- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02549599
Evaluating a Digital Health Information Tool (Chat/Text)
Chat/Text Program: Digital Health Information Efficacy Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
New York
-
New York, New York, États-Unis, 10001
- Planned Parenthood Federation of America
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Autre: Delayed Treatment
Participants will receive a baseline survey and be routed to the Planned Parenthood website.
No subsequent survey will be administered.
|
Participants will receive a baseline survey and be routed to the Planned Parenthood website.
No subsequent survey will be administered
|
Expérimental: 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.
|
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.
|
Autre: Website Content
Participants will be routed to the Planned Parenthood website to information and content about issues regarding sexual and reproductive health.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Increasing clinic attendance
Délai: 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.
|
Measured at 10 days post-intervention
|
Increasing clinic attendance
Délai: 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.
|
Measured at 30 days post-intervention
|
Increasing clinic attendance
Délai: 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.
|
Measured at 3 months post-intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Use of more effective birth control use
Délai: Measured at 10 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 10 days post-intervention
|
Use of more effective birth control use
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Vincent Guilamo-Ramos, PhD, MPH, LCSW, RN, New York University
- Chercheur principal: Leslie Kantor, PhD, MPH, Planned Parenthood Federation of America
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Chat/Text Program
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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