What side effects are associated with this type of intervention?

Common treatments for sexually transmitted infections such as genital herpes and anogenital warts have several known side effects. Antiviral medications like acyclovir, valacyclovir, and famciclovir, used for genital herpes, can cause headaches, nausea, and abdominal pain. In some cases, they may also lead to dizziness and fatigue. Treatments for anogenital warts, such as cryotherapy, can cause pain, blistering, and scarring at the application site. Podophyllotoxin may result in local irritation, burning, and redness, while imiquimod can cause skin reactions including redness, swelling, and erosion. It is important to discuss these potential side effects with a healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for common Sexually Transmitted Infections (STIs). For genital herpes, antiviral medications such as acyclovir, valacyclovir, and famciclovir are commonly used and have been FDA-approved for both episodic and suppressive therapy. Anogenital warts, caused by the human papillomavirus (HPV), can be treated with FDA-approved topical agents like imiquimod, podofilox, and sinecatechins. Bacterial STIs such as chlamydia and gonorrhea are typically treated with antibiotics like azithromycin and ceftriaxone, respectively. These treatments are part of a broader effort to manage and reduce the prevalence of STIs, aligning with the goals of the STIckER study to enhance sexual health education and promote STI testing.

What other types of research exist?

Promising alternatives to the STIckER Decision Aid include: 1) Visual aids that effectively communicate quantitative information about STIs, as they have been shown to influence attitudes, behavioral intentions, and self-reported behavior. 2) Computer-assisted and online technologies for assessing and improving condom use, which can help reduce STI transmission. 3) Brief educational messages tailored to young adults with low numeracy and high graph literacy, which have been effective in promoting STI prevention and detection.

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Behavioral Intervention

Digital Decision Aid for Sexually Transmitted Infections (STIckER Trial)

N/A

Waitlist Available

Led By Lauren Chernick

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

AYA aged 14-24 years

Be younger than 65 years old

Must not have

Inability to speak English

Severe illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at completion of all patient visits (within 6 months of enrollment)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests STIckER, a digital tool in emergency rooms that helps young people decide if they should get tested for STIs. It targets sexually active individuals aged 15-24 years, especially from disadvantaged backgrounds. The tool involves scanning a QR code, learning about STIs, and using a simple chart to discuss testing with a doctor.

Who is the study for?

This trial is for young individuals aged 14-24 who have been sexually active in the past six months and can speak English. It's not suitable for those with severe illness, cognitive impairments, or non-English speakers.

What is being tested?

The STIckER study tests a digital decision aid against standard care to see if it increases STI testing among sexually active youth in emergency departments. Forty providers will use either the new tool or provide usual care over six months.

What are the potential side effects?

Since this trial involves a digital decision aid rather than medication, traditional side effects are not applicable. However, there may be indirect effects on patient privacy or stress levels due to increased awareness about STIs.

Eligibility Criteria

Inclusion Criteria

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

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I am between 14 and 24 years old.

Exclusion Criteria

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

Select...

I cannot speak English.

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I am suffering from a severe illness.

Select...

I have difficulty with memory or thinking clearly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at completion of all patient visits (within 6 months of enrollment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at completion of all patient visits (within 6 months of enrollment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at completion of all patient visits (within 6 months of enrollment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

ED STI Testing Rate

Secondary study objectives

Acceptability of Intervention Measure (AIM) Score

Extragenital STI testing Rate

Feasibility of Intervention Measure (FIM) Score

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: STIckERExperimental Treatment1 Intervention

After enrollment but before the start of their clinical visit, participants assigned to a provider in the intervention arm will scan a QR code using their personal mobile phone at the start of their ED visit. If they do not have a mobile phone present, a secure password-protected tablet will be provided by the research staff. This will lead them to go through the STIckER decision aid modules. After completing the modules, participants will show the final outcome to their ED provider which may facilitate an SDM conversation about STI testing. At the end of the visit, the participant will complete the "Patient Intervention Exit Survey" while the provider will complete the "Provider Intervention Exit Survey.

Group II: ControlExperimental Treatment1 Intervention

After enrollment but before the start of their clinical visit, participants assigned to a provider in the control arm will scan a QR code. They will receive a prompt stating, "If you would like to be tested for a sexually transmitted infection today, please tell your medical doctor." At the end of the visit, the participant will complete the "Patient Control Exit Survey" while the provider will complete the "Provider Control Exit Survey". These participants will not receive STIckER training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

STIckER

2023

N/A

~190

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sexually transmitted infections (STIs) include antibiotics for bacterial infections like chlamydia, gonorrhea, and syphilis, and antiviral medications for viral infections such as herpes and HIV. Antibiotics work by targeting and killing the bacteria or inhibiting their growth, thereby eliminating the infection. Antiviral medications, on the other hand, suppress the replication of viruses, reducing the viral load and the severity of symptoms. These treatments are crucial for STI patients as they not only alleviate symptoms and prevent complications but also reduce the risk of transmission to others. Effective treatment and early detection through tools like the STIckER Decision Aid can significantly improve health outcomes and curb the spread of STIs.

"Shopping" for sexually transmitted disease treatment: focus group discussions among lay persons in rural and urban Zambia.