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Behavioural Intervention

mHealth App for Reducing STI Risk in Pre-Exposure Prophylaxis Users

N/A

Recruiting

Led By Meredith Clement, MD

Research Sponsored by Louisiana State University Health Sciences Center in New Orleans

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prescribed, administered or otherwise taking PrEP via routine care or PrEP clinical trial

Age 18-35 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test a new smartphone app, "PCheck," to see if it reduces the incidence of STIs compared to those who only receive routine care through the LSU-Crescent Care Sexual Health/PrEP Clinic.

Who is the study for?

This trial is for Black or multi-racial men, aged 18-35, who have sex with men and are currently using PrEP to prevent HIV. Participants must own a smartphone and be able to read and write in English. It's not open to those who aren't fluent in English.Check my eligibility

What is being tested?

The study is testing 'PCheck,' a new mobile app designed to lower STI risk among participants, against the standard care provided by the LSU-Crescent Care Sexual Health/PrEP Clinic. A total of 120 eligible individuals from New Orleans will be recruited.See study design

What are the potential side effects?

Since this trial involves an app intervention rather than medication, traditional side effects are not applicable. However, there may be indirect consequences related to privacy concerns or psychological impact due to content exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently taking PrEP for HIV prevention.

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I am between 18 and 35 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

STI incidence

Secondary outcome measures

Social Isolation

Social Support

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PCheckExperimental Treatment1 Intervention

Participants allocated to the intervention arm will receive the intervention (use of the PCheck app) for 12 months of follow-up. Participants will be encouraged to use the app as much as they wish throughout the study and will be informed that there will be no set expectation for how frequently they must use the app, although they will be encouraged to use it regularly to "thoroughly test it". The app will send notification reminders to "check in" (in other words, use the daily check-in feature to track their mood, stress, and behaviors related to STI-prevention over time). The notification settings can be adjusted in phone settings by the participant. To encourage peer support and a sense of community, users can interact with community members anonymously through a message board, monitored by research staff. Participants in the intervention will continue routine PrEP care and STI testing through the clinic.

Group II: Routine CareActive Control1 Intervention

Participants in the routine care arm will continue routine PrEP care and STI testing through the clinic.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansLead Sponsor

114 Previous Clinical Trials

44,081 Total Patients Enrolled

University of VirginiaOTHER

753 Previous Clinical Trials

1,244,911 Total Patients Enrolled

Meredith Clement, MDPrincipal InvestigatorLSUHSC

2 Previous Clinical Trials

436 Total Patients Enrolled

Media Library

PCheck (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05395754 — N/A

Sexually Transmitted Infection Research Study Groups: PCheck, Routine Care

Sexually Transmitted Infection Clinical Trial 2023: PCheck Highlights & Side Effects. Trial Name: NCT05395754 — N/A

PCheck (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05395754 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity for enrolment in this clinical trial?

"The information found on clinicaltrials.gov suggests that this research trial is currently looking for participants; the original posting was posted online June 1st 2022 and most recently updated on 6th of June, 2022."

Answered by AI

How many people have enrolled in this medical study thus far?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was initially shared on June 1st 2022, is still recruiting participants. The goal of the study is to enlist 120 patients across two different sites."

Answered by AI

Can I be included in the current research endeavor?

"This medical trial is looking for 120 volunteers, aged 18-35 and with a sexually transmitted infection. Additionally, they must be cisgender men that have sex with other male individuals (MSM), identify as Black or multi-racial including black race, currently using Prep through regular healthcare or clinical trials, and own a smartphone."

Answered by AI