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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193942
• Other study ID #: 3U54MD012393-05S2
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Florida International University
• Contact: Jason W Mitchell, PhD
• Phone: 305-348-7789
• Email: jamitche[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The beginning of a relationship (i.e., within first year) is a crucial time for male couples to make decisions about their HIV/STI and sexual health needs. Via a recently completed nation-wide pilot RCT, the theoretically-grounded, couples-based app intervention showed high acceptability and feasibility, and strong promise for encouraging 42 male couples to create a tailored, prevention plan consisting of evidence-based strategies that aligned with the dyad's HIV serostatus. Retention was 86%, signifying that both partners of each couple completed all assessments, used the app intervention as designed, and participated in an individual-level exit interview. Acceptability was >95%, and confirmed by using three different data sources (quantitative follow-up assessment, paradata from app intervention use, qualitative interview). The app intervention contained 4 modules (M1-M4) and a geo-locator sexual health resource finder. Although relationship partners individually used the app intervention (on their respective smartphones), questions and activities were built in each module to highlight within-couple comparisons and also encouraged couples to participate in discussion activities together. M1 was about enhancing communication and decision-making skills, while M2 focused on prevention strategies including creating a tailored prevention plan. M3 highlighted statistics of the HIV/STI epidemic, and M4 was about stigma and discrimination. Regarding promise, a two-fold increase was observed in the proportion of couples who created a tailored prevention plan when comparing baseline to follow-up assessment data, and while also considering their paradata. The next steps in this line of work would aim to improve the app intervention by integrating some of the acceptability feedback received, such as offering it in English and Spanish and adding content about importance of ART/PrEP adherence. Next steps also include, investigating - via mixed methods - how best to integrate the app intervention with local AIDS-service organizations (ASOs) and Community-based organizations (CBOs) for future scale up and improve use and adherence of evidence-based strategies among sexual minority men. Last but not least, a 4-month, Type 1 Hybrid Trial will be conducted to establish efficacy on couples' creation of a prevention plan, as well as participants' uptake of new evidence-based strategies (e.g., daily PrEP, regular testing, daily ART) and improving adherence of strategies currently in use. Findings from the Type 1 Hybrid Trial would inform best practices for integrating mHealth intervention science with brick-and-mortar services by including perspectives from the target population and ASOs/CBOs. The Type 1 Hybrid Trial study would occur in locations identified in Ending the HIV Epidemic Plan, such as Miami-Dade and Broward Counties in Florida.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Does not meet one or more of the inclusion criteria

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in goal congruence on sexual health by comparing baseline response to month 4 response	Participants will be asked about their goal congruence regarding sexual health and their relationship partner at both time points. Validated theoretical measure containing 5 items, each containing a Likert-type response range of 1-5.	Baseline, month 4
Secondary	Change in mutual constructive communication by comparing baseline response to month 4 response	Participants will be asked about their mutual constructive communication patterns at both time points. Validated theoretical measure containing 3 items, each containing a Likert-type response range of 1-9.	Baseline, month 4