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Behavioral Intervention

mLab App Plus for HIV and Syphilis Screening

N/A

Recruiting

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Self-report being HIV-negative or unknown status

Not currently taking Pre-Exposure Prophylaxis (PrEP)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3-month follow-up

Awards & highlights

Study Summary

This trial will test an app to help young men who have sex with men and young transgender women to self-test for HIV and syphilis, helping to reduce the high rates of diagnoses in these groups.

Who is the study for?

This trial is for young men and transgender women aged 18-35 who own a smartphone, have sex with men, are at high risk for HIV per CDC guidelines, and haven't been tested for HIV or syphilis in the last 6 months. They must understand English and be able to perform self-tests under supervision.Check my eligibility

What is being tested?

The mLab App Plus intervention is being tested to see if it helps young MSM and TGW self-test for HIV and syphilis. The study aims to increase the number of these individuals initiating self-testing by using this mobile health app.See study design

What are the potential side effects?

Since this trial involves an mHealth app rather than medication, traditional side effects aren't expected. However, participants may experience anxiety or stress related to self-testing outcomes.

Eligibility Criteria

Inclusion Criteria

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

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I am either HIV-negative or unsure of my HIV status.

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I am not currently taking medication to prevent HIV.

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I am between 18 and 35 years old.

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I was assigned male at birth and identify as a man or a trans woman.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The number of participants who are able to self-administer the DPP® HIV-Syphilis test with mLab App Plus

Secondary outcome measures

The number of Young Men who have sex with men/ Young transgender women linked to (attend one appointment) HIV/STI prevention or care services

The number of Young Men who have sex with men/ Young transgender women referred for HIV/STI services (participants with HIV and/or syphilis only)

The number of negative/positive results

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mLab App PlusExperimental Treatment1 Intervention

Participants randomized to intervention will receive standard of care counseling, complete online surveys, be provided with the mLab App Plus, and a box of condoms. The intervention arm will also complete two HIV/Syphilis Ab Combo Rapid Tests (DPP® HIV-Syphilis Test) at their baseline (first test) and 3-month follow- up (second test) appointments.

Group II: Standard of CareActive Control1 Intervention

Participants randomized to standard care will receive standard of care counseling, complete online surveys and be sent an email with links to mobile-optimized online prevention information, including Pre-Exposure Prophylaxis(PrEP) and HIV/STI testing information found on the Centers for Disease Control (CDC) website, and a box of condoms.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,219 Total Patients Enrolled

Frequently Asked Questions

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

To whom is this clinical trial open?

"To participate in the study, applicants must be between 18-35 years of age and have been diagnosed with syphilis. Approximately 40 individuals are accepted into this trial."

Answered by AI

Is the upper age limit for this trial set at 45?

"Applicants aged 18 to 35 are eligible for the clinical trial. There are 162 studies available for minors, and 433 specifically designed for those who have surpassed 65 years of age."

Answered by AI

What is the total population size of this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this trial that was originally posted on September 25th 2023 is currently accepting applications from volunteers. There are 40 spots available at a single medical centre."

Answered by AI

Are there any available openings for individuals interested in participating in this research project?

"Indeed, clinicaltrials.gov confirms that this trial is currently in the recruitment phase; it was initially posted on September 25th 2023 and was last updated two days ago. There are 40 positions to be filled at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention

Rebecca Schnall, RN, MPH, PhD 2023. "mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06059443.