Trial Outcomes & Findings for Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men (NCT NCT04865341)

NCT ID: NCT04865341

Last Updated: 2026-05-01

Results Overview

Self-reported self-administration of HIV testing within the past 3 months (i.e., since baseline assessment).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

118 participants

Primary outcome timeframe

3 months

Results posted on

2026-05-01

Participant Flow

Individuals were recruited to participate in the randomized controlled trial from social media via Meta, Grindr-a men-for-men geosocial networking app, and referrals from other studies conducted at the Center for AIDS Intervention Research beginning March 2024 with enrollment complete by July 2024. We iteratively refined ads in partnership with a youth advisory board and queer-led professional marketing firm to recruit a diverse sample of YSMM by race/ethnicity.

There is no difference between the number of participants enrolled in the study and the number who started the study.

Participant milestones

Participant milestones
Measure
Experimental IMB Group
Individuals randomized to this arm will receive a behavioral intervention based on the Information-Motivation-Behavior (IMB) model designed to increase HIV self-testing and PrEP uptake.
Information-Only Control
Attention-matched comparison condition (information-only)
Overall Study
STARTED
58
60
Overall Study
COMPLETED
58
60
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Experimental IMB Group
n=58 Participants
Individuals randomized to this arm will receive a behavioral intervention based on the Information-Motivation-Behavior (IMB) model designed to increase HIV self-testing and PrEP uptake.
Information-Only Control
n=60 Participants
Attention-matched comparison condition (information-only)
Total
n=118 Participants
Total of all reporting groups
Age, Continuous
21.3 Years
STANDARD_DEVIATION 2.2 • n=14 Participants
21.8 Years
STANDARD_DEVIATION 2.1 • n=34 Participants
21.5 Years
STANDARD_DEVIATION 2.2 • n=69 Participants
Sex/Gender, Customized
Cisgender male
52 Participants
n=14 Participants
57 Participants
n=34 Participants
109 Participants
n=69 Participants
Sex/Gender, Customized
Transgender male or non-binary
6 Participants
n=14 Participants
3 Participants
n=34 Participants
9 Participants
n=69 Participants
Race/Ethnicity, Customized
Asian American/Pacific Islander
5 Participants
n=14 Participants
6 Participants
n=34 Participants
11 Participants
n=69 Participants
Race/Ethnicity, Customized
Black or African American
13 Participants
n=14 Participants
7 Participants
n=34 Participants
20 Participants
n=69 Participants
Race/Ethnicity, Customized
Hispanic or Latino/x
17 Participants
n=14 Participants
25 Participants
n=34 Participants
42 Participants
n=69 Participants
Race/Ethnicity, Customized
White
22 Participants
n=14 Participants
18 Participants
n=34 Participants
40 Participants
n=69 Participants
Race/Ethnicity, Customized
Multiracial or another category
1 Participants
n=14 Participants
4 Participants
n=34 Participants
5 Participants
n=69 Participants

PRIMARY outcome

Timeframe: 3 months

Self-reported self-administration of HIV testing within the past 3 months (i.e., since baseline assessment).

Outcome measures

Outcome measures
Measure
Experimental IMB Group
n=58 Participants
Individuals randomized to this arm will receive a behavioral intervention based on the Information-Motivation-Behavior (IMB) model designed to increase HIV self-testing and PrEP uptake.
Information-Only Control
n=60 Participants
Attention-matched comparison condition (information-only)
Number of Participants With Self-reported Self-administration of HIV Testing
46 Participants
44 Participants

PRIMARY outcome

Timeframe: 3 months

Self-reported PrEP uptake

Outcome measures

Outcome measures
Measure
Experimental IMB Group
n=58 Participants
Individuals randomized to this arm will receive a behavioral intervention based on the Information-Motivation-Behavior (IMB) model designed to increase HIV self-testing and PrEP uptake.
Information-Only Control
n=60 Participants
Attention-matched comparison condition (information-only)
Number of Participants With Self-reported PrEP Uptake
9 Participants
10 Participants

Adverse Events

Experimental IMB Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Information-Only Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven A. John, PhD, MPH

University of Minnesota Medical School

Phone: 612-625-1500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place