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
Sponsored by
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
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
No
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
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.
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
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).
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
No
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
Learn more about this trial
Intervention for HIV-Positive Black Young Men Who Have Sex With Men (YMSM)
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