Evidence on health care worker-managed groups highlights improved client outcomes, both at individual sites and at scale, and suggests benefits to specific client populations, including children, their caregivers and adolescents and increasingly to breastfeeding women and their infants, key populations and clients who have struggled with adherence previously. The majority of evidence for health care worker-managed group models comes from implementation of the ART adherence club (AC) model in Cape Town, South Africa. Details of the model expansion highlight that from January 2011 to March 2015, 32,425 clients were in an AC (25.2% of the total ART cohort). Fifty-five facilities were offering a total of 1,308 ACs (1). In a cluster random sample of 10% of the Cape Town ACs (3,216 adults) from non-research supported ART sites, retention was 95.2% (CI 94-96.4) at 12 months and 89.3% (CI 87.1-91.4) at 24 months. In the 13 months prior to database closure, 88.1% of clients had viral loads (VL) taken with VL ≤400 copies/ml in 97.2% (CI 96.5-97.8) (2). An evaluation of disengagement from care in Khayelitsha, Western Cape reported AC participation as highly protective against disengagement (hazard ratio: 0.27 (0.24-0.30) (3). A 2019 evaluation of long term virologic outcomes of 8 058 clients ever enrolled in AC care in Khayelitsha showed high annual VL completion over 40 months (82-85%) with 6% experiencing an elevated VL at a median of 363 days from AC enrolment (IQR 170-728) (4).
With ACs recognised since 2015 as one of three endorsed differentiated ART delivery models in South Africa, national retention and viral load suppression outcomes were evaluated in a 2019 study comparing 24 randomly allocated intervention and control facilities. AC patients had higher 12-month retention (89.5% versus 81.6%, aRD: 8.3%; CI: 1.1% to 15.6%) and comparable sustained viral suppression (<400 copies/mL any time ≤ 18 months) (80.0% versus 79.6%, aRD: 3.8%; CI: −6.9% to 14.4%). Retention associations were stronger for men than women (men RD: 13.1%, CI: 0.3% to 23.5%; women RD: 6.0%, CI:−0.9% to 12.9%) (5).
Four comparison cohort studies report client outcomes from ACs (6, 7). In the pilot study in Khayelitsha, Cape Town, retention at study end was 97% for those stable clients who enrolled in an AC versus 85% for those who did not. LTFU was reduced by 57% (hazard ratio, HR, 0.43, 95% CI 0.21-0.91) and viral rebound by 67% (HR 0.33, 95% CI 0.16-0.67) (6). In Gugulethu, Cape Town, 94% were retained at 12 months post AC enrolment, with 3% experiencing viral rebound by study end (7). After adjustment, AC participation was associated with a 67% reduction in the risk of LTFU (aHR: 0.33, 95% CI: 0.27-0.40) compared with clients in the standard of care. In rural Cape Winelands, a 2019 retrospective cohort study of all adult clients starting ART in 2014-2015, found lower loss to follow-up in those attending an AC (aHR =0.25, CI: 0.11 to 0.56). This finding was confirmed on analysis restricted to those eligible for AC referral (aHR =0.28, CI: 0.12 to 0.65) (8). A costing study found the Khayelitsha piloted AC model cost effective with a cost per patient year of $300 versus $374 for standard of care (9).
Four additional studies described various aspects of the AC model in the Western Cape. The first describes the AC model and the strategy used by local health authorities to scale the model (10). The second outlines the quality improvement approach embedded in the scale-up strategy (11). The third describes the adjusted AC model implemented in Gugulethu, where ACs were run at a community venue instead of the clinic (12). The Western Cape AC model changed from providing 2-monthly ART refills (6 times a year) to providing a 4-monthly ART refill at year end (5 total visits per year) to accommodate year-end holiday migration. A comparison study found no difference in short-term retention or viral rebound risk comparing clients who receive 2 months versus 4 months of ART over the holiday period (13). A non-inferiority cluster randomized trial comparing retention, VL completion and VL suppression outcomes of experienced AC clients receiving 6-monthly ART refill in their ACs compared with those in the aforementioned Western Cape AC model found similar 24-month retention (Intervention: 93.1% (CI 91.2-94.7); SOC 94.0% (CI 92.4-95.2);, higher VL completion (94.5% vs 89.3%) and similar VL suppression (96.3% vs 97.5%) (14).
In Zambia, urban adherence groups (UAGs) are also part of national DSD policy. A study using a matched-pair cluster randomized study design, only enrolling DSD eligible clients willing to join a UAG at intervention and control clinics, found the rate of late drug pickup was lower in UAG participants compared to clinic-based care participants (aHR 0.26, 95% CI 0.15-0.45) (15). Median medication possession ratio was 100% in intervention participants compared to 96% in control participants. Although 18% of the UAG group meeting visits were missed, on-time drug pickup (within 7 days) still occurred in 51% of these missed visits through alternate means (use of buddy pickup or early return to the facility).
Six qualitative studies looked at healthcare worker and/or client perceptions around ACs. The first explored the acceptability of community-based ACs from a health worker perspective including enablers and barriers to roll out (16). The second explored the perceptions of AC members and non-members at two sites in Khayelitsha and Gugulethu, Cape Town (17). The third explored the perceptions of clients who were enrolled in either community or facility-based ACs in Witkoppen, Johannesburg (18). The fourth took place in Lusaka, Zambia where patient and providers perceptions of UAGs were explored (19). In Cape Town, two recent qualitative studies were undertaken. One nested within a non-inferiority cluster randomized trial explored patient, healthcare worker and key informant experiences and perceptions of receiving 6-month ART refills in ACs (20). The second explored how participation in post-natal ACs affected knowledge transmission, peer support, health seeking behaviour and satisfaction with the care provided (21).
Two studies in Zambia and one in South Africa compared outcomes after providing clients with a choice of differentiated ART delivery model. Within the PopART study in Lusaka, Zambia, clients in two study arms were offered a choice for collecting a three-month ART refill in i) clinic-based care or home delivery (HBD) or ii) clinic-based care or community-based AC (22). 12-month viral suppression was non-inferior in the community DSD models (above 98% in all 3 arms). More clients were lost to care in the clinic-base care arm (52/781; HBD 18/825; AC 20/808) with more deaths in the HBD arm (17; clinic-based 2; AC 7). In a retrospective outcomes analysis of clients who enrolled in DSD models in Zambia from 2015-2017, 12-month retention was 81% in clinic-based care compared with 83% in CAGs, 95% in UAGs, 79% in home delivery and 69% in mobile outreach. Provider costs per person retained was higher in DSD models compared with clinic-based care (23). In Kwa-Zulu Natal, South Africa, clients were offered a choice between community ART groups (CAGs), community ACs, in-facility individual fast lane pick-up or out-of-facility individual pick-up. Overall DSD model retention was high at 12, 24 and 36 months when compared with those who qualified for a DSD model but remained in clinic-based care but viral suppression was significantly lower for those who had participated in the group models by 36 months (24).
Four small studies from Cape Town, South Africa and one from Uganda, reported outcomes for specific populations: adolescents, children and their caregivers, post-natal women and men who have sex with men (MSM) receiving their care from youth-specific ACs, family ACs or adults ACs respectively. For youth ACs, ART client outcomes were good. Retention at 12 months for youth stable on ART was 94.3% (CI 85.4-96.8); for youth newly initiated on ART, it was 86.4% (CI 78.7-91.4); and for youth ineligible for ART, it was 52.9% (CI 40.0-64.2) (25). For family ACs, child and caregiver retention was 93.7% (CI 88.7 – 96.6) and 93.9% (CI 85.9 – 97.4) at 12 months and 86.1 (CI 79.5 – 90.8) and 89.7 (CI 80.4 – 94.8) at 36 months (26). For women initiated on ART during pregnancy, who chose to join an existing community-based adult AC immediately post-delivery (84/129; 65%) compared with ART at their clinic, viral loads above 1000 copies/ml were lower at 12 (AC: 16% and clinic: 23%) and 24 months (AC: 29% and clinic: 37% (p<0.056) (27). In a further study, post-natal women and their infants were offered enrolment into post-natal clubs. These included both stable and high risk mother infant pairs until the infant reached 18 months. 18-month retention was 79.2% (28) with 76% of mothers with a VL taken between 12-18 months and viral suppression of 94%. 81%% of infants completed 9-month HIV testing and 64% 18-month HIV testing compared to 51% and 32% of historical controls (29). In Uganda, ACs were implemented for MSM with 100% viral suppression maintained after 11 months of follow-up (30).
Two studies reported on client outcomes for patients who had previously struggled with adherence. In Cape Town, South Africa clients who had re-suppressed after a nurse-led intervention and were immediately referred into an adult AC, 12-month retention and viral suppression after AC enrolment was 94.8% (CI 89.8-97.4) and 85.2% (CI 78.0-90.1) respectively (31). In Mozambique, ACs were implemented for patients with a history of HIV treatment failure. Retention at months 12 and 24 was 98.9% (95% CI:98.2-99.7) and 96.4% (95% CI:94.6-98.2) respectively. Concurrently, 85.8% (95% CI:83.1-88.2) and 80.9% (95% CI:77.8-84.1) of patients maintained VL suppression. Among 90 patients attending AC and simultaneously having VL rebound, 64 (71.1%) achieved VL re-suppression, 10 (11.1%) did not re-suppress and 14 (15.6%) had no subsequent VL result (32).
In 2020, a study in Cape Town compared retention and viral suppression outcomes of 503 AC clients who had experienced viraemia and had either been referred back to clinic-based care or erroneously remained in ACs. Those who remained in ACs had the same 12-month retention (93%), slightly lower VL completion (77% versus 84%) and higher VL re-suppression (62% versus 53%) (33).
Two early studies have evaluated medication adherence clubs (MACs) which adjusted the AC model to incorporate stable hypertension or diabetic patients. A retrospective descriptive study of 1432 patients in MACs reported LTFU in the first year after enrolment of 3.5% (34). A qualitative study found the model acceptable to both patients and healthcare workers saving patients time and reducing queues at the clinic (35).