At Risk for HIV Clinical Trial
Official title:
PrEP for HBCUs (Study 2)
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02895893 -
PrEP SMART Phase I Trial
|
Phase 1 | |
| Completed |
NCT01347164 -
Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men
|
Phase 2 |