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

Phase 1

Completed

• Conditions: Unsafe Sex; Risk Reduction
• Interventions: Behavioral: PROJECT POWER; Behavioral: Power Health

• Registration Number: NCT01376895
• Lead Sponsor: Nova Southeastern University

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Study Start: 2011-07
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-07
• Last Update Posted: 2014-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POWER	PROJECT 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.
Power Health	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.

Primary Outcome Measures

Name	Time	Method
unprotected sex	last 3 month	Unprotected sex refers to either vaginal or anal sex

Secondary Outcome Measures

Name	Time	Method
number of sex partners	last 3 months	number of sex partners refers to either male or female sex partners

Trial Locations

Locations (1)

John H. Stroger Hospital of Cook county; 🇺🇸 Chicago, Illinois, United States