A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.
HIV
electronic health
men who have sex with men
mobile health
pre-exposure prophylaxis
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
21 Feb 2020
21 Feb 2020
Historique:
received:
12
09
2019
accepted:
15
12
2019
revised:
26
11
2019
entrez:
5
3
2020
pubmed:
5
3
2020
medline:
5
3
2020
Statut:
epublish
Résumé
HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low. The aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States. In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription. Participant recruitment began in January 2020. This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States. ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942. PRR1-10.2196/16231.
Sections du résumé
BACKGROUND
BACKGROUND
HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low.
OBJECTIVE
OBJECTIVE
The aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States.
METHODS
METHODS
In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription.
RESULTS
RESULTS
Participant recruitment began in January 2020.
CONCLUSIONS
CONCLUSIONS
This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
PRR1-10.2196/16231.
Identifiants
pubmed: 32130178
pii: v9i2e16231
doi: 10.2196/16231
pmc: PMC7060494
doi:
Banques de données
ClinicalTrials.gov
['NCT03763942']
Types de publication
Journal Article
Langues
eng
Pagination
e16231Subventions
Organisme : NIAID NIH HHS
ID : P30 AI050409
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI138783
Pays : United States
Organisme : NIDA NIH HHS
ID : R01 DA045612
Pays : United States
Organisme : NIMH NIH HHS
ID : R21 MH112449
Pays : United States
Informations de copyright
©Jeb Jones, Karen Dominguez, Rob Stephenson, Joanne D Stekler, Amanda D Castel, Leandro A Mena, Samuel M Jenness, Aaron J Siegler, Patrick S Sullivan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.02.2020.
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