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.
Verified October 2013 by Medical College of Wisconsin
Sponsor:
Collaborators:
Mississippi State University
AIDS Task Force of Greater Cleveland
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01825252
First received: April 2, 2013
Last updated: October 29, 2013
Last verified: October 2013

April 2, 2013
October 29, 2013
August 2011
July 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01825252 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Prevention of HIV Infection in High-Risk Social Networks of African American Men Who Have Sex With Men (MSM)
Prevention of HIV Infection in High-Risk Social Networks of African American MSM

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
  • Behavioral: Social Network Intervention
    Approximately 20% of people are trained to have discussions endorsing less risky behaviors with members of their social network.
  • Behavioral: Counsel, Test, and Treat
    People receive standard-of-care HIV/STD counseling, testing, and treatment
  • 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.
    Intervention: Behavioral: Social Network Intervention
  • Active Comparator: Counsel, Test, and Treat
    People in this arm will only receive standard-of-care counseling, testing, and treatment for HIV and STDs.
    Intervention: Behavioral: Counsel, Test, and Treat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
960
July 2016
July 2015   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact: Jeffrey Kelly, PhD 414.955.7700 cairdirector@mcw.edu
Contact: Kristin Hackl, MSW 414.955.7712 khackl@mcw.edu
United States
 
NCT01825252
R01MH089128, PRO12662
No
Medical College of Wisconsin
Medical College of Wisconsin
  • Mississippi State University
  • AIDS Task Force of Greater Cleveland
Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin
Medical College of Wisconsin
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP