TAKE Steps: Motivational Interviewing to Prevent STIs

NCT05215262 | Completed Results

• 2 other identifiers: 19-016708K23MH119976-02
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 5

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.

Conditions

Self Efficacy; HIV Prevention; STI Prevention

Outcome Measures

Primary Outcomes (1)

• Change in Prevention Self-efficacy

  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.

  Baseline and 3 months

Secondary Outcomes (4)

• Recruitment Feasibility

  Baseline

• Intervention Acceptability

  1 week

• Intervention Acceptability

  3 months

• Retention Feasibility

  3 months

Study Arms (2)

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

EXPERIMENTAL

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

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

Standard of Care

ACTIVE COMPARATOR

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

Behavioral: Standard or Care

Interventions

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

Intervention sessions will consist of psychoeducation, HIV/STI goal identification, referral to HIV testing and PrEP, and communication skill building.

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

Standard or Care BEHAVIORAL

S.O.C. arm will receive treatment as usual. After the baseline interview, participants will be referred to their PCP for management of any clinical issues that arise. Their clinic visit schedule will follow their clinical needs and recommendations of their clinic provider

Standard of Care

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent due to intoxication or severe psychological distress.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

Primary Care, CHOP Clinic 3550 Market St

Philadelphia, Pennsylvania, 19104, United States

Location

CHOP Primary Care, Roxborough

Philadelphia, Pennsylvania, 19128, United States

Location

CHOP Karabots Pediatric Care Center, West Philadelphia

Philadelphia, Pennsylvania, 19139, United States

Location

CHOP Primary Care, Cobbs Creek

Philadelphia, Pennsylvania, 19139, United States

Location

CHOP Primary Care, South Philadelphia

Philadelphia, Pennsylvania, 19145, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Sarah Wood, MD, MSHP
• Organization: Mount Sinai Adolescent Health Center

Sarah.Wood@mountsinai.org

(332) 227-4355

Study Officials

• Sarah M Wood, MD, MSHP

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: March 8, 2022
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)