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: www.pactr.org
Trial no.: PACTR201810631281009 Date of Approval: 10/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Exploring 6-month dispensing intervals for Adherence Clubs – a cluster randomized study
Official scientific title Exploring 6-month dispensing intervals for Adherence Clubs – a cluster randomized study
Brief summary describing the background and objectives of the trial In South Africa, the current national ART guidelines allow for a maximum of three-month dispensing of ART although in practice the National Department advises provinces to limit ART refills to 2-months. There is increasing evidence for extending ART supply intervals for ART[1] in urban informal settlement settlements and rural areas in sub-Saharan Africa. In the same context as this study, Khayelitsha and Gugulethu townships in the Western Cape, South Africa, the 2 versus 4m club supply cited above[2] showed similar retention and viral load suppression. In Malawi, an appointment-spacing model was implemented for the provision of ART in which patients had a clinical assessment once every six months and collected their pre-packed medication every three months. After 36-months, retention on ART was very high at 94%[3]. References: 1. Bemelmans M, Baert S, Goemaere E, Wilkinson L, Vandendyck M, et al. (2014) Community‐supported models of care for people on HIV treatment in sub‐Saharan Africa. Tropical Medicine & International Health 19: 968-977. 2. Grimsrud A, Patten G, Sharp J, Myer L, Wilkinson L, et al. (2014) Extending dispensing intervals for stable patients on ART. J Acquir Immune Defic Syndr 66: e58-60. 3. McGuire M, Pedrono G, Mukhua B, Huckabee M, Heinzelmann A, et al. (2011) Optimizing patient monitoring after the first year of ART: three years of implementing 6-monthly clinical appointments in rural Malawi. Abstract for IAS. [1] Primary objective: To compare the retention and viral suppression outcomes of patients receiving their ART care and medicine supply through Standard Adherence Clubs vs. 6-monthly ACs over 24 months [2] Secondary objectives To determine: a. Medicine supply chain feasibility of 6-monthly ACs implementation, including medicine losses and wastage associated with the 6 month supply of ART. b. Impact on clinic congestion
Type of trial RCT
Acronym (If the trial has an acronym then please provide) 6 months supply study
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial retention/viral suppression outcomes
Anticipated trial start date 02/10/2017
Actual trial start date 02/10/2017
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date 30/09/2019
Anticipated target sample size (number of participants) 2162
Actual target sample size (number of participants) 2146
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 6 months dispensing interval of ART to HIV stable patients in Adherence clubs 6 months dispensing interval of ART to HIV stable patients in Adherence clubs (6 months supply of ART medication) 6 months dispensing interval. Entire study will run for 24 months This study will compare two models of care for stable ART patients: The Standard of Care (SoC) Adherence Club (AC) model: the current standard of care for stable ART patients with 5 visits per annum (4 with 2-months ART dispensed and 1 with 4-months of dispensed). Two of these visits are aligned (at same visit) with one routine blood draw and one consultation with a clinician. The Intervention 6-month AC model: an adapted AC model with 2 visits per annum (each with 6-months of ART dispensed). One of these visits is aligned (at same visit) with consultation with a clinician. The 6-month AC patients will also be required to attend an additional routine blood draw at a suitable time to the individual patient 1-2 months prior to their AC clinical visit (3 visits total per annum).A five-day grace period is permitted for late attendance. In other words, AC patients need to come within one week of their Club visit to collect their ART or they are up-referred to the general ART service for non-adhering to the model. Unlike the SoC model, patients in the intervention would not be able to send a treatment “buddy” to collect their ART. 1000
Control Group Standard of Care i.e. no intervention 2 months dispensing intervals of ART 2 months dispensing intervals over 24 months The Standard of Care Adherence Club (AC) Model Participants in the Standard of Care AC model will continue to be provided with ART treatment, care and support following the current guidelines. At present, ART ACs are groups of 15- 30 stable patients who have been on ART for 6 months or more, have an undetectable viral load, and are referred by a clinician to this model of care. ACs are generally managed by a lay healthcare worker - either a lay counsellor or community health worker (LHCW) - and a standard club visit involves a brief symptom screen, weighing, and collection of pre-packed ART. There are 5 visits per year – 3 standard club visits, 1 visit where blood is drawn for routine monitoring, and 1 visit where all patients have an annual clinical consultation. Patients are allowed to send a treatment “buddy” to collect their ART on their behalf to every alternate AC. A five-day grace period is permitted for late attendance. In other words, AC patients need to come within one week of their Club visit to collect their ART or they are up-referred to the general ART service for non-adhering to the model. A patient is also up-referred to the general ART service if they experience viral rebound (a viral load of >400 copies/mL) or develop another clinical condition that requires more regular clinical support. 1162 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adherence Club inclusion criteria >90% of patients in the AC consent to be enrolled in study prior to randomization Participant inclusion criteria Age 18 years or older On ART for at least 6-months Most recent documented viral load <400 copies/mL (not older than 12 months)) Able to provide informed consent for research Adherence Clubs (ACs) exclusion criteria ACs catering to patients who require regular clinical follow-up (e.g. Family Clubs, Youth Clubs) ACs facilitated by nurses with limited group interaction/ support and/or which function more as ART pick-up point (e.g. evening clubs) Participant exclusion criteria Intention to relocate out of Cape Town permanently during the study period 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 06/12/2016 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E52-24 Old main Building. Groote Schuur Hospital Observatory 7925 Cape Town 7925 South Africa
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 22/12/2016 Ethics Review Board Instituted by Medecins Sans Frontieres
Ethics Committee Address
Street address City Postal code Country
1 Corner Main and Browning Roads, Floor 4, Deneb House, Observatory 7925, Cape Town Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the retention and viral suppression outcomes of patients receiving their ART care and medicine supply through Standard ACs vs. 6-monthly ACs over 24 months 12 months and 24 months
Secondary Outcome To determine: a. Medicine supply chain feasibility of 6-monthly ACs implementation, including medicine losses and wastage associated with the 6 month supply of ART. b. Impact on clinic congestion. 1. Patient related: a. number of uncollected ART pre-packs at AC visits (including expiry date of medicine in uncollected pack); b. number of study participants regimen switched during study (including date of switch); c. number of returned ART opened or unopened pre-packs by AC patients to the clinic at club or clinic visits (including expiry date of medicine in pack and whether as a result of regimen switch); d. number of study participants reporting ART medicine losses and the reported reason for such losses including but not limited to theft, damage or destruction in the home or unauthorized loan or provision to another person who ran out of ART; e. number of study participants requests for additional ART supply from the clinic pharmacy in between AC visits and the reasons for such requests. 2. System related: a. number of short supplies due to medicine supply shortages, supply chain gaps and expiry date related losses; b. The medicines with quantities wasted due to any of: expiry, re-issue (per (1. d) above), regimen switch, non-collection or any other reason. 12 months and 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ubuntu Clinic Site B, Lwandle Road, Khayelitsha, Cape Town, 7784 Khayelitsha Cape Town 7784 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MSF Brussels Operational Research Unit 1 Corner Main and Browning Roads, Floor 4, Deneb HouseObservatory 7925, Cape Town Cape Town 7925 South Africa MSF studies are sponsored by various charitable bodies and individuals. Operational research studies in MSF have no external sponsors but are sponored or funded by MSF Operational research funds
COLLABORATORS
Name Street address City Postal code Country
Provincial Depatment of Health Site B, Lwandle Road, Khayelitsha, Cape Town, 7784 Khayelitsha Cape Town 7784 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lynne Wilkinson lynne.susan.wilkinson@gmail.com 0027214066808 1 Anzio Rd, Observatory, Cape Town, Centre for Infectious Disease Epidemiology and Research School of Public Health and Family Medicine UCT
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Principal Investigator
Role Name Email Phone Street address
Public Enquiries Rodd Gerstenhaber MSFOCB-Capetown-HOM@brussels.msf.org 0027213645490 1 Anzio Rd, Observatory, Cape Town, Centre for Infectious Disease Epidemiology and Research School of Public Health and Family Medicine UCT
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Principal Investigator MSF
Role Name Email Phone Street address
Scientific Enquiries Laura Trivino Duran MSFOCB-Khayelitsha-Coord-Deputy@brussels.msf.org 0027213645490 1 Julius Tsolo Street, Khayelitsha, 7784
City Postal code Country Position/Affiliation
Khayelitsha Cape Town 7784 South Africa Co Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 09/10/2018 2260 club members signed the consent form and agreed to participate but on the day of ARV pick up only 2146 pitched up and by protocol definition those that do not attend fall out of the study. Two phases of pick up has been completed to date and more have fallen off due to non attendance, as at the time of submission of this application No of participants in study = 2003 2253 2260
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 10/10/2018 pactr update Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 10/10/2018 Clients who do not come to collect their ARV medication at the appointed time period per club are dropped off the trial 2260 2162
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 10/10/2018 Clients who do not come to collect their ARV medication at the appointed time period per club are dropped off the trial 2003 2146