NCT05873855

Acceptability, Feasibility, and Preliminary Impact of a Web-based, HIV Prevention Toolkit With Cisgender Male Couples in Lima, Peru

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Florida International University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This digital couples-based HIV/STI prevention intervention project will determine preliminary efficacy to improve uptake of evidence-based strategies and a tailored prevention plan among cisgender 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 Lima. The 3-year project will update and adapt 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 6-month pilot randomized control trial with 60 at-risk male couples using a delayed, educational control condition of 3 months. Our Specific Aims are to: 1) Assess feasibility to retain 60 consented and eligible male couples in a 6-month pilot RCT through quantitative measurement of enrollment and retention/attrition rates, and by reason for attrition; 2) Describe acceptability of the adapted toolkit intervention using mixed methods23 from 3 data sources. At last follow-up, partners responses to the Health Information Usability Evaluation Scale24 and other survey items (e.g., 3 things liked best/least about the toolkit, features for improvement) will be captured, along with the additional details they will share about their experiences during the individual-level, qualitative exit interview; 3) Examine preliminary impact of the toolkit intervention on couples': a) formation and adherence to a tailored risk-reduction plan and agreement; b) relationship functioning (e.g., communication); c) use of/adherence to evidence-based HIV/STI prevention strategies; and d) HIV/STI incidence. Preliminary impact will be assessed via changes in couples' outcomes a-d over time between trial arms, and for all couples.

Conditions

• HIV Infections
• Hiv
• Sexually Transmitted Infections (Not HIV or Hepatitis)
• Sexually Transmitted Diseases
• Sexual Behavior
• Risk Reduction

Interventions

Type	Name	Description
BEHAVIORAL	Para ti, para mi, para nosotros (P3)	From day 1 to day 180 (i.e., entire 6-month duration, post baseline) of the pilot trial, participants randomized to the intervention arm will have access to use the five modules as directed. The P3 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 Para ti, para mi, para nosotros (P3)	From day 91 to day 180 (i.e., starting after 3-month assessment) of the pilot trial, participants randomized to the waitlist control condition will have access to use the five modules as directed. The P3 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: 2022-12-27
• Primary completion: 2024-04-26
• Completion: 2025-06-30
• First posted: 2023-05-24
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States