Trial Outcomes & Findings for Hepatitis C Pharmacy-based Strategy for Injectors (NCT NCT04698629)

Results Overview

The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

6 months

Results posted on

2025-04-08

Participant Flow

Participants were recruited from community sites that serve PWID in the Seattle area: a non-profit organization with a syringe services program, an opioid treatment program, and several emergency housing units. Potential participants were identified and referred by local providers within their respective site organizations or self-referred after seeing informational flyers at study sites. The first participant was enrolled on 11/05/2020, and the last participant was enrolled on 10/28/2021.

Participant milestones

Participant milestones
Measure	Observational Group Person who injects drugs, with documented positive hepatitis c virus test results.
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Observational Group Person who injects drugs, with documented positive hepatitis c virus test results.
Overall Study Adverse Event	1

Baseline Characteristics

Hepatitis C Pharmacy-based Strategy for Injectors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observational Group n=40 Participants Person who injects drugs, with documented positive hepatitis c virus test results.
Age, Continuous	43.6 years STANDARD_DEVIATION 10.3 • n=93 Participants
Sex/Gender, Customized Man	24 Participants n=93 Participants
Sex/Gender, Customized Woman	12 Participants n=93 Participants
Sex/Gender, Customized Non-binary or Transgender man or woman	4 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants
Race (NIH/OMB) More than one race	5 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.

Outcome measures

Outcome measures
Measure	Observational Group n=40 Participants Person who injects drugs, with documented positive hepatitis c virus test results.
Community Pharmacy Program Successful Linkage	38 Participants

SECONDARY outcome

Timeframe: 6 months

The number/percent who initiate medications for HCV.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Compare at baseline and 6-month follow-up the number of days of drug use within the past 30 days via self-report using the modified Addition Severity Index (ASI).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Compare at baseline and 6-month follow-up the number of injecting episodes using shared needle/syringe within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Compare at baseline and 6-month follow-up the number of episodes of unprotected vaginal or anal sex within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

The number/percent who receive of other medications (naloxone, PrEP, and medications to treat OUD) via the community pharmacy program.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Self-reported participant Likert scale surveys of satisfaction and willingness to refer an injecting partner to the community pharmacy for treatment; 1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree with the level of satisfaction/likelihood of referral to services.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

The number/percent who complete treatment for HCV, defined as having received all planned medication doses.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion.

Outcome measures

Outcome data not reported

Adverse Events

Observational Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Observational Group n=40 participants at risk Person who injects drugs, with documented positive hepatitis c virus test results.
Respiratory, thoracic and mediastinal disorders Hospitalization	2.5% 1/40 • Number of events 1 • 2 years Definitions for adverse event and serious adverse event used to collected adverse event information for this trial does not differ from the clinicaltrials.gov definitions. No event frequency threshold was implemented for this trial, and therefore, all events were reports
Cardiac disorders Death	2.5% 1/40 • Number of events 1 • 2 years Definitions for adverse event and serious adverse event used to collected adverse event information for this trial does not differ from the clinicaltrials.gov definitions. No event frequency threshold was implemented for this trial, and therefore, all events were reports

Other adverse events

Adverse event data not reported

Additional Information

Dr. Judith Tsui

University of Washington

Phone: 206-744-1835

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place