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.: PACTR202204533305867 Date of Approval: 14/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Healthy Talk: Filling the Language Gap
Official scientific title Filling the Language Gap: A Pilot Feasibility Study of Communication Models used in the Provision of Healthcare for HIV/AIDS and Tuberculosis in the Eastern Cape, South Africa
Brief summary describing the background and objectives of the trial Communication resources have been developed to assist healthcare professionals communicate with patients in cases where there are language barriers. This trial is part of a PhD study, for which the research questions are: 1. How do healthcare providers and healthcare users communicate when they are not fluent in the same language? 2. What communication resources and training are appropriate for healthcare provision in South Africa? 3. What are the effects of the suggested communication resources and training in healthcare provision? In order to answer these research questions, the following objectives have been identified: 1. To identify the main communication problems experienced by healthcare providers and healthcare users. 2. To identify the main communication strategies used by healthcare providers and healthcare users. 3. To create and implement communication resources and training for healthcare providers to use in the provision of HIV/AIDS and TB consultations. 4. To analyse the effects of these communication resources and training in terms of satisfaction and feasibility of implementation. This trial focuses on research questions 2 and 3, and objectives 3 and 4.
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,Tuberculosis
Purpose of the trial Education /Training
Anticipated trial start date 30/03/2022
Actual trial start date
Anticipated date of last follow up 19/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 96
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
Parallel: different groups receive different interventions at same time during study 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
Control Group Healthy Talk N/A 10 weeks Participating healthcare professionals receive communication resources and training to complement communication across language barriers for HIV/AIDS and TB. The control group receive the resources and training after 10 weeks. 48 Active-Treatment of Control Group
Experimental Group Healthy Talk N/A 10 weeks Participating healthcare professionals receive communication resources and training to complement communication across language barriers for HIV/AIDS and TB. The experimental group receive the resources and training at the beginning of the trial, and use them for 10 weeks. 48
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthcare professional who provides HIV/AIDS and/or TB treatment. No exclusion criteria. 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 15/10/2019 Rhodes University Ethical Standards Committee
Ethics Committee Address
Street address City Postal code Country
Drostdy Road, Makhanda, 6139 Makhanda 6139 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 30/09/2019 Eastern Cape Health Research Committee
Ethics Committee Address
Street address City Postal code Country
N/A N/A N/A 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 06/04/2022 Rhodes University Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Drostdy Road Makhanda 6139 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improved communication between healthcare professional and patient. T2 midline, i.e. after 4 weeks, and T3 endline, after 10 weeks.
Secondary Outcome Improved patient adherence T2 midline, i.e. after 4 weeks, and T3 endline, after 10 weeks.
Secondary Outcome Improved job satisfaction of healthcare professionals. T2 midline, i.e. after 4 weeks, and T3 endline, after 10 weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rhodes University Drostdy Road Makhanda 6139 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
VLIR UOS Julien Dillensplein 1 Brussels 1060 Belgium
NIHSS 24 St Andrews Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rhodes University Drostdy Road Makhanda 6139 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Katholieke Universiteit Leuven Tiensestraat 102 Leuven 3000 Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Patrick Luyten patrick.luyten@kuleuven.be +3216326135 Tiensestraat 102
City Postal code Country Position/Affiliation
Leuven 3000 Belgium Professor of clinical psychology at KU Leuven
Role Name Email Phone Street address
Public Enquiries Nathalia Lourenco nvonwitt5@gmail.com +32499253024 Tiensestraat 102
City Postal code Country Position/Affiliation
Leuven 3000 Belgium PhD candidate
Role Name Email Phone Street address
Scientific Enquiries Nathalia Lourenco nvonwitt5@gmail.com +32499253024 Tiensestraat 102
City Postal code Country Position/Affiliation
Leuven 3000 Belgium PhD candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), will be shared. Informed Consent Form,Study Protocol Beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal. Proposal should be directed to nvonwitt5@gmail.com. To gain access, data requestors will need to sign a data access agreement.
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