search
Back to results

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

Primary Purpose

HIV, AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOVE Intervention
H4L Comparison Intervention
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

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

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.

Sites / Locations

  • Children's Hospital of Los Angeles
  • Stroger Hospital and the CORE Center
  • Montefiore Medical Center
  • St. Jude Children's Research Hospital
  • Baylor College of Medicine - Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

H4L Comparison Intervention

MOVE Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2012
Last Updated
July 28, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01751594
Brief Title
Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex With Men
Official Title
Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex With Men
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
First, the protocol team will finalize the development and manualization of Health 4 Life (H4L) 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. Following this the protocol team will then implement Trial 1. In this trial, the intervention specialist and a "peer buddy" (intervention co-facilitator) from one AMTU will conduct one wave of both MOVE and H4L. The team will then conduct an analysis of the process data and revise the two interventions (MOVE and H4L). Upon revising the interventions, the protocol team will implement Trial 2. In this trial, the protocol co-chairs and the interventionist from Trial 1 will train interventionists and peer buddies from four new AMTUs; these interventionists and peer buddies will run the revised MOVE and H4L interventions. Each site will be designated as either a treatment or comparison site, and they will conduct two waves of their assigned intervention. The team at that time will conduct data analyses and then modify and manualize the final version of MOVE and H4L.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H4L Comparison Intervention
Arm Type
Active Comparator
Arm Title
MOVE Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
MOVE Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
H4L Comparison Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Finalize and manualize a critical consciousness based intervention for HIV positive B-YMSM
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Harper, PhD
Organizational Affiliation
DePaul University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Stroger Hospital and the CORE Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Montefiore Medical Center
City
The Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Baylor College of Medicine - Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs