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Combine app with all features except the ability to order self-test kits for Sexually Transmitted Infection (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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

CombineApp Trial 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.Check my eligibility

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.See study design

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.

CombineApp Trial 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.

CombineApp Trial 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

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

Primary outcome measures

PrEP initiation

Uptake of HIV testing

Uptake of STI testing

CombineApp 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,641 Previous Clinical Trials

2,561,438 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,787 Previous Clinical Trials

2,689,332 Total Patients Enrolled

Jeb Jones, PhDPrincipal InvestigatorRollins School of Public Health

1 Previous Clinical Trials

658 Total Patients Enrolled

Frequently Asked Questions

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

Are patients currently able to enroll in this ongoing study?

"According to the information available on clinicaltrials.gov, this particular study is not actively seeking participants. The trial was initially posted on February 1st, 2024 and was last updated on January 4th, 2024. However, it is worth noting that there are currently 453 other ongoing clinical trials actively searching for eligible participants at this time."

Answered by AI

Which specific criteria determine eligibility for participation in this experimental study?

"Individuals who are between the ages of 18 and 34, have undergone pre-exposure prophylaxis (Prep), and meet all other eligibility criteria may qualify for participation in this clinical trial. The study is currently accepting a total of 464 eligible candidates."

Answered by AI

Is there a maximum age requirement for participants in this clinical trial, specifically excluding individuals younger than 50?

"To be considered for this clinical trial, participants must fall within the age range of 18 to 34 years old."

Answered by AI

Has Arm 3 received the official endorsement of the FDA?

"Based on our assessment at Power, Arm 3 is deemed to have a safety rating of 3. This determination is made due to the fact that this trial is classified as Phase 4, indicating that the treatment has already received approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men

Jeb Jones 2024. "Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06205368.

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