TAKE Steps: Motivational Interviewing to Prevent STIs

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Pilot phase: Pilot testing will occur over a 3-month period to prime intervention for implementation, with the aim of recruiting n=10 pilot participants. Pilot phase participants will follow the same study procedure timeline as participants randomized to the MI intervention arm of the randomized control trial (RCT), excluding the 6-month follow-up visit. Pilot participants will not be followed in the RCT or contribute outcome data. At the end of every intervention visit in the pilot phase (the baseline, 1-week, 1-month and 3-month visits), participants will complete a brief feedback interview to ensure face validity and identify areas needing refinement. Feedback will be incorporated into the study design, with amendments submitted to the Institutional Review Board (IRB) as needed. Data from pilot participants will not be included in analysis of the RCT. Intervention phase:The RCT will randomize youth with recent STI 2:1 to the TAKE Steps intervention vs a standard of care (SOC) control. Both arms (intervention and SOC) will have data collection visits at the baseline, the 3-month, and the 6-month-follow-up time points. In addition, the intervention group will have intervention sessions at baseline, 1 week, 1 month and 3 months. The study treatment phase for the RCT will consist of data collection and motivational interviewing sessions over a 6-month period. Intervention sessions will consist of HIV and STI prevention education, motivational interviewing, skill building, and referral to therapy. All visits can occur in-person or remotely. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05215262
Study type	Interventional
Source	Children's Hospital of Philadelphia
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 8, 2022
Completion date	July 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

TAKE Steps: Motivational Interviewing to Prevent STIs — TAKE Steps

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms