MedTrace Logo

Type 1 Hybrid Trial of Our Plan - a Brief, Couples-based HIV/STI Prevention Intervention

NCT05193942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-09-26

No results posted yet for this study

Summary

This webapp, couples-based HIV/STI prevention intervention project will use a Type 1 Hybrid Design Trial to determine efficacy to reduce HIV risk via uptake of evidence-based strategies and a tailored prevention plan among male couples who are in a new relationship (defined as 1 year or less). In addition, the project will be one of the first studies to investigate how intervention usage is associated with the outcomes over time, as well as explore best practices for future implementation and dissemination of such interventions by considering a variety of potential contexts. As such, the project is innovative, timely, and rigorous with sound scientific premise for helping to advance and bridge webapp HIV prevention science with existing community-level services.

Conditions

Interventions

BEHAVIORAL

Intervention Our Plan

From day 1 to day 120 (i.e., entire 4 month duration) of the trial, participants randomized to the intervention arm will be granted access and instructed to use the Our Plan program as directed. The Our Plan program includes modules covering topics of communication, decision-making, HIV/STI prevention, and stigma and discrimination. Each module contains content, questions, and activities for the participant and couple to complete. One goal of OurPlan is to help both partners of the couple create and use a risk- reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own confidence, intention, and perceived ability to use these strategies.

BEHAVIORAL

Internation Informational Control

From day 1 to day 120 (i.e., entire 4 month duration) of the trial, participants randomized to the informational control condition will receive a webpage that contains information about HIV/STI prevention options and resources. This control condition represents the current equivalent of a standard of care for online HIV resources.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05193942 on ClinicalTrials.gov