Evidence map›Paper›PMID 28720039›Full record

ReviewHIV clinical trials2017

The REVAMP trial to evaluate HIV resistance testing in sub-Saharan Africa: a case study in clinical trial design in resource limited settings to optimize effectiveness and cost effectiveness estimates.

Mark J Siedner, Mwebesa B Bwana, Mahomed-Yunus S Moosa, Michelle Paul, Selvan Pillay, Suzanne McCluskey, Isaac Aturinda, Kevin Ard, Winnie Muyindike, Pravikrishnen Moodley and 7 more

Registry-linked trialAbstract readReview
In one paragraph

Review in HIV clinical trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02787499 (Resistance Testing Versus Adherence Support for Management of Patients With Virologic Failure on First-Line Antiretroviral Therapy in Sub-Saharan Africa), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–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.

NCT02787499 nacompletednot on this map

Resistance Testing Versus Adherence Support for Management of Patients With Virologic Failure on First-Line Antiretroviral Therapy in Sub-Saharan Africa

TypeinterventionalSponsorMassachusetts General HospitalRan2016 to 2020Enrolled840ConditionsHIV, AIDSArmsHIV-1 RNA Resistance Testing
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

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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

17 authors.

Mark J Siednera Department of Medicine , Massachusetts General Hospital , Boston , MA , USA.
Mwebesa B Bwanab Faculty of Medicine , Mbarara University of Science and Technology , Mbarara , Uganda.
Mahomed-Yunus S Moosac Division of Medicine , University of KwaZulu-Natal , Durban , South Africa.
Michelle Paula Department of Medicine , Massachusetts General Hospital , Boston , MA , USA.
Selvan Pillayc Division of Medicine , University of KwaZulu-Natal , Durban , South Africa.
Suzanne McCluskeya Department of Medicine , Massachusetts General Hospital , Boston , MA , USA.
Isaac Aturindab Faculty of Medicine , Mbarara University of Science and Technology , Mbarara , Uganda.
Kevin Arda Department of Medicine , Massachusetts General Hospital , Boston , MA , USA.
Winnie Muyindikeb Faculty of Medicine , Mbarara University of Science and Technology , Mbarara , Uganda.
Pravikrishnen Moodleyc Division of Medicine , University of KwaZulu-Natal , Durban , South Africa.
Jaysingh Brijkumarc Division of Medicine , University of KwaZulu-Natal , Durban , South Africa.
Tamlyn Rautenbergc Division of Medicine , University of KwaZulu-Natal , Durban , South Africa.
Gavin Georgec Division of Medicine , University of KwaZulu-Natal , Durban , South Africa.
Brent Johnsone Department of Biostatistics and Computational Biology , University of Rochester , Rochester , NY , USA.
Rajesh T Gandhia Department of Medicine , Massachusetts General Hospital , Boston , MA , USA.
Henry Sunpathc Division of Medicine , University of KwaZulu-Natal , Durban , South Africa.
Vincent C Marconid Department of Medicine , Emory University , Atlanta , GA , USA.

Funding

PROGRAM FOR AIDS CLINICAL RESEARCH TRAINING (PACRT)T32AI007433 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI MARK J SIEDNER · 1992 to 2026
$11.4M
Resistance testing versus adherence support for management of patients with virologic failure on first-line antiretroviral therapy in sub-Saharan Africa: An open-label randomized controlled trialR01AI124718 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI MUYINDIKE, WINNIE, SIEDNER, MARK J · 2016 to 2020
$3.0M
Behavioral Aspects of Low-cost Medical Devices to Improve HIV CareK23MH099916 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI SIEDNER, MARK J · 2013 to 2017
$917k
NIAID NIH HHS R01 AI124718NIAID NIH HHS T32 AI007433NIMH NIH HHS K23 MH099916
6 · The paper itself

Abstract

backgroundIn sub-Saharan Africa, rates of sustained HIV virologic suppression remain below international goals. HIV resistance testing, while common in resource-rich settings, has not gained traction due to concerns about cost and sustainability.

objectiveWe designed a randomized clinical trial to determine the feasibility, effectiveness, and cost-effectiveness of routine HIV resistance testing in sub-Saharan Africa. APPROACH: We describe challenges common to intervention studies in resource-limited settings, and strategies used to address them, including: (1) optimizing generalizability and cost-effectiveness estimates to promote transition from study results to policy; (2) minimizing bias due to patient attrition; and (3) addressing ethical issues related to enrollment of pregnant women.

methodsThe study randomizes people in Uganda and South Africa with virologic failure on first-line therapy to standard of care virologic monitoring or immediate resistance testing. To strengthen external validity, study procedures are conducted within publicly supported laboratory and clinical facilities using local staff. To optimize cost estimates, we collect primary data on quality of life and medical resource utilization. To minimize losses from observation, we collect locally relevant contact information, including Whatsapp account details, for field-based tracking of missing participants. Finally, pregnant women are followed with an adapted protocol which includes an increased visit frequency to minimize risk to them and their fetuses.

conclusionsREVAMP is a pragammatic randomized clinical trial designed to test the effectiveness and cost-effectiveness of HIV resistance testing versus standard of care in sub-Saharan Africa. We anticipate the results will directly inform HIV policy in sub-Saharan Africa to optimize care for HIV-infected patients.

Indexed as

Drug Resistance, ViralGenotyping TechniquesMicrobial Sensitivity TestsAfrica South of the SaharaAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveCost-Benefit AnalysisFemaleHealth PromotionHIV-1HIV InfectionsHumansMalePregnancyRandomized Controlled Trials as TopicResearch DesignAnti-HIV AgentsAntiretroviral therapyCost-effectivenessGenotypic resistance testingHIV/AIDSRandomized controlled trialSub-Saharan AfricaTreatment failure

Identifiers

PMID28720039
PMCPMC5598555

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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.