Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836091
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2021-04-05
Brief Title:
Acceptability Feasibility and Preliminary Impact of OurPlan an mHealth HIV Prevention Intervention for Male Couples
Sponsor:
Florida International University
Organization:
Florida International University
Study Overview
Official Title:
A Patient-centered Decision Aid to Inform HIV Prevention Choices for At-risk Male Couples in New Relationships
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OurPlan
Brief Summary:
The study will evaluate the use and preliminary impact of an mHealth app for improving sexual health outcome measures among male couples by assessing whether exposure and use of the app results in improvements in participants and couples self-reported sexual health and prevention behaviors beliefs and attitudes The study will enroll both men of the couple into a randomized controlled trial Participantscouples randomized to the intervention will have access to the app for two months while those assigned to the waitlist group will receive and have access to the app for one month Participants will complete surveys at baseline and at month 2
Detailed Description:
The study will evaluate the use and preliminary impact of an mHealth app for improving sexual health outcome measures among male couples by assessing whether exposure and use of the app results in improvements in participants and couples self-reported sexual health and prevention behaviors beliefs and attitudes The study will enroll both partners of the 42 male couples into a 2-month randomized controlled trial with a waitlist control condition of one month Couples will be assigned to either the immediate intervention group intervention arm or the waitlist-control group waitlist-control arm All participants will take an assessment survey at baseline and the intervention group will be oriented on the installation and use of the app upon randomization to that group The waitlist-control group will follow the same procedures one month later Participantscouples randomized to the intervention arm will have access to the intervention app for two months ie day 1-60 while those assigned to the waitlist-control group will have access to the app for one month ie day 31-60 All participants in the randomized controlled trial will complete a short follow-up survey at month 2 and a brief exit interview
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None