Twelve-Month Outcomes of Community-Based Differentiated Models of Multimonth Dispensing of ART Among Stable HIV-Infected Adults in Lesotho: A Cluster-Randomized Noninferiority Trial

Abstract

Background: Lesotho adopted the test-and-treat approach for HIV treatment in June 2016, which increased antiretroviral treatment (ART) clinic volume. We evaluated community-based vs. facility-based differentiated models of multimonth dispensing of ART among stable HIV-infected adults in Lesotho. Methods: Thirty facilities were randomized to 3 arms, facility 3-monthly ART (3MF) (control), community ART groups (3MC), and 6-monthly community distribution points (6MCD). We estimated risk differences (RDs) between arms using population-averaged generalized estimating equations, controlling for baseline imbalances and specifying for clustering. The primary outcome was retention in ART care by intention-to-treat and virologic suppression as a secondary outcome (ClinicalTrials.gov: NCT03438370). Results: A total of 5,336 participants were enrolled, with 1898, 1558, and 1880 in 3MF, 3MC, and 6MCD, respectively. Retention in ART care was not different across arms and achieved the prespecified noninferiority limit (−3.25%) between 3MC vs. 3MF (control); 6MCD vs. 3MF; and 6MCD vs. 3MC, adjusted RD = −0.1% [95% confidence interval (CI): −1.6% to 1.5%], adjusted RD = −1.3% (95% CI: −3.0% to 0.5%), and adjusted RD = −1.2% (95% CI: −2.9% to 0.5%), respectively. After 12 months, 98.6% (n = 1503), 98.1% (n = 1126), and 98.3% (n = 1285) were virally load (VL) suppressed in 3MF, 3MC, and 6MCD, respectively. There were no differences in VL between 3MC vs. control and 6MCD vs. control, risk ratio (RR) = 1.00 (95% CI: 0.98 to 1.01) and RR = 1.00 (95% CI: 0.98 to 1.01), respectively. Conclusions: There were no differences in retention and VL suppression for stable HIV-infected participants receiving multimonth dispensing of ART within community-based differentiated models when compared with the facility-based standard-of-care model.

Economic evaluation of differentiated service delivery models for HIV treatment in Lesotho: costs to providers and patients

“…A total of 5,336 participants enrolled in the trial, including 1,898 in the 3MF arm, 1,558 in the 3MC arm, and 1,880 in the 6MCD arm [10]. The median age was 42.7 (IQR 34.7 to 54.0) in the 3MF arm, 48.4 (IQR 39.4 to 57.8) in the 3MC arm, and 41.2 (IQR 33.3 to 51.4) in the 6MCD arm.…”

“…Across all arms, the majority of participants were female: 1158 (61%) in the 3MF arm, 1117 (72%) in the 3MC arm and 1264 (67%) in the 6MCD arm. Approximately a quarter of participants lived greater than a 9km radius from their health facility (21.6% to 27.8%) [10]. The retention rates 12 months after enrolment were identical among study arms: 97.1% in 3MF (96.6% for women, 97.7% for men), 96.5% in 3MC (96.8% for women, 95.9% for men) and 94.7% in 6MCD (94.4% for women, 95.3% for men) [10].…”

“…Patients were defined as stable and eligible for the trial if they were (i) 18 years of age or older; (ii) on ART ≥ six months with no periods of defaulting on treatment since the last VL result (ART default defined as missing seven or more consecutive days of ART); (iii) on a first-line ART regimen; and (iv) had no ARV drug substitutions since the last VL result < 1,000 copies/ml and plasma or dried-blood spot VL < 1,000 copies/ ml. Patients were excluded if they were pregnant or less than 12 months postpartum and breastfeeding mothers, had comorbidities, or had been diagnosed with a WHO clinical stage 3 or 4 condition within the past three months [10].…”

“…Participants were enrolled between August 2017 and April 2018, and follow-up continued until July 2019. Details and primary outcomes of the trial are reported elsewhere (ClinicalTrials.gov Identifier: NCT03438370) [8,10].…”

Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study

“…Such approaches are feasible and acceptable, and achieve equivalent or improved retention in care and viral suppression. [4][5][6][7][8] To date, numerous countries in sub-Saharan Africa have adopted DSD models, 9 and some have modified eligibility for these programmes in response to the COVID-19 pandemic as a means to promote social distancing. 10 While most DSD programmes limit eligibility to patients who are clinically stable, heterogeneity exists with respect to definitions of stability.…”