Evidence map›Paper›PMID 31719030›Full record

ArticleJMIR research protocols2019

A Mobile Health App to Improve HIV Medication Adherence: Protocol for a Pilot Randomized Controlled Trial.

Susan Ramsey, Evan Ames, Julia Uber, Samia Habib, Seth Clark

Registry-linked trialAbstract read
In one paragraph

Article in JMIR research protocols, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02676128 (Mobile Health Application to Improve HIV Medication Adherence), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

NCT02676128 nacompletednot on this map

Mobile Health Application to Improve HIV Medication Adherence

TypeinterventionalSponsorRhode Island HospitalRan2016 to 2020Enrolled80ConditionsHIV, Medication Adherence, Mobile HealthArmsTwine Collaborative Care Application, Information-Motivation-Behavioral Skills Model of ART Adherence
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
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

5 authors.

Susan RamseyThe Warren Alpert Medical School of Brown University, Providence, RI, United States.ORCID https://orcid.org/0000-0001-7169-727X
Evan AmesRhode Island Hospital, Providence, RI, United States.ORCID https://orcid.org/0000-0002-4624-1390
Julia UberRhode Island Hospital, Providence, RI, United States.ORCID https://orcid.org/0000-0003-3909-9442
Samia HabibRhode Island Hospital, Providence, RI, United States.ORCID https://orcid.org/0000-0003-2021-1801
Seth ClarkThe Warren Alpert Medical School of Brown University, Providence, RI, United States.ORCID https://orcid.org/0000-0002-0244-732X

Funding

Mobile Health Application to Improve HIV Medication AdherenceR34MH108431 · NIMH · RHODE ISLAND HOSPITAL · PI RAMSEY, SUSAN E · 2015 to 2017
$737k
NIMH NIH HHS R34 MH108431
6 · The paper itself

Abstract

backgroundAdherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence.

objectiveThe primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes.

methodsThis study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations.

resultsPhase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020.

conclusionsThis study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus.

trial registrationClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15356.

Indexed as

HIVmedication adherencemobile health

Identifiers

PMID31719030
PMCPMC6881780

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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.