PrEP for HBCUs (Study 2) | Clinical Trial

Key information

Conditions

At Risk for HIV

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Enrolled as a student in a Historically Black College or University, OR identify as Black/African American
Male
Self-report having sex with men in the past 6 months
18-30 years of age
English-speaking
Currently prescribed PrEP (Truvada) for HIV prevention
Participant has an Android (using v5.x.x or lollipop) or iOS (v6.0) smartphone

Exclusion criteria

History of a chronic/significant medical or psychiatric condition that will interfere with study participation
Unable to attend sessions

Treatment and study plan

PrEP Smart app

Device

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".

Primary outcomes

Feasibility as measured by the number of times per day that subjects initiate an interaction with PrEP Smart

Time frame: 8 weeks

As measured by the number of times per day that subjects initiate an interaction with PrEP Smart
Feasibility as measured by the number of times per day that subjects respond to a PrEP Smart prompt

Time frame: 8 weeks

As measured by the number of times per day that subjects respond to a PrEP Smart prompt

Secondary outcomes

Acceptability will be assessed during the final laboratory visit with an open ended qualitative interview assessing overall feedback

Time frame: 8 weeks

Will be assessed during the final laboratory visit with an open ended qualitative interview assessing overall feedback.
Acceptability will be assessed by feedback specific to each of the six individual PrEP Smart features

Time frame: 8 weeks

Will be assessed by feedback specific to each of the six individual PrEP Smart features.
Adherence will be assessed by the number of times that PrEP was taken daily over the 8 week period and the number of times that it was taken outside of a one hour window in which it was prescribed

Time frame: 8 weeks

Will be assessed by the number of times that PrEP was taken daily over the 8 week period and the number of times that it was taken outside of a one hour window in which it was prescribed.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

Intelligent Automation, Inc.

Registry information

Acronym: PrEP for HBCUs

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Mar 15, 2017
Registry last updated: Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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