Digital Risk Assessment for HIV Prevention

(CHIPPER Trial)

Overseen By Jenell Coleman, MD MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnant, Non-English/Spanish, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1170 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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. ^{1 2 3 4 8}

Research Team

Jenell Coleman, MD MPH

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

I do not speak English or Spanish.

Living with HIV

Pregnant and has established prenatal care (i.e., visit is for prenatal care)

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Patient Level + Multilevel Experimental Treatment 2 Interventions

Participants in the arm will receive the patient level and multi-level intervention

Group II: Multilevel Experimental Treatment 1 Intervention

Participants in this arm will receive the multi-level intervention

Group III: Standard of Care Active Control 1 Intervention

Participants in this arm will receive standard of care

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A new HIV risk prediction model developed using electronic health record data from over 3.7 million patients effectively identified individuals at high risk for HIV, achieving an area under the curve (AUC) of 0.86 in the development dataset and 0.84 in the validation dataset.

The model flagged 13,463 patients as high or very high risk, successfully identifying a significant portion of incident HIV cases, demonstrating its potential to enhance the targeting of pre-exposure prophylaxis (PrEP) for those who need it most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of electronic health record data and machine learning to identify candidates for HIV pre-exposure prophylaxis: a modelling study. Marcus, JL., Hurley, LB., Krakower, DS., et al.[2023]

In a study involving 1172 participants in the iPrEx open-label extension, self-reported recent PrEP dosing was generally reliable, with 84% of participants reporting at least one dose in the past 3 days, and 83% of these having quantifiable drug levels.

However, 82% of those who reported no doses in the past 3 days actually had no detectable drug, indicating a significant discrepancy, particularly among younger individuals and those with lower educational attainment, highlighting the need for better monitoring strategies for PrEP adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported Recent PrEP Dosing and Drug Detection in an Open Label PrEP Study. Amico, KR., Mehrotra, M., Avelino-Silva, VI., et al.[2019]

In a study of 972 individuals using daily oral PrEP over 850 person-years, adherence was high at 92%, and no HIV infections occurred during PrEP use, indicating its effectiveness in real-world settings.

Discontinuation of PrEP was relatively low at 22.5%, primarily due to factors like female sex and substance abuse, while renal toxicity was rare, with only 0.6% stopping due to low kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure Prophylaxis for HIV Prevention in a Large Integrated Health Care System: Adherence, Renal Safety, and Discontinuation. Marcus, JL., Hurley, LB., Hare, CB., et al.[2022]

In a systematic review of 59 studies involving 43,917 participants, it was found that 41% of individuals discontinued HIV pre-exposure prophylaxis (PrEP) within 6 months, with the highest rates observed in sub-Saharan Africa (47.5%).

Implementing adherence interventions significantly reduced discontinuation rates (24.7% vs 36.7%), and offering flexible dosing options (daily or non-daily) led to lower discontinuation among gay or bisexual men and transgender women (21.6% vs 31.5%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. Zhang, J., Li, C., Xu, J., et al.[2023]

The ePrEP clinic, which offers online self-sampling for HIV and STIs, online consultations, and remote medication provision, was found to be highly acceptable among 15 PrEP users and 9 healthcare professionals, suggesting it could enhance convenience and empower users.

While the ePrEP clinic could increase capacity in sexual health services, some users expressed concerns about the need for blood self-sampling, indicating that it may be best suited for established PrEP users with good digital health literacy and no significant medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kincaid, R., Gibbs, J., Dalrymple, J., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Development and validation of an automated HIV prediction algorithm to identify candidates for pre-exposure prophylaxis: a modelling study. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Use of electronic health record data and machine learning to identify candidates for HIV pre-exposure prophylaxis: a modelling study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Self-reported Recent PrEP Dosing and Drug Detection in an Open Label PrEP Study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Preexposure Prophylaxis for HIV Prevention in a Large Integrated Health Care System: Adherence, Renal Safety, and Discontinuation. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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]