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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04064567
• Other study ID #: 239250
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 we 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, we aim to collect data representing diverse perspectives with respect to interest, knowledge, attitudes, and barriers (including substance use) to PrEP uptake. We will also explore 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 high-risk HIV negative individuals being discharged from the Pulaski County Jail or recently discharged from a correctional setting and reporting to a local Community Corrections facility or Re-Entry Center, including: Central Arkansas Community Corrections Center, East Central Arkansas Community Corrections Center, Hidden Creek Opportunity Center, Quality Living Center, Better Community Development, Inc., and Recovery Centers of Arkansas, .Directly informed from formative work (Aim 1), we 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. We will then perform an open pilot with individuals recently released from a correctional facility Aim 3: Conduct a pilot RCT of the PrEP-LINK intervention among high-risk HIV negative individuals being released from the Pulaski County Jail or recruited within 30 days of release from a correctional facility. 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 we will develop the CHW intervention as part of Aim 2, this will be informed by work we have already completed through Aim 1, which was approved under a separate IRB protocol (#207297). Once we have finalized the intervention content, we will conduct the Aim 2 open label evaluation in the exact same way as we 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 we are employing is Ms. Timikia Jackson, 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. Jackson 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. Jackson will be certified in HIV testing and risk reduction counseling. For participants randomized to the intervention group, Ms. Jackson will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence. We anticipate that Ms. Jackson 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. Jackson will be available during regular business hours (Monday-Friday, 9 AM until 5 PM). If participants present to Ms. Jackson 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.Jackson 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. Jackson is considered research staff and has been trained in human subjects through the UAMS CITI program.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 or recently released (within 30 days) from a correctional facility and residing in Central Arkansas.

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:

• 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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Pre-exposure Prophylaxis

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Better Community Development, Inc	Little Rock	Arkansas
United States	Central Arkansas Community Corrections Center	Little Rock	Arkansas
United States	Hidden Creek Opportunity Center	Little Rock	Arkansas
United States	Pulaski County County Regional Detention Facility	Little Rock	Arkansas
United States	Quality Living Center	Little Rock	Arkansas
United States	Recovery Centers of Arkansas	Little Rock	Arkansas
United States	East Central Arkansas Community Correction Center	West Memphis	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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.	12 months
Primary	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	Rate of PrEP Adherence and Retention based on self-reported surveys (PrEP-Use, PrEP-Attitude, PrEP-Adherence)	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.	6 months and 12 months