TAKE Steps: Motivational Interviewing to Prevent STIs

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Self Efficacy; STI Prevention; HIV Prevention

Treatments: Behavioral: Treat Act Know Engage (T.A.K.E.) Steps; Behavioral: Standard or Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05215262

K23MH119976-02 (U.S. NIH Grant/Contract)

19-016708

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 13 to 19 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

T.A.K.E. Steps Motivational Interviewing Intervention

Experimental group

Description:

Four MI intervention sessions, 1:1 with participant and health coach.

Treatment:

Behavioral: Treat Act Know Engage (T.A.K.E.) Steps

Standard of Care

Active Comparator group

Description:

Standard of Care control visit with primary care physician (PCP)

Treatment:

Behavioral: Standard or Care