## Protocol Section
### Identification Module
**NCT ID:** NCT01640379

**Acronym:** TECH-N

**Brief Title:** Technology Enhanced Community Health Nursing (TECH-N) Study

**Official Title:** Technology Enhanced Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease

#### Organization Study ID Info
**ID:** NA_00068846
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
#### Secondary ID Infos
**ID:** 1R01NR013507-01
**Link:** https://reporter.nih.gov/quickSearch/1R01NR013507-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2017-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-01

**Type:** ACTUAL

**Last Update Submit Date:** 2020-05-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-05-07

**Type:** ACTUAL

**Results First Submit Date:** 2017-12-18

**Results First Submit QC Date:** 2018-04-06

#### Start Date
**Date:** 2012-07

**Status Verified Date:** 2020-05

#### Study First Post Date
**Date:** 2012-07-13
**Type:** ESTIMATED
**Study First Submit Date:** 2012-07-11
**Study First Submit QC Date:** 2012-07-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Nursing Research (NINR)

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pelvic Inflammatory Disease (PID)

**Keywords:**

- Pelvic Inflammatory Disease (PID)

- Community Health Nursing

- Text Messaging

- mobile health (mhealth)

- Adolescents

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 286

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Behavioral: Technology Enhanced Community Health Nursing

**Label:** TECH-N

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants receive enhanced standard of care

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TECH-N

**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)

**Name:** Technology Enhanced Community Health Nursing

**Other Names:**

- Sister to Sister Teen

- Short Messaging System (SMS) communication (Text Messages)

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Number of Participants With Positive Sexually Transmitted Infection Test (STI)

**Time Frame:** 90 Days

#### Secondary Outcomes

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

**Measure:** Number of Participants That Adhered to Self-treatment

**Time Frame:** Day 15

### Eligibility Module

**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

**Maximum Age:** 25 Years

**Minimum Age:** 13 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins School of Medicine

**State:** Maryland

**Zip:** 21287

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins School of Medicine

**Name:** Maria Trent, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**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.

**PMID:** 32569258

**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.

**PMID:** 31390037

**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.

**PMID:** 31165630

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-05-01

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 425383

- Type Abbrev: Prot_SAP

- Upload Date: 2018-04-06T11:45

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3644

- Name: Pelvic Inflammatory Disease

- Relevance: HIGH

- As Found: Pelvic Inflammatory Disease

- ID: M24398

- Name: Pelvic Infection

- Relevance: HIGH

- As Found: Pelvic Inflammatory Disease

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000292

- Term: Pelvic Inflammatory Disease

- ID: D000034161

- Term: Pelvic Infection

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Intervention

**Deaths Num At Risk:** 149

**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

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 149

**Serious Number At Risk:** 149

**Title:** Intervention

**Group ID:** EG001

**Title:** Control

**Deaths Num At Risk:** 137

**Description:** Participants receive enhanced standard of care

**ID:** EG001

**Other Num at Risk:** 137

**Serious Number At Risk:** 137

**Title:** Control

**Frequency Threshold:** 0

#### Other Events

**Term:** Miscarriage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** 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).

**Organ System:** Pregnancy, puerperium and perinatal conditions

**Source Vocabulary:** 

**Time Frame:** Women were followed for adverse events for the primary study period of three months.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Group ID:** BG001

**Value:** 137

**Group ID:** BG002

**Value:** 286

**Units:** Participants

### Group

**ID:** BG000

**Title:** Intervention

**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

### Group

**ID:** BG001

**Title:** Control

**Description:** Participants receive enhanced standard of care

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.4

**Value:** 18.6

#### Measurement

**Group ID:** BG001

**Spread:** 2.4

**Value:** 18.8

#### Measurement

**Group ID:** BG002

**Spread:** 2.4

**Value:** 18.7

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Group ID:** BG001

**Value:** 137

**Group ID:** BG002

**Value:** 286

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 149

#### Measurement

**Group ID:** BG001

**Value:** 137

#### Measurement

**Group ID:** BG002

**Value:** 286

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Group ID:** BG001

**Value:** 137

**Group ID:** BG002

**Value:** 286

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 136

#### Measurement

**Group ID:** BG001

**Value:** 126

#### Measurement

**Group ID:** BG002

**Value:** 262

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Group ID:** BG001

**Value:** 137

**Group ID:** BG002

**Value:** 286

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 149

#### Measurement

**Group ID:** BG001

**Value:** 137

#### Measurement

**Group ID:** BG002

**Value:** 286

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Group ID:** BG001

**Value:** 137

**Group ID:** BG002

**Value:** 286

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 25

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 142

**Group ID:** BG001

**Value:** 127

**Group ID:** BG002

**Value:** 269

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Description:** Positive sexually transmitted infection test for gonorrhea (GC) or chlamydia (CT)
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Some baseline tests are inconclusive because the sample was not usable, so only 269 out of 286 have results.
**Title:** Positive Sexually Transmitted Infection Test (GC or CT)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** mtrent2@jhmi.edu
**Organization:** Johns Hopkins University
**Phone:** 4109552910
**Title:** Dr. Maria Trent
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.15
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.09
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The odds ratio is for the difference in chlamydia or gonorrhea (CT/GC) rates between arms at ninety days after intervention.
**Group Description:** A comparison of Chlamydia or Gonorrhea positivity at 90 days post intervention.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.070
**P-Value Comment:** Judged by type one error limit alpha = 0.05.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.40
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.39
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.98
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 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.
**Group Description:** 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.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.043
**P-Value Comment:** Judged by type one error limit alpha = 0.05.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.59
**Statistical Comment:** 
**Statistical Method:** generalized estimating equations
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 37.0
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 230.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 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.
**Group Description:** H0: Women in TECHN arm had 72 hour visit with same frequency as women in control arm.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 92.2
**Statistical Comment:** Adjusted for age, debut age, number of lifetime partners, baseline STI status (any vs none), insurance, and if woman had prior pregnancy.
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.36
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.05
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Odds ratio is for intervention arm relative to control.
**Group Description:** H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.084
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.6
**Statistical Comment:** Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.36
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.34
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm.
**Group Description:** H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.867
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.9
**Statistical Comment:** Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.19
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Odds ratio is for partners of TECH-N recipients versus partners of women in control arm.
**Group Description:** H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.153
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.6
**Statistical Comment:** Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.86
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.06
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Odds ratio is for women in the TECH-N arm relative to women in the control arm.
**Group Description:** H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.351
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.0
**Statistical Comment:** Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 131
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**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.
**Reporting Status:** POSTED
**Time Frame:** 90 Days
**Title:** Number of Participants With Positive Sexually Transmitted Infection Test (STI)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### 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)
**ID:** OG000
**Title:** TECH-N
##### Group
**Description:** Participants receive enhanced standard of care
**ID:** OG001
**Title:** Control
#### Outcome Measure 2
**Description:** Completion of 72-hour assessment visit by medical provider, medication adherence (self-reported), partner notification, partner treatment, and temporary sexual abstinence
**Parameter Type:** COUNT_OF_PARTICIPANTS
**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.
**Reporting Status:** POSTED
**Time Frame:** Day 15
**Title:** Number of Participants That Adhered to Self-treatment
**Type:** SECONDARY
**Unit of Measure:** Participants
##### 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)
**ID:** OG000
**Title:** TECH-N
##### Group
**Description:** Participants receive enhanced standard of care
**ID:** OG001
**Title:** Control
### Participant Flow Module
#### 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
**ID:** FG000
**Title:** Intervention
#### Group
**Description:** Participants receive enhanced standard of care
**ID:** FG001
**Title:** Control
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 149
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 137
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 135
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 125
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
**Has Results:** True