Evidence map›Paper›PMID 32097252›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2020

Outcomes of Three- Versus Six-Monthly Dispensing of Antiretroviral Treatment (ART) for Stable HIV Patients in Community ART Refill Groups: A Cluster-Randomized Trial in Zimbabwe.

Geoffrey Fatti, Nicoletta Ngorima-Mabhena, Eula Mothibi, Trish Muzenda, Regis Choto, Tonderai Kasu, Taurayi A Tafuma, Nyika Mahachi, Kudakwashe C Takarinda, Tsitsi Apollo and 4 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialPragmatic Clinical TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03238846 (Outcomes of Differentiated Models of Care), which is not on this map. Cited by 51 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 4 pooled it
1.7field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03238846 naunknown statusnot on this map

Outcomes of Differentiated Models of Care: Multi-Month Dispensing (MMD) and Community ART Refill Groups (CARGs) in Stable ART Patients

TypeinterventionalSponsorKheth'ImpiloRan2017 to 2019Enrolled4,676ConditionsHIV/AIDSArmsThree month dispensing of ART in CARGs, Six month dispensing of ART in CARGs
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 4 syntheses or guidelines pooled it, 91 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 4 institutions in 2 countries.

Geoffrey FattiKheth'Impilo AIDS Free Living, Cape Town, South Africa.
Nicoletta Ngorima-MabhenaKheth'Impilo, Harare, Zimbabwe.
Eula MothibiKheth'Impilo AIDS Free Living, Cape Town, South Africa.
Trish MuzendaKheth'Impilo AIDS Free Living, Cape Town, South Africa.
Regis ChotoMinistry of Health and Child Care, Zimbabwe.
Tonderai KasuMinistry of Health and Child Care, Zimbabwe.
Taurayi A TafumaFHI360, Zimbabwe.
Nyika MahachiFHI360, Zimbabwe.
Kudakwashe C TakarindaMinistry of Health and Child Care, Zimbabwe.
Tsitsi ApolloMinistry of Health and Child Care, Zimbabwe.
Owen MugurungiMinistry of Health and Child Care, Zimbabwe.
Charles ChaselaEQUIP Health, Centurion, South Africa.
Risa M HoffmanDivision of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, USA.
Ashraf GrimwoodKheth'Impilo AIDS Free Living, Cape Town, South Africa.
Ministry of Health and Child Welfare · ZWKheth’Impilo · ZAEducation Labour Relations Council · ZAUniversity of Cape Town · ZA

Funding

PEPFAR
6 · The paper itself

Abstract

introductionMultimonth dispensing (MMD) of antiretroviral treatment (ART) aims to reduce patient-related barriers to access long-term treatment and improve health system efficiency. However, randomized evidence of its clinical effectiveness is lacking. We compared MMD within community ART refill groups (CARGs) vs. standard-of-care facility-based ART delivery in Zimbabwe.

methodsA three-arm, cluster-randomized, pragmatic noninferiority trial was performed. Thirty health care facilities and associated CARGs were allocated to either ART collected three-monthly at facility (3MF, control); ART delivered three-monthly in CARGs (3MC); or ART delivered six-monthly in CARGs (6MC). Stable adults receiving ART ≥six months with baseline viral load (VL) <1000 copies/ml were eligible. Retention in ART care (primary outcome) and viral suppression (VS) 12 months after enrollment were compared, using regression models specified for clustering (ClinicalTrials.gov: NCT03238846).

results4800 participants were recruited, 1919, 1335, and 1546 in arms 3MF, 3MC, and 6MC, respectively. For retention, the prespecified noninferiority limit (-3.25%, risk difference [RD]) was met for comparisons between all arms, 3MC (94.8%) vs. 3MF (93.0%), adjusted RD = 1.1% (95% CI: -0.5% to 2.8%); 6MC (95.5%) vs. 3MF: aRD = 1.2% (95% CI: -1.0% to 3.6%); and 6MC vs. 3MC: aRD = 0.1% (95% CI: -2.4% to 2.6%). VL completion at 12 months was 49%, 45%, and 8% in 3MF, 3MC, and 6MC, respectively. VS in 3MC (99.7%) was high and not different to 3MF (99.1%), relative risk = 1.0 (95% CI: 1.0-1.0). VS was marginally reduced in 6MC (92.9%) vs. 3MF, relative risk = 0.9 (95% CI: 0.9-1.0).

conclusionRetention in CARGs receiving three- and six-monthly MMD was noninferior versus standard-of-care facility-based ART delivery. VS in 3MC was high. VS in six-monthly CARGs requires further evaluation.

Indexed as

Drug PrescriptionsHIV-1Ambulatory CareAnti-Retroviral AgentsCluster AnalysisCommunity Health ServicesCommunity NetworksFemaleHIV InfectionsHumansMaleMedication AdherenceTime FactorsTreatment OutcomeViral LoadAnti-Retroviral Agents

Identifiers

PMID32097252
PMCPMC7172979
OpenAlexW3010264465

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.