Trial Outcomes & Findings for HIV Prevention Peer Navigation for Justice Involved Women (NCT NCT04680390)
NCT ID: NCT04680390
Last Updated: 2026-08-03
Results Overview
The primary outcome of PrEP linkage will be attendance at a PrEP services appointment, verified by medical records.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
4 months post enrollment
Results posted on
2026-08-03
Participant Flow
Women were recruited from San Francisco Adult Probation, County Jail Health Services, and community-based organizations serving criminal legal system-involved women. Staff shared study information and flyers. Interested individuals contacted staff in person, by phone, link, or QR code to complete consent-to-contact and eligibility screening; UCSF staff also conducted in-person outreach and screening.
Enrolled participants were only excluded from the analysis if they did not complete the baseline assessment or randomization.
Participant milestones
| Measure |
Active-kINSHIP Navigation Intervention
kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
|
Control-Standard Care
The control arm will be standard-of-care, which is as-needed case management for justice-involved women.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
1-Month Assessment
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HIV Prevention Peer Navigation for Justice Involved Women
Baseline characteristics by cohort
| Measure |
Active-kINSHIP Navigation Intervention
n=13 Participants
kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women: kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
|
Control-Standard Care
n=15 Participants
The control arm will be standard-of-care, which is as-needed case management for justice-involved women.
Standard of care engagement practices: The control arm will be standard-of-care, which is as-needed case management for justice-involved women. The goals of case management services are to reduce recidivism, mitigate behavioral challenges, strengthen public safety, and build self-sufficiency skills. Case managers refer clients to appropriate services in the community (e.g., housing, food).
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Age, Continuous
|
30.8461538 Years
STANDARD_DEVIATION 8.4147307 • n=20 Participants
|
36.1333333 Years
STANDARD_DEVIATION 11.9395302 • n=20 Participants
|
33.6785714 Years
STANDARD_DEVIATION 10.6111527 • n=40 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 4 months post enrollmentPopulation: One participant did not consent to having their data extracted from their medical record so were not included it in the analysis.
The primary outcome of PrEP linkage will be attendance at a PrEP services appointment, verified by medical records.
Outcome measures
| Measure |
Active-kINSHIP Navigation Intervention
n=13 Participants
kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women: kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
|
Control-Standard Care
n=14 Participants
The control arm will be standard-of-care, which is as-needed case management for justice-involved women.
Standard of care engagement practices: The control arm will be standard-of-care, which is as-needed case management for justice-involved women. The goals of case management services are to reduce recidivism, mitigate behavioral challenges, strengthen public safety, and build self-sufficiency skills. Case managers refer clients to appropriate services in the community (e.g., housing, food).
|
|---|---|---|
|
Linkage to PrEP Services
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 months post enrollmentPopulation: Two intervention participants did not complete either follow-up assessment with self-reported PrEP continuum outcomes.
Self-report
Outcome measures
| Measure |
Active-kINSHIP Navigation Intervention
n=11 Participants
kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women: kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
|
Control-Standard Care
The control arm will be standard-of-care, which is as-needed case management for justice-involved women.
Standard of care engagement practices: The control arm will be standard-of-care, which is as-needed case management for justice-involved women. The goals of case management services are to reduce recidivism, mitigate behavioral challenges, strengthen public safety, and build self-sufficiency skills. Case managers refer clients to appropriate services in the community (e.g., housing, food).
|
|---|---|---|
|
Accepted PrEP Referral
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 months post enrollmentPopulation: Only four intervention participants had PrEP service information in their electronic medical record.
Reported by via medical record.
Outcome measures
| Measure |
Active-kINSHIP Navigation Intervention
n=4 Participants
kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women: kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
|
Control-Standard Care
The control arm will be standard-of-care, which is as-needed case management for justice-involved women.
Standard of care engagement practices: The control arm will be standard-of-care, which is as-needed case management for justice-involved women. The goals of case management services are to reduce recidivism, mitigate behavioral challenges, strengthen public safety, and build self-sufficiency skills. Case managers refer clients to appropriate services in the community (e.g., housing, food).
|
|---|---|---|
|
Time to PrEP Linkage
|
87 number of days
Standard Deviation 105.73
|
—
|
SECONDARY outcome
Timeframe: 4 months post enrollmentPopulation: Two intervention participants did not complete either follow-up assessment and two participants did not accept the PrEP referral.
Self-report.
Outcome measures
| Measure |
Active-kINSHIP Navigation Intervention
n=9 Participants
kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women: kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
|
Control-Standard Care
The control arm will be standard-of-care, which is as-needed case management for justice-involved women.
Standard of care engagement practices: The control arm will be standard-of-care, which is as-needed case management for justice-involved women. The goals of case management services are to reduce recidivism, mitigate behavioral challenges, strengthen public safety, and build self-sufficiency skills. Case managers refer clients to appropriate services in the community (e.g., housing, food).
|
|---|---|---|
|
Accepted PrEP Prescription
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 months post enrollmentPopulation: Only one intervention participant accepted a PrEP prescription.
Self-report.
Outcome measures
| Measure |
Active-kINSHIP Navigation Intervention
n=1 Participants
kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women: kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
|
Control-Standard Care
The control arm will be standard-of-care, which is as-needed case management for justice-involved women.
Standard of care engagement practices: The control arm will be standard-of-care, which is as-needed case management for justice-involved women. The goals of case management services are to reduce recidivism, mitigate behavioral challenges, strengthen public safety, and build self-sufficiency skills. Case managers refer clients to appropriate services in the community (e.g., housing, food).
|
|---|---|---|
|
PrEP Initiation
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 months post enrollmentPopulation: No participants initiated PrEP during the four-month follow-up period.
Self-report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months post enrollmentPopulation: No participants initiated PrEP during the four-month follow-up period.
Self-report.
Outcome measures
Outcome data not reported
Adverse Events
Active-kINSHIP Navigation Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control-Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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