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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347164
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : April 17, 2018
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Public Health Management Corporation

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:

  • 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 or disease Intervention/treatment Phase
Bisexually-active Men at Risk for HIV Behavioral: RISE life coaching intervention Behavioral: HIV Counseling Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development and Testing of HIV Prevention Interventions Targeting Black MSM/W
Study Start Date : December 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. increased condom use [ Time Frame: at follow-up 3 months post-intervention ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • male and female sex partners 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 identifier (NCT number): NCT01347164

United States, Pennsylvania
Public Health Management Corporation
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Public Health Management Corporation
Centers for Disease Control and Prevention
Principal Investigator: Jennifer L Lauby, PhD Public Health Management Corporation

Responsible Party: Public Health Management Corporation Identifier: NCT01347164     History of Changes
Other Study ID Numbers: 5UR6PS001099 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Public Health Management Corporation:
HIV prevention