PregnancyT2INCT02093884
A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department
A study testing Text Messaging Intervention and Standard Referral in people with Pregnancy, run by Columbia University at 1 site in United States.
Trial summary
The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Text Messaging Intervention and Standard Referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 14-19 years
- Sexually active with males in the past three months
- Presenting to the ED for a reproductive health complaint.
Who cannot join
- Presently pregnant
- Too ill for participation per the attending physician
- Cognitively impaired
- In foster care or a ward of the state
- Does not speak English or Spanish
- Does not own a cellular or mobile phone with text messaging capabilities
- Used contraception at last intercourse and/or is currently using any "highly effective" or "effective" form of contraception (as defined by the World Health Organization)
- Does not live in Manhattan or the Bronx
Trial locations and contacts
1 site in 1 country.
United States1 site
Morgan Stanley Children's Hospital Emergency Department
Manhattan, New York, 10032
About this study
Official title: Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.
Read the detailed description
Our hypothesis is that adolescent females at high pregnancy risk who receive text message reminders and motivational messages that promote contraception and referral to the Family Planning Clinic are more likely to start effective contraception than those who receive standard paper-based referral to the Family Planning Clinic alone.
- Conditions
- Pregnancy
- Being tested
- Text Messaging Intervention, Standard Referral
- Keywords
- Pregnancy, Pregnancy, unplanned, Reproductive behavior, Pregnancy in Adolescence, Text messaging
- Medical subject headings
- Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging InterventionOther
Standard ReferralOther
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging Intervention | Experimental | Patients in the text messaging group will receive educational and motivational text messages. Receives: Other: Text Messaging Intervention |
| Standard Referral | Active comparator | Patients in the standard referral arm will receive paper based information about the Family Planning Clinic. Receives: Other: Standard Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of highly effective contraception, as defined by the World Health Organization.
We will be assessing contraception initiation rates based on electronic medical record review and telephone call follow up.
Measured: 3 months after initial enrollment
Secondary outcomes (3)
Patient visits to Family Planning Clinic
We assess Family Planning Clinic visits using our electronic medical records.
Measured: 3 months after initial enrollment
Follow up for contraceptive counseling to a doctor or nurse
We will be asking patients during our phone call follow if they have had contraceptive counseling with any healthcare professional. We will also be looking through electronic medical records for documentation of contraceptive counseling such as by ICD-9 coding or a physician's/nurse's note.
Measured: 3 months after initial enrollment
Change in pregnancy intentions
We will compare pregnancy intentions elicited from the answers provided in the baseline questionnaire to those reported on the telephone follow up for both study arms.
Measured: 3 months after initial enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Lauren S. Chernick, Columbia University
- Investigators
- Lauren Chernick, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093884
- Sponsor's protocol ID
- AAAM3457
- Acronym
- T2I
- Status last verified
- Jan 2017
- First submitted
- 19 Mar 2014
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
PubMed 32779730
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
- ClinicalTrials.gov ID
- NCT02093884
- Acronym / sponsor ID
- T2I / AAAM3457
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Pregnancy, unplanned, Reproductive behavior, Pregnancy in Adolescence, Text messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.
Detailed description
Our hypothesis is that adolescent females at high pregnancy risk who receive text message reminders and motivational messages that promote contraception and referral to the Family Planning Clinic are more likely to start effective contraception than those who receive standard paper-based referral to the Family Planning Clinic alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Messaging Intervention | Experimental | Other: Text Messaging InterventionPatients in the text messaging group will receive educational and motivational text messages. |
| Standard Referral | Active comparator | Other: Standard ReferralPatients in the standard referral arm will receive paper based information about the Family Planning Clinic. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 14-19 years
- Sexually active with males in the past three months
- Presenting to the ED for a reproductive health complaint.
Key exclusion criteria (8 listed)
- Presently pregnant
- Too ill for participation per the attending physician
- Cognitively impaired
- In foster care or a ward of the state
- Does not speak English or Spanish
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 |
|---|---|---|
| Text Messaging Intervention | Other | Text Messaging Intervention |
| Standard Referral | Other | Standard Referral |
Primary outcome
Initiation of highly effective contraception, as defined by the World Health Organization.
Time frame: 3 months after initial enrollment
We will be assessing contraception initiation rates based on electronic medical record review and telephone call follow up.
3 secondary outcomes
Patient visits to Family Planning Clinic
Time frame: 3 months after initial enrollment
Follow up for contraceptive counseling to a doctor or nurse
Time frame: 3 months after initial enrollment
Change in pregnancy intentions
Time frame: 3 months after initial enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Derived from this study: PubMed 32779730Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
- Individual participant dataSharing planned: No
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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.
Lauren Chernick, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging Intervention and Standard Referral in people with Pregnancy, run by Columbia 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 3 inclusion and 8 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 20 Jan 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Initiation of highly effective contraception, as defined by the World Health Organization. (time frame: 3 months after initial enrollment). 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 NCT02093884, which also lists 1 linked publication.
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 20 Jan 2017.