Personalized Prevention for Couples: A 16-month Digital RCT

Completed · Not applicable

Conditions studied: Hiv, HIV Infections, Sexually Transmitted Infection, Sexually Transmitted Diseases, Sexual Behavior, Risk Reduction

In brief

This couples-based, digital health intervention project is serostatus neutral and seeks to determine efficacy for: a) use and adherence to evidence-based HIV/STI prevention-care strategies; b) creation and adherence to a tailored prevention-care plan; c) creation and adherence to a tailored sexual agreement; and d) improvements in other relationship dynamics among male couples who are in a relationship (defined as greater than 3 months or more).

Key facts

Study ID

NCT05708014

Run by

Florida International University

People needed

778

Starts

2023-01-11

Expected to finish

2025-08-25

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• assigned male at birth and currently identify as male (cis-gender) or gender queer;
• has had condomless anal sex (CAS) within the prior 3 months;
• 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.";
• be in a relationship with current partner for at least 3 months;
• be at least 18 years of age;
• not have any history of intimate partner violence since relationship began;
• self-report not feeling coerced by partner to take part in the study activities,
• has own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
• lives in the U.S. and plans to live in the U.S. for the next 16 months;
• 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).

You may not qualify if…

• Does not meet one or more of the inclusion criteria

Where it is running

• Florida International University — Miami, Florida, United States

Full record on ClinicalTrials.gov

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