Evidence map›Paper›PMID 19939445›Full record

Trial reportLancet (London, England)2009

Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial.

Shabbar Jaffar, Barbara Amuron, Susan Foster, Josephine Birungi, Jonathan Levin, Geoffrey Namara, Christine Nabiryo, Nicaise Ndembi, Rosette Kyomuhangi, Alex Opio and 6 more

2 registry-linked trialsAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Lancet (London, England), 2009. 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 138 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
138citing papers in PubMed, 16 pooled it
–field-weighted citation impact
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.

NCT02776254 nacompletednot on this mapstarted 2016, after this paper: background citation

Community ART for Retention in Zambia: Evaluating the Feasibility, Effectiveness, and Efficiency of Decentralized and Streamlined Antiretroviral Therapy Care Models

TypeinterventionalSponsorCentre for Infectious Disease Research in ZambiaRan2016 to 2017Enrolled3,100ConditionsHIVArmsSTART, CAG, UAG, FAST-TRACK
NCT03058484 nacompletednot on this mapstarted 2015, after this paper: background citation

Short-term Effectiveness of a Community Health Worker Intervention for HIV-infected Pregnant Women in Tanzania to Improve Treatment Adherence and Retention in Care: A Cluster-Randomized Trial

TypeinterventionalSponsorUniversity of California, BerkeleyRan2015 to 2016Enrolled1,830ConditionsVertical Transmission of Infectious Disease, HIV InfectionsArmsCommunity Health Worker intervention
3 · Its place in the literature

Who cites it

138 citing papers in PubMed, 16 syntheses or guidelines pooled it.

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  14. Decentralising HIV treatment in lower- and middle-income countries.The Cochrane database of systematic reviews · 2013
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78 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Shabbar JaffarDepartment of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: shabbar.jaffar@lshtm.ac.uk.
Barbara AmuronMedical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
Susan FosterDepartment of International Health, Boston University School of Public Health, Boston, MA, USA.
Josephine BirungiThe AIDS Support Organisation, Kampala, Uganda.
Jonathan LevinMedical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
Geoffrey NamaraMedical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
Christine NabiryoThe AIDS Support Organisation, Kampala, Uganda.
Nicaise NdembiMedical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
Rosette KyomuhangiMedical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
Alex OpioDepartment of National Disease Control, Ministry of Health, Kampala, Uganda.
Rebecca BunnellUS Centers for Disease Control and Prevention, Nairobi, Kenya.
Jordan W TapperoUS Centers for Disease Control and Prevention, Entebbe, Uganda.
Jonathan MerminUS Centers for Disease Control and Prevention, Nairobi, Kenya.
Alex CoutinhoInfectious Disease Institute, Mulago Hospital, Kampala, Uganda.
Heiner GrosskurthDepartment of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK; Medical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
Jinja trial team

Funding

A Randomized Trail of Home or Facility-Based AIDS CareU01PS000065 · PS · UGANDA VIRUS RESEARCH INSTITUTE · PI GROSSKURTH, HEINER · 2004 to 2008
$2.1M
Medical Research Council G0700837NCHHSTP CDC HHS IU01-PS000065-01NCHHSTP CDC HHS U01 PS000065
6 · The paper itself

Abstract

backgroundIdentification of new ways to increase access to antiretroviral therapy in Africa is an urgent priority. We assessed whether home-based HIV care was as effective as was facility-based care.

methodsWe undertook a cluster-randomised equivalence trial in Jinja, Uganda. 44 geographical areas in nine strata, defined according to ratio of urban and rural participants and distance from the clinic, were randomised to home-based or facility-based care by drawing sealed cards from a box. The trial was integrated into normal service delivery. All patients with WHO stage IV or late stage III disease or CD4-cell counts fewer than 200 cells per microL who started antiretroviral therapy between Feb 15, 2005, and Dec 19, 2006, were eligible, apart from those living on islands. Follow-up continued until Jan 31, 2009. The primary endpoint was virological failure, defined as RNA more than 500 copies per mL after 6 months of treatment. The margin of equivalence was 9% (equivalence limits 0.69-1.45). Analyses were by intention to treat and adjusted for baseline CD4-cell count and study stratum. This trial is registered at http://isrctn.org, number ISRCTN 17184129.

findings859 patients (22 clusters) were randomly assigned to home and 594 (22 clusters) to facility care. During the first year, 93 (11%) receiving home care and 66 (11%) receiving facility care died, 29 (3%) receiving home and 36 (6%) receiving facility care withdrew, and 8 (1%) receiving home and 9 (2%) receiving facility care were lost to follow-up. 117 of 729 (16%) in home care had virological failure versus 80 of 483 (17%) in facility care: rates per 100 person-years were 8.19 (95% CI 6.84-9.82) for home and 8.67 (6.96-10.79) for facility care (rate ratio [RR] 1.04, 0.78-1.40; equivalence shown). Two patients from each group were immediately lost to follow-up. Mortality rates were similar between groups (0.95 [0.71-1.28]). 97 of 857 (11%) patients in home and 75 of 592 (13%) in facility care were admitted at least once (0.91, 0.64-1.28).

interpretationThis home-based HIV-care strategy is as effective as is a clinic-based strategy, and therefore could enable improved and equitable access to HIV treatment, especially in areas with poor infrastructure and access to clinic care.

Indexed as

Community Health ServicesHome Care ServicesAdenineAdultAnti-HIV AgentsCD4 Lymphocyte CountFemaleHIVHIV InfectionsHumansLamivudineMaleNevirapineOrganophosphonatesStavudineTenofovirAdenineAnti-HIV AgentsLamivudineNevirapineOrganophosphonatesStavudineTenofovirZidovudine

Identifiers

PMID19939445
PMCPMC2806484

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.