Trial Outcomes & Findings for Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK (NCT NCT04064567)

Last Updated: 2025-06-08

Results Overview

The acceptability of the intervention will be determined with descriptive statistics of the participants' acceptability ratings, including whether they think the intervention is acceptable. Acceptability is defined as \> 80% of participants expressing high satisfaction with the intervention based on the Client Satisfaction Questionnaire - Revised (CSQ-8). The CSQ-8 is scored using a scale which ranges from 8-32, with a higher number indicating greater satisfaction.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

12 months

Results posted on

2025-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Enhanced Standard of Care PrEP education and referral to a community-based PrEP provider (enhanced standard of care) Enhanced Standard of Care: Participants will receive education about PrEP and referral to a community PrEP provider which exceeds the standards of care these individuals would otherwise receive.	Community Health Worker Involved Enhanced Standard of Care PrEP education, referral to a community-based PrEP provider, and referral to a CHW who will facilitate access to community-based PrEP and other healthcare and social-support services. PrEP-LINK: CHW will assist with healthcare and social service navigation and will utilize adherence counseling techniques. As per the model our intervention is based upon (the national Transitions Clinic Network \[TCN\]), our CHW has a history of incarceration. Participants randomized to the intervention group, the CHW will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence.
Overall Study STARTED	50	50
Overall Study 6 Month Assessment	19	20
Overall Study COMPLETED	20	16
Overall Study NOT COMPLETED	30	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Enhanced Standard of Care PrEP education and referral to a community-based PrEP provider (enhanced standard of care) Enhanced Standard of Care: Participants will receive education about PrEP and referral to a community PrEP provider which exceeds the standards of care these individuals would otherwise receive.	Community Health Worker Involved Enhanced Standard of Care PrEP education, referral to a community-based PrEP provider, and referral to a CHW who will facilitate access to community-based PrEP and other healthcare and social-support services. PrEP-LINK: CHW will assist with healthcare and social service navigation and will utilize adherence counseling techniques. As per the model our intervention is based upon (the national Transitions Clinic Network \[TCN\]), our CHW has a history of incarceration. Participants randomized to the intervention group, the CHW will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence.
Overall Study Lost to Follow-up	23	22
Overall Study Withdrawal by Subject	0	1
Overall Study Reincarcerated	7	10
Overall Study Moved out of U.S.	0	1

Baseline Characteristics

Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Standard of Care n=50 Participants PrEP education and referral to a community-based PrEP provider (enhanced standard of care) Enhanced Standard of Care: Participants will receive education about PrEP and referral to a community PrEP provider which exceeds the standards of care these individuals would otherwise receive.	Community Health Worker Involved Enhanced Standard of Care n=50 Participants PrEP education, referral to a community-based PrEP provider, and referral to a CHW who will facilitate access to community-based PrEP and other healthcare and social-support services. PrEP-LINK: CHW will assist with healthcare and social service navigation and will utilize adherence counseling techniques. As per the model our intervention is based upon (the national Transitions Clinic Network \[TCN\]), our CHW has a history of incarceration. Participants randomized to the intervention group, the CHW will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence.	Total n=100 Participants Total of all reporting groups
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.14 years STANDARD_DEVIATION 8.65 • n=5 Participants	37 years STANDARD_DEVIATION 10.18 • n=7 Participants	36.46 years STANDARD_DEVIATION 9.49 • n=5 Participants
Sex/Gender, Customized Male	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex/Gender, Customized Female	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Community Health Worker Involved Enhanced Standard of Care n=16 Participants PrEP education, referral to a community-based PrEP provider, and referral to a CHW who will facilitate access to community-based PrEP and other healthcare and social-support services. PrEP-LINK: CHW will assist with healthcare and social service navigation and will utilize adherence counseling techniques. As per the model our intervention is based upon (the national Transitions Clinic Network \[TCN\]), our CHW has a history of incarceration. Participants randomized to the intervention group, the CHW will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence.	Community Health Worker Involved Enhanced Standard of Care PrEP education, referral to a community-based PrEP provider, and referral to a CHW who will facilitate access to community-based PrEP and other healthcare and social-support services. PrEP-LINK: CHW will assist with healthcare and social service navigation and will utilize adherence counseling techniques. As per the model our intervention is based upon (the national Transitions Clinic Network \[TCN\]), our CHW has a history of incarceration. Participants randomized to the intervention group, the CHW will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence.
Satisfaction of the Utilization of the CHW to Aid in Accessing PrEP Assessed by the Client Satisfaction Questionnaire-Revised	29.5 Score on CSQ-8 Standard Deviation 3.26	—

PRIMARY outcome

Timeframe: 12 months

Population: No participants in either group reported taking PrEP at 12 month assessment, therefore medical chart review was not completed on any participant.

The preliminary efficacy of the intervention will be determined by assessing the primary outcome of PrEP uptake by looking at the medical charts of the participants. A secondary outcome will be PrEP adherence defined by participants who were adherent to the medication determined by self-report at 6, and 12 months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: One participant in the Community Health Worker Involved Enhanced Standard of Care (intervention) arm reported currently taking PrEP at 6 month assessment (20 intervention arm participants completed the 6 month assessment). No participants in the Enhanced Standard of Care (control) arm reported currently taking PrEP at 6 month reassessment (18 control arm participants completed the 6 month assessment).

A secondary outcome will be PrEP adherence defined by participants who were adherent to the medication determined by self-report at 6, and 12 months.

Outcome measures

Outcome measures
Measure	Community Health Worker Involved Enhanced Standard of Care n=18 Participants PrEP education, referral to a community-based PrEP provider, and referral to a CHW who will facilitate access to community-based PrEP and other healthcare and social-support services. PrEP-LINK: CHW will assist with healthcare and social service navigation and will utilize adherence counseling techniques. As per the model our intervention is based upon (the national Transitions Clinic Network \[TCN\]), our CHW has a history of incarceration. Participants randomized to the intervention group, the CHW will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence.	Community Health Worker Involved Enhanced Standard of Care n=20 Participants PrEP education, referral to a community-based PrEP provider, and referral to a CHW who will facilitate access to community-based PrEP and other healthcare and social-support services. PrEP-LINK: CHW will assist with healthcare and social service navigation and will utilize adherence counseling techniques. As per the model our intervention is based upon (the national Transitions Clinic Network \[TCN\]), our CHW has a history of incarceration. Participants randomized to the intervention group, the CHW will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence.
Rate of PrEP Adherence and Retention Based on Self-reported Surveys (PrEP-Use, PrEP-Attitude, PrEP-Adherence)	0 Participants	1 Participants

Adverse Events

Enhanced Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Community Health Worker Involved Enhanced Standard of 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

Director, Research Programs

University of Arkansas for Medical Sciences

Phone: 501-686-6427

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place