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

 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)

 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

 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