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Table 1 Characteristics of the studies and their Design, nHFBC model and key findings

From: A systematic review of the effectiveness of non- health facility based care delivery of antiretroviral therapy for people living with HIV in sub-Saharan Africa measured by viral suppression, mortality and retention on ART

Study Setting Non-facility based model Comparator Sample Size Length of follow-up Outcomes and key findings
RANDOMIZED CONTROL TRIALS
 Fox 2019 [37] South Africa Adherence clubs Health care facility N = 596
AC n = 275
HCF n = 294
18 months Viral Suppression – comparable 12 months viral suppression between the intervention (80%) and control (79.6%) arms (aRD: 3.8%; 95% CI: −6.9 to14.4%).
Retention – AC’s had a higher 1-year retention (89.5% vs 81.6%, aRD:8.3%; 95% CI: 1.1 to 15.6%)
 Hanrahan 2019 [40] South Africa Community Adherence clubs Health care facility clubs (Standard of care) N = 775 24 months Loss from the club – proportion of patients who dropped out of clubs in both community and facility clubs or were transitioned to standard of care. Overall, 47% [95%CI 44–51%] of patients were returned to health care facility. Among community-based club participants, the cumulative proportion lost from club-based care was 52% (95% CI: 47–57%), compared to 43% (95% CI: 38–48%,
p = 0.002) among clinic-based club participants.
Virological failure - Documented viral rebound was higher among participants assigned to facility-based clubs (21, 95% CI 13–27%) than those assigned to community-clubs (13, 95% CI 8–18%, p = 0.051). But this was not significant.
All-cause mortality – no mortality observed in both arms
Loss from ART care -during follow up, 77 (10%) overall. No significance between the two arms. Among community club participants, the proportion lost from any ART care was 12% (95% CI 9–16%), compared to 7% (95% CI 5–10%, p = 0.024) among facility- club participants, corresponding to a difference of 5% (95% CI 1–9%, p = 0.018). In a univariate Cox proportional hazards model, the risk of loss to any ART care was non-significantly increased among participants assigned to community clubs as compared with those assigned to facility clubs (HR 1.69, 95% CI 0.98–2.91, p = 0.057).
 Geldsetzer 2018 [41] Tanzania Home ART delivery Health care facility N = 2172
HD n = 1163
HCF n = 1009
326 days Virological failure – 10.9% (95/872) in the control arm and 9.7% (91/943) in the intervention arm were failing at the end of the study period.
Risk ratio demonstrated non-inferiority of the HBC to HCF (RR 0.89 [1-sided 95% CI 0.00–1.18])
Lost to follow-up – 18.9% in HBD versus 13.6% in HCF. No P value or CI reported.
Mortality – 0.09% in HBD versus 0.2% in HCF. No P value or CI reported.
 Woodd 2014 [42] Uganda Home ART delivery Health care facility N = 1453
HD n = 859
HCF n = 594
28 months Home delivery of ART and support leads to similar survival rates as clinic-based care.
Mortality – One hundred and ninety-seven participants died over a median follow-up time of 28 months (IQR 15–35) giving an overall mortality rate of 6.36 deaths per 100 person-years [95% confidence interval (CI) 5.53–7.32].
110 (25%) deaths in participants with baseline CD4 < 50 cells and 87 (9%) in those with higher baseline CD4.Among participants with baseline CD4+ count < 50 cells/μl, mortality rates were similar for the home and facility-based arms; adjusted mortality rate ratio 0.80 [95% confidence interval (CI) 0.53–1.18] compared with 1.22 (95% CI 0.78–1.89) for those who presented with higher CD4+ cell count.
In CD4 counts < 50 cells – crude mortality RR 0.81 and In CD4 counts higher - crude mortality RR 0.55
Lost to follow up – 1.8% among those with CD4 < 50 and 2.6% among those with CD4 at least 50.
Amuron 2011 [43] Uganda Home deliveries Health care facility HD n = 594
HCF n = 859
42 months Mortality – in the facility there were 117 deaths (mortality rate 6.3 per 100 persons per yrs.) whereas in HBD, 80 deaths (mortality rate 6.5 per 100 person yrs.). The one, two and three year survival probabilities (95% CI) were 0.89 (0.87–0.91), 0.86 (0.84–0.88) and 0.85 (0.83–0.87) respectively
Selke 2010 [44] Kenya Home ART delivery Health care facility HD n = 96
HCF n = 112
28 months Home delivery of ART and support resulted in similar clinical outcomes as clinic care but with half the number of clinic visits. Task-shifting and mobile technologies can deliver safe and effective community-based care to PLHIV.
LTFU – 4.5% in the HCF and 5.2% in Home delivery [95% CI: 0.24 to 3.03; p = 1.0]
Mortality – 0 in both arms
Viral rebound – no significant difference between the two groups (10.5% in HBD and 13.5% in HCF, 95%CI: 0.54 to 3.31, p = 0.65)
OBSERVATIONAL COHORT STUDIES
 Fox 2019 [37] South Africa Decentralized medication delivery (DMD) Health care facility N = 578
DMD n = 232
HCF n = 346
18 months  
 Tun 2019 [45] Tanzania Community Based ART distribution (CBPDs) Health care facility CBPD n = 309
HCF n = 308
6 months Retention in the CBDP – 82.8% vs 82.1% in the HCF at 6 months
LTFU – 53 in the intervention and 55 in the HCF arms
 Pasipamire 2018 [46] Swaziland 1. Community Adherence groups (CAGs) 2. Facility Based clubs
3. Treatment outreach
No comparator N = 918
CAGs n = 531
FBC n = 289
Outreach n = 98
12 months Retention in the models – The overall care model retention was 90.9 and 82.2% at 6 and 12 months. Retention in the care models differed significantly by model type, being lowest in CAGs at all time points (p < 0.001). Only 70.4% of patients were retained in CAGs at 12 months compared with 86.3% in comprehensive outreach and 90.4% in clubs. Retention in care model was significantly higher in eligible patients compared with non-eligible patients (85.0 and 76.4% at 12 months, p = 0.017.
Retention to ART – over 90% from all three models and no difference noted (p = 0.52).Patients in CAGs had a higher risk of disengaging from the care model (aHR 3.15, 95%CI: 2.01–4.95, P < 0.001) compared with treatment clubs.
Note: disengagement defined as LTFU, Death, return to clinical care)
 Myer 2017 [47] South Africa Adherence clubs [post-partum women] Health care facility N = 110
AC n = 77
HCF n = 33
6 months post-partum follow-up Viral suppression - overall no difference in viral suppression between the two groups.
86% of women remained in the evaluation through 6 months postpartum; in this group, there were no differences in VL < 1000 copies/mL at six months postpartum between women choosing HCFs (88%) vs. adherence clubs (92%; p = 0.483.
 Vogt 2017 [48] Democratic Republic of Congo (DRC) Community based refill centers No comparator N = 2259 24 months Attrition increased steadily after decentralizing services such as drug pick up points.
Low attrition throughout follow-up
LTFU – 9.0% at 24 months
Mortality – 0.3% at 24 months
overall attrition was 5.66/100 person years (95% CI: 4.97 to 6.45)
 Tsondai 2017 [49] South Africa Adherence clubs No comparator N = 3216 24 months Stable patients on ART can safely be offered differentiated care as they overall had good outcomes. Adherence clubs scaled up at large scale had had high levels of retention and viral suppression.
Retention – Retention was 95.2% (95% CI: 94.0–96.4) at 12 months and 89.3% (95% CI: 87.1–91.4) at 24 months after AC enrolment.
Viral suppression - Of the 88.1% who had a viral load assessment, 97.2% (95%CI, 96.5–97.8) were virally suppressed < 400 copies/ml
LTFU – 4.2% (135). Cumulative incidence of LTFU was 2.6% (95% CI, 2.1–3.2) at 12 months, rising to 6.9% (95%CI, 5.7 to 8.1) at 24 months after AC enrolment.
Mortality – 0.1% (95% CI, − 0.01 to 0.2) at 12 months and 0.2% (95%CI, − 0.01 to 0.4)
 Decroo 2017 [50] Mozambique Community ART groups (CAGs) Health care facility CAGs n = 901
HCF n = 1505
24 months LTFU – overall 12% [11.2% in HCF and 0.8% in CAGs]. CAG members had a greater than fivefold reduction in risk of dying or being LTFU (adjusted HR: 0.18, 95% CI 0.11 to 0.29).
Retention - 12-month and 24-month retention in care from the time of eligibility were 89.5 and 82.3% respectively among patients in individual care and 99.1 and 97.5% among those in CAGs (p < 0.0001).
 Auld 2016 [51] Mozambique Community support ART groups (CASG) Health care facility N = 306,335
CASG n = 6766
HCF n = 299,569
4 years Mortality – similar rates in both groups [0.3% among CASG at 2 yrs. and 1.4% at 4 yrs.]
CASG patients were associated with a 35% lower LTFU rates [AHR 0.65; 95% CI:0.46, 0.91] but similar mortality.
 Grimsrud 2016 [52] South Africa Adherence clubs Health care facility N = 8150
AC n = 2113
HCF n = 6037
12 months Viral suppression – high rates of VLS among those who had a VL result, but no comparison made between the two cohorts.
LTFU – clubs were associated with a decreases risk of LTFU compared to facility in all crude and adjusted models. Clubs were associated with a 67% reduction in LTFU compared with facility (aHR 0.33, [95% CI, 0.27–0.40]).
 Okoboi 2016 [53] Uganda Community based distribution points (CBDP) Health care facility CDDP n = 476
HCF n = 752
5 years Overall retention rates were above 80% in both HCF and CBDP
Retention rates – 83.9% in the facility and 82.9% retained in the community distribution model of delivery (p = 0.670)
 Jobarteh 2016 [54] Mozambique Community ART support groups (CASG) Health care facility (non-CASG) CAGs n = 6760
HCF n = 123,178
12 months LTFU – LTFU among CASG and non-CASG members was 7.2 and 15.9%, respectively. Compared with CASG participants, non-CASG participants had significantly higher LTFU (hazard ratio [HR]: 2.36; 95% confidence interval [CI]: 1.54–3.17; p = .04]
Mortality -no significant mortality differences between CASG and non-CASG members (1.4% vs 1.2%) (HR:0.98; 95%CI, 0.14 to 1.82; p = 0.96)
 Okoboi 2015 [36] Uganda Community distribution points (CDDP) No comparator CDDP n = 3340 5 years Community-based ART distribution systems are capable of overcoming barriers to ART retention and result in good rates of virologic suppression.
Viral suppression- of the 870 patients who had a VL measured, 87% were suppressed
Mortality- mortality rate was low (3.22 per 100 person-years)
LTFU- 1.59 per 100 person-years
Retention- more than 69% of patients who initiated ART from 2004 to 2009 were retained in care after more than 5 years of treatment.
 Decroo 2014 [32] Mozambique Community ART groups (CAGs) No comparator CAGs n = 6158 4 years Long-term retention in CAG was exceptionally high [91.8% at 4 years of follow-up (95% CI, 90.1 to 93.2)].
LTFU – event rate was 0.1% per 100-person yrs.
Mortality – event rate was 2.1 per 100-person yrs.
Retention among CAG members at 1 year on ARTwas 97.7% (95% CI 97.4–98.2); at 2 years, 96.0% (95% CI 95.3–96.6); at 3 years, 93.4% (95% CI 92.3–94.3); and at 4 years, 91.8% (95% CI 90.1–93.2).
Overall, the attrition rate was 2.2 per 100 person-years among the 5729 adult members.
Study Setting Non-facility based model Comparator Sample size Length of follow-up Key outcomes
Luque-Fernandez 2013 [55] South Africa Community Adherence clubs Health care facility ACs n = 502
HCF n = 2372
3 years Outcomes less frequent in patients participating in the clubs.
Viral rebound – 214 patients had viral failure at study end in the HCF (90.4 event rates per 1000 person yrs. [95%CI: 79.1–103.4). In the clubs 14 had viral rebound 31.8 event rates per 1000 person yrs.
Retention - 97% of club patients remained in care compared with 85% of other patients. In adjusted analyses club participation reduced loss-to-care by 57% (hazard ratio [HR] 0.43, 95% CI = 0.21–0.91).
Mortality + LTFU - 12.8% of patients were LTF or had died (323 LTF and 40 deaths).
Both outcomes were less frequent for patients participating in the clubs (29.8 vs 116.8 per 1000 person-yrs. for LTFU/death, crude rate ratio [RR = 0.25, 95% CI 0.14–0.41]
Kipp 2012 [56] Uganda Home based ART delivery Health care facility HBD n = 185
HCF n = 200
24 months ART outcomes such as viral suppression in community models were equivalent to those receiving care in the facility.
Viral suppression – patients in the home delivery model were 2.47 times more likely to achieve viral suppression compared to those in the facility based [95% CI for OR 1.02–6.04 p = 0.046].
Mortality – 32(17%) in Home delivery vs 23 (12%) in HCF. This had limitations as the LTFU in both groups includes unknown number of deaths. Crude mortality was higher in the HBD cohort compared to the HCF cohort, though this difference was not statistically significant (17.3% vs. 11.5%, p  =  0.10).
Retention − 70% in home model vs 71% in facility
CROSS-SECTIONAL STUDY
 Chimukangarta 2017 [57] Zimbabwe Outreach ART delivery No comparator N = 143 18 months Viral suppression- over the course of the study period, 94% were virally suppressed