Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2019 by University of Arkansas

Sponsor
University of Arkansas


Information provided by (Responsible Party)
University of Arkansas
ClinicalTrials.gov Identifier
NCT04064567

First received: August 14, 2019
Last updated: November 12, 2019
Last Verified: November 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV/AIDS
Pre-exposure Prophylaxis

Behavioral : PrEP-LINK
Other : Enhanced Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK

Further study details as provided by University of Arkansas:

Primary Outcome Measures

  • Satisfaction of the utilization of the CHW to aid in accessing PrEP assessed by the Client Satisfaction Questionnaire-Revised [ Time Frame: 12 months ]
    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 define as > 80% of participants expressing high satisfaction with the intervention based on the Client Satisfaction Questionnaire - Revised. The investigators will also review data collected by the study staff about time spent on the intervention and the ease of following the research and intervention protocols.
  • Rate of PrEP Uptake Among Participants based on Medical Chart Review [ Time Frame: 12 months ]
    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.
Secondary Outcome Measures:
  • Rate of PrEP Adherence and Retention based on self-reported surveys (PrEP-Use, PrEP-Attitude, PrEP-Adherence) [ Time Frame: 6 months and 12 months ]
    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.

Estimated Enrollment: 120
Study Start Date: September 30, 2019
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Enhanced Standard of Care
PrEP education and referral to a community-based PrEP provider (enhanced standard of care)
Other: 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.

Experimental: 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.
Behavioral: 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.

Detailed Description:

Specific Aims
The specific aims of the project associated with this protocol are:
Aim 1: Perform a qualitative assessment of facilitators and barriers to PrEP uptake among high-risk jail detainees, systems and interactor levels. To achieve this aim the investigators will conduct qualitative interviews with three distinct groups of stakeholders:

  1. Systems interviews (n=6);
  2. Interactor interviews (n=8); and
  3. Individual Key Informant interviews (n=20). Within each of these strata, the
investigators aim to collect data representing diverse perspectives with respect to interest, knowledge, attitudes, and barriers (including substance use) to PrEP uptake. The investigators will also explore the acceptability and feasibility of an intervention to link individuals being released from the Pulaski County jail to PrEP services.
For the purposes of this protocol, Aims 2 and 3 are identical in terms of participant recruitment, enrollment and all study procedures (including data collection and participant follow up). The primary objective of Aim 2 is to conduct a small pilot of the intervention study in order to make any necessary changes to any aspect of the study procedures. If any changes are made, those changes will be submitted to the IRB for further review and approval prior to initiating Aim 3. If no changes are made, this IRB protocol will serve as the protocol for both Aims 2 and 3.
Aim 2: Develop the PrEP-LINK intervention and perform an open-label evaluation with AA high-risk HIV negative individuals being discharged from the Pulaski County Jail. Directly informed from formative work (Aim 1), the investigators will develop the PrEP-LINK intervention, which will include the use of a community health worker (CHW) and adherence counseling (based on ADAPT-ITT) approach to enhance PrEP care and overcome barriers to uptake in this population. The investigators will then perform an open pilot with jail detainees recently released from the Pulaski County Jail to evaluate the intervention.
Aim 3: Conduct a pilot RCT of the PrEP-LINK intervention among high-risk HIV negative individuals being released from the Pulaski County Jail. Based on the formative work in Aim 1 and open pilot evaluation in Aim 2, participants will be randomized to either the PrEP-LINK intervention, or enhanced standard of care arm. Both arms will receive education about PrEP and referral to a community PrEP provider which exceeds the standards of care these individuals would otherwise receive.
While the investigators will develop the CHW intervention as part of Aim 2, this will be informed by work the investigators have already completed through Aim 1, which was approved under a separate IRB protocol (#207297). Once the investigators have finalized the intervention content, the investigators will conduct the Aim 2 open-label evaluation in the exact same way as the investigators will conduct the Aim 3 pilot RCT. To reiterate, the rationale of the open-label evaluation proposed in Aim 2 is to ensure that the intervention is appropriate and does not need additional revision prior to conducting the Aim 3 RCT.
Description of the Community Health Worker (CHW) Intervention (Aims 2 and 3): The intervention arm in both Aims 2 and 3 will receive additional support by a community health worker (CHW) who will assist with healthcare and social service navigation and will utilize adherence counseling techniques. The CHW the investigators are employing is Ms. Ruby Welch, who is a trained CHW with a strong knowledge base of both healthcare and social service systems in the greater Little Rock area. As per the model our intervention is based upon (the national Transitions Clinic Network [TCN], which has 14 sites across the country), Ms. Welch has a history of incarceration. Therefore, she can serve as a true peer to individuals who are enrolled into the study. The national TCN sites employ formerly incarcerated CHWs because these individuals are often able to develop close relationships with their peers who have also been formerly incarcerated thereby building a strong foundation of trust among a population with high levels of distrust of the medical system. Ms. Welch has received training from the national TCN coordinating center in San Francisco. In addition, Ms. Welch has been certified in HIV testing and risk reduction counseling. She has also received training from an Arkansas Department of Health consultant who is an expert in HIV PrEP adherence. For participants randomized to the intervention group, Ms. Welch will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence. The investigators anticipate that Ms. Welch will be in contact with intervention arm participants at least once per week but the exact amount of contact for each participant will vary based on needs. Ms. Welch will be available during regular business hours (Monday-Friday, 9 AM until 5 PM). If participants present to Ms. Welch in crisis, she will refer them immediately to the Emergency Department, in the event of a medical or behavioral health emergency or the Pulaski County Regional Crisis Stabilization Center, which is operated by the UAMS Psychiatric Research Institute (PRI). Ms. Welch will be directly supervised by PI Dr. Zaller through weekly supervision meetings and biweekly phone check-ins. Frequency of check-in may increase or decrease, as needed, during the course of the study period. Ms. Welch is considered research staff and has been trained in human subjects through the UAMS CITI program.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

    1. Age greater than or equal to 18 at study enrollment
    2. Able to understand and speak English and to provide written and verbal informed consent.
    3. Able to provide reliable pieces of locator information (e.g. mailing address, phone number, email address, places frequently visited, etc.)
    4. HIV negative confirmed through an on-site rapid HIV test;
    5. Recently released from the Pulaski County Regional Detention Facility into the community and not into another detention facility
    6. 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.


    Exclusion Criteria:
    1. 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.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT04064567

    Contacts

    Contact:   Nickolas D Zaller, Ph.D 501-686-8366 NDZaller@uams.edu
    Contact:   Taylor L Neher, MPH TLNeher@uams.edu

    Locations

    United States, Arkansas
    Pulaski County County Regional Detention Facility Recruiting
    Little Rock, Arkansas, United States, 72204
    Contact: Ronald Routh    rrouth@pcso.org

    Sponsors and Collaborators

    University of Arkansas

    Investigators

    Principal Investigator: Nickolas D Zaller, Ph.D University of Arkansas
    More Information

    More Information


    Responsible Party: University of Arkansas  
    ClinicalTrials.gov Identifier: NCT04064567   History of Changes  
    Other Study ID Numbers: 239250  
    Study First Received: August 14, 2019  
    Last Updated: November 12, 2019  

    Studies a U.S. FDA-regulated Drug Product: No  
    Studies a U.S. FDA-regulated Device Product: No  

    Keywords provided by University of Arkansas:

    PrEP
    Community Health Worker
    Criminal Justice

    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections

    ClinicalTrials.gov processed this data on August 07, 2020
    This information is provided by ClinicalTrials.gov.