Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Mbarara District
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Mbarara, Mbarara District, Ouganda
- Mbarara Immune Suppression Syndrome(ISS) Clinic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
Autres noms:
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Expérimental: 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.
Autres noms:
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Aucune intervention: control
Real-time adherence monitoring only (no SMS)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Antiretroviral Therapy (ART) Adherence Levels
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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HIV RNA Suppression
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jessica Haberer, MD, MS, Massachusetts General Hospital
- Chercheur principal: Angella Musiimenta, PhD, Mbarara University of Science and Technology
Publications et liens utiles
Publications générales
- 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.
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
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies du système immunitaire
- Maladies à virus lents
- Infections à VIH
- Syndrome immunodéficitaire acquis
Autres numéros d'identification d'étude
- R34MH100940-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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