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Call Senior Fellowship (SF)
Programme EDCTP1
Start Date 2012-02-29
End Date 2014-06-30
Project Code  TA.2011.40200.015
Status Completed

Title

 A randomised controlled trial of real-time electronic adherence monitoring with text message dosing reminders in people starting first-line antiretroviral therapy

Objectives

This study will use a locally developed real time adherence monitoring tool to explore and improve adherence in ART-naïve individuals commencing treatment in an established ART cohort. The study will use adherence, virological and pharmacokinetic data to examine adherence failure discordance. The questions to be answered by the study are: 1. Does a real-time electronic adherence monitoring tool with text message feedback improve adherence, retention in care and virological outcomes among ART-naïve individuals receiving first-line therapy? 2. Does population pharmacokinetic data explain discordance between adherence and virological response?

Host Organisation

Institution Country
University of Cape Town South Africa

Participants

Name Institution Country
David Bangsberg Harvard University United States
Karen Cohen University of Cape Town South Africa
Gary Maartens University of Cape Town South Africa
Robin Wood University of Cape Town South Africa

Study Design

A randomised controlled trial with two arms, as follows: Control arm: Standard of care at ART clinic with use of an electronic adherence monitoring device (EAMD or Wisepill) to monitor adherence only (i.e., without any feedback). Experimental group: Control arm with the addition of the use of the EAMD text message service when dosing late, and EAMD dosing feedback at 4-monthly visits.

Sites

University of Cape Town
Gugulethu Community Health Centre

Results & Outcomes

Research activities: Study recruitment and follow-up was completed with 186 participants completing the study, 19 lost to follow-up, 16 transferred elsewhere , 1 withdrawing consent and 8 dying. Cytochrome 2B6 genotyping and PK sample analysis have been completed and results received. Data analysis is on-going for the primary study outcome. Three manuscripts are underway (one on the primary outcome, namely adherence according to the Wisepill device by randomised arm; one covering the pharmacokinetic and pharmacogenetic results; and one comparing the impact of the different adherence measures used during the study on virological suppression. An abstract for the Conference on Retroviruses and Opportunistic Infections (CROI) has been drafted is to be submitted for presentation in February 2015. Analysis of baseline data was completed and will be presented at the 2014 EDCTP forum (Berlin) Capacity Building: The PI, Dr Catherine Orrell, completed three semesters of training in Biostatistics through the School of Public Health at the University of Cape Town (UCT) in 2012 and 2013. She is also registered for a PhD in the Department of Medicine at UCT. Three counsellors have been trained in in good clinical practice (GCP) and are receiving advanced counselling training in 2014/15. This will enable them become research assistants which will greatly improve their future employment prospects. Several study results or outcomes meetings have been held with clinical site staff Networking: New collaborations have been developed with : Prof Nick Holford from University of Auckland who will provide expertise on efavirenz population pharmacokinectic modelling. Prof David Haas at van der Bilt University, USA, whose expertise will be used to explore the use of genotypes to better understand individual ART levels. Funding: The fellow received a discovery foundation academic fellowship award in 2012.

Publications

Catherine Orrell MBChB MMed MSc, Karen Cohen, Katya Mauff, Daviid R. Bangsberg Gary Maartens, Robin Wood. A randomised controlled trial of real-time electronic adherence monitoring with text message dosing reminders in people starting first-line antiretroviral therapy. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):495-502. doi: 10.1097/QAI.0000000000000770. PubMed PMID: 26218411.

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