Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201311000641402 Date of Approval: 11/09/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The TAP study
Official scientific title A randomised controlled Trial to explore Adherence-failure relationships in a South African antiretroviral delivery site using an electronic adherence device and sparse Pharmacokinetic sampling.
Brief summary describing the background and objectives of the trial Although antiretroviral (ART) adherence in adults from resource poor countries is generally reported as excellent, it may be overestimated, as much of this data is generated from tablet return and pharmacy dispensing data. Many individuals fail ART despite good adherence while others suppress virologically with relatively poor adherence. This study uses a real-time adherence monitoring device (the Wisepill)and drug levels to explore the discordance between adherence and virological failure.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TAP
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Devices
Anticipated trial start date 04/06/2012
Actual trial start date 09/07/2012
Anticipated date of last follow up 08/04/2014
Actual Last follow-up date 13/05/2014
Anticipated target sample size (number of participants) 230
Actual target sample size (number of participants) 230
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
European Drug and Clinical Trial Partnership (EDCTP): TA_11_40200
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised 1:1 randomisation using a random number table generated in excel. Sequentially ordered sealed opaque envelopes.Sealed opa Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised 1:1 randomisation using a random number table generated in excel. Sequentially ordered sealed opaque envelopes.Sealed opa Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ARM 1 not applicable 1 year 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. 115
Experimental Group ARM 2 not applicable 1 year Arm one with the addition of the use of the EAMD text message service when dosing late, and EAMD dosing feedback at 4-monthly visits. 115
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. ART-naïve individual (< 1 month prior ART) 12 years or older. 2. Been prescribed new antiretroviral therapy by a clinician at the clinic /study site. 3. At least one medication of the regimen must be in tablet formulation. 4. Willing to sign the patient informed consent if 18 years of age or above, or assent if 17 years old or below, to participate in the study. Parent or legal guardian must be willing to provide written consent for their child to participate in the study if 17 years or below. 1. Active disease which, in the opinion of the study staff, would preclude the informed consent process. 2. Participant or carer not in possession of a cellular telephone. 12 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/05/2012 University of Cape Town research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E52, OMB, Groote Schuur Hospital, Main Rd, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of patients with a cumulative adherence by EAMD >95% at week 48 by arm. Week 48
Secondary Outcome Proportion of patients with a viral load of <50 copies/ml at week 48; as well as proportion of patients who failed (consecutive VL >1000 copies/ml) by week 48. Week 48
Secondary Outcome Comparison of cumulative EAMD adherence data and tablet count adherence data at weeks 16, 32 and 48. Week 16, 32, 48
Secondary Outcome Proportion of patients still in care at 48 weeks (excluding those transferred to other ART sites); proportion with a treatment interruption of >72 hours. Week 48
Secondary Outcome Mid-dosing efavirenz levels or trough nevirapine and lopinavir levels for discordant participants at weeks 16, 32 and 48. Week 16, 32, 48
Secondary Outcome Exploratory endpoint: relationship of PK results to adherence and to virological outcome at week 16, 32 and 48 Week 16,32, 48
Secondary Outcome Acceptability of EAMD device; impact of qualitative issues on adherence (alcohol, disclosure, mental health status, ART tolerability, life events). Week 48
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hannan Crusaid Treatment Centre NY 3, Gugulethu Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
European Drug and Clinical Trial Partnership (EDCTP) Laan van Niuew Oost Indie 300 Den Haag 2593 CE Netherlands
Discovery Foundation 8 Hillside Rd, Parktown Johannesburg 2017 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EDCTP Laan van Nieuw Oost Indie 300 Den Haag 2593 CE Netherlands Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof David Bangsberg 25 Shattuck Street Boston MA 02115 United States of America
Dr Karen Cohen K45 OMB, Groote Schuur Hospital Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Catherine Orrell catherine.orrell@hiv-research.org.za +27216506958 Werner Beit Building - North, Azio Rd, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Chief Research Officer
Role Name Email Phone Street address
Public Enquiries Christie Heiberg christie.heiberg@hiv-research.org.za +27216503621 J52 OMB, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Clinical Trials Manager
Role Name Email Phone Street address
Scientific Enquiries Catherine Orrell catherine.orrell@hiv-research.org.za +27216506958 Werner Beit Building - North, Azio Rd, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Chief Research Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Registered before this was required Informed Consent Form,Study Protocol Not applicable May contact catherine.orrell@hiv-research.org.za if need access to TAP study data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 02/08/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/08/2024 Result - 02/08/2024 Result - 02/08/2024 Result - 02/08/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information