Pelvic Inflammatory Disease (PID)
Conditions
Keywords
Pelvic Inflammatory Disease (PID), Community Health Nursing, Text Messaging, mobile health (mhealth), Adolescents
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.
Interventions
BEHAVIORALTechnology 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)
Sponsors
National Institute of Nursing Research (NINR)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 25 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 149 |
| Control Participants receive enhanced standard of care | 137 |
| Total | 286 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 18.6 years STANDARD_DEVIATION 2.4 | 18.8 years STANDARD_DEVIATION 2.4 | 18.7 years STANDARD_DEVIATION 2.4 |
| Positive Sexually Transmitted Infection Test (GC or CT) | 16 Participants | 9 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 136 Participants | 126 Participants | 262 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 149 participants | 137 participants | 286 participants |
| Sex: Female, Male Female | 149 Participants | 137 Participants | 286 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 149 | 0 / 137 |
| other Total, other adverse events | 1 / 149 | 0 / 137 |
| serious Total, serious adverse events | 0 / 149 | 0 / 137 |
Outcome results
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).
Time frame: 90 Days
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TECH-N | Number of Participants With Positive Sexually Transmitted Infection Test (STI) | 6 Participants |
| Control | Number of Participants With Positive Sexually Transmitted Infection Test (STI) | 13 Participants |
Comparison: A comparison of Chlamydia or Gonorrhea positivity at 90 days post intervention.p-value: 0.0795% CI: [0.15, 1.09]t-test, 2 sided
Comparison: 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.p-value: 0.04395% CI: [0.39, 0.98]generalized estimating equations
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
Time frame: Day 15
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TECH-N | Number of Participants That Adhered to Self-treatment | 131 Participants |
| Control | Number of Participants That Adhered to Self-treatment | 20 Participants |
Comparison: H0: Women in TECHN arm had 72 hour visit with same frequency as women in control arm.p-value: <0.00195% CI: [37, 230.1]Chi-squared
Comparison: H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm.p-value: 0.08495% CI: [0.36, 1.05]Regression, Logistic
Comparison: H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm.p-value: 0.86795% CI: [0.36, 2.34]Regression, Logistic
Comparison: H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm.p-value: 0.15395% CI: [0.33, 1.19]Regression, Logistic
Comparison: H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm.p-value: 0.35195% CI: [0.86, 1.06]Regression, Logistic