Digital PrEP Toolkit for HIV Prevention

Not yet recruiting at 3 trial locations
VM
MK
Overseen ByMirjam-Colette Kempf, PhD, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
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?

This trial tests whether a Digital PrEP Toolkit can help cisgender women in Alabama and Mississippi learn about and begin taking PrEP, a medication that prevents HIV infection. Researchers aim to determine if the toolkit is quick and easy to use and if it encourages more women to start using PrEP. Women who are HIV-negative, have been sexually active recently or plan to be, and can speak English may be suitable for this trial. Participants will use the toolkit on a tablet at a clinic and discuss PrEP with healthcare staff, with follow-ups to track their progress. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance HIV prevention strategies for women.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a digital tool to learn about PrEP, so it's unlikely that you would need to stop other medications.

What prior data suggests that the Digital PrEP Toolkit is safe for use?

Research has shown that PrEP (pre-exposure prophylaxis) effectively prevents HIV infection. Many people have safely used it to reduce their risk of contracting HIV, and most do not experience serious side effects.

The Digital PrEP Toolkit helps women learn about PrEP and decide if they want to use it. Although specific data on the toolkit's safety is limited, it aims to provide clear and simple information about PrEP. As an educational resource, it does not carry the same safety concerns as a medication.

Overall, the Digital PrEP Toolkit is considered safe. It aids women in making informed health decisions and improves access to a proven method of preventing HIV.12345

Why are researchers excited about this trial?

The Digital PrEP Toolkit is unique because it leverages technology to enhance the entire PrEP care process, from awareness to adherence, especially for individuals at higher risk of HIV. Unlike traditional methods that rely heavily on in-person consultations and physical reminders, this digital approach provides an interactive and personalized experience that can be accessed anytime, anywhere. Researchers are excited because this toolkit aims to address racial and gender disparities in PrEP uptake, potentially making HIV prevention more inclusive and effective for underserved communities.

What evidence suggests that the Digital PrEP Toolkit is effective for increasing PrEP uptake among women?

Research has shown that the Digital PrEP Toolkit, tested in this trial, helps more people start using PrEP, a medication that prevents HIV. One study found that 64.2% of people using a similar digital tool began taking PrEP, compared to only 27.3% who did not use it. Another study found that the Toolkit helps people adhere to their PrEP schedule, with over 83% of users following their medication plan. When used correctly, PrEP is highly effective, reducing the risk of contracting HIV through sex by about 99%. These findings suggest that the Digital PrEP Toolkit could help more women at risk for HIV start and continue using PrEP.56789

Who Is on the Research Team?

MK

Mirjam-Colette Kempf, PhD, MPH

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for cisgender women at risk of HIV infection, located in Alabama and Mississippi. They should be willing to use a digital toolkit on a tablet and discuss PrEP options with healthcare staff. There are no specific exclusion criteria provided.

Inclusion Criteria

English-speaking
HIV-negative
Report sexual activity in the last six months or anticipate sexual activity in the next six months.
See 2 more

Exclusion Criteria

I do not identify as female nor was I assigned female at birth.
Unable or unwilling to provide informed consent
Living with HIV
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Toolkit Use

Participants complete a 30-minute enrollment visit, provide informed consent, complete baseline assessments, and use the Interactive Digital PrEP Toolkit on a tablet.

1 day
1 visit (in-person)

Follow-up

Participants are contacted by phone for a follow-up interview about HIV and PrEP knowledge, sexual health, PrEP uptake and adherence, and experiences with the Toolkit. Medical records are reviewed at 3 months for PrEP prescriptions.

3 months
1 contact (phone)

Extended Follow-up

Research staff review medical records at 6 months for continued PrEP prescriptions.

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Digital PrEP Toolkit

Trial Overview

The study tests an Interactive Digital PrEP Toolkit designed to educate women about Pre-Exposure Prophylaxis (PrEP) for HIV prevention. It checks if the toolkit can be completed quickly, its usability, and whether it encourages starting PrEP treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Implementation of interactive digital PrEP toolkit for increased PrEP uptakeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Citations

Evaluating an Interactive Digital Toolkit for Women's PrEP ...

The goal of this study is to test if a Digital PrEP Toolkit helps cisgender women learn about and access PrEP in Alabama and Mississippi.

Effectiveness of PrEPTECH: Findings From a 180-Day ...

On completion of the 90-day postbaseline survey, 64.2% of those in the PrEPTECH arm had taken PrEP since study start versus 27.3% of those in ...

Enhancing PrEP Uptake with the HIV/PrEP Toolkit

This toolkit is an actionable, scalable solution to improve PrEP uptake and reduce new HIV infections by promoting informed, stigma-free ...

Incorporation of an Evidence-Based HIV Risk Assessment ...

When taken as directed, PrEP is highly effective in preventing HIV acquisition, reducing risk by approximately 99% for sexual transmission and 74% for ...

Real-time digital intervention on oral pre-exposure ...

During follow-ups at 3 and 6 months, the intervention group demonstrated significantly higher PrEP adherence (83.3% and 83.1%) than the control ...

PrEP Ring Safety Data in Adolescent Girls and Youth ...

This toolkit is designed to help clinicians develop knowledge and skills to provide multiple HIV PrEP methods. The toolkit includes resources ...

PrEPared Let's Stop HIV Together Social Media Toolkit

#PrEP is highly effective at preventing HIV regardless of your relationship status, and it can be available to you at low or no cost. ... An image ...

TelePrEP & Youth Toolkit

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WHO PrEP Implementation Tool

The tool contains modules for a range of stakeholders to support them in the consideration, planning, introduction and implementation of oral PrEP.