CompletedNot Applicable

Personalized Prevention for Couples: A 16-month Digital RCT

United States778 participantsStarted 2023-01-11

Plain-language summary

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).

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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);

What they're measuring

Change in HIV incidence by comparing results from test kits received at baseline to 16-months.

Timeframe: Baseline to 16-months

Change in STI incidence by comparing results from test kits received at baseline to 16-months.

Timeframe: Baseline to 16-months

Changes in relationship communication patterns by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.

Timeframe: Baseline to 8-months, 8-months to 16-months, baseline to 16-months

Changes in relationship commitment by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.

Timeframe: Baseline to 8-months, 8-months to 16-months, baseline to 16-months

Changes in relationship trust by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.

Timeframe: Baseline to 8-months, 8-months to 16-months, baseline to 16-months

Changes in relationship communal coping by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.

Timeframe: Baseline to 8-months, 8-months to 16-months, baseline to 16-months

Trial details

NCT IDNCT05708014

SponsorFlorida International University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-25

View on ClinicalTrials.gov More Hiv trials

Plain-language summary

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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);