Trial Outcomes & Findings for STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations (NCT NCT06439329)
NCT ID: NCT06439329
Last Updated: 2026-07-17
Results Overview
Attitudes toward acceptability and feasibility of the PN and PN+PC menu of options will be surveyed from CAB members using the needs assessment created during project ACTION as a foundation. Total score range is 5-20 for each category. Higher scores indicate increased acceptability, appropriateness, and feasibility. Assessed only in CAB members.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 months
Results posted on
2026-07-17
Participant Flow
32 participants signed consent but one was lost to follow up prior to randomization. 31 patient participants were randomized.
Participant milestones
| Measure |
Standard Patient Navigation (PN)- Patients
PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked participants to PrEP/ART and SUD services.
|
PN + Patient Choice (PC) (PN+PC)- Patients
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
Patient Navigation (PN)
PNs have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked participants to PrEP/ART and SUD services.
|
CAB Members
Assist in informing intervention.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
2
|
7
|
|
Overall Study
COMPLETED
|
15
|
14
|
2
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not collected for PN. Four CAB members did not provide or missing.
Baseline characteristics by cohort
| Measure |
Standard Patient Navigation (PN)- Patients
n=16 Participants
PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked participants to PrEP/ART and SUD services.
|
PN + Patient Choice (PC) (PN+PC)- Patients
n=15 Participants
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
Patient Navigation (PN)
PNs have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked participants to PrEP/ART and SUD services.
|
CAB Members
n=7 Participants
Assist in informing intervention.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.5 years
n=16 Participants • Not collected for PN. Four CAB members did not provide or missing.
|
48 years
n=15 Participants • Not collected for PN. Four CAB members did not provide or missing.
|
—
|
44 years
n=3 Participants • Not collected for PN. Four CAB members did not provide or missing.
|
48 years
n=34 Participants • Not collected for PN. Four CAB members did not provide or missing.
|
|
Sex: Female, Male
Female
|
2 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
4 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
3 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
9 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Sex: Female, Male
Male
|
14 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
11 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
2 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
27 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants • Not collected for PN.
|
0 Participants
n=15 Participants • Not collected for PN.
|
—
|
0 Participants
n=7 Participants • Not collected for PN.
|
0 Participants
n=38 Participants • Not collected for PN.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=16 Participants • Not collected for PN.
|
0 Participants
n=15 Participants • Not collected for PN.
|
—
|
0 Participants
n=7 Participants • Not collected for PN.
|
0 Participants
n=38 Participants • Not collected for PN.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants • Not collected for PN.
|
0 Participants
n=15 Participants • Not collected for PN.
|
—
|
0 Participants
n=7 Participants • Not collected for PN.
|
0 Participants
n=38 Participants • Not collected for PN.
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=16 Participants • Not collected for PN.
|
5 Participants
n=15 Participants • Not collected for PN.
|
—
|
2 Participants
n=7 Participants • Not collected for PN.
|
14 Participants
n=38 Participants • Not collected for PN.
|
|
Race (NIH/OMB)
White
|
8 Participants
n=16 Participants • Not collected for PN.
|
9 Participants
n=15 Participants • Not collected for PN.
|
—
|
2 Participants
n=7 Participants • Not collected for PN.
|
19 Participants
n=38 Participants • Not collected for PN.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=16 Participants • Not collected for PN.
|
1 Participants
n=15 Participants • Not collected for PN.
|
—
|
0 Participants
n=7 Participants • Not collected for PN.
|
2 Participants
n=38 Participants • Not collected for PN.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants • Not collected for PN.
|
0 Participants
n=15 Participants • Not collected for PN.
|
—
|
3 Participants
n=7 Participants • Not collected for PN.
|
3 Participants
n=38 Participants • Not collected for PN.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=16 Participants • Not collected for PN.
|
3 Participants
n=15 Participants • Not collected for PN.
|
—
|
0 Participants
n=7 Participants • Not collected for PN.
|
8 Participants
n=38 Participants • Not collected for PN.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=16 Participants • Not collected for PN.
|
12 Participants
n=15 Participants • Not collected for PN.
|
—
|
5 Participants
n=7 Participants • Not collected for PN.
|
28 Participants
n=38 Participants • Not collected for PN.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants • Not collected for PN.
|
0 Participants
n=15 Participants • Not collected for PN.
|
—
|
2 Participants
n=7 Participants • Not collected for PN.
|
2 Participants
n=38 Participants • Not collected for PN.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants • Not collected for PN.
|
15 participants
n=15 Participants • Not collected for PN.
|
—
|
7 participants
n=7 Participants • Not collected for PN.
|
31 participants
n=38 Participants • Not collected for PN.
|
|
Housing
Unhoused
|
4 Participants
n=16 Participants • Not collected for PN or CAB members.
|
5 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
9 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Housing
In a shelter
|
0 Participants
n=16 Participants • Not collected for PN or CAB members.
|
1 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
1 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Housing
Transitional ( time-limited) single room occupancy
|
2 Participants
n=16 Participants • Not collected for PN or CAB members.
|
1 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
3 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Housing
Other residential facility or institution (e.g. healthcare facility, halfway house)
|
4 Participants
n=16 Participants • Not collected for PN or CAB members.
|
1 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
5 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Housing
Rent an apartment /house
|
3 Participants
n=16 Participants • Not collected for PN or CAB members.
|
6 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
9 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Housing
Staying with family/ friends
|
3 Participants
n=16 Participants • Not collected for PN or CAB members.
|
1 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
4 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Education
Did not complete high school
|
5 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
3 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
0 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
8 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Education
GED or equivalent
|
8 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
2 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
0 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
10 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Education
Regular high school diploma
|
1 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
2 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
0 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
3 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Education
Some college credit, but less than 1 year of college credit
|
2 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
2 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
0 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
4 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Education
1 or more years of college credit, but no degree
|
0 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
3 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
1 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
4 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Education
Associate's Degree (e.g., AA or AS)
|
0 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
1 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
1 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
2 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Education
Graduate degree (MSW, MA, MS, JD, MD, DSW, EdD, Ph.D, etc.)
|
0 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
1 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
2 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
3 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Education
Trade School
|
0 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
1 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
0 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
1 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Education
Bachelor's degree
|
0 Participants
n=16 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
0 Participants
n=15 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
—
|
1 Participants
n=5 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
1 Participants
n=36 Participants • Not collected for PN. Two CAB members did not provide or missing.
|
|
Had Insurance, last 30 days
|
15 Participants
n=16 Participants • Not collected for PN or CAB members.
|
15 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
30 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Received public assistance, last 12 months
|
10 Participants
n=16 Participants • Not collected for PN or CAB members.
|
12 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
22 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Injection Drug Use, last 30 days
|
3 Participants
n=16 Participants • Not collected for PN or CAB members.
|
3 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
6 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Participants with Moderate to Severe Substance Use Disorder Diagnoses by Substance
Alcohol
|
0 Participants
n=16 Participants • Not collected for PN or CAB members.
|
3 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
3 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Participants with Moderate to Severe Substance Use Disorder Diagnoses by Substance
Opioids
|
7 Participants
n=16 Participants • Not collected for PN or CAB members.
|
11 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
18 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Participants with Moderate to Severe Substance Use Disorder Diagnoses by Substance
Stimulants
|
12 Participants
n=16 Participants • Not collected for PN or CAB members.
|
9 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
21 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Self-perceived HIV risk
No risk
|
3 Participants
n=16 Participants • Not collected for PN or CAB members.
|
6 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
9 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Self-perceived HIV risk
Low risk
|
7 Participants
n=16 Participants • Not collected for PN or CAB members.
|
5 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
12 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Self-perceived HIV risk
Medium risk
|
2 Participants
n=16 Participants • Not collected for PN or CAB members.
|
1 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
3 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Self-perceived HIV risk
High risk
|
3 Participants
n=16 Participants • Not collected for PN or CAB members.
|
2 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
5 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Self-perceived HIV risk
Living with HIV
|
1 Participants
n=16 Participants • Not collected for PN or CAB members.
|
0 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
1 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Self-perceived HIV risk
No response
|
0 Participants
n=16 Participants • Not collected for PN or CAB members.
|
1 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
1 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
HIV Rapid Testing Results
Reactive
|
0 Participants
n=16 Participants • Not collected for PN or CAB members.
|
0 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
0 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
HIV Rapid Testing Results
Non-Reactive
|
15 Participants
n=16 Participants • Not collected for PN or CAB members.
|
15 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
30 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
HIV Rapid Testing Results
Previous HIV diagnosis
|
1 Participants
n=16 Participants • Not collected for PN or CAB members.
|
0 Participants
n=15 Participants • Not collected for PN or CAB members.
|
—
|
—
|
1 Participants
n=31 Participants • Not collected for PN or CAB members.
|
|
Hepatitis C (HCV) Rapid Testing Results
Non-Reactive
|
8 Participants
n=11 Participants • Data presented here is for all participants that took the test. Not collected for PN or CAB members.
|
7 Participants
n=9 Participants • Data presented here is for all participants that took the test. Not collected for PN or CAB members.
|
—
|
—
|
15 Participants
n=20 Participants • Data presented here is for all participants that took the test. Not collected for PN or CAB members.
|
|
Hepatitis C (HCV) Rapid Testing Results
Reactive
|
1 Participants
n=11 Participants • Data presented here is for all participants that took the test. Not collected for PN or CAB members.
|
0 Participants
n=9 Participants • Data presented here is for all participants that took the test. Not collected for PN or CAB members.
|
—
|
—
|
1 Participants
n=20 Participants • Data presented here is for all participants that took the test. Not collected for PN or CAB members.
|
|
Hepatitis C (HCV) Rapid Testing Results
Previous HCV diagnosis
|
2 Participants
n=11 Participants • Data presented here is for all participants that took the test. Not collected for PN or CAB members.
|
2 Participants
n=9 Participants • Data presented here is for all participants that took the test. Not collected for PN or CAB members.
|
—
|
—
|
4 Participants
n=20 Participants • Data presented here is for all participants that took the test. Not collected for PN or CAB members.
|
PRIMARY outcome
Timeframe: 3 monthsAttitudes toward acceptability and feasibility of the PN and PN+PC menu of options will be surveyed from CAB members using the needs assessment created during project ACTION as a foundation. Total score range is 5-20 for each category. Higher scores indicate increased acceptability, appropriateness, and feasibility. Assessed only in CAB members.
Outcome measures
| Measure |
CAB Members
n=4 Participants
CAB members will be surveyed to evaluate attitudes toward acceptability and feasibility, confidence, and commitment to using the PN+PC approach.
|
PN + Patient Choice (PC) (PN+PC)
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
|---|---|---|
|
Feasibility/Acceptability Will be Assessed Using the CAB Community Needs Assessment
Acceptability
|
16 score on a scale
Interval 15.0 to 17.0
|
—
|
|
Feasibility/Acceptability Will be Assessed Using the CAB Community Needs Assessment
Appropraiteness
|
16 score on a scale
Interval 15.0 to 17.0
|
—
|
|
Feasibility/Acceptability Will be Assessed Using the CAB Community Needs Assessment
Feasibility
|
16 score on a scale
Interval 15.0 to 17.0
|
—
|
PRIMARY outcome
Timeframe: 3 monthsOrganizational readiness for implementing change (ORIC) will be surveyed at start of preparation and sustainment phases with CAB members to evaluate confidence and commitment to using the PN+PC approach. Total scores range from 12 to 60, with higher scores indicating greater readiness. This survey was administered to CAB members only.
Outcome measures
| Measure |
CAB Members
n=4 Participants
CAB members will be surveyed to evaluate attitudes toward acceptability and feasibility, confidence, and commitment to using the PN+PC approach.
|
PN + Patient Choice (PC) (PN+PC)
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
|---|---|---|
|
Feasibility/Acceptability Will be Assessed Using the Organizational Readiness for Implementing Change (ORIC) From the JCOIN Common Measure Survey
|
43.5 score on a scale
Interval 41.25 to 48.0
|
—
|
PRIMARY outcome
Timeframe: 3 monthsParticipant attitudes toward the PN and PN+PC implementation approach (rapport, satisfaction, linkage to services, engagement) will be collected at 3 months using the Scales for Participant Alliance with Recovery Coach; SPARC. The SPARC is scored on a Likert scale (1 = strongly disagree to 5 = strongly agree), higher scores indicate a high perception of the recovery coach alliance. There are six domains (engagement, satisfaction, rapport, motivation and encouragement, role model, and community linkage), and each domain score is between 10 and 50.
Outcome measures
| Measure |
CAB Members
n=14 Participants
CAB members will be surveyed to evaluate attitudes toward acceptability and feasibility, confidence, and commitment to using the PN+PC approach.
|
PN + Patient Choice (PC) (PN+PC)
n=11 Participants
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
|---|---|---|
|
Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC)
SPARC Domain 1 Scoring (Patient Navigator Engagement)
|
43.7 score on a scale
Interval 35.7 to 50.0
|
48.2 score on a scale
Interval 41.4 to 50.0
|
|
Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC)
SPARC Domain 2 Scoring (Satisfaction with Patient Navigator)
|
41.6 score on a scale
Interval 35.5 to 50.0
|
49.2 score on a scale
Interval 46.4 to 50.0
|
|
Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC)
SPARC Domain 3 Scoring (Patient Navigator Rapport)
|
47.6 score on a scale
Interval 36.7 to 50.0
|
49.1 score on a scale
Interval 46.7 to 50.0
|
|
Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC)
SPARC Domain 4 Scoring (Motivation and Encouragement)
|
43.7 score on a scale
Interval 30.0 to 50.0
|
49.9 score on a scale
Interval 48.6 to 50.0
|
|
Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC)
SPARC Domain 5 Scoring (Role Model)
|
41.3 score on a scale
Interval 30.0 to 50.0
|
48 score on a scale
Interval 42.3 to 50.0
|
|
Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC)
SPARC Domain 6 Scoring (Linkage to Community)
|
38.9 score on a scale
Interval 30.0 to 50.0
|
49.6 score on a scale
Interval 36.0 to 50.0
|
PRIMARY outcome
Timeframe: 3 monthsUtilization of Services and PN Engagement data will be used to assess the number of participants that utilized access of PrEP/ART services.
Outcome measures
| Measure |
CAB Members
n=15 Participants
CAB members will be surveyed to evaluate attitudes toward acceptability and feasibility, confidence, and commitment to using the PN+PC approach.
|
PN + Patient Choice (PC) (PN+PC)
n=14 Participants
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
|---|---|---|
|
Number of Participants That Utilized Access of PrEP/ART Services
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 3 monthsDefined as participants that have received a prescription for PrEP/ART
Outcome measures
| Measure |
CAB Members
n=14 Participants
CAB members will be surveyed to evaluate attitudes toward acceptability and feasibility, confidence, and commitment to using the PN+PC approach.
|
PN + Patient Choice (PC) (PN+PC)
n=11 Participants
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
|---|---|---|
|
Number of Participants With Receipt of Treatment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This was out of the number of participants on stimulants.
Number of participants engaged in substance use disorder (SUD) treatment
Outcome measures
| Measure |
CAB Members
n=14 Participants
CAB members will be surveyed to evaluate attitudes toward acceptability and feasibility, confidence, and commitment to using the PN+PC approach.
|
PN + Patient Choice (PC) (PN+PC)
n=11 Participants
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
|---|---|---|
|
Substance Use Treatment
Opioid Treatment
|
4 Participants
|
5 Participants
|
|
Substance Use Treatment
Stimulant Treatment
|
2 Participants
|
0 Participants
|
|
Substance Use Treatment
Alcohol Treatment
|
0 Participants
|
0 Participants
|
Adverse Events
Standard Patient Navigation (PN)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
PN + Patient Choice (PC) (PN+PC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard Patient Navigation (PN)
n=16 participants at risk
PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked participants to PrEP/ART and SUD services.
|
PN + Patient Choice (PC) (PN+PC)
n=15 participants at risk
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric disorder
|
6.2%
1/16 • 3 months
Not collected for PN or CAB members.
|
0.00%
0/15 • 3 months
Not collected for PN or CAB members.
|
Other adverse events
| Measure |
Standard Patient Navigation (PN)
n=16 participants at risk
PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked participants to PrEP/ART and SUD services.
|
PN + Patient Choice (PC) (PN+PC)
n=15 participants at risk
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Participants can select from a menu of options available in their community, which could include brick-and-mortar services, Mobile Health Unit (MHU), or telehealth services.
|
|---|---|---|
|
Psychiatric disorders
Crack Cocaine Withdrawal
|
6.2%
1/16 • 3 months
Not collected for PN or CAB members.
|
0.00%
0/15 • 3 months
Not collected for PN or CAB members.
|
|
Skin and subcutaneous tissue disorders
Sore on Leg & Mouth
|
6.2%
1/16 • 3 months
Not collected for PN or CAB members.
|
0.00%
0/15 • 3 months
Not collected for PN or CAB members.
|
|
Injury, poisoning and procedural complications
Ring Entrapment (stuck on finger)
|
6.2%
1/16 • 3 months
Not collected for PN or CAB members.
|
0.00%
0/15 • 3 months
Not collected for PN or CAB members.
|
|
Renal and urinary disorders
Bacterial Infection in Kidneys
|
6.2%
1/16 • 3 months
Not collected for PN or CAB members.
|
0.00%
0/15 • 3 months
Not collected for PN or CAB members.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place