We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01376895
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : March 11, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 16, 2011
June 20, 2011
March 11, 2014
July 2011
March 2014   (Final data collection date for primary outcome measure)
unprotected sex [ Time Frame: last 3 month ]
Unprotected sex refers to either vaginal or anal sex
unprotected sex [ Time Frame: last 3 month ]
Complete list of historical versions of study NCT01376895 on ClinicalTrials.gov Archive Site
number of sex partners [ Time Frame: last 3 months ]
number of sex partners refers to either male or female sex partners
number of sex partners [ Time Frame: last 3 months ]
Not Provided
Not Provided
 
Project Power: An HIV Risk Reduction Intervention for Black Men Who Have Sex With Men and Women (BMSM/W)
Developing and Testing of an HIV Prevention Intervention Targeting Black Men Who Have Sex With Men and Women (BMSM/W)
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.

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
  • Unsafe Sex
  • Risk Reduction
  • 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.
  • 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
  • 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.
    Intervention: Behavioral: PROJECT POWER
  • 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.
    Intervention: Behavioral: Power Health
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01376895
POWER
5UR6PS0011095 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
No
Not Provided
Not Provided
Nova Southeastern University
Nova Southeastern University
John H. Stroger Hospital
Not Provided
Nova Southeastern University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP