NCT01376895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

2.7 years

First QC Date

June 16, 2011

Last Update Submit

March 7, 2014

Conditions

Keywords

Black MSM/WHIV

Outcome Measures

Primary Outcomes (1)

  • unprotected sex

    Unprotected sex refers to either vaginal or anal sex

    last 3 month

Secondary Outcomes (1)

  • number of sex partners

    last 3 months

Study Arms (2)

POWER

EXPERIMENTAL

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 Health

ACTIVE COMPARATOR

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

Interventions

PROJECT POWERBEHAVIORAL

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.

POWER
Power HealthBEHAVIORAL

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

Power Health

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Previously participated in the study
  • Identify as transgendered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John H. Stroger Hospital of Cook county

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Unsafe SexRisk Reduction Behavior

Interventions

Advance Directives

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

JurisprudenceSocial Control, FormalHealth Care Economics and OrganizationsAdvance Care PlanningPatient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations