Trial Outcomes & Findings for Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky (NCT NCT05037513)
NCT ID: NCT05037513
Last Updated: 2025-03-20
Results Overview
Documented PrEP initiation, measured by dispensed PrEP prescription.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
3 months post-baseline
Results posted on
2025-03-20
Participant Flow
Participant milestones
| Measure |
CDC-PrEP
1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
CDC-PrEP: 1 session PrEP education following CDC guidelines
|
SBCM-PrEP
Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus
|
|---|---|---|
|
Intervention Period
STARTED
|
39
|
41
|
|
Intervention Period
COMPLETED
|
38
|
39
|
|
Intervention Period
NOT COMPLETED
|
1
|
2
|
|
Follow Up Period
STARTED
|
39
|
41
|
|
Follow Up Period
COMPLETED
|
19
|
17
|
|
Follow Up Period
NOT COMPLETED
|
20
|
24
|
Reasons for withdrawal
| Measure |
CDC-PrEP
1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
CDC-PrEP: 1 session PrEP education following CDC guidelines
|
SBCM-PrEP
Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus
|
|---|---|---|
|
Intervention Period
Lost to Follow-up
|
1
|
2
|
|
Follow Up Period
Lost to Follow-up
|
16
|
21
|
|
Follow Up Period
Death
|
0
|
1
|
|
Follow Up Period
Incarcerated
|
4
|
2
|
Baseline Characteristics
Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
Baseline characteristics by cohort
| Measure |
CDC-PrEP
n=39 Participants
1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
CDC-PrEP: 1 session PrEP education following CDC guidelines
|
SBCM-PrEP
n=41 Participants
Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
39.0 years
STANDARD_DEVIATION 9.8 • n=107 Participants
|
39.7 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months post-baselinePopulation: We analyzed both the intent to treat (ITT) and per protocol populations. Per protocol is reported here, which includes those with any exposure to the respective interventions.
Documented PrEP initiation, measured by dispensed PrEP prescription.
Outcome measures
| Measure |
CDC-PrEP
n=38 Participants
1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
CDC-PrEP: 1 session PrEP education following CDC guidelines
|
SBCM-PrEP
n=39 Participants
Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus
|
|---|---|---|
|
Number of Participants Initiating PrEP
|
1 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 6 months post-baselinePopulation: We analyzed intent to treat (ITT) and per protocol populations. Per protocol is reported here, which includes all participants with any exposure to their respective intervention.
Documented PrEP initiation, measured by dispensed PrEP prescription.
Outcome measures
| Measure |
CDC-PrEP
n=38 Participants
1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
CDC-PrEP: 1 session PrEP education following CDC guidelines
|
SBCM-PrEP
n=39 Participants
Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus
|
|---|---|---|
|
Number of Participants Initiating PrEP
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 8 weeks post-baselinePopulation: Intervention engagement measure using the session checklist was collected only on the experimental arm; session checklist ratings are part of the SBCM-PrEP post session checklist forms only per study protocol, administration was planned post each of the 5 offered sessions. One SBCM-PrEP participant is missing data on this measure.
5 item Session Checklist completed by Interventionist post-session; range is 5-20, lower scores are higher engagement
Outcome measures
| Measure |
CDC-PrEP
1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
CDC-PrEP: 1 session PrEP education following CDC guidelines
|
SBCM-PrEP
n=38 Participants
Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus
|
|---|---|---|
|
Level of Intervention Engagement Assessed by Session Checklist
|
—
|
8.68 units on a scale
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: 8 weeks post-baselinePopulation: IAQ acceptability measures were collected from the experimental SBCM-PrEP arm only as part of the post-intervention session forms per protocol. The IAQ is a descriptive measure of acceptability of the newly adapted intervention, not planned for cross-arm comparative analysis. The IAQ is a participant-completed paper survey given to participants post-session to complete independently, which accounts for the high level of missingness; many participants did not return the survey.
10 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 10-50, lower scores are higher acceptability
Outcome measures
| Measure |
CDC-PrEP
1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
CDC-PrEP: 1 session PrEP education following CDC guidelines
|
SBCM-PrEP
n=14 Participants
Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus
|
|---|---|---|
|
Level of Intervention Satisfaction Assessed by the IAQ
|
—
|
13.2 units on a scale
Standard Deviation 3.07
|
Adverse Events
CDC-PrEP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SBCM-PrEP
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CDC-PrEP
n=39 participants at risk
1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
CDC-PrEP: 1 session PrEP education following CDC guidelines
|
SBCM-PrEP
n=41 participants at risk
Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus
|
|---|---|---|
|
Gastrointestinal disorders
Death
|
0.00%
0/39 • Participant level adverse events were collected over 6 months
Adverse events were generally collected during the course of follow-up assessments using standard study instrumentation. For participants lost to follow-up, study staff collected information on deaths through publicly available information.
|
2.4%
1/41 • Participant level adverse events were collected over 6 months
Adverse events were generally collected during the course of follow-up assessments using standard study instrumentation. For participants lost to follow-up, study staff collected information on deaths through publicly available information.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place