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Technology Enhanced Community Health Nursing (TECH-N) Study (TECH-N)

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ClinicalTrials.gov Identifier: NCT01640379
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Condition Pelvic Inflammatory Disease (PID)
Intervention Behavioral: Technology Enhanced Community Health Nursing
Enrollment 286
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support Participants receive enhanced standard of care
Period Title: Overall Study
Started 149 137
Completed 135 125
Not Completed 14 12
Arm/Group Title Intervention Control Total
Hide Arm/Group Description Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support Participants receive enhanced standard of care Total of all reporting groups
Overall Number of Baseline Participants 149 137 286
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 149 participants 137 participants 286 participants
18.6  (2.4) 18.8  (2.4) 18.7  (2.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 137 participants 286 participants
Female
149
 100.0%
137
 100.0%
286
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 137 participants 286 participants
American Indian or Alaska Native
1
   0.7%
0
   0.0%
1
   0.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
136
  91.3%
126
  92.0%
262
  91.6%
White
3
   2.0%
2
   1.5%
5
   1.7%
More than one race
7
   4.7%
5
   3.6%
12
   4.2%
Unknown or Not Reported
2
   1.3%
4
   2.9%
6
   2.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 149 participants 137 participants 286 participants
149 137 286
Positive Sexually Transmitted Infection Test (GC or CT)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 127 participants 269 participants
16
  11.3%
9
   7.1%
25
   9.3%
[1]
Measure Description: Positive sexually transmitted infection test for gonorrhea (GC) or chlamydia (CT)
[2]
Measure Analysis Population Description: Some baseline tests are inconclusive because the sample was not usable, so only 269 out of 286 have results.
1.Primary Outcome
Title Number of Participants With Positive Sexually Transmitted Infection Test (STI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Adolescent and young adult women with pelvic inflammatory disease (PID) in Baltimore City randomized to the intervention or control group and also had results for chlamydia (CT) and gonorrhea (GC) at 90 days after enrollment. All enrolled participants were followed as long as possible for entire 90 days.
Arm/Group Title TECH-N Control
Hide Arm/Group Description:

Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits 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 DEBI STI/HIV prevention component (Sister to Sister Teen)

Participants receive enhanced standard of care
Overall Number of Participants Analyzed 135 125
Measure Type: Count of Participants
Unit of Measure: Participants
6
   4.4%
13
  10.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TECH-N, Control
Comments A comparison of Chlamydia or Gonorrhea positivity at 90 days post intervention.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments Judged by type one error limit alpha = 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.15 to 1.09
Estimation Comments The odds ratio is for the difference in chlamydia or gonorrhea (CT/GC) rates between arms at ninety days after intervention.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TECH-N, Control
Comments

We used generalized estimating equations to test for a difference in the trend of chlamydia or gonorrhea (CT/GC) rates over the study period.

The null hypothesis is that rates of CT/GC for women in the intervention arm were changing over the study period similarly to CT/GC rates in the control arm.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments Judged by type one error limit alpha = 0.05.
Method generalized estimating equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.39 to 0.98
Estimation Comments The odds ratio is for the difference in rate of change over time between arms, so is the difference in the odds increment for those receiving TECH N intervention versus the control group.
2.Secondary Outcome
Title Number of Participants That Adhered to Self-treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Chi-square test results from participants in the intervention and control groups who had data on adherence to treatment. Out of 149 enrolled in the intervention arm, 10 were lost to followup by 72 hours. Out of 137 enrolled in the control arm, 15 were lost by 72 hours and so are missing this outcome measure.
Arm/Group Title TECH-N Control
Hide Arm/Group Description:

Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits 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)

Participants receive enhanced standard of care
Overall Number of Participants Analyzed 139 123
Measure Type: Count of Participants
Unit of Measure: Participants
131
  94.2%
20
  16.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TECH-N, Control
Comments H0: Women in TECHN arm had 72 hour visit with same frequency as women in control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments Adjusted for age, debut age, number of lifetime partners, baseline STI status (any vs none), insurance, and if woman had prior pregnancy.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 92.2
Confidence Interval (2-Sided) 95%
37.0 to 230.1
Estimation Comments Odds ratio is interpretable as the expected chance of having a 72 follow-up for intervention women compared to women in the control arm, given similar age, debut age, number of lifetime partners, baseline STI status, insurance, and pregnancy history.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TECH-N, Control
Comments H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.36 to 1.05
Estimation Comments Odds ratio is for intervention arm relative to control.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TECH-N, Control
Comments H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.867
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.36 to 2.34
Estimation Comments Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection TECH-N, Control
Comments H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.33 to 1.19
Estimation Comments Odds ratio is for partners of TECH-N recipients versus partners of women in control arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection TECH-N, Control
Comments H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.351
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.86 to 1.06
Estimation Comments Odds ratio is for women in the TECH-N arm relative to women in the control arm.
Time Frame Women were followed for adverse events for the primary study period of three months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support Participants receive enhanced standard of care
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/149 (0.00%)      0/137 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/149 (0.00%)      0/137 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/149 (0.67%)      0/137 (0.00%)    
Pregnancy, puerperium and perinatal conditions     
Miscarriage * [1]  1/149 (0.67%)  1 0/137 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Enrolled participant diagnosed with pregnancy after enrollment, and positive for sexually transmitted infection. The patient could not be reached after multiple attempts and certified letters sent to patient and primary care provider (PCP).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Maria Trent
Organization: Johns Hopkins University
Phone: 4109552910
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01640379     History of Changes
Other Study ID Numbers: NA_00068846
1R01NR013507-01 ( U.S. NIH Grant/Contract )
First Submitted: July 11, 2012
First Posted: July 13, 2012
Results First Submitted: December 18, 2017
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018