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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention 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
Control Participants receive enhanced standard of care

Participant Flow:   Overall Study
    Intervention   Control
STARTED   149   137 
COMPLETED   135   125 
NOT COMPLETED   14   12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Intervention 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
Control Participants receive enhanced standard of care
Total Total of all reporting groups

Baseline Measures
   Intervention   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   137   286 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   149   137   286 
   18.6  (2.4)   18.8  (2.4)   18.7  (2.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   149   137   286 
Female      149 100.0%      137 100.0%      286 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   149   137   286 
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 
[Units: Participants]
     
United States       
Participants Analyzed   149   137   286 
United States   149   137   286 
Positive Sexually Transmitted Infection Test (GC or CT) [1] [2] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   142   127   269 
   16   9   25 
[1] Positive sexually transmitted infection test for gonorrhea (GC) or chlamydia (CT)
[2] Some baseline tests are inconclusive because the sample was not usable, so only 269 out of 286 have results.


  Outcome Measures

1.  Primary:   Number of Participants With Positive Sexually Transmitted Infection Test (STI)   [ Time Frame: 90 Days ]

2.  Secondary:   Number of Participants That Adhered to Self-treatment   [ Time Frame: Day 15 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: mtrent2@jhmi.edu



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