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Completed Not applicable Interventional Accepts healthy volunteers

Being Responsible for Ourselves HIV Risk Reduction for Black MSM

ClinicalTrials.gov ID: NCT02561286

Public ClinicalTrials.gov record NCT02561286. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 4:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Help Us, Save Us! HIV/STI Risk Reduction for Black Men Who Have Sex With Men

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The incidence of HIV/AIDS among African American men who have sex with men (MSM) is alarming, and the public health response to this urgent situation has been hampered by a lack of sexual risk reduction interventions with solid evidence of efficacy in this population. Accordingly, the broad, long-term objective of the proposed research is to identify interventions to reduce the risk of sexually transmitted infection (STI) among African American MSM. This application seeks funds to develop and test the efficacy of a theory-based, contextually appropriate behavioral intervention to reduce sexual risk behavior among African American MSM. Intervention development will be guided by social cognitive theory, the theory of planned behavior, qualitative information from focus groups, and findings from a longitudinal survey of men from the study population. A one-on-one intervention will be utilized to address the specific prevention needs of each man and to allay participants' concerns about revealing their sexual involvement with men by virtue of participating in a group or workshop intervention. The study will utilize a randomized controlled trial design, with baseline, immediate post intervention, and 6 and 12 months post intervention assessments. The participants will be African American MSM who will be randomized to a one-on-one sexual risk reduction intervention or a one-on-one health promotion intervention that will serve as the control condition. The primary outcome is consistent condom use during anal and vaginal intercourse. The study will test whether the intervention increases the consistent use of condoms during anal intercourse, the primary outcome, whether it decreases other sexual risk behaviors, and whether social cognitive theory variables mediate the effects of the intervention on consistent condom use. This study will provide an urgently needed intervention to reduce the risk of HIV and other STIs in one of the highest risk populations in the United States.

Study identification

NCT ID
NCT02561286
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Pennsylvania
Other
Enrollment
595 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2008
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012
Last update posted
Sep 28, 2015

2008 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Pennsylvania Philadelphia Pennsylvania 19104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02561286, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 28, 2015 · Synced Sep 9, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02561286 live on ClinicalTrials.gov.

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