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Completed

NCT Number: NCT06056661

Within My Reach (WMR) Adaptation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WMR

Behavioral

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.

Primary outcomes

  1. Acceptability, as measured by the Acceptability of Intervention Measure (AIM)

    Time frame: Up to 3 months

    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.

  2. Appropriateness, as measured by the Intervention Appropriateness Measure (IAM)

    Time frame: Up to 3 months

    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.

Secondary outcomes

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

    Time frame: Baseline compared to up to 3 months

    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.

  2. Change in Acceptance of Couple Violence

    Time frame: Baseline compared to up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Mental Research Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2023
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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