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

 -  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.