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

Not Applicable

Completed

• Conditions: HIV; AIDS
• Interventions: Behavioral: H4L Comparison Intervention; Behavioral: MOVE Intervention

• Registration Number: NCT01751594
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-18
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-03
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
H4L Comparison Intervention	H4L Comparison Intervention	-
MOVE Intervention	MOVE Intervention	-

Primary Outcome Measures

Name	Time	Method
Finalize and manualize a critical consciousness based intervention for HIV positive B-YMSM	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.

Trial Locations

Locations (5)

Stroger Hospital and the CORE Center; 🇺🇸 Chicago, Illinois, United States

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Baylor College of Medicine - Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Montefiore Medical Center; 🇺🇸 The Bronx, New York, United States