An HIV Intervention for Black Men at Risk - The Enhanced Sexual Health Intervention for Men (ES-HIM)
ES-HIM
2 other identifiers
interventional
118
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv
Started Dec 2008
4 active sites
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
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 5, 2012
CompletedFirst Posted
Study publicly available on registry
July 16, 2012
CompletedNovember 28, 2016
November 1, 2016
1.8 years
July 5, 2012
November 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sexual Risk Behavior Change Over Time - At Three Post Intervention Assessments
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.
Baseline (pre-intervention) and Immediate post, and 3-and 6-months post intervention
Mental Health Outcome Change Over Time - At Three Post Intervention Assessments
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 disorder symptoms at immediate post-intervention and at 3- and 6-months post-intervention.
Baseline (pre-intervention) and Immediate post, and 3-and 6-months post intervention
Secondary Outcomes (1)
Associations between Sexual Risk Behaviors, Mental Health Outcomes and Biomarkers - Changes At Two Post Intervention Assessments
Baseline (pre-intervention) and 3-and 6-month post intervention
Study Arms (2)
Enhanced Sexual Health Intervention for Men
EXPERIMENTALES-HIM is a six-session intervention for HIV-positive Black bisexual men who have histories of child sexual abuse. Guided by cognitive behavioral approaches and an ecological framework, ES-HIM effects sexual behavior change and psychological health improvement. Sexual risk reduction is framed from the perspective of being a triple minority (i.e., HIV-positive, ethnic and sexual minority). Issues of stigma and social isolation were discussed in regard to these identities. Sexual ownership focusing on individual responsibility for one's health and well-being was prioritized along with caring for sexual partners, family and community. Decisions regarding sexual behaviors and consequences were framed within a culturally congruent social context. Topics included: 1) the influence of gender and ethnicity; (2) early socialization regarding gender and culture, as well as adult experiences; (3) HIV stigma; and (4) recognizing stressors, including histories of personal trauma.
Health Promotion (HP) Comparison Arm
ACTIVE COMPARATORHealth Promotion Intervention (HP) is the comparison arm. It is designed to control for the Hawthorne effect and reduce the likelihood that effects of ES-HIM could be attributed to special attention and group interaction. HP addresses health issues, including certain cancers, hypertension, diabetes, and heart disease, all of which are common among African American men, but did not focus on sexual behavior. Participants were taught that these diseases could be prevented by changing personal behaviors (e.g., increasing physical activity and healthy dietary practices, ceasing cigarette smoking and alcohol and drug abuse), or managed with early detection and screening behaviors.
Interventions
ES-HIM is a six-session intervention for HIV-positive Black bisexual men who have histories of child sexual abuse. Guided by cognitive behavioral approaches and an ecological framework, ES-HIM effects sexual behavior change and psychological health improvement. Sexual risk reduction is framed from the perspective of being a triple minority (i.e., HIV-positive, ethnic and sexual minority). Issues of stigma and social isolation were discussed in regard to these identities. Sexual ownership focusing on individual responsibility for one's health and well-being was prioritized along with caring for sexual partners, family and community. Decisions regarding sexual behaviors and consequences were framed within a culturally congruent social context. Topics included: 1) the influence of gender and ethnicity; (2) early socialization regarding gender and culture, as well as adult experiences; (3) HIV stigma; and (4) recognizing stressors, including histories of personal trauma.
Health Promotion Intervention (HP) is the comparison arm. It is designed to control for the Hawthorne effect and reduce the likelihood that effects of ES-HIM could be attributed to special attention and group interaction. HP addresses health issues, including certain cancers, hypertension, diabetes, and heart disease, all of which are common among African American men, but did not focus on sexual behavior. Participants were taught that these diseases could be prevented by changing personal behaviors (e.g., increasing physical activity and healthy dietary practices, ceasing cigarette smoking and alcohol and drug abuse), or managed with early detection and screening behaviors.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The AmASSI Health and Cultural Center
Inglewood, California, 90301, United States
Palms Residential Care Facility
Los Angeles, California, 90003, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, 90024, United States
JWCH Institute Inc.
Los Angeles, California, 90026, United States
Related Publications (2)
Glover DA, Williams JK, Kisler KA. Using novel methods to examine stress among HIV-positive African American men who have sex with men and women. J Behav Med. 2013 Jun;36(3):283-94. doi: 10.1007/s10865-012-9421-5. Epub 2012 Apr 27.
PMID: 22538773RESULTWilliams JK, Glover DA, Wyatt GE, Kisler K, Liu H, Zhang M. A sexual risk and stress reduction intervention designed for HIV-positive bisexual African American men with childhood sexual abuse histories. Am J Public Health. 2013 Aug;103(8):1476-84. doi: 10.2105/AJPH.2012.301121. Epub 2013 Jun 13.
PMID: 23763412RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John K Williams, MD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2012
First Posted
July 16, 2012
Study Start
December 1, 2008
Primary Completion
September 1, 2010
Study Completion
May 1, 2011
Last Updated
November 28, 2016
Record last verified: 2016-11