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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01502618
Recruitment Status : Completed
First Posted : December 30, 2011
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Acquired Immunodeficiency Syndrome Behavioral: Focus Group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of a Secondary Prevention Intervention Targeting HIV-Positive Black Young Men Who Have Sex With Men
Study Start Date : August 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Focus Group
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.
Behavioral: Focus Group
N/A. Protocol is the focus group

Primary Outcome Measures :
  1. Produce an intervention focused on promoting critical consciousness among HIV-positive B-YMSM by using focus groups with HIV - positive B-YMSM [ Time Frame: 1 year ]

    The focus groups will be conducted to:

    1. determine the needs of the intervention
    2. participants' views on the content areas that should and should not be included in the newly developed intervention
    3. participants' views on the following areas of intervention design will also be obtained:

      1. the critical consciousness coaching technique;
      2. program structure (e.g., frequency, length, time);
      3. format (group sessions, individual sessions, combined sessions, internet sessions, weekend retreats); (d) session content (e.g., prevention skills, content areas, study incentives).

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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Receives services at one of the selected AMTU sites;
  2. Male sex at birth and male gender at the time of the study;
  3. 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);
  4. HIV-infected as documented by medical record review or verification with referring medical professional;
  5. Between the ages of 16-24 years inclusive at the time of consent;
  6. HIV-infected through sexual behavior;
  7. At least one sexual encounter involving oral or anal sex with a male partner in the past year;
  8. Ability to understand both written and spoken English;
  9. Willingness to participate in a focus group discussion with other HIV-positive B-YMSM; and
  10. Willingness to provide signed informed consent or assent with parental permission as applicable for study participation.

Exclusion Criteria:

  1. 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;
  2. Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior);
  3. 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;
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01502618

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Study Chair: Patrick Wilson, PhD Columbia University

Additional Information:
Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01502618     History of Changes
Other Study ID Numbers: ATN 090
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: May 2016

Keywords provided by University of North Carolina, Chapel Hill:
Adolescent Medicine Trials Network for HIV/AIDS Interventions
Human Immunodeficiency Virus

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases