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Behavioral Intervention for Sexually Transmitted Infections

N/A

Recruiting

Led By Tatjana Calvano, MD

Research Sponsored by Madigan Army Medical Center

Eligibility Criteria Checklist

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

Must have

Self reports vaginal, oral, and/or anal sexual contact in the last 30 days.

Age 18 - 30 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test a new behavior intervention tool to see if it decreases rates of STI/HIV and high-risk sexual behaviors, and increases self-reported condom use.

Who is the study for?

This trial is for Army active duty or beneficiaries aged 18-30, who are not pregnant or trying to conceive, have had sexual contact in the last 30 days, and can receive care at a military clinic for the next year. Participants must be HIV negative, not deploying soon, and considered 'high risk' due to recent STI diagnosis or screening.Check my eligibility

What is being tested?

The study tests if a behavioral intervention program tailored for US military members reduces STI/HIV rates and risky sexual behaviors more effectively than standard care at selected military health clinics.See study design

What are the potential side effects?

Since this is a behavioral intervention rather than a drug treatment, there may not be physical side effects. However, participants might experience discomfort discussing personal behaviors or stress from changing their habits.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have had sexual contact in the last 30 days.

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I am between 18 and 30 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

Acceptability of the intervention

Incident sexually transmitted infections

Secondary outcome measures

Number of sexual partners

Proportion of sexual encounters protect by condom use

Other outcome measures

Change in Knowledge about STIs, HIV and prevention: post-intervention

Change in Knowledge about STIs, HIV and prevention: retention at 12 months

Change in Knowledge about STIs, HIV and prevention: retention at 6 months

Trial Design

2Treatment groups

Active Control

Group I: Intervention ArmActive Control1 Intervention

Intervention Arm will will complete a total of four visits: Visit 1 (Day 1): Recruitment/Baseline Biological Testing, if needed; completion of baseline study surveys including Knowledge Assessment Visit 2 (Day 2-30): Group Intervention Session, Feedback form, and post-intervention knowledge assessment (for intervention arm only) Monthly: Prevention Maintenance Intervention Messages from months 2-11 Visit 3 (Day 180): 6 Month Follow-up biological testing and study survey Visit 4 (Day 365): 12 Month Follow-up biological testing and study surveys

Group II: Control ArmActive Control1 Intervention

Control Arm will will complete a total of three visits: Visit 1 (Day 1): Recruitment/Baseline Biological Testing, if needed; completion of baseline study surveys including Knowledge Assessment Monthly: Prevention Maintenance Intervention Messages from months 2-11 Visit 3 (Day 180): 6 Month Follow-up biological testing and study survey Visit 4 (Day 365): 12 Month Follow-up biological testing and study surveys

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Madigan Army Medical CenterLead Sponsor

48 Previous Clinical Trials

17,504 Total Patients Enrolled

Tatjana Calvano, MDPrincipal InvestigatorMadigan Army Medical Center

Anjali N Kunz, MDPrincipal InvestigatorMadigan Army Medical Center

Media Library

STI/HIV Intervention Behavioral Intervention Program Clinical Trial Eligibility Overview. Trial Name: NCT04547413 — N/A

Sexually Transmitted Diseases Research Study Groups: Intervention Arm, Control Arm

Sexually Transmitted Diseases Clinical Trial 2023: STI/HIV Intervention Behavioral Intervention Program Highlights & Side Effects. Trial Name: NCT04547413 — N/A

STI/HIV Intervention Behavioral Intervention Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04547413 — N/A

Frequently Asked Questions

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

What are the eligibility requirements for taking part in this clinical experiment?

"This research trial is enrolling 700 people with sexually transmitted diseases between 18 and 30 years of age. In order to be considered, participants must have access to military healthcare for at least one year from enrolment date; they must not already be pregnant or planning on becoming so in the following 3 months; additionally, they cannot expect deployment or transfer during this period."

Answered by AI

Are there still openings available to join this investigation?

"According to clinicaltrials.gov, this research is still open and recruiting new participants; the trial was initiated on November 4th 2020 and has been amended most recently on April 22nd 2022."

Answered by AI

How many participants are partaking in this research endeavor?

"Affirmative, the information on clinicialtrials.gov reveals that this trial has been actively seeking out participants since November 4th 2020 and was last updated April 22nd 2022. To date, 700 people have registered across 2 sites."

Answered by AI