Self Efficacy Clinical Trial
— TAKE StepsOfficial title:
TAKE Steps: Motivational Interviewing to Improve Comprehensive HIV and Sexually Transmitted Infection Prevention in Adolescent Primary Care
Verified date | January 2024 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will consist of a randomized controlled trial of a motivational interviewing intervention for adolescents with diagnosed sexually transmitted infections (STIs). The sessions will provide HIV/STI prevention education, use motivational interviewing (MI) to enhance goal setting, and providing skill building and referral to evidence based STI and HIV prevention strategies Pre-Exposure Prophylaxis (PrEP), condom use, and partner notification.
Status | Active, not recruiting |
Enrollment | 114 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 19 Years |
Eligibility | Inclusion Criteria: - Males or females aged 13 to 19 years. - History of =1 STI in the 30 days prior to recruitment - Confirmed treatment for a laboratory confirmed diagnosis of Trichomonas vaginalis (via microscopy or nucleic acid amplification test [NAAT]), Neisseria gonorrhea (NAAT), Chlamydia trachomatis (NAAT), Treponema pallidum [via new positive rapid plasmin reagin (RPR) assay] within the prior 30 days - Self-reported HIV negative status. - Able to speak and understand written English Exclusion Criteria: - Unable to provide informed consent due to intoxication or severe psychological distress. |
Country | Name | City | State |
---|---|---|---|
United States | CHOP Karabots Pediatric Care Center, West Philadelphia | Philadelphia | Pennsylvania |
United States | CHOP Primary Care, Cobbs Creek | Philadelphia | Pennsylvania |
United States | CHOP Primary Care, Roxborough | Philadelphia | Pennsylvania |
United States | CHOP Primary Care, South Philadelphia | Philadelphia | Pennsylvania |
United States | Primary Care, CHOP Clinic 3550 Market St | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in prevention self-efficacy | Differences in the change in prevention self-efficacy scores from baseline to three months between the control arm compared to the intervention arm will be assessed using a modified version of the Generalized Self Efficacy (GSE) measure. This 10-item measure will assess participants' confidence in carrying out their self-identified prevention goals. Higher scores indicate higher self-efficacy. | Baseline and 3 months | |
Secondary | Intervention Acceptability | Intervention acceptability will be measured at baseline, one month, and three months by a 7-item satisfaction survey. | Baseline, one month, three months. | |
Secondary | Recruitment Feasibility | Feasibility of recruitment will be measured by calculating the proportion of patients recruited/patients eligible. | Baseline | |
Secondary | Retention feasibility | Retention feasibility will be measured by calculating the proportion of participants retained in the trial through the six month end point/participants enrolled. | Up to six months |
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