NCT06056661

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

October 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

September 20, 2023

Last Update Submit

May 22, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Change in Sexual Risk Composite, as measured by HIV risk assessment

    Baseline compared to up to 3 months

  • Change in Acceptance of Couple Violence

    Baseline compared to up to 3 months

Study Arms (1)

WMR group

EXPERIMENTAL

Participants in this group will receive the WMR program for up to 5 weeks.

Behavioral: WMR

Interventions

WMRBEHAVIORAL

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.

WMR group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIdentifies as a man
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Audrey Harkness, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

October 27, 2023

Primary Completion

January 16, 2024

Study Completion

March 20, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations