Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men (RISE)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 2, 2011 | ||||||||
| Last Updated Date | May 3, 2011 | ||||||||
| Start Date ICMJE | December 2010 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
increased condom use [ Time Frame: at follow-up 3 months post-intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01347164 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men | ||||||||
| Official Title ICMJE | Development and Testing of HIV Prevention Interventions Targeting Black MSM/W | ||||||||
| Brief Summary | 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:
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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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 250 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01347164 | ||||||||
| Other Study ID Numbers ICMJE | 5UR6PS001099 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jennifer L. Lauby, Principal Investigator, Public Health Management Corporation | ||||||||
| Study Sponsor ICMJE | Public Health Management Corporation | ||||||||
| Collaborators ICMJE | Centers for Disease Control and Prevention | ||||||||
| Investigators ICMJE |
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| Information Provided By | Public Health Management Corporation | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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