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NCT05708014Completed

Personalized Prevention for Couples: A 16-month Digital RCT

Personalized Prevention for Couples

Source: ClinicalTrials.gov · Last updated 17 Sept 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Interventional
Enrollment
778 (actual)
First submitted
23 Jan 2023
Start date
11 Jan 2023
Primary completion date
25 Aug 2025
Lead sponsor
Florida International University
Diseases
HIV
NCT number
NCT05708014

What you commit to

  • Study type: Interventional
  • Participants enrolled: 778
  • From 11 Jan 2023 to the primary completion date, 25 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Does not meet one or more of the inclusion criteria

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Florida International University
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.