Within My Reach (WMR) Adaptation

Hiv Clinical Trial

Official title:

Culturally Adapting Individually-oriented Relationship Education (Within My Reach) for Latino Sexual Minority Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056661
• Other study ID #: 20221114
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: Audrey Harkness, PhD
• Phone: 305-284-1306
• Email: aharkness[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to adapt a relationship education program. The research team is adapting so that it is helpful for Latino sexual minority men.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 1, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

• Identify as Latino/e/x or Hispanic
• Age 18 years or older
• Currently reside in Miami-Dade County or Broward County
• Identify as gay, bisexual, or other non-heterosexual identity
• Identify as a man
• Comfortable speaking English

Exclusion:

• Unable to provide consent
• Deemed that participating would be potentially harmful to the participant or research staff

Related Conditions & MeSH terms

• Hiv
• Violence

Intervention

Behavioral:
• WMR
Participants will complete up to five sessions that will take 2 hours each. Sessions will take place in person. Participants will learn skills related to getting into and out of romantic relationships and identifying and pursuing goals for romantic relationships.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Mental Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability, as measured by the Acceptability of Intervention Measure (AIM)	The AIM consists of four questions that assess acceptability. Responses range from 1 (completely disagree) to 5 (completely agree). Scales are created by averaging responses.	Up to 3 months
Primary	Appropriateness, as measured by the Intervention Appropriateness Measure (IAM)	The IAM consists of four questions that assess appropriateness. Responses range from 1 (completely disagree) to 5 (completely agree). Scales are created by averaging responses.	Up to 3 months
Secondary	Change in Sexual Risk Composite, as measured by HIV risk assessment	Participants will answer questions about engagement in anal or vaginal sex, sexual partners' HIV status, current pre-exposure prophylaxis (PrEP) use and adherence (if HIV-negative or unknown HIV status), viral load (if living with HIV), A composite score will be calculated to determine whether or not the participant engaged in sexual behavior that could lead to HIV transmission or acquisition. A score of 1 means that the participant engaged in sexual behavior that could lead to HIV acquisition or transmission. A score of 0 means that they did not.	Baseline compared to up to 3 months
Secondary	Change in Acceptance of Couple Violence	The outcome will be measured with the five-item general violence subscale from the Acceptance of Couple Violence Scale. The items will be rated on a scale from 1 (strongly disagree) to 4 (strongly agree). Scales are created by averaging responses.	Baseline compared to up to 3 months