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An HIV Intervention for Black Men at Risk


Phase 2
18 Years
N/A
Not Enrolling
Male
HIV, Depression, Posttraumatic Stress Disorder

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Trial Information

An HIV Intervention for Black Men at Risk


The purpose of this small randomized clinical trial was to develop and test the Enhanced
Sexual Health Intervention for Men (ES-HIM), designed for non-gay identifying HIV-positive
African American MSMW with histories of childhood sexual abuse (CSA). The investigators
compared ES-HIM to an attention matched general Health Promotion intervention (HP) on
efficacy in reducing: a) sexual risk behaviors (i.e., unprotected anal and vaginal sex and
number of sex partners); b) psychological symptoms of PTSD and depression; and c) a
biological composite of primary neurohormonal mediators of the stress response (cortisol and
catecholamines). The investigators also explored the intervention effects on neopterin, an
indicator of HIV disease progression, as an outcome.

Project Aims

1. To determine the impact of the ES-HIM intervention on HIV sexual risk behaviors among
non-gay identifying HIV-positive African American men who have sex with men and women
(MSMW) who have histories of childhood sexual abuse (CSA). The investigators
hypothesize that compared to the Health Promotion comparison condition, the ES-HIM
condition will be more effective in decreasing unprotected anal and vaginal sex (i.e.,
increase condom use) and number of sexual partners at immediate post-intervention and
at 3- and 6-months post-intervention.

2. To determine the impact of the ES-HIM intervention on negative psychological symptoms
over time among non-gay identifying HIV-positive African American MSMW who have
histories of CSA. The investigators hypothesized that compared to the Health Promotion
condition, the ES-HIM condition will be more effective in decreasing depressive and
posttraumatic stress symptoms at immediate post-intervention and at 3- and 6-months
post-intervention.

In addition to these aims, the investigators also explored associations between HIV sexual
risk behaviors (i.e., unprotected anal and vaginal sex), negative psychological symptoms
(i.e., depressive & posttraumatic stress symptoms) and biomarkers of allostatic load over
time among ES-HIM participants.

Research Methods

The University of California, Los Angeles (UCLA) ES-HIM Project was a 4-year study conducted
from 2007-2011 to develop and test an HIV risk and stress reduction intervention.
Institutional Review Board (IRB) approval for the protection of human subjects in research
at UCLA and a Certificate of Confidentiality from the National Institutes of Health (NIH)
were obtained.

Intervention Procedures

HIV-positive African American MSMW were recruited through fliers posted at participating
community-based organizations, as well as through outreach at community events, bars, clubs,
and other locations where the target population may be present. Once interested potential
participants were screened and deemed eligible, informed consent was obtained. After
informed consent, participants were asked to complete a baseline survey, as well as complete
locator forms. Upon completion of the baseline survey, participants were randomized into
the ES-HIM active intervention group or the Health Promotion control condition. Both the
ES-HIM and the Health Promotion included six sessions, with each session lasting two hours;
two sessions were administered per week for three consecutive weeks. The primary aims of
the ES-HIM intervention were to increase condom use and decrease symptoms of depression and
posttraumatic stress. Within these six, 120-minute sessions, active ES-HIM intervention
participants had the opportunity to discuss their sexual experiences and issues of
masculinity and stigma associated with being African American, HIV-positive, and a non-gay
identifying MSMW. The Health Promotion condition focused on improving general health and
concentrated on diet, exercise, relaxation/sleep hygiene, and medication adherence. Both
the ES-HIM and Health Promotion curricula were delivered by trained Facilitators.

Data Collection

Enrolled participants were administered surveys via Audio-Computer Assisted Self Interview
(A-CASI) at four time points: baseline, immediate post-intervention (upon completion of the
sixth ES-HIM or Health Promotion session), and at 3- and 6-months post-intervention. Also,
participants were asked to provide 12-hour urine collections for biomarkers of stress and a
one time urine sample for neopterin at baseline and 3- and 6-months post-intervention.
Non-urinary biomarkers, including height and weight (body mass index), heart rate, blood
pressure, and waist-to-hip ratio measurements were collected at these same time points.
Data collection (i.e., survey administration, urine container drop-off, and non-urinary
biomarker measurements) were administered in confidential settings at collaborative
community agencies and/or UCLA.


Inclusion Criteria:



- At least 18 years of age

- Male

- English speaking

- HIV-positive

- non-gay identifying

- Black/African American

- Sexually active and engaged in unprotected anal and/or vaginal sex with both a male
and female partner in the previous 90 days

- Have a history of child sexual abuse

Exclusion Criteria:

- Younger than 18 years of age

- Female

- Non-English speaking

- HIV-negative or unknown HIV-serostatus

- Race/Ethnicity other than Black / African American

- Not sexually active, uses condoms and/or lacks both male and female partners in past
90 days

- No history of child sexual abuse

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Sexual Risk Behavior Change Over Time - At Three Post Intervention Assessments

Outcome Description:

To determine the impact of the ES-HIM intervention on HIV sexual risk behaviors among non-gay identifying HIV-positive African American men who have sex with men and women (MSMW) who have histories of childhood sexual abuse (CSA). The investigators hypothesized that compared to the Health Promotion comparison condition, the ES-HIM condition will be more effective in decreasing unprotected anal and vaginal sex (i.e., increase condom use) and number of sexual partners at immediate post-intervention and at 3- and 6-months post-intervention.

Outcome Time Frame:

Baseline (pre-intervention) and Immediate post, and 3-and 6-months post intervention

Safety Issue:

No

Principal Investigator

John K Williams, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles (UCLA)

Authority:

United States: UCLA DSMB

Study ID:

11-000617

NCT ID:

NCT01641146

Start Date:

December 2008

Completion Date:

May 2011

Related Keywords:

  • HIV
  • Depression
  • Posttraumatic Stress Disorder
  • HIV risk reduction
  • Stress reduction
  • Trauma reduction
  • PTSD
  • Depression
  • Depressive Disorder
  • Stress Disorders, Post-Traumatic
  • Stress Disorders, Traumatic

Name

Location

University of California, Los Angeles (UCLA)Los Angeles, California  90095-1740
The AmASSI Health and Cultural CenterInglewood, California  90301
JWCH Institute Inc.Los Angeles, California  90026
Palms Residential Care FacilityLos Angeles, California  90003