PrEP for HBCUs (Study 2)
Condition: At Risk for HIV
Study type: Interventional

Summary: 
      The investigators' overall goals are to target (a) pre-exposure prophylaxis (PrEP) uptake by
      addressing access and acceptability and (b) PrEP adherence among Historically Black Colleges
      and Universities (HBCU) students.
    

Detailed description: 
      The following is only pertaining to study 2, HBCUs. PrEP Smart (study 1) is not included in
      this record.

      The investigators' overall goals are to target (a) pre-exposure prophylaxis (PrEP) uptake by
      addressing access and acceptability and (b) PrEP adherence among Historically Black Colleges
      and Universities (HBCU) students.

      Aim 1/Study 1. Investigate uptake of PrEP services on HBCU campuses. Making PrEP available on
      HBCU campuses may address uptake by increasing (a) accessibility by allowing students to gain
      access to tenofovir disproxil fumarate/emtricitabine (TDF/FTC) without having to leave campus
      and (b) acceptability by providing trained practitioners and student advocates on campus to
      educate students on the benefits of PrEP. Aim 1a will target PrEP uptake at HBCUs at the
      healthcare systems level. The investigators will identify Student health centers (SHC)
      practitioners on 6 HBCUs (North Carolina Central, St. Augustine's, Fayetteville State
      University, Shaw, North Carolina A&T, and Bennett College). After a comprehensive SHC needs
      assessment, the investigators will train practitioners on eligibility for PrEP,
      pre-initiation counseling, and prescribing in partnership with the North Carolina AIDS
      Education and Training Center (NC AETC). The investigators will also engage key student
      organizations on campus and train motivated student advocates for the dissemination of
      information about PrEP on campus. Aim 1b will target PrEP uptake at the individual level.
      First, the investigators will collect data on all clinical encounters for PrEP at
      participating SHCs during the study period. Data will be collected on the basic demographics
      and risk factors necessitating the initiation of PrEP. The investigators will also collect
      data on PrEP initiations, as well as the number of prescriptions written in follow up during
      the period of study. To better understand PrEP behaviors on campus, the investigators will
      ask students initiated on PrEP to take a brief, anonymous questionnaire on relevant topics
      including: (1) PrEP awareness, (2) Motivation for initiating PrEP, (3) Perceived stigma of
      HIV and HIV associated risk factors on campus, and (4) Perceptions of confidentiality
      regarding seeking PrEP services on campus. The investigators anticipate enrolling
      approximately 250 students for this portion of the study.

      Aim 2/Study 2. Adapt a smartphone-based contingency management (CM) application ("app")
      intervention designed to improve PrEP adherence. CM is a behavioral intervention that
      involves the systematic use of reinforcement dependent on the occurrence of a predefined
      behavior. CM improves adherence to antiretroviral therapy (ART) and post-exposure prophylaxis
      (PEP), and is currently being developed by the investigative team for PrEP. Since the cost of
      traditional CM interventions may be prohibitive in practice, the investigators will adapt
      this intervention using a lower cost reinforcement procedure and therefore improve the
      scalability of this adherence intervention. In a sample of young men who have sex with men
      (YMSM) prescribed PrEP (n = 20) over an 8 week period, Aim 2a will assess app interaction to
      address feasibility, Aim 2b will assess acceptability via self-report quantitative ratings
      and qualitative interviewing, Aim 2c will assess the validity of daily camera-based
      medication ingestion assessment via the app to validate medication adherence against blood
      tests to detect PrEP, and Aim 2d will assess barriers to adherence via app-based daily
      assessments following missed doses.
    

Intervention name(s): PrEP Smart app
Intervention type(s): Device
Intervention description(s): English-speaking males, between the ages of 18-30, who are enrolled at a HBCU or identify as Black/African American, who are currently prescribed PrEP (Truvada) for HIV Prevention, and owners of either an Android or iOS smartphone, will be asked to use an application on their smart phones called "PrEP Smart".an application on their smart phones called "PrEP Smart".
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility