1170 Participants Needed

Digital Risk Assessment for HIV Prevention

(CHIPPER Trial)

JC
Overseen ByJenell Coleman, MD MPH
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is PrEP safe for humans?

Studies have shown that daily oral pre-exposure prophylaxis (PrEP) is generally safe for preventing HIV infection, with research supporting its safety in both controlled and real-world settings.12345

How is the digital risk assessment for HIV prevention different from other treatments?

This treatment is unique because it uses digital tools, like an automated prediction algorithm and a digital pill system, to identify individuals at risk for HIV and to monitor adherence to HIV prevention medication in real-time, which is not a feature of traditional methods.45678

What data supports the effectiveness of the drug for HIV prevention?

Research shows that using digital systems to monitor adherence to pre-exposure prophylaxis (PrEP) can help ensure people take the medication as prescribed, which is crucial for its effectiveness in preventing HIV. Studies have demonstrated that these systems are feasible, acceptable, and accurate in tracking medication use, which can improve adherence and, consequently, the drug's effectiveness.24578

Who Is on the Research Team?

JC

Jenell Coleman, MD MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for cis-gender women aged 15-65 who are seeing their doctors for preventive care like well-woman exams. It's not for those who are pregnant with established prenatal care, living with HIV, or can't complete the electronic health form in English or Spanish.

Inclusion Criteria

I am between 15 and 65 years old and seeing my doctor for preventive care.

Exclusion Criteria

Living with HIV
Pregnant and has established prenatal care (i.e., visit is for prenatal care)
Unable to complete the eHxForm

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete an electronic history form and are categorized into risk groups. Depending on their risk score, they may receive different interventions including viewing a PrEP video or receiving an EHR alert.

6 months

Follow-up

Participants are monitored for PrEP uptake and completion of the electronic history form.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Control
  • Multilevel
  • Patient Level
Trial Overview The study is testing if using electronic medical and sexual history data to identify HIV risk can increase the use of PrEP (a medication to prevent HIV) during routine gynecologic visits.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Patient Level + MultilevelExperimental Treatment2 Interventions
Group II: MultilevelExperimental Treatment1 Intervention
Group III: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

A study involving 71 HIV-negative adults using a digital health feedback system with ingestible-sensor-enabled Truvada® showed that 88.7% of participants adhered to the medication for at least 28 days, with an average adherence rate of 86.2%.
Adherence patterns indicated that older age and negative methamphetamine screens were associated with better adherence, suggesting that substance use may negatively impact the effectiveness of oral PrEP.
Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection.Browne, SH., Vaida, F., Umlauf, A., et al.[2023]
A pilot study involving 16 HIV-negative men who have sex with men (MSM) demonstrated that a digital pill system (DPS) is a feasible and acceptable method for measuring adherence to daily PrEP, with 92.2% of expected ingestions recorded accurately.
The DPS showed strong correlations between recorded adherence and actual drug levels in the blood, indicating its effectiveness in tracking PrEP use, which is crucial for preventing HIV transmission.
DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances.Chai, PR., Mohamed, Y., Bustamante, MJ., et al.[2023]
An automated prediction algorithm using electronic health record data was developed and validated to identify individuals at increased risk for HIV acquisition, demonstrating a high performance with a cv-AUC of 0.86 in the development cohort and 0.91 in prospective validation.
The algorithm successfully identified 9515 potential PrEP candidates (1.8% of patients) in one health system and 4385 candidates (15.3% of patients) in another, suggesting that integrating such models into EHRs could enhance PrEP prescribing and help prevent new HIV infections.
Development and validation of an automated HIV prediction algorithm to identify candidates for pre-exposure prophylaxis: a modelling study.Krakower, DS., Gruber, S., Hsu, K., et al.[2020]

Citations

Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection. [2023]
DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. [2023]
Development and validation of an automated HIV prediction algorithm to identify candidates for pre-exposure prophylaxis: a modelling study. [2020]
Use of electronic health record data and machine learning to identify candidates for HIV pre-exposure prophylaxis: a modelling study. [2023]
Self-reported Recent PrEP Dosing and Drug Detection in an Open Label PrEP Study. [2019]
Preexposure Prophylaxis for HIV Prevention in a Large Integrated Health Care System: Adherence, Renal Safety, and Discontinuation. [2022]
Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. [2023]
Delivering HIV prevention medication online: Findings from a qualitative study exploring the acceptability of an online HIV pre-exposure prophylaxis (PrEP) care pathway among service users and healthcare professionals. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security