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Intervention for HIV-Positive Black Young Men Who Have Sex With Men (YMSM)

Primary Purpose

Acquired Immunodeficiency Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Focus Group

About this trial

This is an interventional prevention trial for Acquired Immunodeficiency Syndrome focused on measuring Adolescent Medicine Trials Network for HIV/AIDS Interventions, Human Immunodeficiency Virus

Eligibility Criteria

16 Years - 24 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Receives services at one of the selected AMTU sites;
Male sex at birth and male gender at the time of the study;
Self identifies as "Black" (including Black/African-American, Black Latino, Black/Afro-Caribbean, Black/African immigrant, or any self-identified member of the African Diaspora);
HIV-infected as documented by medical record review or verification with referring medical professional;
Between the ages of 16-24 years inclusive at the time of consent;
HIV-infected through sexual behavior;
At least one sexual encounter involving oral or anal sex with a male partner in the past year;
Ability to understand both written and spoken English;
Willingness to participate in a focus group discussion with other HIV-positive B-YMSM; and
Willingness to provide signed informed consent or assent with parental permission as applicable for study participation.

Exclusion Criteria:

Active psychiatric condition that in the opinion of the site personnel would interfere with the ability to give true informed consent and to adhere to the study requirements;
Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior);
Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focus Group

Arm Description

The focus group participants for this study will be Black Young Men who have Sex with Men (B-YMSM) ages 16-24 years (inclusive) who are diagnosed as HIV-positive and receive medical care at one of the two participating AMTUs or their community partners.

Outcomes

Primary Outcome Measures

Produce an intervention focused on promoting critical consciousness among HIV-positive B-YMSM by using focus groups with HIV - positive B-YMSM

The focus groups will be conducted to: determine the needs of the intervention participants' views on the content areas that should and should not be included in the newly developed intervention participants' views on the following areas of intervention design will also be obtained: the critical consciousness coaching technique; program structure (e.g., frequency, length, time); format (group sessions, individual sessions, combined sessions, internet sessions, weekend retreats); (d) session content (e.g., prevention skills, content areas, study incentives).

Secondary Outcome Measures

Full Information

NCT ID

NCT01502618

First Posted

March 10, 2011

Last Updated

February 27, 2017

Sponsor

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT01502618

Brief Title

Intervention for HIV-Positive Black Young Men Who Have Sex With Men (YMSM)

Official Title

Development of a Secondary Prevention Intervention Targeting HIV-Positive Black Young Men Who Have Sex With Men

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study involves conducting formative research to develop a culturally appropriate secondary prevention intervention for HIV-positive Black young men who have sex with men (B-YMSM). The intervention draws upon the principles of Critical Consciousness Theory (CCT). The formative research includes reviewing data and findings from relevant ATN protocols (i.e., 070, 068, and 073) and existing health promotion interventions targeting young men of color (i.e., the Young Warriors program, Hermanos de Luna y Sol [HLS]) and conducting focus groups with up to 32 HIV- positive B-YMSM.

Detailed Description

Focus groups will be conducted at two Adolescent Medicine Trials Unit (AMTU) sites and will guide the selection of the intervention content areas and the development of the intervention manual. The intervention aims to increase participation in health promoting behaviors and improve self-worth and self-concept among HIV-positive B-YMSM. Specifically, the intervention aims to address the following health promoting behaviors: 1) increasing engagement in HIV treatment; 2) improving medication adherence; 3) reducing sexual risk behaviors; 4) reducing substance use behaviors; and 5) increasing HIV status disclosure. Based on reviews of ATN 070 data and existing related interventions (ATN 068, ATN 073, Young Warriors, HLS), draft components of the intervention curriculum for B-YMSM will be developed. Four focus groups will then be convened (two per AMTU) with HIV-positive B-YMSM to a) obtain input on the draft intervention curriculum, b) refine intervention components, and c) examine psychosocial factors that may mediate or moderate the intervention effect. The focus groups will be implemented using a "Rapid Approach" which allows for a focus on key areas of inquiry by asking fewer questions and focusing on targeted responses of focus group participants. All focus groups will be digitally recorded and transcribed. The transcripts will be reviewed and data analyzed using a phenomenological approach; protocol team members and members of two Youth Advisory Boards (YABs), which will include youth who are existing members of ATN site CABs as well as youth recruited from other local agencies and organizations), will work on the analysis of the data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Immunodeficiency Syndrome

Keywords

Adolescent Medicine Trials Network for HIV/AIDS Interventions, Human Immunodeficiency Virus

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Focus Group

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Focus Group

Intervention Description

N/A. Protocol is the focus group

Primary Outcome Measure Information:

Title

Produce an intervention focused on promoting critical consciousness among HIV-positive B-YMSM by using focus groups with HIV - positive B-YMSM

Description

Time Frame

1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Receives services at one of the selected AMTU sites; Male sex at birth and male gender at the time of the study; Self identifies as "Black" (including Black/African-American, Black Latino, Black/Afro-Caribbean, Black/African immigrant, or any self-identified member of the African Diaspora); HIV-infected as documented by medical record review or verification with referring medical professional; Between the ages of 16-24 years inclusive at the time of consent; HIV-infected through sexual behavior; At least one sexual encounter involving oral or anal sex with a male partner in the past year; Ability to understand both written and spoken English; Willingness to participate in a focus group discussion with other HIV-positive B-YMSM; and Willingness to provide signed informed consent or assent with parental permission as applicable for study participation. Exclusion Criteria: Active psychiatric condition that in the opinion of the site personnel would interfere with the ability to give true informed consent and to adhere to the study requirements; Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior); Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements; Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Wilson, PhD

Organizational Affiliation

Columbia University

Official's Role

Study Chair

12. IPD Sharing Statement

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Intervention for HIV-Positive Black Young Men Who Have Sex With Men (YMSM)

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