Pelvic Inflammatory Disease (PID)TECH-NNCT01640379
Technology Enhanced Community Health Nursing (TECH-N) Study
A study testing Technology Enhanced Community Health Nursing in people with Pelvic Inflammatory Disease (PID), run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 25 years, women only
- Conditions the study is for
- Pelvic Inflammatory Disease (PID)
- What is being tested?
- Technology Enhanced Community Health Nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mild-moderate PID
- Outpatient treatment disposition
- Permanently reside in the Baltimore Metropolitan area
- Willing to sign informed consent \& be randomized
Who cannot join
- Pregnant
- Concurrent diagnosis of Sexual Assault
- Unable to communicate/complete study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Technology Enhanced Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease
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).
Read the 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
- Pelvic Inflammatory Disease (PID)
- Being tested
- Technology Enhanced Community Health Nursing
- Keywords
- Pelvic Inflammatory Disease (PID), Community Health Nursing, Text Messaging, mobile health (mhealth), Adolescents
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology Enhanced Community Health NursingBehavioural
Also called Sister to Sister Teen, Short Messaging System (SMS) communication (Text Messages)
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Technology Enhanced Community Health Nursing |
| Control | No intervention | Participants receive enhanced standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 Days
Secondary outcomes (1)
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
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Inflammatory Disease (PID)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Maria Trent, MD, MPH, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640379
- Sponsor's protocol ID
- NA_00068846
- Other IDs
- 1R01NR013507-01
- Acronym
- TECH-N
- Status last verified
- May 2020
- First submitted
- 11 Jul 2012
- Last updated
- 1 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32569258Trent 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.
PubMed 31390037Ha 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.
PubMed 31165630
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Enhanced Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease
- ClinicalTrials.gov ID
- NCT01640379
- Acronym / sponsor ID
- TECH-N / NA_00068846
- Conditions
- Pelvic Inflammatory Disease (PID)
- Keywords
- Pelvic Inflammatory Disease (PID), Community Health Nursing, Text Messaging, mobile health (mhealth), Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jul 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Posted 7 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECH-N | Experimental | Behavioral: Technology Enhanced Community Health NursingParticipants 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 |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Mild-moderate PID
- Outpatient treatment disposition
- Permanently reside in the Baltimore Metropolitan area
- Willing to sign informed consent \& be randomized
Key exclusion criteria (3 listed)
- Pregnant
- Concurrent diagnosis of Sexual Assault
- Unable to communicate/complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology Enhanced Community Health NursingAlso: Sister to Sister Teen, Short Messaging System (SMS) communication (Text Messages)* 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) | Behavioural | TECH-N |
Primary outcome
Number of Participants With Positive Sexually Transmitted Infection Test (STI)
Time frame: 90 Days
STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).
1 secondary outcome
Number of Participants That Adhered to Self-treatment
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32569258Trent 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.
- Derived from this study: PubMed 31390037Trent 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.
- Derived from this study: PubMed 31165630Ha 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.
- JHU Institute for Clinical and Translational Research (ICTR) Registry LinkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Trent, MD, MPH principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology Enhanced Community Health Nursing in people with Pelvic Inflammatory Disease (PID), run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Positive Sexually Transmitted Infection Test (STI) (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01640379, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.