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

Abstract

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.

Impact of differentiated service delivery models on retention in HIV care and viral suppression among people living with HIV in sub‐Saharan Africa: A systematic review and meta‐analysis of randomised controlled trials

“…18,19 Disagreement was resolved using arbitration by a third reviewer. A total of 16 RCTs were assessed, of which seven studies had low risk, 11,14,[20][21][22][23][24] seven studies had some concerns, 12,13,[25][26][27][28] and two articles had high risk of bias. 29,30 (Figure 2).…”

“…In total 1596 records were screened for inclusion, of which 16 RCTs met eligibility criteria. 10,11,13,14,[20][21][22][23][24][25][26][27][28][29][30][31] The trials included more than 13,800 PLHIV (Table 1). Most of the trials were conducted in South Africa, [12][13][14]22,23,25,29,31 with most (11 studies) conducted among adult men and women (≥18 years).…”

“…10,11,13,14,[20][21][22][23][24][25][26][27][28][29][30][31] The trials included more than 13,800 PLHIV (Table 1). Most of the trials were conducted in South Africa, [12][13][14]22,23,25,29,31 with most (11 studies) conducted among adult men and women (≥18 years). [12][13][14]20,23,[25][26][27][28]30,31 Two studies were conducted in postpartum women, 22,29 and three were conducted in mixed adolescent and adult populations (Ferrand et al 2017 24…”

“…We describe the impact of ACs in the retention in HIV care, timely refill and viral suppression. Generally, the ACs comprised of 15-30 members per group, [11][12][13][14]22,23,29,31 club members could choose the meeting place either be at the clinic or community locations. Club members met for 1 hour every 2-6 months [11][12][13][14]22,23,29,31 medications re-fill.…”

“…Generally, the ACs comprised of 15-30 members per group, [11][12][13][14]22,23,29,31 club members could choose the meeting place either be at the clinic or community locations. Club members met for 1 hour every 2-6 months [11][12][13][14]22,23,29,31 medications re-fill. Members who were not able to attend the meeting in person were allowed to send someone else (treatment buddy) to collect their ART, 11,14,23 Roy et al 2020 11 did not use the attendance as the criteria for being referred to the standard care from the club while two consecutive buddy pickups were one of the reasons used by Hanrahan et al 2019 14 to exclude participants from participating in the ACs.…”