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Personalized Prevention for Couples: A 16-month Digital RCT

NCT05708014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 778

Last updated 2025-09-17

No results posted yet for this study

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).

Conditions

  • Hiv
  • HIV Infections
  • Sexually Transmitted Infection
  • Sexually Transmitted Diseases
  • Sexual Behavior
  • Risk Reduction

Interventions

BEHAVIORAL

Intervention LuvHub

From day 1 to day 487 (i.e., entire 16-month duration, post baseline) of the trial, participants randomized to the intervention arm will have access to use the five modules as directed. The LuvHub intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening relationships and creating goals, and physical activity.

BEHAVIORAL

Waitlist Control LuvHub

From day 243 to day 487 (i.e., starting after 8-month assessment) of the trial, participants randomized to the waitlist control condition will have access to use the five modules as directed. The LuvHub intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening relationships and creating goals, and physical activity.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Florida International University

    lead OTHER

Principal Investigators

  • Jason W Mitchell, PhD · Florida International University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2025-08-25
Completion
2025-08-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05708014 on ClinicalTrials.gov