Study | Design | Study duration | Setting | Inclusion and exclusion criteria | Age | Gender | Sample size analysed | Intervention | Interval to viral load measure | HIV viral load outcomes |
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Jaffar et al. [37] | Cluster randomised trial: Equivalence trial | 36 months | Home and Outpatient clinics in Jinja district, Uganda | Included: 1. Patients >18 years old; 2. Starting ART for the first time. Excluded: Patients living 100 km away from the ART clinic, where the provision of the home-based intervention was not possible. | Mean age in intervention arm 37 years (range 32–44); Mean age in control arm 38 years (range 33–44) | 73% Female (625/859) in intervention arm; 68% Female (406/594) in control arm | n = 1212: 729 (22 clusters) in intervention arm; 483 (22 clusters) in control arm | Intervention arm: monthly visits to a patient’s home by field staff to deliver ARVs and monitor signs and symptoms of drug toxicity or disease progression, and provide adherence support. Control arm: Standard care provided at the clinic. | Viral load measured at 6, 12, 18, 24,30 and 36 months | Time to RNA viral load >500 copies/ml. “Home-based HIV care was as effective as was facility-based care.”% of persons with undetectable viral load at 12 months in intervention arm = (729–117)/729 = 84.0%;% of persons with undetectable viral load at 12 months in control arm: (483–80)/483 = 83.4%. Rate ratio 1 · 04 (95% CI: 0 · 78 – 1 · 40; equivalence shown). Odds Ratio = 1.04 (95% CI: 0.78 – 1.40) § |
Nachega et al. [35] | Randomised controlled trial: Superiority trial | 24 months | Home and Public clinic in Cape Town, South Africa | Included: 1. Male or non-pregnant female ≥18 years old; 2. HIV infection documented by two serologic tests; 3. Eligible to start ART (CD4 ≤ 200 cells/μL or WHO Clinical Stage IV disease); 4. Living in the study site catchment area at a stable address; 5. Willing to disclose HIV status to a treatment supporter; 6. Signed informed consent. Excluded: 1. Patients with prior ART use; 2. Life expectancy <6 months; 3. Karnofsky Performance Score <60; 4. Serious liver disease; or 5. History of single dose nevirapine for prevention of mother to child transmission of HIV infection. | Mean age in intervention arm 35.7 years (SD 9.7); Mean age in control arm 36.7 years (SD 9.2) | 57.7% female in intervention arm; 57.7% female in control arm | n = 272: 136 in intervention arm; 136 in control arm | Intervention arm: In addition to standard care at the clinic, trained treatment supporters provided ART adherence support, observed at least one medication dose daily and documented it on a study adherence chart. Control arm: Standard care provided at the clinic. | Viral load measured at 12 and 24 months | RNA viral load <400 copies/ml. “DOT-ART showed no effect on virologic outcomes”.% of persons with undetectable viral load at 12 months in intervention arm = 99/(99 + 37) = 72.8%;% of persons with undetectable viral load at 12 months in control arm = 93/(93 + 43) = 68.4%. Odds Ratio of HIV suppression at 12 months = (99/37)/ (93/43) = 1.24 (95% CI: 0.73 – 2.09) |
Chang et al. [38] | Cluster randomised trial: Superiority trial | 48 months | Home and Public clinics in rural Rakai District, South West Uganda | Included: All adult patients who were either already on ART at the start of the trial or were started on ART at any time during the trial. | Mean age in intervention arm 35.5 years (range 15–76); Mean age in control arm 34.0 years (range 17–70) | 65.8% female in intervention arm; 67.5% female in control arm | n = 620: 456 (10 clusters) in intervention arm; 164 (5 clusters) in control arm | Intervention arm: Standard care of ARV delivery at the clinic plus biweekly home-based review by a peer health worker who checked for symptoms of treatment failure; patient self-report of adherence; pill count and provision of counselling and education in ART adherence and general HIV/AIDS-related issues. Control arm: Standard ART care provided at the clinic. | Viral load measured at 6, 12, 18, 24,30, 36, 42, 48 months | RNA viral load >400 copies/ml. At 12 months (48 weeks), no significant differences were found between the intervention and control arm.% of persons with undetectable viral load at 12 months in intervention arm = (456–42)/456 = 90.8%;% of persons with undetectable viral load at 12 months in control arm = (164–18)/164 = 89.0%. Risk Ratio 0.83 (95% CI: 0.47 – 1.48). Odds Ratio of HIV suppression at 12 months = 1/0.83 = 1.20 (95% CI: 0.68 – 2.13) |
Taiwo et al. [36] | Randomised controlled trial: Superiority trial | 12 months | Home and Tertiary Hospital HIV clinic in Jos, Nigeria | Included: 1. HIV-1-infected; 2. Treatment-naïve; 3. Age >15 years; 4. Eligible for ART (clinical diagnosis of AIDS, CD4 count <350 cells/μL with HIV-related symptoms or CD4 count <200 cells/μL regardless of symptoms); 5.Willingness and ability to select a treatment partner. Excluded: Patients with severe illness. | Mean age 34.2 years (SD 8.9) | 66.1% female in intervention arm; 63.3% in control arm | n = 499: 248 in the intervention arm; 251 in the control arm | Intervention arm: In addition to standard care at the clinic, a treatment partner residing in same house or close proximity observed the ingestion of ARVs at least once daily. The treatment partner reported adverse effects and reminded participants of drug pick-up at the hospital. Control arm: Standard care provided at the Hospital HIV clinic. | Viral load measured at 6 and 12 months | RNA viral load <400 copies/ml. At 12 months (48 weeks), no significant differences were found in HIV suppression between the intervention and control arm. % of persons with undetectable viral load at 12 months in intervention arm = 162/248 = 65.3%;% of persons with undetectable viral load at 12 months in control arm = 149/251 = 59.4%. Odds Ratio = 1.28 (95% CI: 0.89 – 1.84) |
Matovu et al. [17] | Randomised controlled trial: Non-inferiority trial | 12 months | Home and PMTCT follow-up clinic, Mulago National Referral Hospital in Kampala, Uganda | Included: 1. Female; 2. Age ≥18 years; 3. Provision of written informed consent; 4. ≥36 weeks of gestation; 5. Eligible for ART (WHO Clinical Stage II/IV or CD4 counts <200 cells/μL); 6. Demonstrated compliance with ART screening visits; 7. Residence in a stable home within 15 km of Mulago Hospital; 8. Willing and able to come to the clinic regularly without transport reimbursement; 9. Willing to be home visited. | Mean age in intervention arm 27.8 years (SD 4.9); Mean age in control arm 27.0 years (SD 5.4) | All Females | n = 85: 45 in the intervention arm; 40 in the control arm | Intervention arm: Involved peer counsellors and home visiting, combined with nurses providing care at routine visits, and longer intervals between scheduled visits. Control arm: Standard care provided at the Hospital promoted adherence through routine counselling at each scheduled visit, care provided by a medical officer at each visit, and shorter intervals between visits. | Viral load measured at 6 and 12 months | RNA viral load <400 copies/ml.% of persons with undetectable viral load at 12 months was similar in the intervention (= 88%) and control (= 91%) arm. Odds Ratio of HIV suppression at 12 months = (0.88/ (1–0.88)) / (0.91/ (1–0.91)) = 0.73 (95% CI: 0.18 – 2.96) |