View Clinical Trial (Medical Research Study)
Development and Testing of HIV Prevention Interventions Targeting Black MSM/W
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19102 |
| Conditions: |
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Bisexually-active Men - at Risk for HIV |
| Purpose: |
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Black men who have sex with men (MSM) have the highest rates of HIV infection in the United
States and represent a population in need of new HIV prevention interventions. Although 20
to 40% of Black MSM are estimated to have female partners, no interventions tailored to the
needs of Black MSM/W have been developed and rigorously evaluated. This project will
develop, implement, and evaluate an individual-level intervention (ILI), titled "RISE", that
will assist Black MSM/W to reduce their risk for acquiring and transmitting HIV infection.
This intervention will address the effect of individual level factors, interpersonal
relationships including sexual, peer and family relationships, and socio-cultural influences
on the sexual risk behaviors of MSM/W. The intervention will consist of six counseling
sessions held between a trained counselor and participant, and will be guided by three
theoretical perspectives: an ecological perspective of behavior, stress and coping theory,
and social cognitive theory. The COLOURS Organization, the sole agency in Philadelphia
dedicated to exclusively serving the Black LGBT community, will be a key collaborator in the
development and implementation of the intervention. The evaluation design utilizes a
randomized controlled trial to test the effectiveness of the proposed intervention. Chain
referral, based on principles of respondent-driven sampling, will be used to recruit 250
HIV-positive and HIV-negative Black bisexually-active men into this study.
The specific aims of this research are to:
- develop a new theoretically-based individual-level HIV prevention intervention
culturally tailored to the needs of HIV-positive and HIV-negative Black MSM/W;
- evaluate the intervention with a randomized control group design, using RDS to recruit
250 Black MSM/W who do not inject drugs and who report recent unprotected sex;
- assess the efficacy of the intervention and test the intervention model through the
collection of behavioral risk assessments and HIV and STD testing at three time points:
baseline, immediately post-intervention and three-months post-intervention;
- examine and describe individual factors, interpersonal relationships and network
factors, and socio-cultural factors that may affect risk behaviors for HIV infection
and transmission among Black MSM/W;
- develop recommendations for recruiting Black bisexually-active men and providing them
with targeted HIV prevention interventions.
Evaluation data collection will be conducted using ACASI. Data analysis will include
Repeated Measures ANOVA to make assessments of changes over time and intervention dose
effects and structural equation modeling to assess causal associations between factors in
the conceptual model. This proposed study has significance for increasing our understanding
various types of factors that may affect sexual risk behaviors of Black MSM/W as well as
potentially providing an important new tool for HIV prevention specifically targeting the
needs and risk behaviors of Black MSM/W.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- male and female sex partners past 12 months
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| NCT ID: |
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NCT01347164 |
| Primary Contact: |
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Principal Investigator
Jennifer L Lauby, PhD
Public Health Management Corporation
Jennifer L Lauby, PhD
Phone: 215 985-2556
Email: jennifer@phmc.org
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| Backup Contact: |
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Email: lisab@phmc.org
Lisa Bond, PhD
Phone: 215 985-2531
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| Location Contact: |
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Philadelphia, Pennsylvania 19102
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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