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Trial record 27 of 1927 for:    Sexually Transmitted Diseases | NIH

Being Responsible for Ourselves HIV Risk Reduction for Black MSM (BRO)

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ClinicalTrials.gov Identifier: NCT02561286
Recruitment Status : Completed
First Posted : September 28, 2015
Last Update Posted : September 29, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Infection (HIV) Sexually Transmitted Disease (STD) Behavioral: BRO HIV Risk Reduction Intervention Behavioral: Health Promotion Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 595 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Help Us, Save Us! HIV/STI Risk Reduction for Black Men Who Have Sex With Men
Study Start Date : April 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIV risk reduction
BRO HIV Risk Reduction Intervention
Behavioral: BRO HIV Risk Reduction Intervention
BRO HIV Risk Reduction Intervention was designed to strengthen outcome expectancies supporting condom use and other sexual risk reduction strategies and skill and self-efficacy to use condoms and reduce sexual risk behaviors. It consisted of three 90-min one-on-one individual sessions implemented during 3 consecutive weeks by specially trained facilitators using standardized intervention manuals. Sessions 1 and 2 included take-home assignments that the participants reviewed at the subsequent session. The delivery of the intervention was tailored to the information that the participants provided during the sessions, including the context in which behaviors occurred and participants' motivation for the behaviors.
Other Name: HIV Risk Reduction Intervention

Active Comparator: Health promotion control
Health Promotion Intervention
Behavioral: Health Promotion Intervention
Health Promotion Intervention was designed to provide a control for "Hawthorne effects," reducing the likelihood that the HIV/STI risk-reduction intervention's effects could be attributed to non-specific features, including special attention. It focused on increasing physical activity and fruit-and-vegetable consumption and decreasing fat consumption to reduce the risk of chronic diseases, including heart disease, hypertension, stroke, diabetes, and certain cancers—leading causes of morbidity and mortality among African Americans It also consisted of three 90-min one-on-one individual sessions implemented during 3 consecutive weeks by specially trained facilitators using standardized intervention manuals.
Other Names:
  • Attention Control Intervention
  • BRO Health Promotion Intervention
  • Health Promotion Control




Primary Outcome Measures :
  1. Consistent (100%) condom use during anal and vaginal intercourse in the past 3 months [ Time Frame: 6 and 12 months post-intervention ]
    Men who reported at least one intercourse act and whose number of reported protected acts equaled their number of acts were coded as practicing consistent condom use. Men who reported at least one intercourse act and whose reported number of protected acts was less than their number of acts were coded as not practicing consistent condom use.


Secondary Outcome Measures :
  1. Receptive anal intercourse in the past 3 months [ Time Frame: 6 and 12 months post-intervention ]
    A binary variable indicating whether the man reported having receptive anal intercourse in the past 90 days.

  2. Insertive anal intercourse in the past 3 months [ Time Frame: 6 and 12 months post-intervention ]
    A binary variable indicating whether the participant reported having insertive anal intercourse with a man in the past 90 days.

  3. Proportion condom-protected intercourse in the past 3 months [ Time Frame: 6 and 12 months post-intervention ]
    The denominator was the sum of reported anal and vaginal intercourse acts in the past 90 days and the numerator was the sum of condom-protected anal and vaginal intercourse act in the past 90 days.

  4. Multiple sexual partners in the past 3 months [ Time Frame: 6 and 12 months post-intervention ]
    Participants whose sum of anal and vaginal intercourse partners in the past 90 days was 2 or greater were coded as having multiple partners, and those who reported having 0 or 1 anal and vaginal intercourse partners in the past 90 days were coded as not having multiple partners.

  5. Unprotected intercourse in the past 3 months [ Time Frame: 6 and 12 months post-intervention ]
    A binary variable indicating whether the participants reported having vaginal or anal intercourse in the past 90 days without using a condom. It was constructed by subtracting the sum of the condom-protected anal and vaginal intercourse acts from the total number of anal and vaginal intercourse acts in the past 90 days. If the difference was one or greater the participant was coded as having unprotected intercourse; if the difference was zero or if the person reported no vaginal or anal intercourse in the past 90 days, the person was coded as not having unprotected intercourse.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Self-identified as black or African American
  • Born a male
  • Reported having anal intercourse with a man in the previous 90 days.

Exclusion Criteria:

  • Reported having anal intercourse with only one main male partner in the past 90 days
  • Participated in an HIV/STI risk-reduction intervention in the past 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561286


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: John B Jemmott III, PhD University of Pennsylvania

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02561286     History of Changes
Other Study ID Numbers: 806708
R01MH079736 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by University of Pennsylvania:
Human immunodeficiency virus
Sexually transmitted disease
Men who have sex with men
African Americans
Behavioral intervention
Randomized controlled trial
Sexual behavior
Mediation analysis
Social cognitive theory
Theory of planned behavior

Additional relevant MeSH terms:
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Virus Diseases
Sexually Transmitted Diseases
Immune System Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Infection