NCT05708014

Personalized Prevention for Couples: A 16-month Digital RCT

Personalized Prevention for Couples

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 778 (actual)
• Sponsor: Florida International University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

The project draws on our strong findings from the preliminary work we conducted in the US (R34 pilot randomized control trial \& mixed method acceptability project). The 5-year project will revise and update an existing digital health couples-based HIV/STI prevention toolkit intervention that showed promise for reducing couples' HIV risk. The intervention is theoretically grounded in Couples Interdependence Theory for health behavior change. The project is a 16-month randomized control trial with 375 at-risk male couples using a delayed, educational control condition of 8 months. Our Specific Aims are to: 1) examine efficacy of the intervention on couples' a) formation and adherence to a risk-reduction plan and agreement, b) relationship functioning, c) self-reported and biomarker-confirmed indicators of risk (sexual behavior and STI), and engagement in HIV prevention (PrEP adherence) and care (ART adherence); 2) evaluate use of the intervention over time by using three different data sources; 3) explore moderating and mediating effects on couples' outcomes a-c. The project has high Public Health significance given the HIV disparities and the importance of attending to couples' unique relationship and prevention needs.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-11
• Primary completion: 2025-08-25
• Completion: 2025-08-25
• First posted: 2023-02-01
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States