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Motivational Interviewing for STI Prevention (TAKE Steps Trial)

N/A
Waitlist Available
Led By Sarah M Wood, MD, MSHP
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females aged 13 to 19 years
Confirmed treatment for a laboratory confirmed diagnosis of Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, Treponema pallidum within the prior 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months
Awards & highlights

TAKE Steps Trial Summary

This trial will test a motivational interviewing intervention to see if it can help prevent STIs in adolescents. The intervention will provide education on STIs and HIV, help set goals, and provide skills and referrals for evidence-based STI and HIV prevention strategies.

Who is the study for?
This trial is for English-speaking males and females aged 13 to 19 who have had at least one STI in the past month, treated for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or Treponema pallidum. They must be HIV negative and able to give informed consent without being intoxicated or in severe psychological distress.Check my eligibility
What is being tested?
The TAKE Steps study tests a motivational interviewing intervention against standard care for teens with STIs. It aims to educate on HIV/STI prevention, set goals using motivational interviewing techniques, build skills, and refer participants to prevention strategies like PrEP and condom use.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medications, traditional side effects are not expected. However, participants may experience discomfort discussing personal topics during interviews.

TAKE Steps Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 13 and 19 years old.
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I have been treated for an STD within the last 30 days.

TAKE Steps Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, one month, three months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, one month, three 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
Change in prevention self-efficacy
Secondary outcome measures
Intervention Acceptability
Recruitment Feasibility
Retention feasibility

TAKE Steps Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: T.A.K.E. Steps Motivational Interviewing InterventionExperimental Treatment1 Intervention
Four MI intervention sessions, 1:1 with participant and health coach.
Group II: Standard of CareActive Control1 Intervention
Standard of Care control visit with primary care physician (PCP)

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,161 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,161 Total Patients Enrolled
Sarah M Wood, MD, MSHPPrincipal InvestigatorChildren's Hospital of Philadelphia

Media Library

Treat Act Know Engage (T.A.K.E.) Steps Clinical Trial Eligibility Overview. Trial Name: NCT05215262 — N/A
Self-Efficacy Clinical Trial 2023: Treat Act Know Engage (T.A.K.E.) Steps Highlights & Side Effects. Trial Name: NCT05215262 — N/A

Frequently Asked Questions

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

Are there any restrictions on who can participate in this experiment?

"This experiment seeks to enrol 185 individuals who demonstrate self-efficacy, falling within the age range of 13 and 19. To be considered, prospective participants must meet a series of conditions such as being male or female between 13 and 19 years old; having had at least one sexually transmitted infection (STI) in the last 30 days; obtaining confirmation for Trichomonas vaginalis via microscopy or nucleic acid amplification test (NAAT), Neisseria gonorrhea (NAAT), Chlamydia trachomatis (NAAT) or Treponema pallidum through new positive rapid plasmin reagin assay"

Answered by AI

Is this experiment in need of additional participants?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical trial which was initiated on March 8th 2022 is actively recruiting participants. 185 individuals are needed from two distinct locations for completion of the study's objectives."

Answered by AI

How many individuals have been selected to partake in this experimental research?

"Affirmative. According to the clinicaltrials.gov entry, this medical experiment is still welcoming patient enrolment and commenced on March 8th 2022. The most recent update was November 21st 2022 and 185 individuals are needed across two sites for completion of the trial."

Answered by AI

Are persons above the age of seventy eligible to take part in this experiment?

"Adolescents aged between 13 and 19 years old are eligible to partake in the trial."

Answered by AI

Who else is applying?

What site did they apply to?
Primary Care, CHOP Clinic 3550 Market St
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
TAKE Steps: Motivational Interviewing to Prevent STIs
2022. "TAKE Steps: Motivational Interviewing to Prevent STIs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05215262.
~8 spots leftby Jul 2024
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