Evidence map›Paper›PMID 35349466›Full record

ArticleJMIR research protocols2022

Evaluation of the Implementation and Effectiveness of a Mobile Health Intervention to Improve Outcomes for People With HIV in the Washington, DC Cohort: Study Protocol for a Cluster Randomized Controlled Trial.

Jacqueline Hodges, Sylvia Caldwell, Wendy Cohn, Tabor Flickinger, Ava Lena Waldman, Rebecca Dillingham, Amanda Castel, Karen Ingersoll

Registry-linked trialAbstract read
In one paragraph

Article in JMIR research protocols, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04998019 (Pragmatic Efficacy Trial of mHealth to Improve HIV Outcomes in the DC Cohort), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT04998019 nacompletednot on this map

Pragmatic Efficacy Trial of mHealth to Improve HIV Outcomes in the DC Cohort

TypeinterventionalSponsorGeorge Washington UniversityRan2022 to 2025Enrolled682ConditionsHIV/AIDSArmsPositiveLinks
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
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

8 authors.

Jacqueline HodgesDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, United States.ORCID https://orcid.org/0000-0001-9879-7502
Sylvia CaldwellDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, United States.ORCID https://orcid.org/0000-0003-3222-9355
Wendy CohnPublic Health Sciences, University of Virginia, Charlottesville, VA, United States.ORCID https://orcid.org/0000-0002-4351-8497
Tabor FlickingerDepartment of Medicine, University of Virginia, Charlottesville, VA, United States.ORCID https://orcid.org/0000-0001-8820-2536
Ava Lena WaldmanDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, United States.ORCID https://orcid.org/0000-0002-7784-3159
Rebecca DillinghamDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, United States.ORCID https://orcid.org/0000-0001-9748-1215
Amanda CastelMilken Institute School of Public Health, George Washington University, Washington, DC, United States.ORCID https://orcid.org/0000-0002-9095-2413
Karen IngersollDepartment of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, VA, United States.ORCID https://orcid.org/0000-0001-8115-2548

Funding

Terry Beirn CPCRA Clinical Trials UnitUM1AI069503 · NIAID · GEORGE WASHINGTON UNIVERSITY · PI KAN, VIRGINIA · 2012 to 2020
$38.5M
The DC Cohort: A Longitudinal Population-Based Cohort Study of People Living with HIV in Washington, DCR24AI152598 · NIAID · GEORGE WASHINGTON UNIVERSITY · PI Amanda Derryck Castel, Marinella Temprosa · 2020 to 2026
$37.9M
INFECTIOUS DISEASES TRAINING PROGRAMT32AI007046 · NIAID · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI Alison K Criss, William A Petri · 1985 to 2026
$15.3M
Pragmatic Efficacy Trial of mHealth to Improve HIV Outcomes in the DC CohortR01MH122375 · NIMH · GEORGE WASHINGTON UNIVERSITY · PI CASTEL, AMANDA DERRYCK, INGERSOLL, KAREN S · 2020 to 2024
$3.5M
NIAID NIH HHS R24 AI152598NIAID NIH HHS T32 AI007046NIAID NIH HHS UM1 AI069503NIMH NIH HHS R01 MH122375
6 · The paper itself

Abstract

backgroundGaps remain in achieving retention in care and durable HIV viral load suppression for people with HIV in Washington, DC (hereafter DC). Although people with HIV seeking care in DC have access to a range of supportive services, innovative strategies are needed to enhance patient engagement in this setting. Mobile health (mHealth) interventions have shown promise in reaching previously underengaged groups and improving HIV-related outcomes in various settings.

objectiveThis study will evaluate the implementation and effectiveness of a clinic-deployed, multifeature mHealth intervention called PositiveLinks (PL) among people with HIV enrolled in the DC Cohort, a longitudinal cohort of people with HIV receiving care in DC. A cluster randomized controlled trial will be conducted using a hybrid effectiveness-implementation design and will compare HIV-related outcomes between clinics randomized to PL versus usual care.

methodsThe study aims are threefold: (1) We will perform a formative evaluation of PL in the context of DC Cohort clinics to test the feasibility, acceptability, and usability of PL and tailor the platform for use in this context. (2) We will conduct a cluster randomized controlled trial with 12 DC Cohort clinics randomized to PL or usual care (n=6 [50%] per arm) and measure the effectiveness of PL by the primary outcomes of patient visit constancy, retention in care, and HIV viral load suppression. We aim to enroll a total of 482 participants from DC Cohort clinic sites, specifically including people with HIV who show evidence of inconsistent retention in care or lack of viral suppression. (3) We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to measure implementation success and identify site, patient, provider, and system factors associated with successful implementation. Evaluation activities will occur pre-, mid-, and postimplementation.

resultsFormative data collection was completed between April 2021 and January 2022. Preliminary mHealth platform modifications have been performed, and the first round of user testing has been completed. A preimplementation evaluation was performed to identify relevant implementation outcomes and design a suite of instruments to guide data collection for evaluation of PL implementation throughout the trial period. Instruments include those already developed to support DC Cohort Study activities and PL implementation in other cohorts, which required modification for use in the study, as well as novel instruments designed to complete data collection, as guided by the CFIR and RE-AIM frameworks.

conclusionsFormative and preimplementation evaluations will be completed in spring 2022 when the trial is planned to launch. Specifically, comprehensive formative data analysis will be completed following data collection, coding, preliminary review, and synthesis. Corresponding platform modifications are ready for beta testing within the DC Cohort. Finalization of the platform for use in the trial will follow beta testing.

trial registrationClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/ct2/show/NCT04998019. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37748.

Indexed as

cluster randomized controlled trialHIVhuman immunodeficiency virusimplementation sciencemHealthmobile healthsmartphone

Identifiers

PMID35349466
PMCPMC9077495

What OpenQuestion holds

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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.