Technology Enhanced Community Health Nursing (TECH-N) Study

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01640379
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 286
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Pelvic Inflammatory Disease (PID)	Behavioral: Technology Enhanced Community Health Nursing	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 286 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Technology Enhanced Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: 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 Names: Sister to Sister Teen Short Messaging System (SMS) communication (Text Messages)
No Intervention: Control Participants receive enhanced standard of care

Outcome Measures

Primary Outcome Measures

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

   STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).

Secondary Outcome Measures

1. Number of Participants That Adhered to Self-treatment [Day 15]

   Completion of 72-hour assessment visit by medical provider, medication adherence (self-reported), partner notification, partner treatment, and temporary sexual abstinence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 25 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins School of Medicine	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Maria Trent, MD, MPH, Johns Hopkins School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 1, 2017

More Information

Additional Information:

• JHU Institute for Clinical and Translational Research (ICTR) Registry Link

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01640379
• Other Study ID Numbers: NA_00068846; 1R01NR013507-01
• First Posted: Jul 13, 2012
• Last Update Posted: Jun 1, 2020
• Last Verified: May 1, 2020

• Keywords provided by Johns Hopkins University: Pelvic Inflammatory Disease (PID); Community Health Nursing; Text Messaging; mobile health (mhealth); Adolescents
• Additional relevant MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection

Study Results

Participant Flow

Arm/Group Title	Intervention	Control
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

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
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 Participants	149	137	286
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	18.6 (2.4)	18.8 (2.4)	18.7 (2.4)
Sex: Female, Male (Count of Participants)
Female	149 100%	137 100%	286 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.7%	0 0%	1 0.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	136 91.3%	126 92%	262 91.6%
White	3 2%	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 (participants) [Number]
United States	149 100%	137 100%	286 100%
Positive Sexually Transmitted Infection Test (GC or CT) (Count of Participants)
Count of Participants [Participants]	16 10.7%	9 6.6%	25 8.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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
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
Measure Participants	135	125
Count of Participants [Participants]	6 4%	13 9.5%

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
Statistical Test of Hypothesis	p-Value	0.070
	Comments	Judged by type one error limit alpha = 0.05.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.40
	Confidence Interval	(2-Sided) 95%; 0.15 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	The odds ratio is for the difference in chlamydia or gonorrhea (CT/GC) rates between arms at ninety days after intervention.

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
Statistical Test of Hypothesis	p-Value	0.043
	Comments	Judged by type one error limit alpha = 0.05.
	Method	generalized estimating equations
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95%; 0.39 to 0.98
	Parameter Dispersion	Type: Value:
	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
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

Outcome Measure Data

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
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
Measure Participants	139	123
Count of Participants [Participants]	131 87.9%	20 14.6%

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
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	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
	Parameter Dispersion	Type: Value:
	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.

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
Statistical Test of Hypothesis	p-Value	0.084
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is for intervention arm relative to control.

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
Statistical Test of Hypothesis	p-Value	0.867
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm.

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
Statistical Test of Hypothesis	p-Value	0.153
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is for partners of TECH-N recipients versus partners of women in control arm.

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
Statistical Test of Hypothesis	p-Value	0.351
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is for women in the TECH-N arm relative to women in the control arm.

Adverse Events

Time Frame	Women were followed for adverse events for the primary study period of three months.
Arm/Group Title	Intervention		Control
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/149 (0%)		0/137 (0%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/149 (0%)		0/137 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/149 (0.7%)		0/137 (0%)
Pregnancy, puerperium and perinatal conditions
Miscarriage	1/149 (0.7%)	1	0/137 (0%)	0

Limitations/Caveats

[Not Specified]

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.