Trial Outcomes & Findings for Reaching mEthadone Users Attending Community pHarmacies With HCV (NCT NCT03935906)
NCT ID: NCT03935906
Last Updated: 2026-07-17
Results Overview
Percentage of patients in a population of stable opiate substitution therapy patients achieving Sustained Viral Response at 12 weeks post-treatment in the REACH pathway versus education-only pathway (Intention to Treat analysis).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1410 participants
Primary outcome timeframe
12 weeks after participants finish their hepatitis C treatment, up to 14 weeks from Baseline.
Results posted on
2026-07-17
Participant Flow
At pharmacies participating in the trial, there were 1,410 clients in receipt of opioid agonist therapy at baseline.
The overall number of 'consented' trial participants is represented by the overall number of OST clients at all participating pharmacies in both arms of the trial baseline (i.e. 1,410). In the baseline characteristics module, the 210 patients that 'consented' represents the number of participants to explicitly agreed to rececive a HCV test.
Participant milestones
| Measure |
Reach Pathway
Interventional arm of the trial, where point-of-care hepatitis c virus RNA testing was offered in community pharmacies.
|
Education-only Pathway
The control pathway of the trial, which represents conventional care.
|
|---|---|---|
|
OAT clients at intervention sites
STARTED
|
762
|
648
|
|
OAT clients at intervention sites
COMPLETED
|
762
|
648
|
|
OAT clients at intervention sites
NOT COMPLETED
|
0
|
0
|
|
OAT clients counselled by pharmacist
STARTED
|
387
|
267
|
|
OAT clients counselled by pharmacist
COMPLETED
|
387
|
267
|
|
OAT clients counselled by pharmacist
NOT COMPLETED
|
0
|
0
|
|
OAT clients interested in testing
STARTED
|
168
|
133
|
|
OAT clients interested in testing
COMPLETED
|
168
|
133
|
|
OAT clients interested in testing
NOT COMPLETED
|
0
|
0
|
|
OAT clients agreed to test
STARTED
|
148
|
62
|
|
OAT clients agreed to test
COMPLETED
|
148
|
62
|
|
OAT clients agreed to test
NOT COMPLETED
|
0
|
0
|
|
OAT clients HCV tested
STARTED
|
144
|
17
|
|
OAT clients HCV tested
COMPLETED
|
144
|
17
|
|
OAT clients HCV tested
NOT COMPLETED
|
0
|
0
|
|
OAT clients HCV positive
STARTED
|
23
|
6
|
|
OAT clients HCV positive
COMPLETED
|
23
|
6
|
|
OAT clients HCV positive
NOT COMPLETED
|
0
|
0
|
|
HCV-positive clients commenced treatment
STARTED
|
22
|
5
|
|
HCV-positive clients commenced treatment
COMPLETED
|
19
|
4
|
|
HCV-positive clients commenced treatment
NOT COMPLETED
|
3
|
1
|
|
OAT client obtained SVR12
STARTED
|
18
|
2
|
|
OAT client obtained SVR12
COMPLETED
|
18
|
2
|
|
OAT client obtained SVR12
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Consented Population REACH Pathway
n=148 Participants
Basic demographic descriptors for individuals who consented to testing through the trial.
|
Consented Population Education-Only Pathway
n=62 Participants
Basic demographic descriptors for individuals who consented to testing through the trial.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 8.5 • n=148 Participants
|
43.7 years
STANDARD_DEVIATION 9.8 • n=62 Participants
|
42.6 years
STANDARD_DEVIATION 8.9 • n=210 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=148 Participants
|
21 Participants
n=62 Participants
|
73 Participants
n=210 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=148 Participants
|
41 Participants
n=62 Participants
|
137 Participants
n=210 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 weeks after participants finish their hepatitis C treatment, up to 14 weeks from Baseline.Percentage of patients in a population of stable opiate substitution therapy patients achieving Sustained Viral Response at 12 weeks post-treatment in the REACH pathway versus education-only pathway (Intention to Treat analysis).
Outcome measures
| Measure |
Reach Pathway
n=762 Participants
Interventional arm of the trial, where point-of-care hepatitis c virus RNA testing was offered in community pharmacies.
|
Education-only Pathway
n=648 Participants
The control pathway of the trial, which represents conventional care.
|
|---|---|---|
|
SVR12
|
18 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after participants finish their hepatitis C treatment regimenPopulation: There was an insufficient quantity of HCV RNA+ patients to enable this analysis to be undertaken.
Percentage of patients achieving Sustained Viral Response at 12 weeks post-treatment from the patient population that tested positive for HCV in each arm (modified Intention to Treat analysis).
Outcome measures
| Measure |
Reach Pathway
n=23 Participants
Interventional arm of the trial, where point-of-care hepatitis c virus RNA testing was offered in community pharmacies.
|
Education-only Pathway
n=6 Participants
The control pathway of the trial, which represents conventional care.
|
|---|---|---|
|
Determine Whether the REACH Pathway Compared With the Education Only Pathway Leads to More People on Opiate Substitution Therapy Who Are Confirmed HCV RNA Positive Being Treated and Cured.
|
18 Participants
|
02 Participants
|
SECONDARY outcome
Timeframe: Up to 30 weeksPercentage of patients being tested for HCV in each arm
Outcome measures
| Measure |
Reach Pathway
n=762 Participants
Interventional arm of the trial, where point-of-care hepatitis c virus RNA testing was offered in community pharmacies.
|
Education-only Pathway
n=648 Participants
The control pathway of the trial, which represents conventional care.
|
|---|---|---|
|
Determine Whether the REACH Pathway Compared With the Education-only Pathway Leads to More People on Opiate Substitution Therapy Being Tested for HCV.
|
144 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeksPercentage of patients adhering to therapy in each arm (taking ≥ 85% of prescribed tablets) as reported in the observed therapy adherence log.
Outcome measures
| Measure |
Reach Pathway
n=22 Participants
Interventional arm of the trial, where point-of-care hepatitis c virus RNA testing was offered in community pharmacies.
|
Education-only Pathway
n=5 Participants
The control pathway of the trial, which represents conventional care.
|
|---|---|---|
|
Compare Adherence and Persistence to HCV Therapy in the Reach Pathway to the Education-only Pathway.
|
19 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: This is the population of participants who initiated treatment, and therefore had an outcome available for whether their treatment was a standard or extended duration.
Percentage of patients in whom changes in therapy are advised due to blood test results, as recorded at start of HCV therapy.
Outcome measures
| Measure |
Reach Pathway
n=22 Participants
Interventional arm of the trial, where point-of-care hepatitis c virus RNA testing was offered in community pharmacies.
|
Education-only Pathway
n=5 Participants
The control pathway of the trial, which represents conventional care.
|
|---|---|---|
|
Assess the Impact of Baseline Blood Tests on Treatment Decisions.
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 16 monthsPopulation: Consented population
Count of number of eligible participants tested for HCV
Outcome measures
| Measure |
Reach Pathway
n=148 Participants
Interventional arm of the trial, where point-of-care hepatitis c virus RNA testing was offered in community pharmacies.
|
Education-only Pathway
n=62 Participants
The control pathway of the trial, which represents conventional care.
|
|---|---|---|
|
Number of Participants Tested for HCV
|
144 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Consented participants
Number of eligible participants treated for HCV
Outcome measures
| Measure |
Reach Pathway
n=148 Participants
Interventional arm of the trial, where point-of-care hepatitis c virus RNA testing was offered in community pharmacies.
|
Education-only Pathway
n=62 Participants
The control pathway of the trial, which represents conventional care.
|
|---|---|---|
|
Number of Participants Treated for HCV
|
22 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after end of treatmentPopulation: Eligible participants
Number of eligible participants who achieved SVR (cured of HCV infection)
Outcome measures
| Measure |
Reach Pathway
n=148 Participants
Interventional arm of the trial, where point-of-care hepatitis c virus RNA testing was offered in community pharmacies.
|
Education-only Pathway
n=62 Participants
The control pathway of the trial, which represents conventional care.
|
|---|---|---|
|
Number of Participants Achieved SVR
|
18 Participants
|
2 Participants
|
Adverse Events
Reach Pathway (Consented to Test)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Education-only Pathway (Consented to Test)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reach Pathway (Consented to Test)
n=148 participants at risk
Those who consented to participate in the internventional component of the trial by taking a HCV test in the internvention arm. Note, this differs from the overall number who 'participated' in the trial by receiving OST at a participating pharmacy (n=1,410).
|
Education-only Pathway (Consented to Test)
n=62 participants at risk
Those who consented to participate in the internventional component of the trial by taking a HCV test in the control arm. Note, this differs from the overall number who 'participated' in the trial by receiving OST at a participating pharmacy (n=1,410).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Recreational drug overdose
|
0.68%
1/148 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
0.00%
0/62 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
Other adverse events
| Measure |
Reach Pathway (Consented to Test)
n=148 participants at risk
Those who consented to participate in the internventional component of the trial by taking a HCV test in the internvention arm. Note, this differs from the overall number who 'participated' in the trial by receiving OST at a participating pharmacy (n=1,410).
|
Education-only Pathway (Consented to Test)
n=62 participants at risk
Those who consented to participate in the internventional component of the trial by taking a HCV test in the control arm. Note, this differs from the overall number who 'participated' in the trial by receiving OST at a participating pharmacy (n=1,410).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bilateral radial wrist fractures secondary to fall.
|
0.68%
1/148 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
0.00%
0/62 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
|
General disorders
Back pain secondary to fall from bicycle.
|
0.00%
0/148 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
1.6%
1/62 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
|
Psychiatric disorders
Psychosis in the background of increasing paranoia and delusions; secondary to drug misuse.
|
0.68%
1/148 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
0.00%
0/62 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
|
Infections and infestations
Cellulitis left lower leg.
|
0.68%
1/148 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
0.00%
0/62 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
|
Vascular disorders
Right Leg deep vein thrombosis.
|
0.68%
1/148 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
0.00%
0/62 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
|
Social circumstances
Assault: multiple wounds left side of face
|
0.68%
1/148 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
0.00%
0/62 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
|
Immune system disorders
Pyrexia of unknown origin.
|
0.00%
0/148 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
1.6%
1/62 • From date of consent to maximum 30 days following paricipant's final study visit/study exit date.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place