Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01347164
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2011-05-02
Brief Title:
Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men
Sponsor:
Public Health Management Corporation
Organization:
Public Health Management Corporation
Study Overview
Official Title:
Development and Testing of HIV Prevention Interventions Targeting Black MSMW
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISE
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 MSMW have been developed and rigorously evaluated This project will develop implement and evaluate an individual-level intervention ILI titled RISE that will assist Black MSMW 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 MSMW 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 MSMW
evaluate the intervention with a randomized control group design using RDS to recruit 250 Black MSMW 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 MSMW
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 MSMW as well as potentially providing an important new tool for HIV prevention specifically targeting the needs and risk behaviors of Black MSMW
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 MSMW
evaluate the intervention with a randomized control group design using RDS to recruit 250 Black MSMW 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 MSMW
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 MSMW as well as potentially providing an important new tool for HIV prevention specifically targeting the needs and risk behaviors of Black MSMW
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None