Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex With Men
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ClinicalTrials.gov Identifier: NCT01751594 |
Recruitment Status
:
Completed
First Posted
: December 18, 2012
Last Update Posted
: August 1, 2017
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Condition or disease | Intervention/treatment | Phase |
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HIV AIDS | Behavioral: MOVE Intervention Behavioral: H4L Comparison Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 92 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex With Men |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: H4L Comparison Intervention |
Behavioral: H4L Comparison Intervention
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.
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Experimental: MOVE Intervention |
Behavioral: MOVE Intervention
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.
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- Finalize and manualize a critical consciousness based intervention for HIV positive B-YMSM [ Time Frame: 2 years ]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.

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

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 ClinicalTrials.gov identifier (NCT number): NCT01751594
United States, California | |
Children's Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Illinois | |
Stroger Hospital and the CORE Center | |
Chicago, Illinois, United States, 60612 | |
United States, New York | |
Montefiore Medical Center | |
The Bronx, New York, United States, 10467 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
Baylor College of Medicine - Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Study Chair: | Gary Harper, PhD | DePaul University |
Additional Information:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01751594 History of Changes |
Other Study ID Numbers: |
ATN 104 |
First Posted: | December 18, 2012 Key Record Dates |
Last Update Posted: | August 1, 2017 |
Last Verified: | March 2016 |