Study Results
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View full resultsBasic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2022-03-08
2024-06-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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T.A.K.E. Steps Motivational Interviewing Intervention
Four MI intervention sessions, 1:1 with participant and health coach.
Treat Act Know Engage (T.A.K.E.) Steps
Intervention sessions will consist of psychoeducation, HIV/STI goal identification, referral to HIV testing and PrEP, and communication skill building.
Standard of Care
Standard of Care control visit with primary care physician (PCP)
Standard or Care
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
Interventions
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Treat Act Know Engage (T.A.K.E.) Steps
Intervention sessions will consist of psychoeducation, HIV/STI goal identification, referral to HIV testing and PrEP, and communication skill building.
Standard or Care
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
Eligibility Criteria
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Inclusion Criteria
* 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
13 Years
19 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Sarah M Wood, MD, MSHP
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Primary Care, CHOP Clinic 3550 Market St
Philadelphia, Pennsylvania, United States
CHOP Primary Care, Roxborough
Philadelphia, Pennsylvania, United States
CHOP Karabots Pediatric Care Center, West Philadelphia
Philadelphia, Pennsylvania, United States
CHOP Primary Care, Cobbs Creek
Philadelphia, Pennsylvania, United States
CHOP Primary Care, South Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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19-016708
Identifier Type: -
Identifier Source: org_study_id
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