Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prevention of HIV Infection in High-Risk Social Networks of African American Men Who Have Sex With Men (MSM) (C3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Medical College of Wisconsin
Mississippi State University
AIDS Task Force of Greater Cleveland
Information provided by (Responsible Party):
Medical College of Wisconsin Identifier:
First received: April 2, 2013
Last updated: October 29, 2013
Last verified: October 2013

During the formative research phase, investigators will undertake formative studies to locate, understand, and characterize high-risk social networks of African American MSM in the community; gain community participation, involvement, and input; and undertake interviews with key informants and community members to gain information needed to pilot test study recruitment procedures, measures, and intervention content.

During a 4-year main outcome trial phase, the investigators will enroll 24 separate sociocentric ("bounded") social networks composed predominantly of Black MSM. Each sociocentric network will consist of the ring of friends surrounding an initial high-risk index as well as all friends surrounding persons in this second ring and then friends surrounding a successive third snowball ring of enrollees. Each 3-ring sociocentric network is expected to consist of approximately 40 unique members (n=24 networks, each with 40 members = approximately 960 individual participants).

All participants will be assessed at baseline to measure sexual practices, substance use, and other risk characteristics over the past 3 months; asked to provide biological specimens to be tested for HIV and other sexually transmitted diseases (STDs); and counseled in HIV/STD risk reduction. STDs will be treated and those with HIV will be referred for treatment.

The investigators will identify the individuals in intervention condition networks with the greatest number of reciprocal interconnections and the most favorable sociometric standing in the network. These individuals--expected to constitute approximately 20% of the sociocentric network and designated as network leaders--will be recruited to attend a 9-session program that provides training and guidance in how to deliver on-going, theoretically-based, and culturally tailored risk reduction advice and counseling to other members within the same network.

Six and 18 months following the intervention, all participants will be reassessed on risk behavior and STD/HIV laboratory measures as well as measures of intervention exposure, with positive STD and HIV cases respectively treated or referred to care at each assessment point. Outcome analyses will test whether there is greater reduction in high-risk sexual practices, substance use associated with risky sex, and HIV/STD incidence within social networks in the intervention condition. The primary trial endpoints are reductions in prevalence and frequency of unprotected anal intercourse with nonexclusive partners, increased condom use, and lower incidence on a composite biological measure of new HIV/STD disease during the followup period.

Condition Intervention
Behavioral: Social Network Intervention
Behavioral: Counsel, Test, and Treat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of HIV Infection in High-Risk Social Networks of African American MSM

Resource links provided by NLM:

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Reduction of unprotected anal intercourse with nonexclusive partners [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    We will compare the prevalence and frequency of unprotected anal intercourse with nonexclusive partners pre- and post-intervention.

  • Condom use [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    We will measure rates of condom pre- and post-intervention

  • HIV/STD incidence rates [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    We will compare HIV/STD incidence rates pre- and post-intervention

Estimated Enrollment: 960
Study Start Date: August 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social Network Intervention
Approximately 20% of people in this condition will be trained to have discussions endorsing less risky behaviors with their social network members.
Behavioral: Social Network Intervention
Approximately 20% of people are trained to have discussions endorsing less risky behaviors with members of their social network.
Active Comparator: Counsel, Test, and Treat
People in this arm will only receive standard-of-care counseling, testing, and treatment for HIV and STDs.
Behavioral: Counsel, Test, and Treat
People receive standard-of-care HIV/STD counseling, testing, and treatment


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • are age 18 or older;
  • except for the initial index, were named as part of a friendship circle of an already-enrolled participant;
  • provide written informed consent and do not exhibit intoxication, drug use,or psychiatric impairment that leads the research staff member to question capacity to provide informed consent;
  • can complete study measures and participate in study activities in English;
  • reside in or near the study city and do not have definite plans to leave the area in the next 12 months.

Exclusion Criteria:

  • are age 17 or younger;
  • exhibit intoxication, drug use, or psychiatric impairment such that they are unable to provide written informed consent;
  • cannot complete study measures or adequately comprehend study activities conducted in English; or
  • live in a location distant from the study city.
  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 identifier: NCT01825252

Contact: Jeffrey Kelly, PhD 414.955.7700
Contact: Kristin Hackl, MSW 414.955.7712

United States, Ohio
AIDS TaskForce of Greater Cleveland Recruiting
Cleveland, Ohio, United States, 44113
Contact: LaRaun Clayton    216-621-0766 ext 286      
Contact: Travis Garry         
Sub-Investigator: Tracy Jones         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53202
Contact: Cheryl Sitzler    414-955-7700      
Contact: Kristin Hackl    414.955.7700      
Principal Investigator: Jeffrey A. Kelly, PhD         
Sponsors and Collaborators
Medical College of Wisconsin
Mississippi State University
AIDS Task Force of Greater Cleveland
Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Medical College of Wisconsin Identifier: NCT01825252     History of Changes
Other Study ID Numbers: R01MH089128, PRO12662
Study First Received: April 2, 2013
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
sexually transmitted diseases

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases processed this record on February 25, 2015