Project Power: An HIV Risk Reduction Intervention for Black Men Who Have Sex With Men and Women (BMSM/W)

This study has been completed.
Sponsor:
Collaborator:
John H. Stroger Hospital
Information provided by (Responsible Party):
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT01376895
First received: June 16, 2011
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

The goal of this study is to develop and test a program to help Black men who have sex with men and women reduce their chances of getting or giving HIV infection to their sex partners. The program is designed to be delivered via the internet so that it would be available to more men. Men who agree to participate in the study will be assigned by chance to receive the POWER intervention or a similar program that is focused on general health called POWER-HEALTH. They will also complete a computer administered interview when they first enroll in the study, 2 weeks following the last session of the program and 3 months after that. Participants will receive a small compensation for their time and effort.


Condition Intervention Phase
Unsafe Sex
Risk Reduction
Behavioral: PROJECT POWER
Behavioral: Power Health
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Developing and Testing of an HIV Prevention Intervention Targeting Black Men Who Have Sex With Men and Women (BMSM/W)

Resource links provided by NLM:


Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:
  • unprotected sex [ Time Frame: last 3 month ] [ Designated as safety issue: No ]
    Unprotected sex refers to either vaginal or anal sex


Secondary Outcome Measures:
  • number of sex partners [ Time Frame: last 3 months ] [ Designated as safety issue: No ]
    number of sex partners refers to either male or female sex partners


Enrollment: 211
Study Start Date: July 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POWER
Power is a 3 session intervention delivered through the internet in real time by a trained health educator. It focuses on reducing HIV risk. Each session last from 1 to 2 hours.
Behavioral: PROJECT POWER
POWER is a three session intervention to help Black men who have sex with men and women lead healthier lives, make informed sexual choices and reduce their chances of getting or giving HIV to their sex partners. Interventions are designed to be delivered via the internet in real time by a trained health educator. Each session will last between 1 and 2 hours. The sessions are grounded on the social learning theory and use cognitive behavioral approaches. Participants learn the multiple influences on their behavior, how to identify their triggers and then use problem solving skills to develop a safer strategy for life. The sessions use videos and games to teach the lessons; participants are also given work that they must complete between the sessions.
Active Comparator: Power Health
Power Health is a 1 session general health promotion program designed to be delivered via the internet in real time by a trained health educator. The sessions focus on healthy life styles, cardiovascular health, and prostate health. Participants also receive information regarding safe sex.
Behavioral: Power Health
Power Health is a one session intervention designed to help Black men who have sex with men and women improve their general health. It focuses on health issues (including HIV) that affect Black men. The program consists of 1 session delivered via the internet in real time by a trained health educator and last approximately 2 hours

Detailed Description:

The purpose of this study is to examine the preliminary efficacy, feasibility and acceptability of delivering a culturally and developmentally tailored HIV risk reduction intervention via the Internet in real-time that promotes risk reduction among black men who have sex with men and women (BMSMW). During the Developmental Phase, our activities will consist of completing development (finalizing sessions, completing the manuals) of a theoretically grounded, culturally based, individual intervention, Project POWER, to reduce risk of HIV acquisition and transmission among BMSMW.

The investigators will then conduct a randomized controlled trial (RCT) to test the preliminary efficacy, acceptability, and feasibility of POWER compared to HEALTH. Using chain referral methods, the investigators will recruit 200 BMSMW (100 per arm) and assign them to 1 of 2 conditions (POWER or HEALTH). Participants will complete an assessment battery delivered via ACASI at baseline, immediate post intervention and at 3 months post intervention. The investigators will also measure uptake of HIV and STI testing. Participants will also complete acceptability/feasibility assessments after the

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self identify as Black or African descent
  • At least 18 years of age
  • Resident of Chicago MSA
  • Sexually active with men and women

Exclusion Criteria:

  • Previously participated in the study
  • Identify as transgendered
  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: NCT01376895

Locations
United States, Illinois
John H. Stroger Hospital of Cook county
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Nova Southeastern University
John H. Stroger Hospital
  More Information

No publications provided

Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT01376895     History of Changes
Other Study ID Numbers: POWER, 5UR6PS0011095
Study First Received: June 16, 2011
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Nova Southeastern University:
Black MSM/W
HIV

ClinicalTrials.gov processed this record on September 18, 2014