- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02128087
Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders (RATA)
12. april 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
330
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Santa Monica, California, Forente stater, 90407
- RAND
-
-
-
-
-
Kampala, Uganda
- Infectious Diseases Institute
-
Kampala, Uganda
- Mildmay Uganda
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
15 år til 24 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Control group
This study arm will receive care as usual.
|
|
Eksperimentell: 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.
|
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.
|
Eksperimentell: 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.
|
Clients will receive a weekly one-way SMS message.
There will be no prompt for any response.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Tidsramme: 6 months after enrollment
|
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).
|
6 months after enrollment
|
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Tidsramme: 12 months after enrollment
|
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).
|
12 months after enrollment
|
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Tidsramme: 24 months after enrollment
|
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).
|
24 months after enrollment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fraction of clients displaying adherence of 90% or more
Tidsramme: At 6, 12, 18 and 24 months
|
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.
|
At 6, 12, 18 and 24 months
|
Indicator for treatment interruptions of more than 48 hours
Tidsramme: At 6, 12, 18 and 24 months
|
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.
|
At 6, 12, 18 and 24 months
|
Viral load assays
Tidsramme: At month 12
|
A randomized subset of 30 clients from each intervention arm (90 total) will measure viral load assays at month 12.
|
At month 12
|
Self-reported adherence
Tidsramme: At baseline, 6, 12, 18 and 24 months
|
We will ask about number of missed doses over the past 7 days.
Adherence is calculated as a proportion of prescribed doses taken.
|
At baseline, 6, 12, 18 and 24 months
|
Pharmacy Refill Adherence
Tidsramme: Months 6, 12, 18 and 24
|
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.
|
Months 6, 12, 18 and 24
|
Clinic Attendance
Tidsramme: Continuous over 24 months
|
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.
|
Continuous over 24 months
|
Cluster of differentiation 4 (CD4) count
Tidsramme: Occasionally over 24 months
|
CD4 counts will be chart abstracted from the clinic data; they are typically taken about every six months
|
Occasionally over 24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
31. januar 2016
Studiet fullført (Faktiske)
31. mars 2017
Datoer for studieregistrering
Først innsendt
15. april 2014
Først innsendt som oppfylte QC-kriteriene
29. april 2014
Først lagt ut (Anslag)
1. mai 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. april 2017
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- 1R01HD074925-01 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Humant immunsviktvirus
-
Columbia UniversityNational Institute of Mental Health (NIMH); Ministry of Health and Social...FullførtHIV (Human Immunodeficiency Virus) | AIDS (ervervet immunsviktsyndrom)Tanzania
-
Columbia UniversityFullførtHIV (Human Immunodeficiency Virus)Forente stater
-
University of California, BerkeleyHealth for a Prosperous Nation; Tanzania Ministry of Health, Community... og andre samarbeidspartnereAktiv, ikke rekrutterendeHIV (Human Immunodeficiency Virus)Tanzania
-
University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health og andre samarbeidspartnereAktiv, ikke rekrutterende
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID); New York... og andre samarbeidspartnereFullførtHIV (Human Immunodeficiency Virus)Swaziland
-
Columbia UniversityNational Institute of Nursing Research (NINR)FullførtHIV (Human Immunodeficiency Virus) | AIDS (ervervet immunsviktsyndrom)Forente stater
-
Columbia UniversityMinistry of Health, SwazilandFullført
-
University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health og andre samarbeidspartnereRekruttering
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)FullførtSeksuelt overførbare sykdommer | HIV (Human Immunodeficiency Virus)Forente stater
-
University of California, Los AngelesAvsluttetHepatitt C | HIV (Human Immunodeficiency Virus)Forente stater