Table 2

Characteristics of included studies
Study Design Study duration Setting Inclusion and exclusion criteria Age Gender Sample size analysed Intervention Interval to viral load measure HIV viral load outcomes
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)

§Jaffar et al. [37]: The rate ratio obtained from this trial was based on time to virologic failure measured over a period of 36 months in contrast to the other studies included in this search that used risk ratios or odds ratios (OR) at 12 months. This rate ratio was reciprocated so as to change it from time to failure to time to HIV suppression. The rate ratio was reciprocated again so that the ratio is of home-based to facility-base care. Finally this home-based to facility-based care rate ratio was used to approximate the OR of HIV suppression, which resulted in the same estimate OR of 1.04 (95% CI: 0.78 – 1.40).

Chishinga et al.

Chishinga et al. BMC Public Health 2014 14:239   doi:10.1186/1471-2458-14-239

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