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Completed Phase 2 Interventional Accepts healthy volunteers

An HIV Intervention for Black Men at Risk - The Enhanced Sexual Health Intervention for Men (ES-HIM)

ClinicalTrials.gov ID: NCT01641146

Public ClinicalTrials.gov record NCT01641146. 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 1, 2026, 3:11 PM EDT

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

Official title

An HIV Intervention for Black Men at Risk

Brief summary

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

HIV continues to spread among Black men who have sex with men (MSM), but few interventions target high-risk Black men who have sex with men and women (MSMW). Black MSMW with histories of childhood sexual abuse (CSA) may be an especially vulnerable population for: a) high-risk sexual behaviors; b) negative psychological sequelae (e.g., depressive or posttraumatic stress disorder (PTSD) symptoms); and c) neurobiological abnormalities in cardiovascular, neuroendocrine and/or immune systems (e.g., cortisol and norepinephrine), and HIV/AIDS progression. The purpose of this study was to test an HIV risk reduction intervention, guided by the Social Learning Theory, the Ecological Model, and the concept of allostatic load, a composite of the cumulative effects of stress on biological systems including psychoneuroimmunologic markers. The investigators tested the 6-session Enhanced Sexual Health Intervention for Men (ES-HIM) on 88 non-gay identifying HIV-positive Black MSMW with histories of CSA. The outcomes were to reduce high-risk sexual behaviors (i.e., unprotected anal and vaginal sex and number of sex partners) and negative psychological symptoms of depression and PTSD. Links between these outcomes and biomarkers of stress were also explored. Randomization to either the ES-HIM or a health promotion control group occurred with study participants assessed at baseline, post, 3- and 6-months.

Study identification

NCT ID
NCT01641146
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
118 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
Nov 30, 2008
Primary completion
Aug 31, 2010
Completion
Apr 30, 2011
Last update posted
Nov 27, 2016

2008 – 2011

United States locations

U.S. sites
4
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
The AmASSI Health and Cultural Center Inglewood California 90301
Palms Residential Care Facility Los Angeles California 90003
University of California, Los Angeles (UCLA) Los Angeles California 90024
JWCH Institute Inc. Los Angeles California 90026

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 NCT01641146, 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 Nov 27, 2016 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01641146 live on ClinicalTrials.gov.

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