NCT03823209

Brief Summary

This study evaluates the use of a social-network approach to encourage African-American men who have sex with men (AAMSM) to adopt pre-exposure prophylaxis (PrEP) to prevent HIV infection. Thirty-six networks of AAMSM will be recruited in Milwaukee, WI, and Cleveland, OH. Half of these networks will have their leaders trained to endorse PrEP to their social network members, and the other half will be given brief HIV prevention counseling.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

5.2 years

First QC Date

January 24, 2019

Last Update Submit

February 18, 2025

Conditions

Keywords

Pre-exposure prophylaxis (PrEP)

Outcome Measures

Primary Outcomes (1)

  • Self-report of pre-exposure prophylaxis (PrEP) use

    Change in self-reported PrEP use

    6 and 15 months

Secondary Outcomes (5)

  • Pre-Exposure Prophylaxis (PrEP) Knowledge

    6 and 15 months

  • Pre-Exposure Prophylaxis Attitudes

    6 and 15 months

  • Pre-Exposure Prophylaxis Norm Perceptions

    6 and 15 months

  • Pre-Exposure Prophylaxis Intentions

    6 and 15 months

  • Pre-Exposure Prophylaxis Self-Efficacy

    6 and 15 months

Study Arms (2)

Social Network Approach

EXPERIMENTAL

Participants will receive brief HIV counseling at baseline visit. Leaders of social networks will be determined using data from participants. These leaders will then be invited to attend a 5-session small-group training that will teach them how to communicate the benefits of PrEP to their social network members. All social network members will be asked about intervention exposure at 6- and 15-month followups.

Behavioral: Social NetworkBehavioral: Brief HIV Prevention Counseling

Comparison

ACTIVE COMPARATOR

Participants will receive brief HIV counseling at baseline visit.

Behavioral: Brief HIV Prevention Counseling

Interventions

Social NetworkBEHAVIORAL

Leaders of social networks will be statistically determined. Over 5 small-group training sessions, these leaders will be trained to communicate to their social network members accurate information about PrEP and its availability; correct PrEP misconceptions and negative stereotypes; endorse PrEP use and its benefits; and strengthen friends' attitudes, intentions, perceived peer norms, and self-efficacy regarding PrEP as a personal HIV protective strategy.

Social Network Approach

Participants will receive brief (15-minute) counseling on how to prevent HIV infection.

ComparisonSocial Network Approach

Eligibility Criteria

Age16 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • INDIVIDUALS:
  • Age 16 or older
  • For the seed only, self-report of HIV-negative serostatus or unknown serostatus
  • Except for the seed, being named as a friend by an already-enrolled participant
  • Male at birth
  • Sex with at least one male partner in the past 12 months
  • NETWORKS
  • More than 49% of the seed's eligible friends agree to participate
  • More than 49% of all network members self-report they are HIV-negative at baseline

You may not qualify if:

  • INDIVIDUALS:
  • Age 15 or younger
  • For the seed only, self-report of HIV-positive serostatus
  • Except for the seed, not being named as a friend by an already-enrolled participant
  • Not male at birth
  • No report of sex with at least one male partner in the past 12 months
  • NETWORKS
  • Less than 50% of the seed's eligible friends agree to participate
  • Less than 50% of all network members self-report they are HIV-negative at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 (3)

  • Kelly JA. Ten Things We Need to Do to Achieve the Goals of the End the HIV Epidemic Plan for America. J Acquir Immune Defic Syndr. 2019 Dec 1;82 Suppl 2(2):S94-S98. doi: 10.1097/QAI.0000000000002166.

  • Quinn KG, Christenson E, Spector A, Amirkhanian Y, Kelly JA. The Influence of Peers on PrEP Perceptions and Use Among Young Black Gay, Bisexual, and Other Men Who Have Sex with Men: A Qualitative Examination. Arch Sex Behav. 2020 Aug;49(6):2129-2143. doi: 10.1007/s10508-019-01593-x. Epub 2020 Feb 3.

  • Kelly JA, Amirkhanian YA, Walsh JL, Brown KD, Quinn KG, Petroll AE, Pearson BM, Rosado AN, Ertl T. Social network intervention to increase pre-exposure prophylaxis (PrEP) awareness, interest, and use among African American men who have sex with men. AIDS Care. 2020 May;32(sup2):40-46. doi: 10.1080/09540121.2020.1739207. Epub 2020 Mar 13.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jeffrey A. Kelly, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
  • Yuri A. Amirkhanian, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 30, 2019

Study Start

January 24, 2019

Primary Completion

April 22, 2024

Study Completion

December 1, 2025

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations