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

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Network Intervention
Counsel, Test, and Treat
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, sexually transmitted diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • AIDS TaskForce of Greater Cleveland
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social Network Intervention

Counsel, Test, and Treat

Arm Description

Approximately 20% of people in this condition will be trained to have discussions endorsing less risky behaviors with their social network members.

People in this arm will only receive standard-of-care counseling, testing, and treatment for HIV and STDs.

Outcomes

Primary Outcome Measures

Reduction of unprotected anal intercourse with nonexclusive partners
We will compare the prevalence and frequency of unprotected anal intercourse with nonexclusive partners pre- and post-intervention.
Condom use
We will measure rates of condom pre- and post-intervention
HIV/STD incidence rates
We will compare HIV/STD incidence rates pre- and post-intervention

Secondary Outcome Measures

Full Information

First Posted
April 2, 2013
Last Updated
February 13, 2018
Sponsor
Medical College of Wisconsin
Collaborators
Mississippi State University, AIDS Task Force of Greater Cleveland
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1. Study Identification

Unique Protocol Identification Number
NCT01825252
Brief Title
Prevention of HIV Infection in High-Risk Social Networks of African American Men Who Have Sex With Men (MSM)
Acronym
C3
Official Title
Prevention of HIV Infection in High-Risk Social Networks of African American MSM
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Mississippi State University, AIDS Task Force of Greater Cleveland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, sexually transmitted diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
856 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Network Intervention
Arm Type
Experimental
Arm Description
Approximately 20% of people in this condition will be trained to have discussions endorsing less risky behaviors with their social network members.
Arm Title
Counsel, Test, and Treat
Arm Type
Active Comparator
Arm Description
People in this arm will only receive standard-of-care counseling, testing, and treatment for HIV and STDs.
Intervention Type
Behavioral
Intervention Name(s)
Social Network Intervention
Intervention Description
Approximately 20% of people are trained to have discussions endorsing less risky behaviors with members of their social network.
Intervention Type
Behavioral
Intervention Name(s)
Counsel, Test, and Treat
Intervention Description
People receive standard-of-care HIV/STD counseling, testing, and treatment
Primary Outcome Measure Information:
Title
Reduction of unprotected anal intercourse with nonexclusive partners
Description
We will compare the prevalence and frequency of unprotected anal intercourse with nonexclusive partners pre- and post-intervention.
Time Frame
24 months
Title
Condom use
Description
We will measure rates of condom pre- and post-intervention
Time Frame
24 months
Title
HIV/STD incidence rates
Description
We will compare HIV/STD incidence rates pre- and post-intervention
Time Frame
24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Kelly, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDS TaskForce of Greater Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44113
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24980248
Citation
Dickson-Gomez J, Owczarzak J, St Lawrence J, Sitzler C, Quinn K, Pearson B, Kelly JA, Amirkhanian YA. Beyond the ball: implications for HIV risk and prevention among the constructed families of African American men who have sex with men. AIDS Behav. 2014 Nov;18(11):2156-68. doi: 10.1007/s10461-014-0836-6.
Results Reference
background
PubMed Identifier
26010312
Citation
St Lawrence JS, Kelly JA, Dickson-Gomez J, Owczarzak J, Amirkhanian YA, Sitzler C. Attitudes Toward HIV Voluntary Counseling and Testing (VCT) Among African American Men Who Have Sex With Men: Concerns Underlying Reluctance to Test. AIDS Educ Prev. 2015 Jun;27(3):195-211. doi: 10.1521/aeap.2015.27.3.195.
Results Reference
background
PubMed Identifier
26010313
Citation
Quinn K, Dickson-Gomez J, DiFranceisco W, Kelly JA, St Lawrence JS, Amirkhanian YA, Broaddus M. Correlates of internalized homonegativity among black men who have sex with men. AIDS Educ Prev. 2015 Jun;27(3):212-26. doi: 10.1521/aeap.2015.27.3.212.
Results Reference
background
PubMed Identifier
25566762
Citation
Broaddus MR, DiFranceisco WJ, Kelly JA, St Lawrence JS, Amirkhanian YA, Dickson-Gomez JD. Social Media Use and High-Risk Sexual Behavior Among Black Men Who Have Sex with Men: A Three-City Study. AIDS Behav. 2015 Jun;19 Suppl 2(0 2):90-7. doi: 10.1007/s10461-014-0980-z.
Results Reference
background
PubMed Identifier
21204625
Citation
Kelly JA, Amirkhanian YA, Seal DW, Galletly CM, Difranceisco W, Glasman LR, Stevenson LY, Rosado N. Levels and Predictors of Sexual HIV Risk in Social Networks of Men who Have Sex with Men in the Midwest. AIDS Educ Prev. 2010 Dec;22(6):483-95. doi: 10.1521/aeap.2010.22.6.483.
Results Reference
background
PubMed Identifier
26562130
Citation
Kelly JA, St Lawrence JS, Tarima SS, DiFranceisco WJ, Amirkhanian YA. Correlates of Sexual HIV Risk Among African American Men Who Have Sex With Men. Am J Public Health. 2016 Jan;106(1):96-102. doi: 10.2105/AJPH.2015.302945. Epub 2015 Nov 12.
Results Reference
result
PubMed Identifier
23387951
Citation
Kelly JA, St Lawrence JS, Amirkhanian YA, DiFranceisco WJ, Anderson-Lamb M, Garcia LI, Nguyen MT. Levels and predictors of HIV risk behavior among Black men who have sex with men. AIDS Educ Prev. 2013 Feb;25(1):49-61. doi: 10.1521/aeap.2013.25.1.49.
Results Reference
result
PubMed Identifier
23868691
Citation
Kelly JA, DiFranceisco WJ, St Lawrence JS, Amirkhanian YA, Anderson-Lamb M. Situational, partner, and contextual factors associated with level of risk at most recent intercourse among Black men who have sex with men. AIDS Behav. 2014 Jan;18(1):26-35. doi: 10.1007/s10461-013-0532-y.
Results Reference
result

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

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