Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders (RATA)
12 de abril de 2017 actualizado por: Sebastian Linnemayr, RAND
In this project the investigators develop and test a short message service (SMS) intervention based on the Information Motivation and Behavior skills (IMB) model.
Reminding Adolescents To Adhere (RATA) prompts youths at two clinics in Uganda to take their medications and offers social support via weekly text messages.
The investigators propose to adapt their previous successful SMS-intervention to the specific needs of youths and to evaluate the relative effectiveness of one-way versus two-way text messages (where two-way messages allow youths to respond to messages and we hypothesize that this may increase perceived social support that may be important for youth populations).
We will also test the effectiveness of SMS messages over the longer-term (2 years), for which currently no information is available.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The primary goal of the proposed study is to develop and test SMS-based text messages for improving medication adherence among HIV-positive youths in a resource-limited setting.
The study will be conducted in three phases: Phase 1 will consist of qualitative interviews with patients, clinic providers and directors, and community leaders and will elicit information on barriers to treatment and adherence patterns and cognitive obstacles to adherence that may be addressed by RATA.
A second focus of this phase will be to investigate the familiarity with and attitude towards SMS messages among adolescents, and their attitudes towards different aspects of these messages.
Parameters of the messages that will be probed include their frequency, content, and form using Figure 1 as a guiding principle for this exploratory phase.
Phase 2 will use the findings from Phase 1 to develop and implement RATA in a randomized controlled trial (RCT).
A sample of 330 clients aged 15-24 who are in HIV care and show signs of problems with adherence will be recruited and randomized into one of three equal-sized intervention arms: a control group that will receive usual care, or one of two treatment groups in which participants will receive usual care and additionally will receive either two-way SMS messages or one-way SMS messages.
All RATA participants will be followed for two years.
Assessments will be conducted at baseline and every 6 months over the course of 24 months.
Medication event monitoring system (MEMS)-caps measured medication adherence will be the primary outcome measure, while viral load (for a subset of clients) CD4 count, self-reported adherence and pharmacy refill data as well as retention in care constitute secondary outcomes.
Phase 3 will be used to analyze the collected data, conduct qualitative interviews with providers, clinic administrators, and study participants to learn about implementation difficulties and areas of improvement, and to share preliminary results and project implementation insights with these key players.
This stage allows evaluating the feasibility and sustainability of the intervention for potential scale-up, for which we will also conduct a relative cost-effectiveness analysis of two- versus one-way messages.
RATA will be extended to the control group in Year 5 if findings from phase 2 suggest its success at improving outcomes.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
330
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Santa Monica, California, Estados Unidos, 90407
- RAND
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Kampala, Uganda
- Infectious Diseases Institute
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Kampala, Uganda
- Mildmay Uganda
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
15 años a 24 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- age 15-24
- have been in HIV care at the clinic for at least three months
- are currently taking HIV-related medication (ART or co-trimoxazole)
- have demonstrated adherence problems (defined as having missed at least one medication dose per week on average)
- either own a phone or have regular access to one
- intend to stay at the clinic for the study period
- are not in boarding school (where phones are forbidden)
Exclusion Criteria:
- does not speak or understand either English or Luganda
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control group
This study arm will receive care as usual.
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Experimental: Two-way SMS intervention group
Two-way messages allow the recipient of the SMS message (the patient) to respond to the messages ("We hope you are feeling well today.
Reply 1 if well, 2 if unwell") to request a follow-up call from the clinic.
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Clients will receive a weekly two-way SMS, meaning that the clients in this group will receive the same message as in the one-way SMS study arm, but in addition will be asked how they feel.
Clients are required to either press 1 or respond "well" or press 2 or write 'Unwell" in response in the language of their choice within 48 hours.
A missing response after 48 hours triggers a second SMS to remind the client to respond.
If after 24 more hours the participant still does not respond or if at any point s/he responds "unwell" then the study coordinator will follow up with a call within 24 hours.
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Experimental: One-way SMS intervention group
Clients will receive a weekly one-way SMS with the message "We hope you are feeling well today."
There will be no prompt for response.
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Clients will receive a weekly one-way SMS message.
There will be no prompt for any response.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Medication adherence rates using electronically monitored adherence (MEMS cap) data
Periodo de tiempo: 6 months after enrollment
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Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing.
MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the primary outcome variable of adherence (# of actual bottle openings / # of prescribed bottle openings).
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6 months after enrollment
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Medication adherence rates using electronically monitored adherence (MEMS cap) data
Periodo de tiempo: 12 months after enrollment
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Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing.
MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the primary outcome variable of adherence (# of actual bottle openings / # of prescribed bottle openings).
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12 months after enrollment
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Medication adherence rates using electronically monitored adherence (MEMS cap) data
Periodo de tiempo: 24 months after enrollment
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Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing.
MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the primary outcome variable of adherence (# of actual bottle openings / # of prescribed bottle openings).
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24 months after enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fraction of clients displaying adherence of 90% or more
Periodo de tiempo: At 6, 12, 18 and 24 months
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MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the secondary outcome measures of fraction of clients displaying adherence of 90% or more.
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At 6, 12, 18 and 24 months
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Indicator for treatment interruptions of more than 48 hours
Periodo de tiempo: At 6, 12, 18 and 24 months
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MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the secondary outcome measures of an indicator for treatment interruptions of more than 48 hours.
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At 6, 12, 18 and 24 months
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Viral load assays
Periodo de tiempo: At month 12
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A randomized subset of 30 clients from each intervention arm (90 total) will measure viral load assays at month 12.
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At month 12
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Self-reported adherence
Periodo de tiempo: At baseline, 6, 12, 18 and 24 months
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We will ask about number of missed doses over the past 7 days.
Adherence is calculated as a proportion of prescribed doses taken.
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At baseline, 6, 12, 18 and 24 months
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Pharmacy Refill Adherence
Periodo de tiempo: Months 6, 12, 18 and 24
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All patients on ART receive their medications in 30-day supplies from the Infectious Disease Institute (IDI) and Mildmay clinic pharmacies.
For clients on co-trimoxazole, the drugs are typically dispensed in units of 90 count.
We will adjust the measure according to the refill period specific to each client.
A composite continuous multiple interval measure of medication availability or refill rate will be calculated (# of pills dispensed/ # pills prescribed per day)/ days between refills.
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Months 6, 12, 18 and 24
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Clinic Attendance
Periodo de tiempo: Continuous over 24 months
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Attendance at regularly scheduled clinic visits as part of usual care will be tracked for all participants from the electronic client database and will be available in real-time to the study coordinator.
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Continuous over 24 months
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Cluster of differentiation 4 (CD4) count
Periodo de tiempo: Occasionally over 24 months
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CD4 counts will be chart abstracted from the clinic data; they are typically taken about every six months
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Occasionally over 24 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2013
Finalización primaria (Actual)
31 de enero de 2016
Finalización del estudio (Actual)
31 de marzo de 2017
Fechas de registro del estudio
Enviado por primera vez
15 de abril de 2014
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2014
Publicado por primera vez (Estimar)
1 de mayo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
12 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Enfermedades de virus lentos
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
Otros números de identificación del estudio
- 1R01HD074925-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .