Combination Primary Care and Prevention Services for Women Who Inject Drugs and Exchange Sex in Seattle, Washington

NCT06187064 | Completed Results DMC

• 2 other identifiers: STUDY00015337R34DA054588-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will implement a non-randomized observational clinical trial that will include a pop-up clinic for women who inject drugs (WWID) near venues for exchange sex and drug use in north Seattle. The pop-up clinic will be housed within a van and serve as a research extension of the SHE Clinic, a Harborview Medical Center run clinic for women who exchange sex and use drugs in north Seattle. Through the implementation of the pop-up clinic, the investigators will aim to assess:

1. 1.The impact of the pop-up clinic on uptake and sustained use of HIV pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD) among WWID.
2. 2.The impact of point of care (POC) sexually transmitted infection (STI) testing on STI treatment completion rates.
3. 3.The acceptability and feasibility of providing HIV prevention care for WWID and exchange sex in a pop-up van clinic.

Conditions

Trichomonas; Opioid Use Disorder; HIV Infections; Chlamydia; Gonorrhea; Syphilis

Keywords

Women who inject drugs; Medications for opioid use disorder; HIV pre-exposure prophylaxis; Venue-based healthcare

Outcome Measures

Primary Outcomes (2)

• Evaluate Uptake of Pre-exposure Prophylaxis (PrEP)

  Proportion of participants who initiate PrEP

  6 months

• Evaluate Uptake of Medications for Opioid Use Disorder (MOUD)

  Proportion of participants who initiate MOUD

  6 months

Other Outcomes (5)

• Evaluate Sustained Use of PrEP and MOUD

  6 months

• Evaluate Treatment Completion Rate After Point-of-care (POC) Sexually Transmitted Infection (STI) Testing

  6 months

• Evaluate Testing Time to Completion After POC STI Testing

  6 months

Study Arms (1)

Study cohort

OTHER

The investigators will enroll 50 female-identifying people who present to the clinical van for care and follow them for 6 months. The investigators will assess uptake of PrEP and buprenorphine; POC STI testing and treatment completion rates; sustained use of PrEP and buprenorphine at months 3 and 6 (n=50). The investigators will conduct surveys to assess and characterize the acceptability and feasibility of venue-based primary and HIV prevention care among women who inject drugs (WWID).

Other: Mobile Van Clinic

Interventions

Mobile Van Clinic OTHER

The investigators will implement a pilot clinic one evening per week, with the primary goal of measuring a community-based extension of SHE Clinic's impact on uptake and sustained use of HIV pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD). The clinic will be dispatched with a driver, nurse, physician, and research assistant. The van clinic will be outfitted with space to obtain a confidential history and physical exam and include a space for sample collection. In addition to standard of care, the investigators will provide participants with rapid point-of-care HIV and STI testing, and HIV PrEP and MOUD counseling and prescriptions.

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female identifying
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Female identifying
• Ever injected drugs
• Not known to have HIV
• Willing and able to provide informed consent to participate in the study

You may not qualify if:

• \<18 years of age
• Never injected drugs
• Living with HIV
• Medical or psychological co-morbidities that prevent participation per study team assessment.
• Non-English speaking

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; HIV Infections; Chlamydia Infections; Gonorrhea; Syphilis; Trichomonas Infections

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Treponemal Infections; Spirochaetales Infections; Protozoan Infections; Parasitic Diseases

Results Point of Contact

• Title: Dr. Maria Corcorran
• Organization: University of Washington

corcom@uw.edu

205-685-1653

Study Officials

• Maria Corcorran, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine

Model Details: Pilot of novel care model for low-barrier care and adherence support for uptake and sustained use of biomedical HIV prevention and medications for opioid use disorder for women who inject drugs

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 2, 2024
• Study Start: March 18, 2024
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)