Tech-PN for Pelvic Inflammatory Disease

Overseen By Arlene Butz, ScD, MSN

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnant, Sexual assault, Communication issues

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to support young women with pelvic inflammatory disease (PID) in Baltimore. It uses community health nurse visits and text messages to help women adhere to their treatment plans and prevent future infections. One group will receive extra support through additional testing and visits, while the other group receives standard care. The trial seeks women with mild to moderate PID who are managing it outside the hospital and live permanently in the Baltimore area. As an unphased trial, it offers participants the chance to contribute to innovative care strategies that could improve treatment adherence and prevent future infections.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this protocol is safe for young women with pelvic inflammatory disease?

A previous study found the TECH-PN treatment to be well-tolerated by participants. Research shows that this approach, which includes visits from community health nurses, support through text messages, and extra testing, is safe for young women with pelvic inflammatory disease (PID). Participants reported no serious side effects and found the program easy to follow and helpful. This suggests that TECH-PN is safe and could be a promising way to improve adherence to PID treatment among young women. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tech-PN for Pelvic Inflammatory Disease because it offers a comprehensive approach by combining community health nurse visits, text-messaging support, and additional testing with field-based visits from a nurse practitioner. Unlike standard care, which typically involves only antibiotics and basic follow-up, Tech-PN introduces a more personalized and supportive care model. This approach aims to improve patient adherence and outcomes by ensuring continuous care and communication, potentially leading to better health results for those affected by the condition.

What evidence suggests that this trial's treatments could be effective for pelvic inflammatory disease?

Research has shown that the TECH-PN program, which participants in this trial may receive, could assist women with pelvic inflammatory disease (PID). Studies have found that similar technology-based community health nursing methods help people adhere to their treatment plans and reduce the risk of recurrent infections. The program also includes a proven plan to prevent sexually transmitted infections (STIs), which should help reduce repeat infections. Early results suggest that TECH-PN is practical and well-received by young women, making it a promising approach to managing PID. While more research is needed, the initial findings are hopeful for better health outcomes and cost savings. ^{1 2 6 7 8}

Who Is on the Research Team?

Maria Trent, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Permanently reside in the Baltimore Metropolitan area

Willing to sign informed consent & be randomized

My pelvic inflammatory disease is not severe.

Exclusion Criteria

I cannot communicate or follow study procedures.

You have experienced sexual assault at the same time as the clinical trial.

You are pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive community health nurse visits, text-messaging support, additional testing, and field-based visits with a nurse practitioner

4 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Tech-PN

Trial Overview 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.

How Is the Trial Designed?

Group I: TECH-PN Experimental Treatment 1 Intervention

Participants receive community health nurse visits, text-messaging support, additional testing and field based visits with a nurse practitioner.

Group II: TECH-N Active Control 1 Intervention

Participants receive enhanced standard of care with community health nurse visits and text-messaging support.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39976993/

Cost-Effectiveness Analysis of the Technology-Enhanced ... Our model suggests the TECH-N intervention yields better outcomes at lower overall costs. In addition, the nature of TECH-N lends itself to ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2747480

Efficacy of a Technology-Enhanced Community Health ... This randomized clinical trial examines the efficacy of a technology-enhanced community health nursing intervention for improving pelvic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6686980/

Efficacy of a Technology-Enhanced Community Health ... This randomized clinical trial examines the efficacy of a technology-enhanced community health nursing intervention for improving pelvic inflammatory disease ( ...

4. jahonline.org jahonline.org/article/S1054-139X(22)00809-6/fulltext

19. Cost-Effectiveness of the Technology-Enhanced ... Our model suggests TECH-N is a cost-effective public health intervention that yields better outcomes at slightly higher costs.

5. academic.oup.com academic.oup.com/jid/article/224/Supplement_2/S145/6352154

Using Innovation to Address Adolescent and Young Adult ... Preliminary enrollment, STI, intervention delivery, and retention data demonstrate the feasibility and acceptability of the TECH-PN intervention ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03828994

Technology Based Community Health Nursing(TECH-N) to ... Pelvic Inflammatory Disease (PID) is a common, serious reproductive disorder that is associated with significant adverse reproductive health outcomes such ...

7. clinicaltrial.be clinicaltrial.be/en/details/65351?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Technology Based Community Health Nursing(TECH-N) to ... Pelvic Inflammatory Disease (PID) is a common, serious reproductive disorder that is associated with significant adverse reproductive health ...

8. hopkinsmedicine.org hopkinsmedicine.org/news/newsroom/news-releases/2019/08/visits--phones--better-outcomes-for-teens-young-women-with-pelvic-inflammatory-disease

Visits + Phones = Better Outcomes For Teens, Young ... A Johns Hopkins Medicine-led clinical trial shows that a patient-centered, technology-enhanced care program improves PID outcomes in underserved populations.