Behavior and Behavior MechanismsChat/TextNCT02549599
Evaluating a Digital Health Information Tool
A study testing Chat/Text Program, Website Content and Delayed Treatment in people with Behavior and Behavior Mechanisms, run by New York University at 1 site in United States.
Trial summary
The primary aim of the proposed project is to conduct a randomized controlled trial to evaluate the efficacy of a digital intervention tool that enables young people to correspond with trained staff via online chat or text messages about urgent questions related to sexual/reproductive health. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms
- What is being tested?
- Chat/Text Program, Website Content and Delayed Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,220 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Mar 2016
- 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 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- Aged 15-25
- Had sex within the past 30 days prior to enrollment
- Never used the Planned Parenthood Chat/Text program
Who cannot join
- Males
- Females outside the ages of 15-25
- Female who report not having sex in the past 30 days
- Have used the Planned Parenthood Chat/Text program
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Federation of America
New York, New York, 10001
About this study
Official title: Chat/Text Program: Digital Health Information Efficacy Trial
The primary aim of the proposed project is to conduct a randomized controlled trial to evaluate the efficacy of a digital intervention tool that enables young people to correspond with trained staff via online chat or text messages about urgent questions related to sexual/reproductive health.
Read the detailed description
The present evaluation study engages digital technology to target young people to impact their use of sexual health services. The primary aim of the proposed project is to conduct a randomized controlled trial to evaluate the efficacy of an intervention tool that enables young people to correspond with trained staff via online chat or text messages about urgent questions related to sexual/reproductive health. Specifically, Chat/Text is a program designed to provide immediate answers to urgent sexual and reproductive health questions from a reliable and confidential source and to link young people to sexual and reproductive health services. Agents are trained on substantive topics, and on responding compassionately and appropriately. They are provided scripted responses to specific topics. Agent performance is monitored and evaluated to ensure high-quality responses that meet the goals of the program. The program targets groups experiencing sexual and reproductive health disparities, particularly Black and Latino/Hispanic teens and young adults. The Chat/Text program was launched in September 2010 by Planned Parenthood Federation of America (PPFA). The present project is evaluating the efficacy of the Chat/Text program. Specifically, the investigators will compare the effect of the Chat/Text program to the standard of care available from PPFA (website content) in the absence of the Chat/Text program.
Participants will be randomized into one of the three arms of the evaluative study (experimental, control, and passive control). Participants in the experimental arm will receive access to the digital Chat/Text program where they can ask questions and receive answers about sexual and reproductive health issues in real-time, immediately followed by a combined baseline and follow-up assessment. Participants in the control arm of the study will be routed to the Planned Parenthood website to content and information on sexual and reproductive health issues, also followed by the combined assessment. Participants in the passive control will receive a standalone baseline assessment and then be routed to the website. No additional contact will be made with the passive control group.
The experimental participants will receive booster sessions in the form of e-mail and SMS communications. The first (5 days post-intervention) and second (3 weeks post-intervention) booster sessions will focus on appointment adherence. The third (2 months post-intervention) and fourth (2.5 months post-intervention) booster sessions will focus on effective birth control methods in addition to appointment adherence.
The control condition will not receive booster sessions, but will receive communications that aim to obtain additional tracking information. These tracking communications will be sent at the same time points as the experimental booster sessions (i.e., 5 days-, 3 weeks-, 2 months-, and 2.5 months-post website exposure).
- Conditions
- Behavior and Behavior Mechanisms
- Being tested
- Chat/Text Program, Website Content, Delayed Treatment
- Keywords
- Digital and mobile health, Sexual and reproductive health, Adolescents and young adults
- Medical subject headings
- Behavior, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chat/Text ProgramBehavioural
Participants will receive access to the Chat/Text program on the internet via computer or mobile device. The Chat/Text program involves interactive, immediate, and tailored messages (with pre-determined content) delivered by Chat/Text agents via online chat or mobile phone text. At the conclusion of the session, the participants will receive a combination-baseline and follow-up survey.
Website ContentBehavioural
Participants will be directed to content and information on the Planned Parenthood website. The website contains information on birth control methods, locations of Planned Parenthood health clinics, and on sexual and reproductive health more broadly.
Delayed TreatmentOther
Participants will receive a baseline survey and be routed to the Planned Parenthood website. No subsequent survey will be administered
| Study group | Role | What they receive |
|---|---|---|
| Delayed Treatment | Other | Participants will receive a baseline survey and be routed to the Planned Parenthood website. No subsequent survey will be administered. Receives: Other: Delayed Treatment |
| Chat/Text Program | Experimental | Participants will receive real-time answers to questions they have about sexual and reproductive health topics from trained chat agents via the digital intervention program. Receives: Behavioral: Chat/Text Program |
| Website Content | Other | Participants will be routed to the Planned Parenthood website to information and content about issues regarding sexual and reproductive health. Receives: Behavioral: Website Content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing clinic attendance
Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
Measured: Measured at 10 days post-intervention
Increasing clinic attendance
Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
Measured: Measured at 30 days post-intervention
Increasing clinic attendance
Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
Measured: Measured at 3 months post-intervention
Secondary outcomes (3)
Use of more effective birth control use
The use of more effective birth control use is determined, through a self-report question asking if a participant changed her method of birth control to a more effective one. For example, a participant may change from a barrier method (e.g., condom) to a hormonal method.
Measured: Measured at 10 days post-intervention
Use of more effective birth control use
The use of more effective birth control use is determined, through a self-report question asking if a participant changed her method of birth control to a more effective one. For example, a participant may change from a barrier method (e.g., condom) to a hormonal method.
Measured: Measured at 30 days post-intervention
Use of more effective birth control use
The use of more effective birth control use is determined, through a self-report question asking if a participant changed her method of birth control to a more effective one. For example, a participant may change from a barrier method (e.g., condom) to a hormonal method.
Measured: Measured at 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior and Behavior MechanismsStudies of the same condition, open and under way.
- 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
- 5,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Responsible party
- Sponsor
- Investigators
- Vincent Guilamo-Ramos, PhD, MPH, LCSW, RN, Principal investigator, New York UniversityLeslie Kantor, PhD, MPH, Principal investigator, Planned Parenthood Federation of AmericaJames Jaccard, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549599
- Sponsor's protocol ID
- Chat/Text Program
- Acronym
- Chat/Text
- Status last verified
- Sep 2017
- First submitted
- 10 Sep 2015
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chat/Text Program: Digital Health Information Efficacy Trial
- ClinicalTrials.gov ID
- NCT02549599
- Acronym / sponsor ID
- Chat/Text / Chat/Text Program
- Conditions
- Behavior and Behavior Mechanisms
- Keywords
- Digital and mobile health, Sexual and reproductive health, Adolescents and young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,220 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Sep 2015 (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 primary aim of the proposed project is to conduct a randomized controlled trial to evaluate the efficacy of a digital intervention tool that enables young people to correspond with trained staff via online chat or text messages about urgent questions related to sexual/reproductive health.
Detailed description
The present evaluation study engages digital technology to target young people to impact their use of sexual health services. The primary aim of the proposed project is to conduct a randomized controlled trial to evaluate the efficacy of an intervention tool that enables young people to correspond with trained staff via online chat or text messages about urgent questions related to sexual/reproductive health. Specifically, Chat/Text is a program designed to provide immediate answers to urgent sexual and reproductive health questions from a reliable and confidential source and to link young people to sexual and reproductive health services. Agents are trained on substantive topics, and on responding compassionately and appropriately. They are provided scripted responses to specific topics. Agent performance is monitored and evaluated to ensure high-quality responses that meet the goals of the program. The program targets groups experiencing sexual and reproductive health disparities, particularly Black and Latino/Hispanic teens and young adults. The Chat/Text program was launched in September 2010 by Planned Parenthood Federation of America (PPFA). The present project is evaluating the efficacy of the Chat/Text program. Specifically, the investigators will compare the effect of the Chat/Text program to the standard of care available from PPFA (website content) in the absence of the Chat/Text program.
Participants will be randomized into one of the three arms of the evaluative study (experimental, control, and passive control). Participants in the experimental arm will receive access to the digital Chat/Text program where they can ask questions and receive answers about sexual and reproductive health issues in real-time, immediately followed by a combined baseline and follow-up assessment. Participants in the control arm of the study will be routed to the Planned Parenthood website to content and information on sexual and reproductive health issues, also followed by the combined assessment. Participants in the passive control will receive a standalone baseline assessment and then be routed to the website. No additional contact will be made with the passive control group.
The experimental participants will receive booster sessions in the form of e-mail and SMS communications. The first (5 days post-intervention) and second (3 weeks post-intervention) booster sessions will focus on appointment adherence. The third (2 months post-intervention) and fourth (2.5 months post-intervention) booster sessions will focus on effective birth control methods in addition to appointment adherence.
The control condition will not receive booster sessions, but will receive communications that aim to obtain additional tracking information. These tracking communications will be sent at the same time points as the experimental booster sessions (i.e., 5 days-, 3 weeks-, 2 months-, and 2.5 months-post website exposure).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delayed Treatment | Other | Other: Delayed TreatmentParticipants will receive a baseline survey and be routed to the Planned Parenthood website. No subsequent survey will be administered. |
| Chat/Text Program | Experimental | Behavioral: Chat/Text ProgramParticipants will receive real-time answers to questions they have about sexual and reproductive health topics from trained chat agents via the digital intervention program. |
| Website Content | Other | Behavioral: Website ContentParticipants will be routed to the Planned Parenthood website to information and content about issues regarding sexual and reproductive health. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female
- Aged 15-25
- Had sex within the past 30 days prior to enrollment
- Never used the Planned Parenthood Chat/Text program
Key exclusion criteria (4 listed)
- Males
- Females outside the ages of 15-25
- Female who report not having sex in the past 30 days
- Have used the Planned Parenthood Chat/Text program
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 |
|---|---|---|
| Chat/Text ProgramParticipants will receive access to the Chat/Text program on the internet via computer or mobile device. The Chat/Text program involves interactive, immediate, and tailored messages (with pre-determined content) delivered by Chat/Text agents via online chat or mobile phone text. At the conclusion of the session, the participants will receive a combination-baseline and follow-up survey. | Behavioural | Chat/Text Program |
| Website ContentParticipants will be directed to content and information on the Planned Parenthood website. The website contains information on birth control methods, locations of Planned Parenthood health clinics, and on sexual and reproductive health more broadly. | Behavioural | Website Content |
| Delayed TreatmentParticipants will receive a baseline survey and be routed to the Planned Parenthood website. No subsequent survey will be administered | Other | Delayed Treatment |
Primary outcome
Increasing clinic attendance
Time frame: Measured at 10 days post-intervention
Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
Increasing clinic attendance
Time frame: Measured at 30 days post-intervention
Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
Increasing clinic attendance
Time frame: Measured at 3 months post-intervention
Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
3 secondary outcomes
Use of more effective birth control use
Time frame: Measured at 10 days post-intervention
Use of more effective birth control use
Time frame: Measured at 30 days post-intervention
Use of more effective birth control use
Time frame: Measured at 3 months post-intervention
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 27 Oct 2022.
- Website Content InformationLink provided by the sponsor.
Related trials for Behavior and Behavior Mechanisms
Not yet recruitingPhase 2
Psilocybin for Depression in Veterans
Major Depression
RecruitingObservational study
Characterization and Treatment of Adolescent Depression
Depression
Not yet recruiting
Individual Variability in Energy Compensation After a 12-Week Supervised Exercise Intervention
Physical Inactivity, Overweight
Recruiting
Readiness and Progress in Emotion Regulation Therapy
Rumination, Worry
Not yet recruitingObservational study
Effect of TMS Treatment on Defense Mechanisms and Functionality in Patients With Depression
Major Depressive Disorder (MDD)
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.
Vincent Guilamo-Ramos, PhD, MPH, LCSW, RN principal investigator
New York University
Leslie Kantor, PhD, MPH principal investigator
Planned Parenthood Federation of America
James Jaccard, PhD principal investigator
New York 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 Chat/Text Program, Website Content and Delayed Treatment in people with Behavior and Behavior Mechanisms, run by New York 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 4 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 27 Oct 2022. 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?
Increasing clinic attendance (time frame: Measured at 10 days post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2022.