18 and older, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Retention in Care at 12 MonthsPrimary· 12 months
The primary outcome to be studied is whether scripting/dispensing of ART for intervals of six months is non-inferior to three months with respect to retention in care.
Group
Value
95% CI
Standard of Care ART Dispensing (SOC)
2478
Three-month ART Dispensing (3MD)
2356
Six-month ART Dispensing (6MD)
2729
Standard of Care ART Dispensing (SOC)
60
Three-month ART Dispensing (3MD)
66
Six-month ART Dispensing (6MD)
58
Standard of Care ART Dispensing (SOC)
11
Three-month ART Dispensing (3MD)
8
Six-month ART Dispensing (6MD)
8
Standard of Care ART Dispensing (SOC)
463
Three-month ART Dispensing (3MD)
296
Six-month ART Dispensing (6MD)
186
Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI)Secondary· 12 months
The secondary outcome to be studied is the cost-effectiveness of scripting/dispensing of ART for intervals of six months compared to three months and SOC. Cost-effectiveness will be estimated as the average cost per successful outcome (patient retained at 12 months).
Achieved primary outcome
Group
Value
95% CI
Malawi: Standard of Care (SOC)
89.00
87.90 – 91.90
Malawi: 3 Month Dispensing (3MD)
88.40
86.44 – 90.36
Malawi: 6 Month Dispensing (6MD)
85.92
83.97 – 87.89
Zambia: Standard of Care (SOC)
143.60
141.68 – 145.60
Zambia: 3 Month Dispensing (3MD)
141.60
139.64 – 143.56
Zambia: 6 Month Dispensing (6MD)
131.13
129.20 – 133.12
Did not achieve primary outcome
Group
Value
95% CI
Malawi: Standard of Care (SOC)
63.40
61.42 – 65.37
Malawi: 3 Month Dispensing (3MD)
62.30
60.35 – 64.30
Malawi: 6 Month Dispensing (6MD)
66.10
64.12 – 68.09
Zambia: Standard of Care (SOC)
99.00
97.04 – 100.98
Zambia: 3 Month Dispensing (3MD)
99.00
97.04 – 100.98
Zambia: 6 Month Dispensing (6MD)
99.00
96.98 – 100.92
All patients
Group
Value
95% CI
Malawi: Standard of Care (SOC)
86.50
84.50 – 88.42
Malawi: 3 Month Dispensing (3MD)
86.00
83.99 – 87.91
Malawi: 6 Month Dispensing (6MD)
84.60
82.62 – 86.54
Zambia: Standard of Care (SOC)
132.00
130.43 – 134.35
Zambia: 3 Month Dispensing (3MD)
134.00
132.09 – 136.02
Zambia: 6 Month Dispensing (6MD)
128.00
125.64 – 129.57
Sponsor's own description
This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression, and cost compared to the standard of care. The study will be conducted in Malawi and Zambia among approximately 8,200 HIV-1-infected adults (18 years or older) who are stable on ART. Clusters will be randomized to one of three study arms: (1) standard of care (SOC) ART scripting (varies by country, region, clinic, and/or provider), (2) three-month ART scripting, and (3) six-month ART scripting. 30 clusters will be selected for the study, 15 in Malawi and 15 in Zambia, and will be randomized to a study arm.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07293559 — Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
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NCT06919016 — A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-
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NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
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· recruiting
NCT06774872 — Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Succes
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· recruiting
NCT06890988 — Ending the Epidemic Interventions in the Dental Setting - UH3
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by University of California, Los Angeles
Last refreshed: 27 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03101592.