TAKE Steps: Motivational Interviewing to Prevent STIs

Not Applicable

Completed

• Conditions: Self Efficacy; HIV Prevention; STI Prevention
• Interventions: Behavioral: Treat Act Know Engage (T.A.K.E.) Steps; Behavioral: Standard or Care

• Registration Number: NCT05215262
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Study Start: 2022-03-08
• Primary Completion: 2024-06-05
• Study Completion: 2024-06-05
• Results First Submitted: 2025-04-14
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Results First Posted: 2025-05-22
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T.A.K.E. Steps Motivational Interviewing Intervention	Treat Act Know Engage (T.A.K.E.) Steps	Four MI intervention sessions, 1:1 with participant and health coach.
Standard of Care	Standard or Care	Standard of Care control visit with primary care physician (PCP)

Primary Outcome Measures

Name	Time	Method
Change in Prevention Self-efficacy	Baseline and 3 months	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. The GSE measure is a 10-item measure assessing participants' confidence in carrying out their self-identified prevention goals. The total score of the GSE measure is calculated by finding the sum of all 10 items - the sum ranging between 10 and 40 with a higher score indicating more self-efficacy. This outcome is measuring the differences in mean total scores over time.

Secondary Outcome Measures

Name	Time	Method
Intervention Acceptability	3 months	Intervention acceptability will be measured at 1-week and 3-months by a 7-item satisfaction survey. This outcome measures the percentage participants who agreed or strongly agreed with statements on a 7-item acceptability survey completed at their 3-month intervention coaching session.
Recruitment Feasibility	Baseline	Feasibility of recruitment will be measured by calculating the proportion of patients enrolled / patients recruited.
Retention Feasibility	3 months	Retention feasibility will be measured by calculating the proportion of participants who completed the three month (final) intervention visit out of participants randomized to the intervention arm who completed at least one intervention session..

Trial Locations

Locations (5)

CHOP Karabots Pediatric Care Center, West Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Primary Care, CHOP Clinic 3550 Market St; 🇺🇸 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