Prevention of HIV Infection in High-Risk Social Networks of African American Men Who Have Sex With Men (MSM) (C3)
|ClinicalTrials.gov Identifier: NCT01825252|
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : February 15, 2018
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 or disease||Intervention/treatment|
|HIV||Behavioral: Social Network Intervention Behavioral: Counsel, Test, and Treat|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||856 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of HIV Infection in High-Risk Social Networks of African American MSM|
|Study Start Date :||August 2011|
|Primary Completion Date :||July 2016|
|Study Completion Date :||December 2017|
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
- 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.
- Condom use [ Time Frame: 24 months ]We will measure rates of condom pre- and post-intervention
- HIV/STD incidence rates [ Time Frame: 24 months ]We will compare HIV/STD incidence rates pre- and post-intervention
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825252
|United States, Ohio|
|AIDS TaskForce of Greater Cleveland|
|Cleveland, Ohio, United States, 44113|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53202|
|Principal Investigator:||Jeffrey A. Kelly, PhD||Medical College of Wisconsin|