Prevention Ambassadors: Intervention to Promote HIV Service Engagement in the Networks of SSP Clients

NCT06848686 | Recruiting DMC

• 2 other identifiers: HS-2023-0051R34DA058389
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

HIV testing and service uptake are infrequent among people who use drugs (PWUD) in the United States. In partnership with a community-based syringe service program (SSP), this project will develop the SSP-based "Prevention Ambassadors" (PA) intervention to promote HIV testing and service uptake among PWUD via the secondary distribution (i.e., peer delivery) of HIV self-testing (HIVST) kits with local HIV service information and referrals to HIV service navigation in the social networks of SSP clients (i.e., PWUD). The PA intervention will then be piloted to assess its preliminary effects, acceptability, and feasibility among PWUD in the Ending the HIV Epidemic priority jurisdiction of Riverside County, California.

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

• HIV testing (past 3 months)

  Self-reported via survey and abstracted from medical record

  3-month follow-up

• Linkage to PrEP/HIV care (past 3 months)

  Self-reported via survey and abstracted from medical record

  3-month follow-up

• PrEP/ART uptake (past 3 months)

  Self-reported via survey and abstracted from medical record

  3-month follow-up

Secondary Outcomes (4)

• PA Acceptability (Peer-Recruit Participants)

  Baseline

• PA Acceptability (Index Participants)

  3-month follow-up

• PA Feasibility (Peer-Recruit Participants)

  Baseline

• PA Feasibility (Index Participants)

  3-month follow-up

Study Arms (2)

Prevention Ambassadors

EXPERIMENTAL

Behavioral: Prevention Ambassadors

SSP Standard of Care

OTHER

Behavioral: SSP Standard of Care

Interventions

Prevention Ambassadors BEHAVIORAL

Delivery of prevention supplies and information on local services plus training to build the capacity of PWUD to distribute HIV self-testing (HIVST) kits with information and referrals to other PWUD in their social networks to promote HIV testing and HIV service engagement among PWUD.

Prevention Ambassadors

SSP Standard of Care BEHAVIORAL

Delivery of prevention supplies and information on local services.

SSP Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being greater than or equal to 18 years old
• Reporting drug use (past month)
• Having other people who use drugs (PWUD) in one's social network
• Being willing to talk about HIV testing and services with at least 2 PWUD in their networks and attempt to refer them to the study
• Speaking English fluently
• Being greater than or equal to 18 years old
• Reporting drug use (past 3 months)
• Being recruited by an index participant (evidenced by presenting the coupon used to recruit them)
• Speaking English fluently

You may not qualify if:

• \- Persons who participated in formative study activities related to the development of the PA intervention will not be eligible to participate.

Sponsors & Collaborators

• San Diego State University: lead
• University of California, San Diego: collaborator
• University of California, Riverside: collaborator
• Dap Health: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

RECRUITING

Study Officials

• Heather A Pines

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Angela R Bazzi

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Pines

CONTACT

619-594-2481; hpines@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 27, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Approximately 6 months after the publication of the study's primary findings.
• Access Criteria: Requests from researchers for de-identified data will be reviewed by the research team (Multiple Principal Investigators and Co-Investigators).

Locations

US (1)