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

NCT04064567 | Completed Results DMC

• 1 other identifier: 239250
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

Our proposed study will: provide a novel exploration of facilitators and barriers to PrEP; allow us to target hard to reach populations, including men who have sex with men (MSM) and substance users (both of which are top funding priority groups for the National Institutes of Health) who experience intersecting markers of HIV risk; and inform regional, and possibly national, intervention approaches to combat the overlapping epidemic of HIV and incarceration.

Conditions

HIV/AIDS; Pre-exposure Prophylaxis

Keywords

PrEP; Community Health Worker; Criminal Justice

Outcome Measures

Primary Outcomes (2)

• Satisfaction of the Utilization of the CHW to Aid in Accessing PrEP Assessed by the Client Satisfaction Questionnaire-Revised

  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.

  12 months

• Rate of PrEP Uptake Among Participants Based on Medical Chart Review

  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.

  12 months

Secondary Outcomes (1)

• Rate of PrEP Adherence and Retention Based on Self-reported Surveys (PrEP-Use, PrEP-Attitude, PrEP-Adherence)

  6 months

Study Arms (2)

Enhanced Standard of Care

ACTIVE COMPARATOR

PrEP education and referral to a community-based PrEP provider (enhanced standard of care)

Other: Enhanced Standard of Care

Community Health Worker Involved Enhanced Standard of Care

EXPERIMENTAL

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.

Behavioral: PrEP-LINK

Interventions

PrEP-LINK BEHAVIORAL

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

Enhanced Standard of Care OTHER

Participants will receive education about PrEP and referral to a community PrEP provider which exceeds the standards of care these individuals would otherwise receive.

Enhanced Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 at study enrollment
• Able to understand and speak English and to provide written and verbal informed consent.
• Able to provide reliable pieces of locator information (e.g. mailing address, phone number, email address, places frequently visited, etc.)
• HIV negative confirmed through an on-site rapid HIV test;
• Recently released from the Pulaski County Regional Detention Facility into the community and not into another detention facility or recently released (within 30 days) from a correctional facility and residing in Central Arkansas.
• At substantial risk for HIV as determined by CDC/WHO PrEP guidelines, which includes engaging in any of the following behaviors in the last six months:
• Having condomless vaginal or anal sex with more than one partner,
• Having a sex partner with one or more HIV risk (e.g. PWID, a sex worker),
• Being diagnosed with a STI,
• Reporting history of sharing injection material/equipment, or
• Having a sexual partner who is HIV positive.

You may not qualify if:

• Potential participants unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate (e.g., dementia), will be excluded.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (7)

Better Community Development, Inc

Little Rock, Arkansas, 72204, United States

Location

Central Arkansas Community Corrections Center

Little Rock, Arkansas, 72204, United States

Location

Pulaski County County Regional Detention Facility

Little Rock, Arkansas, 72204, United States

Location

Quality Living Center

Little Rock, Arkansas, 72204, United States

Location

Recovery Centers of Arkansas

Little Rock, Arkansas, 72209, United States

Location

Hidden Creek Opportunity Center

Little Rock, Arkansas, 72211, United States

Location

East Central Arkansas Community Correction Center

West Memphis, Arkansas, 72301, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

The COVID-19 pandemic forced closure of research activities within the original study recruitment site, the county detention center. The study team then shifted recruitment to community based re-entry settings. Barriers caused by the COVID-19 pandemic, conditions specific to re-entry centers, and competing priorities of those leaving incarceration may have all contributed to lack of study engagement and PrEP use. Some participants were reincarcerated within their year of study participation.

Results Point of Contact

• Title: Director, Research Programs
• Organization: University of Arkansas for Medical Sciences

hkhorton@uams.edu

501-686-6427

Study Officials

• Nickolas D Zaller, Ph.D

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be two groups that participants can be assigned to if they choose to participate in the study. Each person will be randomly assigned to one of these groups. One group will provide information about PrEP and HIV prevention and referral to PrEP clinics in the community. The second group will the same as the first group but will also provide access to a CHW who will assist them with getting to a PrEP clinic and also helping them with other needs they may have.

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 22, 2019
• Study Start: September 30, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 8, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-06

Locations

US (7)