Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
In this study, the investigators propose to develop a real-time adherence intervention based on SMS (i.e., text messages), wireless adherence monitoring (with the Wisepill device), and engagement of social support that is tailored to rural sub-Saharan Africa. The investigators will build on research by others who have shown SMS reminders improve adherence and viral suppression in Kenya, albeit with relatively small effect sizes and suboptimal virologic failure rates even in the intervention arm. Moreover, little is known about which patients benefit from SMS, why they benefit, and what can be done to further improve adherence and treatment success rates. Understanding the mechanisms of effect will make it possible to design and test evidence-based interventions with the highest likelihood for efficacy.
In a cohort of HIV-infected individuals starting ART and being monitored with Wisepill, the investigators will test 1) daily SMS reminders, 2) weekly SMS reminders, 3) SMS reminders linked to real-time detection of missed doses, and 4) SMS reminders plus SMS notifications of 48+hour gaps in adherence to members of social support networks. The investigators will conduct qualitative interviews to learn the experiences of participants and members of their social support networks with the different types of SMS. This staged approach will allow us to fully understand and compare the additive effects and acceptability of SMS-based interventions. The investigators will also determine behavioral effect mechanisms, as well as compare the impact of each type of SMS with a control population receiving only Wisepill monitoring on adherence and HIV RNA.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Mbarara District
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Mbarara, Mbarara District, Uganda
- Mbarara Immune Suppression Syndrome(ISS) Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Wisepill Participants:
Inclusion Criteria:
- HIV-infected
- Initiating ART within the next two weeks
- Age 18 years and older
- Owns a cell phone for personal use and has reliable cellular phone reception at home on a network supported by the technology used in this study
- Lives in the Mbarara District (i.e, within 20 km of the ISS Clinic)
- Has at least one person who could be named as a social supporter(see criteria below).
Exclusion Criteria:
- Unable to use SMS
- Unwilling to receive SMS reminders
- Severe mental condition limiting the ability to provide consent
- Cellular phone reception is not reliable
Social supporters (i.e., recipients of the SMS notifications for Wisepill participants in the intervention arms):
Inclusion criteria:
- Knows Wisepill participant has HIV
- Age 18 years or older
- Reports having provided social support to the intervention participant at least once
- Own a cell phone for personal use and have reliable cellular phone reception at home on a network supported by the technology used in this study
- Lives in the Mbarara District
Exclusion criteria:
- Unable to use SMS
- Unwilling to receive SMS notifications regarding interruptions in the intervention participant's adherence
- Severe mental condition limiting the ability to provide consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Fixed SMS, real-time monitoring
SMS will be sent daily for one month, then weekly for two months.
Participants will have real-time adherence monitoring and social supporters will be notified of gaps in adherence of 48+ hours in the last six months of the study.
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SMS reminders will be sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence.
The Wisepill system will automatically capture and report each time the device is opened as a proxy for the participant's adherence.
Andre navn:
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Eksperimentell: Triggered SMS, real-time monitoring
Participants will have real-time adherence monitoring and social supporters will be notified of gaps in adherence of 48+ hours in the last six months of the study.
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SMS reminders will be sent as needed for missed doses to encourage adherence.
The Wisepill system will automatically capture and report each time the device is opened as a proxy for the participant's adherence.
Andre navn:
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Ingen inngripen: control
Real-time adherence monitoring only (no SMS)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Antiretroviral Therapy (ART) Adherence Levels
Tidsramme: real time (for 9 months)
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ART adherence in each study arms.
Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%.
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real time (for 9 months)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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HIV RNA Suppression
Tidsramme: After month 9
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HIV RNA suppression (<100 copies/ml) in each study arm
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After month 9
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jessica Haberer, MD, MS, Massachusetts General Hospital
- Hovedetterforsker: Angella Musiimenta, PhD, Mbarara University of Science and Technology
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Musiimenta A, Atukunda EC, Tumuhimbise W, Haberer JE. Resilience after withdrawing a technology-based medication adherence support intervention from people living with HIV in rural Uganda. AIDS Care. 2018 Aug;30(sup5):S89-S96. doi: 10.1080/09540121.2018.1510107. Epub 2019 Jan 9.
- Musiimenta A, Atukunda EC, Tumuhimbise W, Pisarski EE, Tam M, Wyatt MA, Ware NC, Haberer JE. Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 May 17;6(5):e122. doi: 10.2196/mhealth.9031.
- Haberer JE, Musiimenta A, Atukunda EC, Musinguzi N, Wyatt MA, Ware NC, Bangsberg DR. Short message service (SMS) reminders and real-time adherence monitoring improve antiretroviral therapy adherence in rural Uganda. AIDS. 2016 May 15;30(8):1295-300. doi: 10.1097/QAD.0000000000001021.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
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
- R34MH100940-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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