Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men (RISE)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jennifer Lauby, Public Health Management Corporation
ClinicalTrials.gov Identifier:
NCT01347164
First received: May 2, 2011
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Bisexually-active Men
at Risk for HIV
Behavioral: RISE life coaching intervention
Behavioral: HIV Counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Development and Testing of HIV Prevention Interventions Targeting Black MSM/W

Resource links provided by NLM:


Further study details as provided by Public Health Management Corporation:

Primary Outcome Measures:
  • increased condom use [ Time Frame: at follow-up 3 months post-intervention ] [ Designated as safety issue: No ]

Enrollment: 169
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Life coaching sessions
6 2-hour counseling session with trained therapist/counselor. The sessions deal with coping and stress reduction as well as sexual health.
Behavioral: RISE life coaching intervention
6 2-hour sessions
Active Comparator: HIV counseling session
One 60-minute counseling session, based on standard HIV counseling content.
Behavioral: HIV Counseling
Standard one-hour HIV counseling session

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male and female sex partners past 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347164

Locations
United States, Pennsylvania
Public Health Management Corporation
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Public Health Management Corporation
Investigators
Principal Investigator: Jennifer L Lauby, PhD Public Health Management Corporation
  More Information

No publications provided

Responsible Party: Jennifer Lauby, Senior Research Scientist, Public Health Management Corporation
ClinicalTrials.gov Identifier: NCT01347164     History of Changes
Other Study ID Numbers: 5UR6PS001099
Study First Received: May 2, 2011
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Public Health Management Corporation:
bisexual
HIV prevention

ClinicalTrials.gov processed this record on July 29, 2014