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.: PACTR202101847907585 Date of Approval: 29/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Person-centred public health for HIV treatment in Zambia
Official scientific title Person-centred public health for HIV treatment in Zambia
Brief summary describing the background and objectives of the trial In Zambia, mortality among patients on ART reached 7% at 2 years in 2018, far higher than in developed country settings - and continued to accrue at about 2% per year for up to 8 years on ART. LTFU or missing visits were the strongest predictor of mortality. High prevalence of clinic-based barriers to care, including rude health worker behaviour, short intervals between clinic appointments, and long wait times were describe as barriers-to-care by patients. When patients perceive encounters with the health system to be high-quality, respectful, accessible, responsive, and effective, engagement is strengthened. We therefore set out to make public health HIV treatment more patient centred, manage and enhance perceptions of quality, and strengthen engagement to optimize treatment. The PCC intervention is a health systems intervention that seeks to improve the patient-centredness of HIV care to improve the patient experience and, ultimately, clinical and care outcomes by: 1) systematically assessing patient experience (e.g., satisfaction, barriers to care), facility approaches to patient care (e.g., use of differentiated service delivery models, monitoring viral load, how late and lost patients are welcomed back to care), and key patient outcomes (e.g., retention); 2) providing HCWs training in patient-centred principles and skills and mentoring to improve patient-centred practice using the collected data to target action; and 3) offering incentives to motivate facilities above and beyond their innate desire to help improve patient lives. Our four main study objectives are: 1. To evaluate the implementation of the PCC intervention in routine care setting in Zambia 2. To evaluate the effect of the PCC intervention on service delivery and patient experience 3. To evaluate the effect of the PCC intervention on retention and viral suppression 4. To evaluate the cost and cost effectiveness of the PCC intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PCPH
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: Other
Anticipated trial start date 12/08/2019
Actual trial start date 12/08/2019
Anticipated date of last follow up 17/11/2021
Actual Last follow-up date 30/11/2021
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Patient Centered Training and Mentorship Curriculum training takes place at cross over of intervention into control sites every 6 (six) months. Mentorship provided to facilities on a continuous basis through use of quarterly data review meetings and facility level feedback of patient experience. Small incentives at the end of each 6-month study period. Approximately two (2) years The PCC intervention is a health systems intervention that seeks to improve the patient-centredness of HIV care to improve the patient experience and, ultimately, clinical and care outcomes by: 1) systematically assessing the patient experience (e.g., satisfaction, barriers to care), training and mentoring to facilitate patient centered approaches to patient care (e.g., use of differentiated service delivery models, monitoring viral load, how late and lost patients are welcomed back to care), systematic measurement of patient experience and feedback of that data to the facilities, and offering reputation and material incentives. 480
Control Group Standard of Care This is routine standard of care for ART patients in Zambia Wave 1: 0, Wave 2: 6 months, Wave 3: 12 months, Wave 4:18 months Routine Standard of Care 480 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The population for treatment failure endpoint will meet the following inclusion criteria: Make a visit to one of the study facilities in the first 6 months of the 24 month study period Will have initiated ART at this facility, were in care at that facility or LTFU from the facility population Not planning on leaving the area Resident of the catchment area of the clinic Agree to having a viral load done 12 months after enrollment in this viral load sub-cohort Participants will be over 18 For sub-studies on health care workers: Participant will be healthcare workers providing ART services in 24 sites in Lusaka province For sub-study using SMS to assess experience: Participants for the SMS survey will be able to read and respond to patient experience questions Facility not part of the PCPH supported sites Unwillingness to participate Under 18 Not employed by the facility or not working at the facility 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 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 29/03/2019 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ridgeway Campus, Nationalist Road, Lusaka Lusaka 10101 Zambia
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 28/06/2019 UAB
Ethics Committee Address
Street address City Postal code Country
470 Administration Building 701 20th Street South Birmingham Alabama AL 35294 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HIV treatment failure which is a composite of disengagement, viral load non suppression, regimens switch for non suppression and mortality. Approximately 15 months after study enrollment
Secondary Outcome Patient Experience using exit surveys Every 6 months
Secondary Outcome Health care worker experience and satisfaction Every 6 months
Secondary Outcome Patient experience using trained exit surveys. Every 6 months
Secondary Outcome Patient Provider Communication using Roter interaction analysis system Every 6 months
Secondary Outcome Retention in Care at Original Facility among in care patients, new ART starters, and patients reengaging in care Every 6 months
Secondary Outcome Transfers to New Facility Every 6 months
Secondary Outcome Cost-Effectiveness of PCC Intervention End of Study Period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for Infectious Disease Research In Zambia Off Danny Pule Road, Mass media area, Lusaka Lusaka 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 Fifth Avenue North, Seattle, WA 98109. Washington 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bill and Melinda Gates Foundation 500 Fifth Avenue North, Seattle, WA 98109 Washington 98109 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
University of Alabama at Birmingham 1720 2nd Ave South Birmingham 35294 United States of America
Washington University School of Medicine 4523 Clayton Avenue St. Louis 63110 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Izukanji Sikazwe Izukanji.Sikazwe@cidrz.org +260211242257 Plot 34620, Corner of Danny Pule and Lukasu Road, Mass Media Area
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Chief Executive Officer
Role Name Email Phone Street address
Public Enquiries Kombatende Sikombe Kombatende.Sikombe@cidrz.org +260973824000 Plot 34620, Corner of Danny Pule and Lukasu Road, Mass Media Area
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Research Manager
Role Name Email Phone Street address
Principal Investigator Elvin H Geng elvin.geng@wustl.edu +13144548354 4523 Clayton Ave., CB 8051
City Postal code Country Position/Affiliation
St Louis 63110 United States of America Professor of Medicine
Role Name Email Phone Street address
Principal Investigator Carolyn BoltonMoore carolynmoore@uabmc.edu +260211242257 845 19th Street South
City Postal code Country Position/Affiliation
Birmingham 35294 United States of America Assistant Professor and CIDRZ Chief Medical Officer
Role Name Email Phone Street address
Principal Investigator Charles B Holmes Charles.Holmes@georgetown.edu +12026629203 Center for Innovation in Global Health Medical-Dental Building, NW 306, 3900 Reservoir Road NW
City Postal code Country Position/Affiliation
Washington DC 20057 United States of America Program Director
Role Name Email Phone Street address
Scientific Enquiries Elvin H Geng elvin.geng@wustl.edu +13144548354 4523 Claytone Avenue, CB 8051
City Postal code Country Position/Affiliation
St. Louis 63110 United States of America Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this, after de identification (text, tables, figures, and appendices) Study Protocol, Informed Consent form, Clinical Study Report, Analysis plan Informed Consent Form,Study Protocol After study completion, Nov 2021 The Government of Zambia allows data sharing when applicable local conditions are satisfied. In this case, the data from the study will be made available to any interested researchers upon request. The CIDRZ Ethics and Compliance Committee is responsible for approving such request. To request data access, one must write to the Committee chair/Chief Scientific Officer, Dr. Roma Chilengi, (Roma.Chilengi@cidrz.org) or the Secretary to the Committee/Head of Research Operations, Ms. Hope Mwanyungwi Chinganya (Hope.Mwanyungwi@cidrz.org) mentioning the intended use for the data. The Committee will then facilitate review and authorization to release the data as requested. Data requests must include contact information, a research project title, and a description of the intended use.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.cidrz.org 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