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Completed

NCT Number: NCT01825252

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

AIDS TaskForce of Greater Cleveland, Cleveland, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Social network intervention

Behavioral

Approximately 20% of people are trained to have discussions endorsing less risky behaviors with members of their social network.

Counsel, Test, and Treat

Behavioral

People receive standard-of-care HIV/STD counseling, testing, and treatment

Primary outcomes

  1. Reduction of unprotected anal intercourse with nonexclusive partners

    Time frame: 24 months

    We will compare the prevalence and frequency of unprotected anal intercourse with nonexclusive partners pre- and post-intervention.

  2. Condom use

    Time frame: 24 months

    We will measure rates of condom pre- and post-intervention

  3. HIV/STD incidence rates

    Time frame: 24 months

    We will compare HIV/STD incidence rates pre- and post-intervention

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • AIDS Task Force of Greater Cleveland
  • Mississippi State University

Registry information

Official study title

Prevention of HIV Infection in High-Risk Social Networks of African American MSM

Acronym: C3

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Apr 5, 2013
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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