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

NCT01825252 | Completed

• 2 other identifiers: R01MH089128PRO12662
• Study Type: interventional
• Target: 856
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV

Keywords

HIV; sexually transmitted diseases

Outcome Measures

Primary Outcomes (3)

• 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.

  24 months

• Condom use

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

  24 months

• HIV/STD incidence rates

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

  24 months

Study Arms (2)

Social Network Intervention

EXPERIMENTAL

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

Counsel, Test, and Treat

ACTIVE COMPARATOR

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

Behavioral: Counsel, Test, and Treat

Interventions

Social Network Intervention BEHAVIORAL

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

Social Network Intervention

Counsel, Test, and Treat BEHAVIORAL

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

Counsel, Test, and Treat

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Mississippi State University: collaborator
• AIDS Task Force of Greater Cleveland: collaborator

Study Sites (2)

AIDS TaskForce of Greater Cleveland

Cleveland, Ohio, 44113, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53202, United States

Location

Related Publications (8)

• 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.

  PMID: 24980248 BACKGROUND

• 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.

  PMID: 26010312 BACKGROUND

• 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.

  PMID: 26010313 BACKGROUND

• 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.

  PMID: 25566762 BACKGROUND

• 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.

  PMID: 21204625 BACKGROUND

• 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.

  PMID: 26562130 RESULT

• 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.

  PMID: 23387951 RESULT

• 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.

  PMID: 23868691 RESULT

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Coal Tar

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Study Officials

• Jeffrey A. Kelly, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 5, 2013
• Study Start: August 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

US (2)