Trial record 6 of 31 for:    " February 16, 2011":" March 18, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01502618
First received: March 10, 2011
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

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 Intervention
Acquired Immunodeficiency Syndrome
Behavioral: Focus Group Guide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Development of a Secondary Prevention Intervention Targeting HIV-Positive Black Young Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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).


Enrollment: 18
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Focus Group Guide
    N/A. Protocol is the focus group
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.

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502618

Sponsors and Collaborators
Investigators
Study Chair: Patrick Wilson, PhD Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01502618     History of Changes
Other Study ID Numbers: ATN 090
Study First Received: March 10, 2011
Last Updated: December 27, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Adolescent Medicine Trials Network for HIV/AIDS Interventions
Human Immunodeficiency Virus

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

ClinicalTrials.gov processed this record on July 22, 2014