Trial no.:	PACTR202112664251086	Date of Registration:	01/12/2021
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Indlela Behavioural Hub

Official scientific title

Behavioural Hub

Brief summary describing the background and objectives of the trial

Background: The Indlela team proposes the formation of a Behavioural Hub to assemble a group of individuals, to provide feedback on the BIT project development process. A Behavioural Insights Test (BIT) is a project that will implement and test low-cost, scalable behavioural interventions or service delivery innovations that are informed by behavioural economics and have the potential to overcome behavioural barriers to essential health and HIV services. Incorporating care recipient and healthcare worker perspectives in a rapid and efficient manner can inform the design of the behavioural interventions and service delivery innovations. Objectives: We aim to (1) Recruit and expand a cohort of individuals who will comprise a “behavioural hub” for assessing the likely effectiveness of behavioural nudges; (2) Explore knowledge, attitudes and beliefs of healthcare workers and care recipients on candidate interventions; (3) Test the usability and relevance of interventions prior to evaluating and scaling in a larger population; and (4) Set up a retention strategy for enrolled participants.

Type of trial

CCT

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

testing the usability and feasibility of projects before they are implemented

Anticipated trial start date

10/01/2022

Actual trial start date

Anticipated date of last follow up

30/09/2026

Actual Last follow-up date

31/12/2026

Anticipated target sample size (number of participants)

3000

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	Non-randomised		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	Care recipients		The care recipients will participate in the behavioural Hub for a period of 12 months at least	We will also recruit care recipients to obtain their perspectives and opinions, as this will be central in understanding and co-designing interventions where people similar to them will be the users of the interventions. Expanding recruitment beyond care recipients to community members who are not regularly accessing care offers an opportunity to obtain diverse views on interventions that are aimed at reaching individuals who are not engaged in care. Participants can provide great insights on how health services can be tailored to appeal to individuals that do not frequently access health facilities. We will seek to achieve some level of representation across gender, age groups and area of residence. Phase 2 will include exploring the knowledge, attitudes and beliefs of participants on proposed HIV, COVID-19 vaccination and other health-related interventions. This phase will also include testing the usability and relevance of interventions prior to implementation. Amendments will be submitted to the ethics committee for approval once the tools are developed and prior to implementation.	1250
Control Group	Healthcare providers		The healthcare workers will participate in the Behavioural Hub for at least a period of 12 months	We plan to recruit healthcare workers, care recipients and community members to take part in the behavioural hub. Healthcare workers will be recruited to provide their perspective on provider and patient focussed interventions. The healthcare workers may be recruited from both private and public health facilities. We will recruit different cadres of healthcare workers in order to ensure a fair representation of the different cadres and allow for varied views. Healthcare worker cadres will include, but are not limited to, doctors, nurses, community healthcare workers, outreach teams, HTS counsellors, data capturers and admin clerks. Phase 2 will include exploring the knowledge, attitudes and beliefs of participants on proposed HIV, COVID-19 vaccination and other health-related interventions. This phase will also include testing the usability and relevance of interventions prior to implementation. Amendments will be submitted to the ethics committee for approval once the tools are developed and prior to implementation.	500	Uncontrolled
Experimental Group	Community members		The community members will participate in the Behavioural Hub for at least 12 months	We will also recruit community members to obtain their perspectives and opinions, as this will be central in understanding and co-designing interventions where people similar to them will be the users of the interventions. Expanding recruitment beyond care recipients to community members who are not regularly accessing care offers an opportunity to obtain diverse views on interventions that are aimed at reaching individuals who are not engaged in care. Participants can provide great insights on how health services can be tailored to appeal to individuals that do not frequently access health facilities. We will seek to achieve some level of representation across gender, age groups and area of residence. Phase 2 will include exploring the knowledge, attitudes and beliefs of participants on proposed HIV, COVID-19 vaccination and other health-related interventions. This phase will also include testing the usability and relevance of interventions prior to implementation. Amendments will be submitted to the ethics committee for approval once the tools are developed and prior to implementation	1250

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
The inclusion criteria will be different for healthcare workers and care recipients. Inclusion criteria for healthcare workers: 1. Based at selected private or public health facilities 2. Cadre of staff can include doctors, nurses, community health workers, outreach teams, HTS counsellors, data capturers and admin clerks 3. Willing to engage with the recruiter and be part of the consumer panel 4. Has access to a mobile phone 5. Age ≥18 years old Inclusion criteria for care recipients accessing health facilities for routine care: 1. Attending the selected private or public health facilities and presenting at key entry points (eg. family planning, chronic section, patients presenting for HIV testing in the HTS counsellor’s room, people living with HIV who are on ART, etc) for routine services 2. Willing to engage with the recruiter at the facility and interested in being part of the consumer panel 3. Have access to a mobile phone 4. Age ≥18 years old 5. Able to communicate in one of the study approved languages	The exclusion criteria will be different for healthcare workers and care recipients. Exclusion criteria for healthcare workers: 1. Refuse to sign the written informed consent and choose not to participate 2. Less than 3 months of work experience at the selected health facility 3. Does not provide any HIV related care Exclusion criteria for participants accessing health facilities for routine care: 1. Refuse to sign the written informed consent and choose not to participate	80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 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

07/06/2023

Wits HREC Medical

Ethics Committee Address
Street address	City	Postal code	Country
31 Princess of Wales Terrace, Parktown	Johannesburg	2193	South Africa

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	1. Enrol healthcare workers, care recipients and community members into the behavioural hub 2. Assess knowledge of behavioural challenges to accessing HIV care, COVID-19 vaccination and other health-related programmes 3. Assess attitudes and beliefs toward HIV care and COVID-19 vaccination and other health-related programmes	monthly
Secondary Outcome	Explore perceptions of HIV, COVID-19 vaccination and other health-related interventions and data collection tools specific to the BIT projects	monthly

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Gauteng	Gauteng districts	All districts		South Africa
Limpopo	Limpopo districts	Cities in Limpopo districts		South Africa
KwaZulu Natal	KwaZulu Natal Districts	KwaZulu Natal cities		South Africa

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Bill and Melinda Gates Foundation	500 Fifth Avenue North, Seattle,	Washington	98119	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,	Washington	98119	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	Harsha Thirumurthy	hthirumu@pennmedicine.upenn.edu	2157460410	3451 Walnut Street
City	Postal code	Country	Position/Affiliation
Philadelphia	19104	United States of America	Associate Professor
Role	Name	Email	Phone	Street address
Scientific Enquiries	Candice Chetty Makkan	cchetty@heroza.org	+27832892181	32 Princess of Wales Terrace, Parktown
City	Postal code	Country	Position/Affiliation
Johannesburg	2193	South Africa	Principal Researcher
Role	Name	Email	Phone	Street address
Public Enquiries	Candice Chetty Makkan	cchetty@heroza.org	+27832892181	32 Princess of Wales Terrace, Parktown
City	Postal code	Country	Position/Affiliation
Johannesburg	2193	South Africa	Principal Researcher

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Confidentiality measures will apply to all aspects of the study process from the time of first engaging with a participant at recruitment through the data collection procedures. All study-related information will be stored securely. All paper-based participant information that includes any personal identifying information will be stored in locked file cabinets in areas with access control. Forms will be identified by a unique identification number to maintain participant confidentiality. All electronic databases will be secured with password-protected access systems. Forms, lists, logbooks, appointment books, and any other listings that link participant ID numbers to other identifying information will be secured according to the study protocol. Participant study information will not be released without their written permission, except as necessary for monitoring by funders or local government authorities. Presentation and publication of the results of this study will be governed by the Health Economics and Epidemiology Research Office (HE2RO), University of Pennsylvania and Boston University. For publication of the main findings of this study, the investigators will be considered as authors. Other key contributors to the research will be acknowledged or included depending on substantive contribution.	Informed Consent Form,Study Protocol	12 months	De-identified aggregate data
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

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