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Couples app aims to cut HIV and STI rates in male partners

NCT ID NCT05708014

Prevention Sponsor: Florida International University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed trial tested a digital program called LuvHub for male couples. The program includes modules on HIV/STI prevention, communication, and relationship goals. Over 16 months, 778 couples used the tool to create personalized prevention plans and agreements. The study measured new HIV and STI infections, as well as changes in relationship dynamics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LuvHub digital intervention
What this could lead to
If successful, this could provide an effective, scalable way for male couples to reduce HIV and STI risk together.
What could go wrong
The trial is completed but results are not yet widely reported; the intervention is behavioral, so its impact may vary by couple.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

778 people

The number who actually took part.

Started

Jan 2023

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. assigned male at birth and currently identify as male (cis-gender) or gender queer; 2. has had condomless anal sex (CAS) within the prior 3 months; 3. both partners endorse being in a relationship with one another, defined as "someone you feel emotionally or romantically committed to above all others, and may be referred to as partner, husband, boyfriend etc."; 4. be in a relationship with current partner for at least 3 months; 5. be at least 18 years of age; 6. not have any history of intimate partner violence since relationship began; 7. self-report not feeling coerced by partner to take part in the study activities, 8. has own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer); 9. lives in the U.S. and plans to live in the U.S. for the next 16 months; 10. willing to complete the activities required to obtain and mail back their biomedical data (i.e., self-administer a rapid HIV test (if applicable), willing to use swabs to self-collect their own specimens for STI testing, willing to provide dried blood spot for ART adherence (if applicable), willing to provide dried blood spot for PrEP adherence (if applicable). Exclusion Criteria: * Does not meet one or more of the inclusion criteria

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Conditions

The condition(s) this trial relates to.

AIDS Risk Reduction Behavior Sexual Behavior sexually transmitted disease HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV HIV infections Risk reduction Sexual behavior Sexually transmitted diseases Sexually transmitted infection

Contacts and locations

Locations

  • Florida International University

    Miami, Florida, 33199, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.