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.: PACTR202108508272899 Date of Approval: 23/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Using behavioural science to increase demand for free HIV Testing Services at private General Practitioners (GPs) in the GP Care Cell (GPCC) network, Johannesburg Health District, Gauteng Province, South Africa
Official scientific title Using behavioural science to increase demand for free HIV Testing Services at private General Practitioners
Brief summary describing the background and objectives of the trial Background: Increasing the utilization of HIV services among people living with HIV (PLHIV) and individuals at high risk of HIV exposure is essential for ending the HIV epidemic in South Africa. There is low uptake of HIV testing services (HTS) by uninsured people at the contracted General Practitioner Care Cell (GPCC) sites who provide HIV tests. The GPCC is a well-functioning National Health Insurance (NHI)-aligned demonstration programme which aims to expand access to HIV testing services (HTS) and antiretroviral therapy (ART) for uninsured PLHIV by leveraging the capacity of private general practitioners (GPs) outside of public sector health facilities in a controlled manner. There is a social media campaign called Your Care Network (YCN), but it is not sufficient for promoting utilization of HIV services at GP practices that are nearby individuals’ homes and workplaces. Although the GP care cell (GPCC) programme offers a standardized Your Care Network (YCN) demand creation package, GPs are expected to generate HTS demand independently. Many GPs do not invest in community demand creation at their practices as the immediate benefits to the practice are not clear and they have limited expertise in community outreach. In addition, individuals may not be aware that GPs who participate in the GPCC programme offer free HIV testing services. By using behavioural insights to promote the availability of free HIV services, it may be possible to increase uptake of HTS at GP practices. Objectives: To determine whether HTS demand creation material that leverages behavioural science principles will increase the demand for HIV testing at GP practices.
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 Early detection /Screening
Anticipated trial start date 15/09/2021
Actual trial start date
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 12000
Actual target sample size (number of participants)
Recruitment status Not yet 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
Experimental Group Healthy Lifestyle Screening Brochure 1 brochure distributed to 1 participant over a period of 13 weeks. 13 weeks A brochure promoting a free healthy lifestyle screen which includes HIV testing. This brochure will offer individuals options for a healthy lifestyle screen (weight, height, blood pressure, rapid glucose and HIV test). This brochure will be in addition to the standard of care demand creation material. 4000
Experimental Group Recipient of care voucher 1 brochure distributed to 1 eligible participant over a period of 13 weeks. 13 weeks A patient voucher for HTS (and ART): A voucher redeemable for free services valued at ZAR100 (USD 7) for HTS and approximately ZAR5,048 (USD 337) for ART (based on eligibility). The voucher will emphasize the value of the services offered. This brochure will be in addition to the standard of care demand creation material. 4000
Control Group Standard of Care 1 brochure per participant 13 weeks Your Care Network (YCN) brochure advertising free HTS and free ART (for those who test positive) and the name and telephone contact number of the GP practice. This approach also includes existing social media platforms. 4000 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults (≥18 years old); Willing to engage with the field worker for a few minutes to learn about GPCC; Willing to accept an envelope containing promotion materials Individuals who refuse to engage with an YCN field worker 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) 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 23/12/2021 Wits Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
29 Princess of Wales Terrace Parktown, Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome for this study will be presentation at the GP practice. For each adult who is enrolled in the study and given information about the GPCC, we will determine whether they presented at one of the GP practices. At the end of 13 weeks of data collection.
Secondary Outcome HIV testing uptake: We will assess whether participants complete HIV testing at GP practices. Weekly
Secondary Outcome HIV-positivity among participants who get tested for HIV. Weekly
Secondary Outcome Linkage to care among newly diagnosed individuals. We will assess whether participants who tested HIV-positive initiate ART at the GP practices. Weekly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Johannesburg Health District Johannesburg Johannesburg 2000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Pennsylvania 3451 Walnut Street Philadelphia 19104 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Pennsylvania 3451 Walnut Street Philadelphia 19104 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Suzanne Mabaso suzannem@foundation.co.za +27878211109 173 Mary Rd
City Postal code Country Position/Affiliation
173 Mary Rd 0184 South Africa Head of Cluster Innovations
Role Name Email Phone Street address
Public Enquiries Suzanne Mabaso suzannem@foundation.co.za +27878211109 173 Mary Road
City Postal code Country Position/Affiliation
Pretoria 0184 South Africa Head of Cluster Innovations
Role Name Email Phone Street address
Scientific Enquiries Candice Chetty Makkan cchetty@heroza.org +270100017941 39 Empire Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Foundation for Professional Development will develop a data sharing plan. Informed Consent Form,Study Protocol 10 months A date request form outlining intended use of data will be requested.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.foundation.co.za/ Yes 10/09/2024 06/08/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 10/09/2024 Result - 10/09/2024 Result - 10/09/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information