N/A
N=94
TAKE Steps: Motivational Interviewing to Prevent STIs
Self Efficacy · HIV Prevention · STI Prevention
Bottom Line
View on ClinicalTrials.gov: NCT05215262 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Prevention Self-efficacy — 1.87; 0.20 score on a scale — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treat Act Know Engage (T.A.K.E.) Steps (Behavioral); Standard or Care (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Prevention Self-efficacy |
1.87; 0.20 | 0.04 sig |
| SECONDARY Recruitment Feasibility |
94 | — |
| SECONDARY Intervention Acceptability |
27 | — |
| SECONDARY Intervention Acceptability |
27 | — |
| SECONDARY Retention Feasibility |
28 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05215262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.