Evidence map›Paper›PMID 39210314›Full record

ArticleBMC public health2024

Supporting treatment adherence for resilience and thriving (START): protocol for a mHealth randomized controlled trial.

Leah Davis-Ewart, Lindsay Atkins, Delaram Ghanooni, José E Diaz, Chika C Chuku, Raymond Balise, Britt A DeVries, Michael Miller-Perusse, Donovan Ackley Iii, Judith T Moskowitz and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC public health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05140876 (Supporting Treatment Adherence for Resilience and Thriving), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05140876 nacompletednot on this map

Supporting Treatment Adherence for Resilience and Thriving

TypeinterventionalSponsorFlorida International UniversityRan2022 to 2025Enrolled286ConditionsAdherence, Medication, HIV-1-infection, Stimulant UseArmsSTART mHealth Intervention
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

15 authors.

Leah Davis-EwartDepartment of Disease Prevention and Health Promotion, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 S.W. 8th Street, AHC5, #407, Miami, Fl, 33199, USA.
Lindsay AtkinsDepartment of Psychology, San Diego State University, San Diego, CA, USA.
Delaram GhanooniDepartment of Disease Prevention and Health Promotion, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 S.W. 8th Street, AHC5, #407, Miami, Fl, 33199, USA.
José E DiazDepartment of Medicine, State University of New York Downstate Health Sciences University, New York, NY, USA.
Chika C ChukuDepartment of Disease Prevention and Health Promotion, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 S.W. 8th Street, AHC5, #407, Miami, Fl, 33199, USA.
Raymond BaliseDepartment of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.
Britt A DeVriesDepartment of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.
Michael Miller-PerusseDepartment of Psychology, San Diego State University, San Diego, CA, USA.
Donovan Ackley IiiDepartment of Psychology, San Diego State University, San Diego, CA, USA.
Judith T MoskowitzDepartment of Medical Social Sciences, Northwestern University School of Medicine, Chicago, IL, USA.
Kathryn McCollisterDepartment of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.
Erminia FardoneDepartment of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.
Sabina HirshfieldDepartment of Medicine, State University of New York Downstate Health Sciences University, New York, NY, USA.
Keith J HorvathDepartment of Psychology, San Diego State University, San Diego, CA, USA.
Adam W CarricoDepartment of Disease Prevention and Health Promotion, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 S.W. 8th Street, AHC5, #407, Miami, Fl, 33199, USA. acarrico@fiu.edu.

Funding

Supporting Treatment Adherence For Resilience and Thriving (START): A MHealth Intervention to Improve ART Adherence For HIV-Positive Stimulant Using Men - Diversity SupplementR01DA049843 · NIDA · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI CARRICO, ADAM WAYNE · 2019 to 2023
$3.9M
NIDA NIH HHS R01 DA049843NIDA NIH HHS R01DA049843
6 · The paper itself

Abstract

backgroundAlthough behavioral interventions show some promise for reducing stimulant use and achieving durable viral suppression in sexual minority men (SMM) with HIV, scalable mHealth applications are needed to optimize their reach and cost-effectiveness.

methodsSupporting Treatment Adherence for Resilience and Thriving (START) is a randomized controlled trial (RCT) testing the efficacy and cost-effectiveness of a mHealth application that integrates evidence-based positive affect regulation skills with self-monitoring of adherence and mood. The primary outcome is detectable HIV viral load (i.e., > 300 copies/mL) from self-collected dried blood spot (DBS) specimens at 6 months. Secondary outcomes include detectable DBS viral load at 12 months, self-reported stimulant use severity, anti-retroviral therapy (ART) adherence, and positive affect over 12 months. A national sample of up to 250 SMM with HIV who screen positive for stimulant use disorder and reporting suboptimal ART adherence is being recruited via social networking applications through April of 2024. After providing informed consent, participants complete a run-in period (i.e., waiting period) including two baseline assessments with self-report measures and a self-collected DBS sample. Those who complete the run-in period are randomized to either the START mHealth application or access to a website with referrals to HIV care and substance use disorder treatment resources. Participants provide DBS samples at baseline, 6, and 12 months to measure HIV viral load as well as complete self-report measures for secondary outcomes at quarterly follow-up assessments over 12 months. DISCUSSION: To date, we have paid $117,500 to advertise START on social networking applications and reached 1,970 eligible participants ($59.77 per eligible participant). Although we identified this large national sample of potentially eligible SMM with HIV who screen positive for a stimulant use disorder and report suboptimal ART adherence, only one-in-four have enrolled in the RCT. The run-in period has proven to be crucial for maintaining scientific rigor and reproducibility of this RCT, such that only half of consented participants complete the required study enrollment activities and attended a randomization visit. Taken together, findings will guide adequate resource allocation to achieve randomization targets in future mHealth research SMM with HIV who use stimulants.

trial registrationThis protocol was registered on clinicaltrials.gov (NCT05140876) on December 2, 2021.

Indexed as

HIV InfectionsTelemedicineAdultAnti-Retroviral AgentsCost-Benefit AnalysisHumansMaleMedication AdherenceRandomized Controlled Trials as TopicResilience, PsychologicalSexual and Gender MinoritiesSubstance-Related DisordersTreatment Adherence and ComplianceViral LoadAnti-Retroviral AgentsDried blood spotsHIVMen who have sex with menmHealthStimulant useViral load

Identifiers

PMID39210314
PMCPMC11360769

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.