Technology Enhanced Community Health Nursing (TECH-N) Study (TECH-N)
Primary Purpose
Pelvic Inflammatory Disease (PID)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technology Enhanced Community Health Nursing
Sponsored by
About this trial
This is an interventional prevention trial for Pelvic Inflammatory Disease (PID) focused on measuring Pelvic Inflammatory Disease (PID), Community Health Nursing, Text Messaging, mobile health (mhealth), Adolescents
Eligibility Criteria
Inclusion Criteria:
- Mild-moderate PID
- Outpatient treatment disposition
- Permanently reside in the Baltimore Metropolitan area
- Willing to sign informed consent & be randomized
Exclusion Criteria:
- Pregnant
- Concurrent diagnosis of Sexual Assault
- Unable to communicate/complete study procedures
Sites / Locations
- Johns Hopkins School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TECH-N
Control
Arm Description
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
Participants receive enhanced standard of care
Outcomes
Primary Outcome Measures
Number of Participants With Positive Sexually Transmitted Infection Test (STI)
STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).
Secondary Outcome Measures
Number of Participants That Adhered to Self-treatment
Completion of 72-hour assessment visit by medical provider, medication adherence (self-reported), partner notification, partner treatment, and temporary sexual abstinence
Full Information
NCT ID
NCT01640379
First Posted
July 11, 2012
Last Updated
May 14, 2020
Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01640379
Brief Title
Technology Enhanced Community Health Nursing (TECH-N) Study
Acronym
TECH-N
Official Title
Technology Enhanced Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are enrolling 350 young women 13-25 years old diagnosed with pelvic inflammatory disease (PID) in Baltimore and randomize them to receive community health nurse (CHN) clinical support using a single post-PID face-to-face clinical evaluation and short messaging system communication support during the 30. The investigators hypothesize that repackaging the recommended Centers for Disease Control and Prevention (CDC) follow-up visit using a technology-enhanced community health nursing intervention (TECH-N) with integration of an evidence-based sexually transmitted infection (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).
Detailed Description
Pelvic Inflammatory Disease (PID) remains a serious reproductive health disorder and disease rates remain unacceptably high among minority adolescent girls and young adult women. Each episode of this upper reproductive tract infection, usually caused by a sexually transmitted infection (STI), increases the risk for multiple sequelae including tubal infertility, ectopic pregnancy, and chronic pelvic pain (CPP). Previous research demonstrates that inpatient treatment for PID is expensive without incremental increases in effectiveness when compared with outpatient treatment. The investigators' work and that of others suggest that additional outpatient cost-effective PID health care supports are needed for this vulnerable population to improve short and long-term reproductive health outcomes, including recurrent sexually transmitted infection and PID.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease (PID)
Keywords
Pelvic Inflammatory Disease (PID), Community Health Nursing, Text Messaging, mobile health (mhealth), Adolescents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TECH-N
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants receive enhanced standard of care
Intervention Type
Behavioral
Intervention Name(s)
Technology Enhanced Community Health Nursing
Other Intervention Name(s)
Sister to Sister Teen, Short Messaging System (SMS) communication (Text Messages)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of Participants With Positive Sexually Transmitted Infection Test (STI)
Description
STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Number of Participants That Adhered to Self-treatment
Description
Completion of 72-hour assessment visit by medical provider, medication adherence (self-reported), partner notification, partner treatment, and temporary sexual abstinence
Time Frame
Day 15
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild-moderate PID
Outpatient treatment disposition
Permanently reside in the Baltimore Metropolitan area
Willing to sign informed consent & be randomized
Exclusion Criteria:
Pregnant
Concurrent diagnosis of Sexual Assault
Unable to communicate/complete study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Trent, MD, MPH
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32569258
Citation
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.
Results Reference
derived
PubMed Identifier
31390037
Citation
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.
Results Reference
derived
PubMed Identifier
31165630
Citation
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.
Results Reference
derived
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Technology Enhanced Community Health Nursing (TECH-N) Study
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