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- Klinische proef NCT02549599
Evaluating a Digital Health Information Tool (Chat/Text)
Chat/Text Program: Digital Health Information Efficacy Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10001
- Planned Parenthood Federation of America
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Female
- Aged 15-25
- Had sex within the past 30 days prior to enrollment
- Never used the Planned Parenthood Chat/Text program
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: Delayed Treatment
Participants will receive a baseline survey and be routed to the Planned Parenthood website.
No subsequent survey will be administered.
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Participants will receive a baseline survey and be routed to the Planned Parenthood website.
No subsequent survey will be administered
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Experimenteel: Chat/Text Program
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.
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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.
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Ander: Website Content
Participants will be routed to the Planned Parenthood website to information and content about issues regarding sexual and reproductive health.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Increasing clinic attendance
Tijdsspanne: Measured at 10 days post-intervention
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Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
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Measured at 10 days post-intervention
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Increasing clinic attendance
Tijdsspanne: Measured at 30 days post-intervention
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Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
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Measured at 30 days post-intervention
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Increasing clinic attendance
Tijdsspanne: Measured at 3 months post-intervention
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Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
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Measured at 3 months post-intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Use of more effective birth control use
Tijdsspanne: Measured at 10 days post-intervention
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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.
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Measured at 10 days post-intervention
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Use of more effective birth control use
Tijdsspanne: Measured at 30 days post-intervention
|
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 at 30 days post-intervention
|
Use of more effective birth control use
Tijdsspanne: Measured at 3 months post-intervention
|
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 at 3 months post-intervention
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Vincent Guilamo-Ramos, PhD, MPH, LCSW, RN, New York University
- Hoofdonderzoeker: Leslie Kantor, PhD, MPH, Planned Parenthood Federation of America
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Chat/Text Program
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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