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Acceptability, Feasibility and Preliminary Impact of OurPlan, an mHealth HIV Prevention Intervention for Male Couples (OurPlan)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Waitlist
Intervention
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for both partners of the male couple:

  • self-reported that currently self-identifies as a male
  • self-reported in a sexual relationship with another self-identified male
  • self-reported relationship length between 1 and 12 months
  • self-reported anal sex with relationship partner in past 2 months
  • owns and uses an Internet-connected smartphone or tablet
  • resides in the U.S.
  • self-reported ability to read and understand English-language

Exclusion Criteria:

  • Does not meet one or more the inclusion criteria

Sites / Locations

  • Florida International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate intervention

Waitlist-delayed intervention

Arm Description

From baseline to 2-month post-test, participants in the intervention arm will have access to the OurPlan program app.

Participants in this study arm will not have access to the OurPlan program in the app from baseline to day 30 (month 1) of the trial. From day 31 to day 60, participants in this study arm will be given access to the OurPlan program in the app.

Outcomes

Primary Outcome Measures

Change in presence of a detailed risk-reduction plan
Men will be asked if they created a detailed risk-reduction plan containing evidence-based strategies of routine HIV/STI testing, consistent condom use, PrEP, and ART
Change in number of evidence-based prevention strategies being used over time
Men will be asked how many evidence-based HIV/STI prevention strategies they are currently using
Change in willingness to use evidence-based prevention strategies over time
Men will be asked about their willingness to use evidence-based prevention strategies
Change in intention to use evidence-based prevention strategies over time
Men will be asked about their intention to use evidence-based prevention strategies

Secondary Outcome Measures

Change in HIV transmission and prevention knowledge
Men will be asked about their knowledge on HIV transmission and prevention over time
Change in goal congruence on sexual health
Men will be asked about their goal congruence regarding sexual health and their relationship partner
Change in mutual constructive communication
Men will be asked about their mutual constructive communication patterns over time

Full Information

First Posted
April 5, 2021
Last Updated
September 14, 2021
Sponsor
Florida International University
Collaborators
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04836091
Brief Title
Acceptability, Feasibility and Preliminary Impact of OurPlan, an mHealth HIV Prevention Intervention for Male Couples
Acronym
OurPlan
Official Title
A Patient-centered Decision Aid to Inform HIV Prevention Choices for At-risk Male Couples in New Relationships
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida International University
Collaborators
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. Participants/couples 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. Participants/couples 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-month pilot randomized controlled trial with a a waitlist control condition of one month
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate intervention
Arm Type
Experimental
Arm Description
From baseline to 2-month post-test, participants in the intervention arm will have access to the OurPlan program app.
Arm Title
Waitlist-delayed intervention
Arm Type
Experimental
Arm Description
Participants in this study arm will not have access to the OurPlan program in the app from baseline to day 30 (month 1) of the trial. From day 31 to day 60, participants in this study arm will be given access to the OurPlan program in the app.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Intervention Description
From day 31 to day 60 (ie., during month 2) of the trial, participants in the waitlist arm will be granted access and instructed to use the OurPlan program as directed. The OurPlan program includes 4 modules covering topics of communication, HIV/STI prevention, HIV/STI statistics, and stigma / discrimination. Each module contains content, questions, and an activity for the participant and couple to complete. OurPlan also includes a resource locator using GPS-capabilities to allow participants to find sexual health resources, as well as a calendar and reminder system. One goal of OurPlan is to help both partners of the couple create and use a risk-reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own and partner-related attitudes toward these strategies.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
From day 1 to day 60 (ie., entire 2 month duration) of the trial, participants in the intervention arm will be granted access and instructed to use the OurPlan program as directed. The OurPlan program includes 4 modules covering topics of communication, HIV/STI prevention, HIV/STI statistics, and stigma / discrimination. Each module contains content, questions, and an activity for the participant and couple to complete. OurPlan also includes a resource locator using GPS-capabilities to allow participants to find sexual health resources, as well as a calendar and reminder system. One goal of OurPlan is to help both partners of the couple create and use a risk-reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own and partner-related attitudes toward these strategies.
Primary Outcome Measure Information:
Title
Change in presence of a detailed risk-reduction plan
Description
Men will be asked if they created a detailed risk-reduction plan containing evidence-based strategies of routine HIV/STI testing, consistent condom use, PrEP, and ART
Time Frame
Baseline, month 2
Title
Change in number of evidence-based prevention strategies being used over time
Description
Men will be asked how many evidence-based HIV/STI prevention strategies they are currently using
Time Frame
Baseline, month 2
Title
Change in willingness to use evidence-based prevention strategies over time
Description
Men will be asked about their willingness to use evidence-based prevention strategies
Time Frame
Baseline, month 2
Title
Change in intention to use evidence-based prevention strategies over time
Description
Men will be asked about their intention to use evidence-based prevention strategies
Time Frame
Baseline, month 2
Secondary Outcome Measure Information:
Title
Change in HIV transmission and prevention knowledge
Description
Men will be asked about their knowledge on HIV transmission and prevention over time
Time Frame
Baseline, month 2
Title
Change in goal congruence on sexual health
Description
Men will be asked about their goal congruence regarding sexual health and their relationship partner
Time Frame
Baseline, month 2
Title
Change in mutual constructive communication
Description
Men will be asked about their mutual constructive communication patterns over time
Time Frame
Baseline, month 2

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Trans men and cisgender men
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for both partners of the male couple: self-reported that currently self-identifies as a male self-reported in a sexual relationship with another self-identified male self-reported relationship length between 1 and 12 months self-reported anal sex with relationship partner in past 2 months owns and uses an Internet-connected smartphone or tablet resides in the U.S. self-reported ability to read and understand English-language Exclusion Criteria: Does not meet one or more the inclusion criteria
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
Starting 6 months after publication
IPD Sharing Access Criteria
Interested researchers must email the PI with a request to access de-identified, anonymous IPD. The PI will review such requests for secondary analyses using de-identified data that have already been published.

Learn more about this trial

Acceptability, Feasibility and Preliminary Impact of OurPlan, an mHealth HIV Prevention Intervention for Male Couples

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