Evidence map›Paper›PMID 27658873›Full record

Trial reportThe lancet. HIV2016

Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial.

Gideon Amanyire, Fred C Semitala, Jennifer Namusobya, Richard Katuramu, Leatitia Kampiire, Jeanna Wallenta, Edwin Charlebois, Carol Camlin, James Kahn, Wei Chang and 4 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. HIV, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 102 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 10 pooled it
11.4field-weighted citation impact, top 1% 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.

NCT01810289 nacompletednot on this map

The "START" (a Streamlined ART Initiation Strategy) Study

TypeinterventionalSponsorUniversity of California, San FranciscoRan2013 to 2016Enrolled12,024ConditionsHIVArmsSTART
NCT04712058 naunknown statusnot on this mapstarted 2021, after this paper: background citation

A Multicenter Clinical Trial to Evaluate the Feasibility and Outcome of Same-day Antiretroviral Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Among Patients Testing Positive by HIV Confirmatory Tests

TypeinterventionalSponsorNational Taiwan University HospitalRan2021 to 2023Enrolled200ConditionsHIV InfectionsArmsBictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy]
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 10 syntheses or guidelines pooled it, 145 citations in OpenAlex.

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  3. Audit and feedback: effects on professional practice.The Cochrane database of systematic reviews · 2025
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  8. Rapid initiation of antiretroviral therapy for people living with HIV.The Cochrane database of systematic reviews · 2019
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42 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 2 institutions in 2 countries.

Gideon AmanyireMakerere University, Kampala, Uganda.
Fred C SemitalaMakerere University, Kampala, Uganda.
Jennifer NamusobyaMakerere University, Kampala, Uganda.
Richard KaturamuMakerere University, Kampala, Uganda.
Leatitia KampiireMakerere University, Kampala, Uganda.
Jeanna WallentaUniversity of California San Francisco, San Francisco, CA, USA.
Edwin CharleboisUniversity of California San Francisco, San Francisco, CA, USA.
Carol CamlinUniversity of California San Francisco, San Francisco, CA, USA.
James KahnUniversity of California San Francisco, San Francisco, CA, USA.
Wei ChangUniversity of California San Francisco, San Francisco, CA, USA.
David GliddenUniversity of California San Francisco, San Francisco, CA, USA.
Moses KamyaMakerere University, Kampala, Uganda.
Diane HavlirUniversity of California San Francisco, San Francisco, CA, USA.
Elvin GengUniversity of California San Francisco, San Francisco, CA, USA. Electronic address: elvin.geng@ucsf.edu.
University of California, San Francisco · USMakerere University · UG

Funding

Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Sheri Ann Lippman · 2001 to 2026
$57.4M
Reducing Failure-to-Initiate ART: Streamlined ART Start Strategy (START)U01AI099959 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2012 to 2016
$39.7M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
NIAID NIH HHS U01 AI099959NIAID NIH HHS UM1 AI069496NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

backgroundIn Africa, up to 30% of HIV-infected patients who are clinically eligible for antiretroviral therapy (ART) do not start timely treatment. We assessed the effects of an intervention targeting prevalent health systems barriers to ART initiation on timing and completeness of treatment initiation.

methodsIn this stepped-wedge, non-blinded, cluster-randomised controlled trial, 20 clinics in southwestern Uganda were randomly assigned in groups of five clinics every 6 months to the intervention by a computerised random number generator. This procedure continued until all clinics had crossed over from control (standard of care) to the intervention, which consisted of opinion-leader-led training and coaching of front-line health workers, a point-of-care CD4 cell count testing platform, a revised counselling approach without mandatory multiple pre-initiation sessions, and feedback to the facilities on their ART initiation rates and how they compared with other facilities. Treatment-naive, HIV-infected adults (aged ≥18 years) who were clinically eligible for ART during the study period were included in the study population. The primary outcome was ART initiation 14 days after first clinical eligibility for ART. This study is registered with ClinicalTrials.gov, number NCT01810289.

findingsBetween April 11, 2013, and Feb 2, 2015, 12 024 eligible patients visited one of the 20 participating clinics. Median CD4 count was 310 cells per μL (IQR 179-424). 3753 of 4747 patients (weighted proportion 80%) in the intervention group had started ART by 2 weeks after eligibility compared with 2585 of 7066 patients (38%) in the control group (risk difference 41·9%, 95% CI 40·1-43·8). Vital status was ascertained in a random sample of 208 patients in the intervention group and 199 patients in the control group. Four deaths (2%) occurred in the intervention group and five (3%) occurred in the control group.

interpretationA multicomponent intervention targeting health-care worker behaviour increased the probability of ART initiation 14 days after eligibility. This intervention consists of widely accessible components and has been tested in a real-world setting, and is therefore well positioned for use at scale.

fundingNational Institute of Allergy and Infectious Diseases (NIAID) and the President's Emergency Fund for AIDS Relief (PEPFAR).

Indexed as

Antiretroviral Therapy, Highly ActiveTime-to-TreatmentAdultAfricaAnti-HIV AgentsCD4 Lymphocyte CountDrug Administration ScheduleFemaleHIV InfectionsHumansMaleMiddle AgedTreatment OutcomeUgandaViral LoadYoung AdultAnti-HIV Agents

Identifiers

PMID27658873
PMCPMC5408866
OpenAlexW2512229472

What OpenQuestion holds

Textmetadata
LicenceTDM
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.