TAKE Steps: Motivational Interviewing to Improve Comprehensive HIV and Sexually Transmitted Infection Prevention in Adolescent Primary Care (TAKE Steps)

  • End date
    Jun 10, 2023
  • participants needed
  • sponsor
    Children's Hospital of Philadelphia
Updated on 10 October 2022


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.


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 1:1 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.

Condition Self Efficacy, HIV Prevention, STI Prevention
Treatment Treat Act Know Engage (T.A.K.E.) Steps, Standard or Care
Clinical Study IdentifierNCT05215262
SponsorChildren's Hospital of Philadelphia
Last Modified on10 October 2022


Yes No Not Sure

Inclusion Criteria

Males or females aged 13 to 19 years
History of ≥1 STI in the 30 days prior to recruitment
Laboratory confirmed diagnosis Trichomonas vaginalis (via microscopy or nucleic acid amplification test [NAAT]), Neisseria gonorrhea (NAAT), Chlamydia trachomatis (NAAT), Treponema pallidum (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
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How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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