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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR013507-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TECH-N | Experimental | 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 |
|
| Control | No Intervention | Participants receive enhanced standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology Enhanced Community Health Nursing | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Trent, MD, MPH | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32569258 | Derived | 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. | |
| 31390037 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control | Participants receive enhanced standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Count of Participants | Participants | 90 Days |
|
Women were followed for adverse events for the primary study period of three months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Trent | Johns Hopkins University | 4109552910 | mtrent2@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2017 | Apr 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| ID | Term |
|---|---|
| D034161 | Pelvic Infection |
| D007239 | Infections |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
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| ID | Term |
|---|---|
| D013097 | Spermine Synthase |
| ID | Term |
|---|---|
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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|
|
| 31165630 | Derived | 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. |
Participants receive enhanced standard of care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Positive Sexually Transmitted Infection Test (GC or CT) | Positive sexually transmitted infection test for gonorrhea (GC) or chlamydia (CT) | Some baseline tests are inconclusive because the sample was not usable, so only 269 out of 286 have results. | Count of Participants | Participants |
|
| OG001 | Control | Participants receive enhanced standard of care |
|
|
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| Secondary | 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 | 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. | Posted | Count of Participants | Participants | Day 15 |
|
|
|
|
| 0 |
| 149 |
| 0 |
| 149 |
| 1 |
| 149 |
| EG001 | Control | Participants receive enhanced standard of care | 0 | 137 | 0 | 137 | 0 | 137 |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm. | Regression, Logistic | Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance. | 0.084 | Odds Ratio (OR) | 0.6 | 2-Sided | 95 | 0.36 | 1.05 | Odds ratio is for intervention arm relative to control. | Superiority |
| H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm. | Regression, Logistic | Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance. | 0.867 | Odds Ratio (OR) | 0.9 | 2-Sided | 95 | 0.36 | 2.34 | Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm. | Superiority |
| H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm. | Regression, Logistic | Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance. | 0.153 | Odds Ratio (OR) | 0.6 | 2-Sided | 95 | 0.33 | 1.19 | Odds ratio is for partners of TECH-N recipients versus partners of women in control arm. | Superiority |
| H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm. | Regression, Logistic | Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance. | 0.351 | Odds Ratio (OR) | 1.0 | 2-Sided | 95 | 0.86 | 1.06 | Odds ratio is for women in the TECH-N arm relative to women in the control arm. | Superiority |