Trial Outcomes & Findings for Providing Suboxone and PrEP Using Telemedicine (NCT NCT04521920)
NCT ID: NCT04521920
Last Updated: 2023-06-09
Results Overview
Defined as self-reported opioid use in prior month
COMPLETED
NA
17 participants
3 months
2023-06-09
Participant Flow
Recruited people who inject drugs, who access services at syringe services programs in Wilmington and Charlotte, North Carolina.
Participant milestones
| Measure |
Medication and Telemedicine Follow up
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Month 3
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Providing Suboxone and PrEP Using Telemedicine
Baseline characteristics by cohort
| Measure |
Medication and Telemedicine Follow up
n=17 Participants
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
|
Education
Some high school
|
3 Participants
n=5 Participants
|
|
Education
High school or GED
|
4 Participants
n=5 Participants
|
|
Education
Any college
|
10 Participants
n=5 Participants
|
|
Insurance status
Private
|
3 Participants
n=5 Participants
|
|
Insurance status
Public
|
1 Participants
n=5 Participants
|
|
Insurance status
No insurance
|
13 Participants
n=5 Participants
|
|
Relationship status
Single/ Separated
|
11 Participants
n=5 Participants
|
|
Relationship status
Married/ Partnered
|
6 Participants
n=5 Participants
|
|
Employment
Working full-time
|
3 Participants
n=5 Participants
|
|
Employment
Working part-time
|
5 Participants
n=5 Participants
|
|
Employment
Student
|
1 Participants
n=5 Participants
|
|
Employment
Disabled, unable to work
|
1 Participants
n=5 Participants
|
|
Employment
Unemployed
|
6 Participants
n=5 Participants
|
|
Employment
Stay at home parent
|
1 Participants
n=5 Participants
|
|
Ever taken Suboxone
Yes
|
16 Participants
n=5 Participants
|
|
Ever taken Suboxone
No
|
1 Participants
n=5 Participants
|
|
Ever Overdosed
Yes
|
9 Participants
n=5 Participants
|
|
Ever Overdosed
No
|
8 Participants
n=5 Participants
|
|
Access to technology
Computer with video camera
|
6 participants
n=5 Participants
|
|
Access to technology
Computer without video camera
|
1 participants
n=5 Participants
|
|
Access to technology
Smartphone
|
17 participants
n=5 Participants
|
|
Access to technology
Tablet
|
1 participants
n=5 Participants
|
|
Access to technology
Basic telephone (without internet capabilities)
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data not collected on 8 participants.
Defined as self-reported opioid use in prior month
Outcome measures
| Measure |
Medication and Telemedicine Follow up
n=9 Participants
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
|
|---|---|
|
Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months
|
6 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data not collected on 11 participants.
Defined as self-reported opioid use in prior month.
Outcome measures
| Measure |
Medication and Telemedicine Follow up
n=6 Participants
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
|
|---|---|
|
Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months
|
5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Received labs to confirm HIV status from 8 participants at month 3.
Measured via negative HIV test.
Outcome measures
| Measure |
Medication and Telemedicine Follow up
n=8 Participants
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
|
|---|---|
|
Number of Participants Who Remain HIV Negative at 3 Months
|
8 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Received labs to confirm HIV status from 3 participants at month 6
Measured via negative HIV test.
Outcome measures
| Measure |
Medication and Telemedicine Follow up
n=3 Participants
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
|
|---|---|
|
Number of Participants Who Remain HIV Negative at 6 Months
|
3 Participants
|
PRIMARY outcome
Timeframe: 3 monthsDefined as the number of participants who remain on treatment (MOUD or PrEP).
Outcome measures
| Measure |
Medication and Telemedicine Follow up
n=17 Participants
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
|
|---|---|
|
Persistence in Care at 3 Months
|
13 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDefined as the number of participants who remain on treatment (MOUD or PrEP).
Outcome measures
| Measure |
Medication and Telemedicine Follow up
n=17 Participants
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
|
|---|---|
|
Persistence in Care at 6 Months
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthExploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthExploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthExploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthExploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthExploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthExploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthExploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthExploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthExploratory method, conducted in the form of individual interviews to document the personal experiences of each participant over time (qualitative method)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthExploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Outcome measures
Outcome data not reported
Adverse Events
Medication and Telemedicine Follow up
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place