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Trial registered on ANZCTR


Registration number
ACTRN12618001503213
Ethics application status
Approved
Date submitted
28/08/2018
Date registered
6/09/2018
Date last updated
6/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Strengthening health systems to improve tuberculosis contact screening and management in Timika, Indonesia
Scientific title
Strengthening health systems to improve tuberculosis contact screening and management in Timika, Indonesia
Secondary ID [1] 295820 0
None
Universal Trial Number (UTN)
Trial acronym
Short title: Preventing TB in children in Timika (PeTiT study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 309259 0
Latent tuberculosis 309524 0
Condition category
Condition code
Infection 308133 308133 0 0
Other infectious diseases
Public Health 308353 308353 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a mixed-methods, before-and-after, multi-site, intervention study to implement the WHO tuberculosis contact management and investigation policy. Activities fulfill the definition of a complex intervention

Setting: Mimika district, Papua Province, Indonesia. Five healthcare facilities will participate in phase 1 and seven in phase 2 of the policy roll out.

Physical or informational materials that will be used in the intervention:
- Indonesian Policy on TB Contact management
- Resources (paper, video) designed for patients

Procedures, activities, and/or processes used:
1. Training
Training will be provided by the doctoral research student and Indonesian medical experts in prevention and management of TB, in the form of workshops for healthcare providers from the five primary participating sites, and any additional healthcare providers from other sites who wish to attend (including the follow-up sites). Training sessions will be free of charge and during usual working hours, by arrangement with management at their respective workplaces. The elements of TB contact investigation and management policy will be taught, including practical implications and logistics of rolling this out at each clinic. Hands-on training will also be provided in the medical or nursing skills required to implement the policy, such as collection of induced sputum from contacts found to have symptoms of TB, and accurate weight-based dosing of isoniazid. Pre- and post-training tests will be conducted to understand knowledge and measure the effectiveness of the training.

Continuous quality improvement
2. Continuous quality improvement (CQI) forms a cornerstone of implementation of this project at the five initial sites. CQI cycles will be implemented whereby every three months (approximately, coinciding with study staff and participant availability), a workshop will be held to allow staff at the five sites to engage pro-actively with the data they routinely collect and report (but rarely review) on TB outcomes and contact management. Plots and pictograms will be generated that are easy for healthcare providers to understand, showing progress in key performance indicators, such as the proportion of contacts who are investigated, and the proportion of eligible contacts who are commenced on IPT. Discussions to congratulate and motivate staff will be undertaken, and challenges will be workshopped. Where appropriate, recommendations arising from these CQI workshops to address challenges in policy implementation (e.g. staffing allocations, access to transport for outreach services) will be communicated by the doctoral researcher to the District Health Authority. The approach will draw on lessons learned in previous research using CQI cycles in primary care to improve adherence to guidelines.

3. Social media discussion forum
Mentoring and clinical support will be provided via a ‘WhatsApp’ group. ‘WhatsApp Messenger’ is the most widely-used, freely-available communication application in Indonesia, accessible from mobile devises or desktop computers. It allows sharing of text messages, photographs, documents, voice calls and video calls. Healthcare providers participating in the study at both initial and follow-up sites will be invited to the ‘WhatsApp’ group moderated by the doctoral research student and with access to an Indonesian TB specialist. This will provide a forum for information sharing relevant to the study, and participants will be able to post questions relating to the contact management policy or other aspects of TB care.

3. Awareness-raising activities and promotional materials
Posters and information brochures have been developed by the project team in the main local Papuan language and Bahasa Indonesian. These provide pictures and writing about latent TB, how it can progress to active TB, and how preventive treatment can stop it.

Who will deliver the intervention:
- PhD student with medical background and masters in public health working alongside District Health Authority and staff at healthcare facilities.

Mode of delivery:
- face to face training and CQI workshops
- social media information and support group

Number of times the intervention will be delivered:
- CQI workshops for 2 hours every 3 months, face to face using data generated by healthcare facilities on TB key performance indicators
- Training, social media support, visits to healthcare facilities to provide motivation and support - ongoing throughout the 2-year intervention period

Location where the intervention occurs:
- Five primary sites: 2 hospitals and 3 Puskesmas (primary healthcare facilities)
- Seven secondary sites (7 Puskesmas) which will receive training and support from staff at the first 5 sites

Study design:
This is a mixed-methods intervention study. Interrupted time series analysis will be used to analyse longitudinal data before, during and after the intervention. Study periods comprise a 26-month retrospective baseline period from 1 January 2015 – 31 March 2017, a 5-month prospective baseline period with active data cleaning and validation, a 24-month intervention period (including activities at initial and follow-up sites) and a 12-month sustainability period. These periods were pragmatically chosen based on data and resource availability. These periods were chosen pragmatically on the basis of available data and timing of study commencement. An annotated line graph will be produced to show the primary outcome (numbers of people completing isoniazid preventive therapy) over time, with the timing of key study activities, external activities and environmental influences being indicated on the graph.
A two-tiered approach to the intervention will be used to provide an additional measure of sustainability: intensive activities will take place with the five initial participating sites, then healthcare providers at these sites will then be trained (using a ‘train the trainer’ approach) to share their knowledge with the seven follow-up sites.
Intervention code [1] 312150 0
Early detection / Screening
Intervention code [2] 312151 0
Behaviour
Intervention code [3] 312152 0
Treatment: Drugs
Comparator / control treatment
The control period is the baseline period prior to implementation of study activities.
This is a 31-month period of data collection as follows:
1 January 2015 – 31 March 2017: routinely-collected data are available
1 April 2017 - 17 Sept 2017: routinely-collected data plus active data cleaning / cross checking with primary records
Control group
Historical

Outcomes
Primary outcome [1] 307112 0
Completion of tuberculosis preventive therapy among eligible contacts, during the 2-year intervention period compared with completion rate during the baseline period.

Rates of completion of TB preventive therapy will be plotted during the baseline period, intervention phase and maintenance phase. The slopes will be compared for the different time periods (primary outcome is rate of completion in intervention phase versus baseline phase).

How the primary outcome is assessed: using the 'TB16' form. This is the form used by TB case facilities to document management and outcomes including adverse effects and treatment outcome (completed, defaulted, transferred, died) of TB contacts.
Timepoint [1] 307112 0
Completion of TB preventive therapy will be plotted every month during the two year intervention period. The monthly rate will be calculated as the total number of people completing treatment course, divided by the total number of people eligible for TB preventive therapy. The slope during the 2-year intervention period will be compared with the slope during the baseline period.

All eligible participants reached by study staff will be offered TB preventive therapy during the two year intervention phase.
Secondary outcome [1] 350724 0
Number and proportion of tuberculosis index cases for whom contact investigation and management is undertaken (sub-grouped as smear-positive and smear-negative index cases);
This is assessed using the TB03, TB05 and TB15 forms which collect data on all TB cases, contacts, and child contacts.
Timepoint [1] 350724 0
This outcome will be plotted every month during the two year intervention period. The slope during the 2-year intervention period will be compared with the slope during the baseline period.
Secondary outcome [2] 351531 0
Number and proportion of contacts reached for symptom screening;
This is assessed using the TB03, TB05 and TB15 forms which collect data on all TB cases, contacts, and child contacts
Timepoint [2] 351531 0
This outcome will be plotted every month during the two year intervention period. The slope during the 2-year intervention period will be compared with the slope during the baseline period.
Secondary outcome [3] 351532 0
Number and proportion of contacts found to have active TB;
This is assessed using the TB03, TB05 and TB15 forms which collect data on all TB cases, contacts, and child contacts
Timepoint [3] 351532 0
This outcome will be plotted every month during the two year intervention period. The slope during the 2-year intervention period will be compared with the slope during the baseline period.
Secondary outcome [4] 351533 0
Number and proportion of contacts eligible for TB preventive therapy
This is assessed using the TB03, TB05 and TB15 forms which collect data on all TB cases, contacts, and child contacts
Timepoint [4] 351533 0
This outcome will be plotted every month during the two year intervention period. The slope during the 2-year intervention period will be compared with the slope during the baseline period.
Secondary outcome [5] 351534 0
Number and proportion of contacts commencing TB preventive therapy
This is assessed using the TB03, TB05 and TB15 forms which collect data on all TB cases, contacts, and child contacts
Timepoint [5] 351534 0
This outcome will be plotted every month during the two year intervention period. The slope during the 2-year intervention period will be compared with the slope during the baseline period.

Eligibility
Key inclusion criteria
Quantitative study:
- people with active TB managed at a participating healthcare facility
- people who are household contacts of TB cases managed at a participating healthcare facility

Household contacts most at risk of tuberculosis are infants and children aged <5 years. They will be included in the study - that it, screened for TB disease and offered TB preventive therapy as per international and Indonesian guidelines. Their parents will be invited to participate in interviews about the experience of preventive therapy.
Qualitative study:
- consenting healthcare provider or key stakeholder involve in delivery of TB care
- consenting TB patient or their parent / guiardian
- consenting TB contact or their parent / guardian
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is not a trial. It is policy implementation. There is no allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study has three phases. Analysis will be by time-series analysis.
Phase 1: a 26-month retrospective baseline period from 1 January 2015 – 31 March 2017,
Phase 2: a 5-month prospective baseline period with active data cleaning and validation from April - September 2017
Phase 3: a 24-month intervention period commencing September 17 2017.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Time-series analysis and qualitative methods (thematic analysis)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/09/2017
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
800
Accrual to date
200
Final
Recruitment outside Australia
Country [1] 20779 0
Indonesia
State/province [1] 20779 0
Papua

Funding & Sponsors
Funding source category [1] 300414 0
Government body
Name [1] 300414 0
Department of Foreign Affairs and Trade
Country [1] 300414 0
Australia
Primary sponsor type
University
Name
Menzies School of Health Research
Address
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus
Rocklands Drv Casuarina NT 0810 Australia
Country
Australia
Secondary sponsor category [1] 299875 0
Charities/Societies/Foundations
Name [1] 299875 0
Papuan Health and Development
Address [1] 299875 0
Mimika District Hospital
JL Yos Sudarso, Timika, Papua - 99910
Indonesia
Country [1] 299875 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301219 0
Medical and Health Research Ethics Committee Faculty of Medicine, Gadjah Mada University
Ethics committee address [1] 301219 0
Ethics committee country [1] 301219 0
Indonesia
Date submitted for ethics approval [1] 301219 0
25/06/2018
Approval date [1] 301219 0
20/07/2018
Ethics approval number [1] 301219 0
KE/FK/0745/EC/2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86270 0
A/Prof Anna Ralph
Address 86270 0
Menzies School of Health Research
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus
Rocklands Drv Casuarina NT 0810 Australia
Country 86270 0
Australia
Phone 86270 0
+61 (08) 8946 8600
Fax 86270 0
+61 (08) 8946 8464
Email 86270 0
Anna.Ralph@menzies.edu.au
Contact person for public queries
Name 86271 0
Anna Ralph
Address 86271 0
Menzies School of Health Research
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus
Rocklands Drv Casuarina NT 0810 Australia
Country 86271 0
Australia
Phone 86271 0
+61 (08) 8946 8600
Fax 86271 0
+61 (08) 8946 8464
Email 86271 0
Anna.Ralph@menzies.edu.au
Contact person for scientific queries
Name 86272 0
Anna Ralph
Address 86272 0
Menzies School of Health Research
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus
Rocklands Drv Casuarina NT 0810 Australia
Country 86272 0
Australia
Phone 86272 0
+61 (08) 8946 8600
Fax 86272 0
+61 (08) 8946 8464
Email 86272 0
Anna.Ralph@menzies.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.