLUSION: Stable adults referred to DSDs at 4 months post-ART initiation had comparable virologic outcomes at 12 months on ART versus PHC clinics, with no evidence of superiority. Further research on long-term outcomes is required.