Evidence map›Paper›PMID 34275866›Full record

Trial reportBMJ global health2021

Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation: a cluster randomised trial in Malawi.

Pitchaya P Indravudh, Katherine Fielding, Richard Chilongosi, Rebecca Nzawa, Melissa Neuman, Moses K Kumwenda, Rose Nyirenda, Cheryl C Johnson, Miriam Taegtmeyer, Nicola Desmond and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ global health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02718274 (HIV Self-testing Africa), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.6field-weighted citation impact, top 30% 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.

NCT02718274 nacompletednot on this map

HIV Self-testing Africa (STAR) Malawi: General Population - A Cluster Randomized Trial of Providing HIV and Self-testing Kits Through Community-based Distribution Agents

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2016 to 2018Enrolled5,504ConditionsHIVArmsOraQuick ADVANCE HIV I/II test kits, packaged for self-use (manufactured in Thailand), Home-based initiation of ARVs
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Inequalities in the provision of rapid HIV testing in primary health care: ecological study, Paraná, 2013-2023.Epidemiologia e servicos de saude : revista do Sistema Unico de Saude do Brasil · 2026
    Article
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  6. Review
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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

12 authors at 5 institutions in 5 countries.

Pitchaya P IndravudhDepartment of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK pitchaya.indravudh@lshtm.ac.uk.ORCID 0000-0003-4013-7645
Katherine FieldingDepartment of Infectious Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.
Richard ChilongosiPopulation Services International, Blantyre, Malawi.
Rebecca NzawaMalawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
Melissa NeumanDepartment of Infectious Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.ORCID 0000-0002-8870-6504
Moses K KumwendaMalawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
Rose NyirendaDepartment of HIV and AIDS, Ministry of Health, Lilongwe, Malawi.
Cheryl C JohnsonGlobal HIV, Hepatitis and Sexually Transmitted Infections Programmes, World Health Organization, Geneve, Switzerland.
Miriam TaegtmeyerDepartment of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.
Nicola DesmondMalawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
Karin HatzoldPopulation Services International, Washington, DC, USA.
Elizabeth L CorbettMalawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
University of Liverpool · GBLondon School of Hygiene & Tropical Medicine · GBMinistry of Health · MWPopulation Services International · USUniversity of the Witwatersrand · ZA

Funding

Medical Research Council MR/R010161/1Wellcome Trust 200901/Z/16/ZWellcome Trust WT091769World Health Organization 001
6 · The paper itself

Abstract

introductionReaching high coverage of HIV testing remains essential for HIV diagnosis, treatment and prevention. We evaluated the effectiveness and safety of door-to-door distribution of HIV self-testing (HIVST) kits in rural Malawi.

methodsThis cluster randomised trial, conducted between September 2016 and January 2018, used restricted 1:1 randomisation to allocate 22 health facilities and their defined areas to door-to-door HIVST alongside the standard of care (SOC) or the SOC alone. The study population included residents (≥16 years). HIVST kits were provided door-to-door by community-based distribution agents (CBDAs) for at least 12 months. The primary outcome was recent HIV testing (in the last 12 months) measured through an endline survey. Secondary outcomes were lifetime HIV testing and cumulative 16-month antiretroviral therapy (ART) initiations, which were captured at health facilities. Social harms were reported through community reporting systems. Analysis compared cluster-level outcomes by arm.

resultsOverall, 203 CBDAs distributed 273 729 HIVST kits. The endline survey included 2582 participants in 11 HIVST clusters and 2908 participants in 11 SOC clusters. Recent testing was higher in the HIVST arm (68.5%, 1768/2582) than the SOC arm (48.9%, 1422/2908), with adjusted risk difference (RD) of 16.1% (95% CI 6.5% to 25.7%). Lifetime testing was also higher in the HIVST arm (86.9%, 2243/2582) compared with the SOC arm (78.5%, 2283/2908; adjusted RD 6.3%, 95% CI 2.3% to 10.3%). Differences were most pronounced for adolescents aged 16-19 years (adjusted RD 18.6%, 95% CI 7.3% to 29.9%) and men (adjusted RD 10.2%, 95% CI 3.1% to 17.2%). Cumulative incidence of ART initiation was 1187.2 and 909.0 per 100 000 population in the HIVST and SOC arms, respectively (adjusted RD 309.1, 95% CI -95.5 to 713.7). Self-reported HIVST use was 42.5% (1097/2582), with minimal social harms reported.

conclusionDoor-to-door HIVST increased recent and lifetime testing at population level and showed high safety, underscoring potential for HIVST to contribute to HIV elimination goals in priority settings. TRIAL REGISTRATION NUMBER: NCT02718274.

Indexed as

HIV InfectionsHIV TestingAdolescentHumansMalawiMaleMass ScreeningSelf-TestingCluster randomised trialepidemiologyHIVother diagnostic or tool

Identifiers

PMID34275866
PMCPMC8287599
OpenAlexW3184054388

What OpenQuestion holds

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LicenceCC BY-NC
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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.