Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex With Men

NCT01751594 | Completed

• 1 other identifier: ATN 104
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

The proposed research study aims to conduct a culturally-based secondary prevention intervention targeted toward HIV-positive Black young men who have sex with men (B-YMSM) to explore (1) feasibility and acceptability (Trial 1 and Trial 2) and (2) evidence of potential efficacy (Trial 2). The primary outcomes will be health promotion behaviors (i.e., treatment adherence, sexual risk reduction, reduction in substance use behaviors, and HIV status disclosure). Psychosocial factors (i.e. self-esteem, critical consciousness, and socio-political awareness) will be examined as secondary outcomes.

Conditions

HIV; AIDS

Outcome Measures

Primary Outcomes (1)

• Finalize and manualize a critical consciousness based intervention for HIV positive B-YMSM

  To finalize and manualize Mobilizing Our Voices for Empowerment (MOVE) resulting in an intervention with evidence of potential efficacy in reducing sexual risk and substance use behaviors and promoting treatment adherence and HIV status disclosure, as well as self-esteem, critical consciousness, and socio-political awareness. At the same time a non-critical consciousness intervention Health 4 Life (H4L) which will be used as comparison will also be finalized and manualized. H4L is primarily a health promotion and life skills intervention for HIV-positive B-YMSM.

  2 years

Study Arms (2)

H4L Comparison Intervention

ACTIVE COMPARATOR

Behavioral: H4L Comparison Intervention

MOVE Intervention

EXPERIMENTAL

Behavioral: MOVE Intervention

Interventions

MOVE Intervention BEHAVIORAL

MOVE involves four sessions. Sessions 1 and 2 occur over a two-day time frame and are each one day long (approximately 8 hours in length). They will: lay the groundwork for the intervention; provide HIV and other sexual health-related information; introduce critical consciousness; Sessions 1 and 2 will begin the enhancement of critical consciousness and the action-reflection-action cycle. Sessions 3 and 4 are also one-day sessions each (approximately 8 hours in length) and will be administered at one month intervals following the completion of sessions 1 and 2. These sessions will be used to provide continued enhancement of critical consciousness and guided support, feedback, and social reinforcement for behavior change and self-efficacy related to increasing health-promoting behaviors and reducing HIV-related health risk behaviors.

MOVE Intervention

H4L Comparison Intervention BEHAVIORAL

Health 4 Life (H4L) is a comparison intervention which will serve as the basis of comparison for Mobilizing Our Voices for Empowerment (MOVE), the treatment intervention. H4L will be a health promotion and life skills intervention to account for time and attention.

H4L Comparison Intervention

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

To be considered eligible for enrollment into Trial 1 and Trial 2, an individual must meet the criteria listed below: * Receives services at one of the selected AMTU sites or one of their community partners; * Biological male at birth and self identifies as male gender at the time of consent; * 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 group-based intervention with other HIV-positive B-YMSM and agree to respect the privacy of other group members; * Willingness and ability to attend the first group session on any of the date chosen by the site staff and; * Willingness to provide signed informed consent or assent with parental/legal guardian permission as applicable. To be considered eligible for enrollment, an individual must not meet any of the criteria listed below. * 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. * Previous participation in ATN 090, "Development of a Secondary Prevention Intervention Targeting HIV-Positive Black Young Men Who have Sex with Men." (NOTE: YAB members from ATN090 cannot participate in ATN 104) * Previous participation in Trial 1 of ATN104 and; * Current enrollment in any other behavioral intervention study or program. Any cases that are uncertain require Protocol Team approval.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Stroger Hospital and the CORE Center

Chicago, Illinois, 60612, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Baylor College of Medicine - Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Links

• ATN Website

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Gary Harper, PhD

  DePaul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 1, 2017

Record last verified: 2016-03

Locations

US (5)