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Behavioral Intervention
Tech-PN for Pelvic Inflammatory Disease
N/A
Waitlist Available
Led By Maria Trent, MD, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Must not have
Unable to communicate/complete study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to provide support to young women with pelvic inflammatory disease, using technology-enhanced community health nursing intervention with an evidence-based STI prevention curriculum, to see if it reduces rates of repeat infection.
Who is the study for?
This trial is for young women aged 13-25 in the Baltimore area who have been diagnosed with mild to moderate pelvic inflammatory disease (PID) and are not pregnant. Participants must be willing to sign informed consent, agree to randomization, and be able to communicate and complete study procedures.
What is being tested?
The trial is testing a new approach called TECH-PN which includes community health nurse visits and text message support for 30 days, plus additional field testing and treatment. It aims to improve adherence to PID treatment, reduce unprotected sex, prevent repeat STI infections, and evaluate cost-effectiveness against standard care.
What are the potential side effects?
Since this intervention primarily involves nursing support and communication rather than medication or invasive procedures, significant side effects are not expected. However, there may be privacy concerns related to personal health data management.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot communicate or follow study procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of STI Mycoplasma genitalium
Rate of STI Trichomonas vaginalis
Vaginal health as assessed by proportion of high Lactobacilli community state-type 1 properties (CST)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TECH-PNExperimental Treatment1 Intervention
Participants receive community health nurse visits, text-messaging support, additional testing and field based visits with a nurse practitioner.
Group II: TECH-NActive Control1 Intervention
Participants receive enhanced standard of care with community health nurse visits and text-messaging support.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,523 Total Patients Enrolled
1 Trials studying Pelvic Inflammatory Disease
286 Patients Enrolled for Pelvic Inflammatory Disease
National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,378,566 Total Patients Enrolled
1 Trials studying Pelvic Inflammatory Disease
286 Patients Enrolled for Pelvic Inflammatory Disease
Maria Trent, MD, MPHPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
386 Total Patients Enrolled
1 Trials studying Pelvic Inflammatory Disease
286 Patients Enrolled for Pelvic Inflammatory Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot communicate or follow study procedures.You have experienced sexual assault at the same time as the clinical trial.My pelvic inflammatory disease is not severe.You are pregnant.I am receiving treatment without needing to stay in the hospital.
Research Study Groups:
This trial has the following groups:- Group 1: TECH-PN
- Group 2: TECH-N