TAKE Steps: Motivational Interviewing to Prevent STIs

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Self Efficacy, HIV Prevention, STI Prevention

Intervention / Treatment
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* Behavioral: Treat Act Know Engage (T.A.K.E.) Steps
* Behavioral: Standard or Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T.A.K.E. Steps Motivational Interviewing Intervention<br>Four MI intervention sessions, 1:1 with participant and health coach. | Behavioral: Treat Act Know Engage (T.A.K.E.) Steps<br>* Intervention sessions will consist of psychoeducation, HIV/STI goal identification, referral to HIV testing and PrEP, and communication skill building.<br>|
| Active Comparator: Standard of Care<br>Standard of Care control visit with primary care physician (PCP) | Behavioral: Standard or Care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. This 10-item measure will assess participants' confidence in carrying out their self-identified prevention goals. Higher scores indicate higher self-efficacy. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Acceptability | Intervention acceptability will be measured at baseline, one month, and three months by a 7-item satisfaction survey. | Baseline, one month, three months. | 
| Recruitment Feasibility | Feasibility of recruitment will be measured by calculating the proportion of patients recruited/patients eligible. | Baseline | 
| Retention feasibility | Retention feasibility will be measured by calculating the proportion of participants retained in the trial through the six month end point/participants enrolled. | Up to six months |