Evidence map›Paper›PMID 32787925›Full record

ArticleImplementation science : IS2020

Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda.

Jillian L Kadota, Allan Musinguzi, Juliet Nabunje, Fred Welishe, Jackie L Ssemata, Opira Bishop, Christopher A Berger, Devika Patel, Amanda Sammann, Anne Katahoire and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Implementation science : IS, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03934931 (Options for Delivering Isoniazid-Rifapentine), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
0.3field-weighted citation impact, top 28% 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.

NCT03934931 nacompletednot on this map

Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention: the 3HP Options Implementation Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2020 to 2025Enrolled1,656ConditionsTuberculosis, Latent Tuberculosis, HIV/AIDSArmsStreamlined weekly DOT visits, Weekly DOT visit reminders, Cost reimbursement DOT, 99DOTS, Weekly SAT dosing reminders/check-ins
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 23 citations in OpenAlex.

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  13. Understanding patient-level costs of weekly isoniazid-rifapentine (3HP) among people living with HIV in Uganda.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
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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

21 authors at 8 institutions in 2 countries.

Jillian L KadotaDivision of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
Allan MusinguziInfectious Diseases Research Collaboration, Kampala, Uganda.
Juliet NabunjeInfectious Diseases Research Collaboration, Kampala, Uganda.
Fred WelisheInfectious Diseases Research Collaboration, Kampala, Uganda.
Jackie L SsemataInfectious Diseases Research Collaboration, Kampala, Uganda.
Opira BishopMakerere University Joint AIDS Program, Kampala, Uganda.
Christopher A BergerDivision of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
Devika PatelDepartment of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
Amanda SammannDepartment of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
Anne KatahoireChild Health and Development Centre, Makerere University, Kampala, Uganda.
Payam NahidDivision of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
Robert BelknapDenver Health and Hospital Authority, Denver, CO, USA.
Patrick P J PhillipsDivision of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
Jennifer NamusobyaUniversity Research Company, Center for Human Services, Department of Defense HIV/AIDS Prevention Program (URC-DHAPP), Kampala, Uganda.
Moses KamyaInfectious Diseases Research Collaboration, Kampala, Uganda.
Margaret A HandleyCenter for Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, San Francisco, CA, USA.
Noah KiwanukaDepartment of Epidemiology and Biostatistics, School of Public Health, Makerere University, Kampala, Uganda.
Achilles KatambaDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
David DowdyUganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.
Fred C SemitalaInfectious Diseases Research Collaboration, Kampala, Uganda. semitala@gmail.com.ORCID 0000-0002-0624-7640
Adithya CattamanchiDivision of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
Infectious Diseases Research Collaboration · UGMakerere University · UGSan Francisco General Hospital · USUniversity of California, San Francisco · USDenver Health Medical Center · USJohns Hopkins University · USMulago Hospital · UGUniversity Research Co (United States) · US

Funding

Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
Options for Delivery of Short-Course Tuberculosis Preventive Therapy: The 3HP Options TrialR01HL144406 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Adithya Cattamanchi, David Wesley Dowdy · 2018 to 2026
$4.4M
NHLBI NIH HHS R01 HL144406NHLBI NIH HHS R01HL144406NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

backgroundRecently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain.

methodsWe developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. DISCUSSION: 3HP-one of the most promising interventions for TB prevention-will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion.

trial registrationClinicalTrials.gov: NCT03934931 ; Registered 2 May 2019.

Indexed as

HIV InfectionsLatent TuberculosisTuberculosisAntitubercular AgentsHumansPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicUgandaAntitubercular AgentsEffectiveness-implementation hybridHIV/AIDSIsoniazidPatient choicePerson-centered carePreference trialsRifapentineTuberculosis preventive therapy

Identifiers

PMID32787925
PMCPMC7425004
OpenAlexW3048415721

What OpenQuestion holds

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LicenceCC BY
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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.