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

NCT05193942 | Completed DMC

• 1 other identifier: 3U54MD012393-05S2
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS

Outcome Measures

Primary Outcomes (5)

• Change in creation of a detailed risk-reduction plan by comparing baseline response to month 4 response

  At both time points, participants will be asked if they created a detailed risk-reduction plan that contains evidence-based strategies with their partner. Dichotomous measure: yes/no

  Baseline, month 4

• Change in number of evidence-based prevention strategies being used over time by comparing baseline response to month 4 response

  Participants will be asked how many evidence-based HIV/STI prevention strategies they are currently using at both time points.

  Baseline, month 4

• Change in confidence about using evidence-based prevention strategies over time by comparing baseline response to month 4 response

  Participants will be asked about their perceived confidence in using evidence-based HIV/STI prevention strategies at both time points. Validated theoretical measure (single item) with Likert-type scale response range of 1-5.

  Baseline, month 4

• Change in intention to use evidence-based prevention strategies over time by comparing baseline response to month 4 response

  Participants will be asked about their perceived intention to use evidence-based prevention strategies at both time points. Validated theoretical measure (single item) with Likert-type scale response range of 1-5.

  Baseline, month 4

• Change in self-efficacy to use evidence-based prevention strategies over time by comparing baseline response to month 4 response

  Participants will be asked about their perceived ability to use evidence-based prevention strategies at both time points. Validated theoretical measure (single item) with Likert-type response range of 1-5.

  Baseline, month 4

Secondary Outcomes (2)

• Change in goal congruence on sexual health by comparing baseline response to month 4 response

  Baseline, month 4

• Change in mutual constructive communication by comparing baseline response to month 4 response

  Baseline, month 4

Study Arms (2)

Intervention

EXPERIMENTAL

From baseline to 4-month post-test, participants in the intervention arm will have access to the Our Plan web app program.

Behavioral: Intervention Our Plan

Informational control

OTHER

From baseline to 4-month post-test, participants in the informational control arm will not have access to the Our Plan web app program. Participants will instead receive a webpage with information about HIV/STI prevention options and resources to represent the current equivalent of a standard of care for online HIV resources.

Behavioral: Internation Informational Control

Interventions

Intervention Our Plan BEHAVIORAL

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.

Intervention

Internation Informational Control BEHAVIORAL

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.

Informational control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-reported that currently self-identifies as a male
• self-reported in a sexual relationship with another self-identified male
• self-reported relationship length between 1 and 12 months
• self-reported anal sex with relationship partner in past month
• owns and uses an Internet-connected device (smartphone, tablet, computer)
• resides in the U.S.
• self-reported ability to read and understand English-language

Sponsors & Collaborators

• Florida International University: lead
• University of Michigan: collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants (and their relationship partner) will not know in advance which arm (intervention, control) assigned to in the trial from randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4-month randomized controlled trial with an informational control condition

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: January 18, 2022
• Study Start: February 17, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: Interested research must email the PI with a request to access de-identified, anonymous IPD. The PI will review such requests for secondary analyses using de-identified data that have already been published.

Locations

US (1)