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Procedure

Mobile App for HIV Prevention (CombineApp Trial)

N/A

Recruiting

Led By Jeb Jones, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Report anal sex with a man in the past 12 months

Not currently using PrEP

Must not have

Unable to provide consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, month 6, month 12, month 18, month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a mobile app called Combine to see if it can increase HIV and STI testing and the use of PrEP over a period of 24 months. The trial will also look at

Who is the study for?

This trial is for men aged 18-34 who have had anal sex with another man in the past year, live in rural areas of the U.S. South or Missouri, and are not currently on PrEP. They must be HIV-negative or unsure of their status, own a smartphone with service, speak English, and be willing to use a study app.

What is being tested?

The trial tests if a mobile app called Combine can boost HIV/STI testing and start using PrEP among rural men who have sex with men over two years. Participants will download the app and randomly join one of four groups: control (app only), self-testing (app + test kits), motivational interview (app + planning support), or both self-testing and interview.

What are the potential side effects?

Since this trial involves an app-based intervention rather than medication, traditional side effects aren't expected. However, participants may experience discomfort from increased awareness about their sexual health risks.

Eligibility Criteria

Inclusion Criteria

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

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I have had anal sex with a man in the last year.

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I am not currently taking medication to prevent HIV.

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I was assigned male at birth and identify as male.

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I am between 18 and 34 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give my consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, month 6, month 12, month 18, month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, month 6, month 12, month 18, month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, month 6, month 12, month 18, month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PrEP initiation

Uptake of HIV testing

Uptake of STI testing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Combine app with all features except the ability to order self-test kitsExperimental Treatment1 Intervention

Participants will receive a modified standard of care which consists of the Combine app with all features except the ability to order self-test kits. The HIV/STI testing locator in the app will be available.

Group II: Combine app + motivational interview + ability to order HIV/STI test kits via the appExperimental Treatment3 Interventions

In addition to the other Combine app features, participants in this arm will receive both the motivational interview and the ability to order HIV/STI test kits via the app.

Group III: Combine app + motivational interviewExperimental Treatment2 Interventions

In addition to the other Combine app features, participants will receive a motivational interview within 4 weeks of downloading the app.

Group IV: Combine app + ability to order up 2 free HIV/STI self-test kitsExperimental Treatment2 Interventions

In addition to the other Combine app features, participants in this arm will be able to order up to two HIV/STI self-test kits at no charge during each year of follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Motivational interview

2022

N/A

~1940

0 / 5Eligibility criteria met