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Behavioral Intervention
Digital Prevention Program for HIV/STI Risk Reduction in Couples (LuvHub Trial)
N/A
Waitlist Available
Led By Jason W Mitchell, PhD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8-months, 8-months to 16-months, baseline to 16-months
Awards & highlights
LuvHub Trial Summary
This trial tests an online program to reduce HIV/STI risk among male couples in long-term relationships.
Who is the study for?
This trial is for male couples in the U.S. who've been together for at least 3 months, are over 18, have had unprotected sex recently, and can use a web-connected device. They should not feel coerced to participate and must not have a history of intimate partner violence.Check my eligibility
What is being tested?
The study tests 'LuvHub', a digital health intervention aimed at improving HIV/STI prevention-care strategies among male couples. One group uses LuvHub immediately while another waits (Waitlist Control) before accessing it.See study design
What are the potential side effects?
Since this is a digital intervention focusing on education and behavior change rather than medication or medical procedures, traditional physical side effects are not expected.
LuvHub Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 8-months, 8-months to 16-months, baseline to 16-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8-months, 8-months to 16-months, baseline to 16-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HIV incidence by comparing results from test kits received at baseline to 16-months.
Change in STI incidence by comparing results from test kits received at baseline to 16-months.
Changes in adherence to agreement by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
+9 moreLuvHub Trial Design
2Treatment groups
Experimental Treatment
Group I: Waitlist ControlExperimental Treatment1 Intervention
From baseline to 8-months, participants in the waitlist control condition will have access to the LuvHub web app for post-baseline assessments of 4 and 8 months, and the resources section.
From 8-months to 16-months, participants randomized to the waitlist control arm will then have access to the LuvHub web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur every 4 months (12 & 16-months).
Group II: InterventionExperimental Treatment1 Intervention
From baseline to 16-months, participants randomized to the intervention arm will have access to the LuvHub web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur every 4 months (4, 8, 12, & 16-months).
Find a Location
Who is running the clinical trial?
University of MichiganOTHER
1,795 Previous Clinical Trials
6,373,186 Total Patients Enrolled
Florida International UniversityLead Sponsor
99 Previous Clinical Trials
16,555 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,357 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am in a committed relationship, recognized by both of us.I was assigned male at birth and identify as male or gender queer.I have had unprotected anal sex in the last 3 months.I am 18 years old or older.I am willing to self-test for HIV, STIs, and provide samples for medication adherence.My partner and I are committed to each other above anyone else.You own a web-enabled device such as a smartphone, laptop, tablet, or computer.I am 18 years old or older.You have been with your current partner for a minimum of three months.You are not being forced by your partner to participate in the study.You have not experienced any intimate partner violence since the start of your relationship.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Waitlist Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing recruitment effort for this research project?
"Affirmative. According to the clinicaltrials.gov records, this examination is actively looking for volunteers and was first posted on November 1st 2023 with its most recent update taking place on January 23rd 2023. The trial requires 600 participants distributed across two sites."
Answered by AI
How many study participants have registered for this research project?
"Affirmative. Per the records hosted on clinicaltrials.gov, this trial is currently recruiting patients with 600 individuals being sought from 2 distinct medical centers. The study was originally posted on January 11th 2023 and has since been updated as recently as January 23rd 2023."
Answered by AI
Who else is applying?
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
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