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

Status Active, not recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04064567
• Study type: Interventional
• Source: University of Arkansas
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2019
• Completion date: April 30, 2024