Methods
AIDS, decline an HIV test, trauma
AIDS, RECRUITMENT
The study named ‘Leveraging the ED Visit to Increase Willingness for PrEP’ study (iPrEP study) is a parallel randomized controlled trial (RCT) with a 1:1 allocation ratio to an experimental or control group. The trial is registered at Clinicaltrials.gov (NCT03930654, 29/04/2019). The trial was conducted by research staff at the University of Texas Health Science Center at Houston (UTHealth), McGovern Medical School in partnership with two community clinics, Legacy Community Health and AIDS Foundation Houston. The institutional review board at UTHealth, The Center for Protection of Human Subjects, approved the study protocol for this trial (HSC-MS-16-0892). Study materials included variables in the screening REDCap database, informed consent, recruitment, intervention, and English-only electronic assessment forms developed using Qualtrics software. The experimental group mobilized the iPrEP intervention, a tablet-based intervention strategy that uses a survey model that aims to increase awareness of personal sexual risk through case scenarios (Fig. The control group consisted of usual care for mitigating behavioral health risks in the ED. Providing direct access to PrEP at the two sites is not a part of the usual care process. However, if a patient acknowledges substance use and is seen by the social worker, they have an opportunity to request a referral to PrEP services. The usual care by the social work team requires an in-person visit to each patient with active substance use during the ED visit. The social work team offers 24/7 services at both hospitals. These services include a needs assessments and referral for substance use treatment services. In many cases, several visits during the ED visit by the social work team are required, as patient responses direct referrals.The study team led a 12-month RCT (August 2019–July 2021) to evaluate whether the iPrEP intervention coupled with a referral to a local PrEP clinic, relative to usual care, is capable of increasing willingness for PrEP uptake enough to prompt behavior change, specifically attendance to an initial PrEP clinic visit among cisgender Black women within a 6-month period, with a 1, 3 and 6-month follow-up [The study established a new protocol of linking enrolled participants to a local PrEP clinic through a warm hand-off process co-managed by academic researchers and community-based PrEP providing agencies. The academic-community partnership was cultivated through mutual community-based work on a local PrEP advisory board led by the Houston health department. By linking enrolled participants to healthcare providers that are esteemed as pillars of the community, we enhanced access to social and contextual resources among cisgender Black women who were eligible for PrEP.We recruited participants during wait times of an ED visit at two participating hospitals, Lyndon B. Johnson Hospital (LBJ) and Memorial Hermann Health System (MHH). Both hospitals are located in the Houston metropolitan area of Texas. LBJ is a public hospital and is the state’s busiest level 3 trauma center with more than 80,000 unique ED visits annually [Eligibility criteria of cisgender Black womenAge: 18–55 yearsDoes not decline an HIV test during the ED visitCurrent HIV negative status (based on the HIV test outcome in the ED and/or self-report)Acknowledges condomless sexual activity in the last three monthsAcknowledges substance use within the last three monthsVisual and comprehension capabilitiesPrEP eligible (based on established CDC criteria [Has a working mobile device with themAble to read and understand English sufficiently to provide informed consent and participate the studyCurrently taking medication with known contraindications for PrEP (brand name: Truvada)Currently on PrEPWhen recruited patients were deemed eligible for study participation, a trained researcher engaged them in the informed consent process. The research team member explained the study, allowed the participants to read the consent form and ask any question, and obtained the participant’s signature. A copy of the signed consent form was given to the participant and a separate copy was added to the EMR. Enrolled participants were assigned a unique three-digit study identification (ID) number once the consent form was signed.