Technology Enhanced Community Health Nursing (TECH-N) Study
NCT ID: NCT01640379
Last Updated: 2020-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
286 participants
INTERVENTIONAL
2012-07-31
2017-04-30
Brief Summary
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Detailed Description
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Prior research has also demonstrated that community health nurse (CHN) interventions can increase access to appropriate resources enhance health care utilization and promote risk-reducing behavior. The investigators propose that integrating a technology component conducted by the CHN will increase appeal to adolescent females. The investigators' pilot data of a text messaging intervention for reproductive health clinical reminders has demonstrated that use of cell phones to assist urban adolescents residing in high STI prevalent communities with self-care is both highly acceptable and feasible.
The investigators hypothesize that repackaging the recommended CDC-follow-up visit using a technology-enhanced community health nursing intervention (TECH-N) with integration of an evidence-based STI prevention curriculum will reduce rates of short-term repeat infection by improving adherence to PID treatment and reducing unprotected intercourse and be more cost-effective compared with outpatient standard of care (and hospitalization). We are enrolling 350 young women 13-21years old diagnosed with PID in Baltimore and randomizing them to receive CHN clinical support using a single post-PID face-to-face clinical evaluation and SMS communication support during the 30-days following the PID diagnosis or optimized standard of care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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TECH-N
Participants receive the Technology Enhanced Community Health Nursing Visit (CHN) within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
Technology Enhanced Community Health Nursing
* Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)
* Enhanced community health nursing visit on day 3-5, includes evidence-based STI/HIV prevention component (Sister to Sister Teen)
Control
Participants receive enhanced standard of care
No interventions assigned to this group
Interventions
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Technology Enhanced Community Health Nursing
* Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)
* Enhanced community health nursing visit on day 3-5, includes evidence-based STI/HIV prevention component (Sister to Sister Teen)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Outpatient treatment disposition
* Permanently reside in the Baltimore Metropolitan area
* Willing to sign informed consent \& be randomized
Exclusion Criteria
* Concurrent diagnosis of Sexual Assault
* Unable to communicate/complete study procedures
13 Years
25 Years
FEMALE
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Maria Trent, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine
Locations
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Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Countries
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References
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Trent M, Yusuf HE, Perin J, Anders J, Chung SE, Tabacco-Saeed L, Rowell J, Huettner S, Rothman R, Butz A, Gaydos CA. Clearance of Mycoplasma genitalium and Trichomonas vaginalis Among Adolescents and Young Adults With Pelvic Inflammatory Disease: Results From the Tech-N Study. Sex Transm Dis. 2020 Nov;47(11):e47-e50. doi: 10.1097/OLQ.0000000000001221.
Trent M, Perin J, Gaydos CA, Anders J, Chung SE, Tabacco Saeed L, Rowell J, Huettner S, Rothman R, Butz A. Efficacy of a Technology-Enhanced Community Health Nursing Intervention vs Standard of Care for Female Adolescents and Young Adults With Pelvic Inflammatory Disease: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e198652. doi: 10.1001/jamanetworkopen.2019.8652.
Ha MM, Belcher HME, Butz AM, Perin J, Matson PA, Trent M. Partner Notification, Treatment, and Subsequent Condom Use After Pelvic Inflammatory Disease: Implications for Dyadic Intervention With Urban Youth. Clin Pediatr (Phila). 2019 Oct;58(11-12):1271-1276. doi: 10.1177/0009922819852979. Epub 2019 Jun 5.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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JHU Institute for Clinical and Translational Research (ICTR) Registry Link
Other Identifiers
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NA_00068846
Identifier Type: -
Identifier Source: org_study_id
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