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.: PACTR201508001148419 Date of Approval: 26/05/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The impact of ART pharmacy supply services interventions on the quality and efficiency of ART refills.
Official scientific title Determining the impact of ART pharmacy supply services interventions on the quality and efficiency of ART refills: A pair-matched, cluster-randomised difference-in-difference study
Brief summary describing the background and objectives of the trial Facility congestion is a significant concern in Zambia. With demand for treatment greater than the available capacity of health infrastructure, the MOH and other stakeholders are concerned about the effect that congestion within facilities may have on patient retention in Antiretroviral therapy (ART), particularly in urban areas. We have undertaken a matched, randomized, difference in difference study that will determine the effectiveness of the interventions outlined below, in 16 ART facilities across Lusaka, Zambia. 1. Basic improvements to all 16 facilities: Support in ordering and stock planning to guarantee adequate stock levels for the expected patient volumes. Additionally, all facilities within the study will receive a memo to direct staff to follow MOH policy to provide 3-month refills. 2. Comprehensive improvements to 8 intervention facilities: Along with reinforcement of stock and awareness of the 3-month prescription policy, the intervention facilities will also have a Facility Quality Improvement Officer who will administer QI checklists and facility protocol guides. Existing QI protocols and standard operating procedures related to dispensing ARVs will be refined to ensure the research outcomes are addressed. The QI officers will facilitate the completion of checklists, ensure that stock is available at the clinic level for both ART drugs and lab commodities, and troubleshoot problems as they arise. In addition, pharmacists will be provided a checklist to promote standardized prescribing behaviours (3-month refills for stable patients). We hypothesize that improvement to ART service efficiency and the quality of pharmacy ART supply will result in an increase in the proportion of patients receiving 3-month refills, which in turn will reduce the frequency of patients visiting the ART clinic and patient wait times.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 09/02/2015
Actual trial start date 09/02/2015
Anticipated date of last follow up 08/05/2015
Actual Last follow-up date 08/05/2015
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 16
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
Parallel: different groups receive different interventions at same time during study Randomised Matched allocation Un-blinded Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Quality Improvement Package Checklists and job aid and Quality Improvement Officer to facilitate work 8
Experimental Group Quality Improvement Package Checklists and job aid and Quality Improvement Officer to facilitate work 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ART facility in the Lusaka district Not currently participating in another trial Have less than 80% of stable patients on 3-month refills Facilities will be excluded if they are currently participating in research that may interfere with our primary or secondary outcomes 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 19/01/2015 ERES Converge
Ethics Committee Address
Street address City Postal code Country
33 Joseph Mwilwa Road Rhodes Park Lusaka Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Patients receiving 3-month refill Endline
Secondary Outcome Patient wait times Endline
Secondary Outcome Perceptions of staff Endline
Secondary Outcome Perceptions of patients Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ART Clinics Lusaka, Lusaka Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Department for International Development 22 Whitehall London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Clinton Health Access Initiative Plot 175 Kudu Road Kabulonga Zambia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Pharmaceutical Services, Ministry of Health Haile Selassie Avenue Lusaka Zambia
Medical Stores Limited c/o Haile Selassie Avenue Lusaka Zambia
Ministry of Community Development Mother and Child Health Opposite Levy Junction Lusaka Zambia
Center for Infectious Disease Research Zambia Plot 5032 Great North Rd Lusaka Zambia
Ministry of Health Haile Selassie Avenue Lusaka Zambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sarah Moberley smoberley@clintonhealthaccess.org +61 491108157
City Postal code Country Position/Affiliation
Melbourne Australia Senior Technical Advisor
Role Name Email Phone Street address
Public Enquiries Benjamin Chibuye bchibuye@clintonhealthaccess.org +26 0211 267 985/987 Plot 175 Kudu Road, Kabulonga
City Postal code Country Position/Affiliation
Lusaka Zambia Project Manager
Role Name Email Phone Street address
Scientific Enquiries Elizabeth McCarthy emccarthy@clintonhealthaccess.org +26 0211 267 985 Plot 175 Kudu Road, Kabulonga
City Postal code Country Position/Affiliation
Lusaka Zambia Director, Applied Analytics Team
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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