Project Description Template

1. Research Aims & Questions (Maximum of 150 words)

The aim of this project is to analyse the impact of the COVID-19 outbreak on access to and the delivery of TB and HIV
care in Indonesia. The research questions/hypotheses that this study seeks to address are:

1. Compare cascades of care before and during the COVID-19 outbreak, quantifying gaps
2. Identify patient and clinic-level factors associated with health outcomes during the pandemic
3. Explore experiences and responses of patients and health workers related to care disruptions
4. Calculate incidence and intensity of catastrophic health expenditure on TB and HIV care during the pandemic
5. With stakeholders, co-produce recommendations on how to limit disruptions to care during the current and
any future pandemics

2. Lay Summary & Background Literature Review – (Maximum of 400 words)

The disruption to TB and HIV health services brought about by the COVID-19 pandemic, if sustained over six-months,
has been predicted to result in 1.4 million extra deaths from TB-related illnesses and over 500,000 from HIV [1,2]. If
correct, these predictions correspond to deaths rates for HIV and TB last seen globally more than a decade ago.
Indonesia, the fourth most populous country in the world, has the highest number of COVID-19 infection cases in
Southeast Asia [3]. The country is also ranked third for TB burden globally [4] and one of few countries with an
increasing number of new HIV infections [5]. While Indonesia has recently strengthened efforts to control these
diseases, the diversion of resources to the pandemic combined with social distancing policies is creating new
vulnerabilities and exacerbating existing ones for people who rely on TB and HIV services. The country urgently
needs to understand the wider impact of the pandemic on TB and HIV care to inform mitigation strategies. We will
build on strong, existing collaborative research relationships to rapidly assess the impact of the COVID-19 outbreak
(and policy responses to it) on the delivery of and access to TB and HIV care in Indonesia, with a particular emphasis
on highly vulnerable sub populations. Our findings will be used to design strategies to safeguard the continuity of care
for TB and HIV patients in the near and medium term, thereby ensuring the country does not lose ground on the major
advances it has made towards the control of these diseases.

1) Hogan A et al. The Potential Impact of the COVID-19 Epidemic on HIV, TB and Malaria
https://www.imperial.ac.uk/mrc-global-infectious-disease-analysis/covid-19/report-19-hiv-tb-malaria/
2) Adepoju P (2020) Tuberculosis and HIV responses threatened by COVID-19. Lancet Online April 8, 2020
https://doi.org/10.1016/S23523018(20)301 09-0
3) Johns Hopkins COVID-19 World Tracker 2020 https://coronavirus.jhu.edu/
4) WHO (2018) Global Tuberculosis report
https://www.who.int/tb/publications/global_report/gtbr2018_main_text_28Feb2019.pdf? ua=1
5) UNAIDS. Indonesia Country Snapshot 2017. https://www.who.int/tb/publications/global_report/gtbr2018

3. Research Design and Methodology (Maximum 1 page for Low Risk Applications)

This study will run from November 2020 to April 2021 and be conducted according to the following timeline:
Work Package Activity Year 1 Year 2
Q1 Q2 Q3 Q4 Q1 Q2
Capacity Strengthening
On-the-job training of Research Fellows (RFs)
Training field team for clinical data collection (includes refresher)
Training field teams and RFs for diaries and interviews
On-line learning for Research Fellows
Community Engagement
Stakeholder meetings
Advisory Committee meetings
Webinar series
Set-up activities
Develop protocol
Ethics clearance and local approvals
Sub-contracts
Staff appointments
Set up governance
Work Package 1
Measure TB/HIV cascades of care
Measure determinants of health outcomes for TB/HIV
Work package 2
Interviews with patients and health workers
Structured diaries to measure out-of-pocket spending on TB/HIV
Work package 3
Measure HIV and TB medicine stock-outs
Financing assessment (health facility)
Work package 4
Synthesise quantitative/qualitative findings
Stakeholder workshop
National and international dissemination

Date: November 2020

This project uses the following data collection method/s:
1. Secondary use of existing datasets
2. Questionnaires and structured diaries

These are standard epidemiological methods, will extract all necessary data, and will have negligible impact on health
facility resources.

The data will be collected in the following way:

The study will be conducted in Bandung and Yogyakarta. These cities were selected because they have high
incidence of COVID-19; have a high burden of TB and HIV; and our team has a long track record of working with
services there. All TB and HIV clinics in these cities (62 in Bandung, 30 in Yogyakarta) will be invited to take part.
Four research fellows (2 UGM, 1 LSHTM, and 1 UNSW) will be recruited and will be responsible for data collection.
They will receive on-the-job training in their local country on infectious diseases epidemiology, biostatistics, health
economics and health systems. They will also engage in an online LSHTM learning module on COVID-19.

Data Collection Method 1 [Secondary use of existing datasets – includes patients only]:
We will establish an observational cohort comparing clinical outcomes across three sub-cohorts, separately for TB
and HIV: (1): all new diagnoses (Mar 2018-Feb 2019), followed for 1y; (2) all new diagnoses before and during the
epidemic (Mar 2019-Feb 2020), followed for 1y; (3) all new diagnoses during the epidemic (Mar 2020-Feb 2021),
followed for 1y. Electronic data will be extracted monthly from TB and HIV monitoring and evaluation records at each
site (Sistem Informasi HIV/AIDS, Sistem Informasi TB). Letters of support from participating institutes have been
provided in our attachments. Data variables to be collected will include basic demographics, family history of illness,
medical diagnoses, pathology results, medical treatments received, adherence to treatments, adverse events to
treatments, and death records. Trained research staff will use a secure web-based, open-source database. We will
also assess stocks of medicines/tests and funding allocations to clinics over a 12-month period. Data on medicine/test
stocks and funding allocations will be extracted monthly from electronic and paper records (dispensing logbooks,
diagnostic registers and financial accounts) at sites in sub-cohort 3. Data will be analysed with statistical software
(e.g. STATA).

Data Collection Method 2 [Questionnaires – includes patients and healthcare workers; Structured diaries – includes
patients only]:
*Patient Questionnaires - patients in sub-cohort 3 experiencing disruptions to care will be identified in consultation
with clinic staff who will invite patients to contact the research team. Interviews with patients will focus on: background
information on access to care (e.g. health insurance and other payment methods; costs; accessibility of health
services); the impact of disruptions due to COVID-19 on access to services in terms of service availability, quality of
care, adherence to HIV/TB medicines and associated costs; any actions taken to mitigate disruptions; concerns with
COVID-19 exposure at HIV/TB clinics. A draft patient interview guide (to be piloted) is included in our attachments.
Each patient interview will take ~30-60 min.

*Health worker questionnaires - health workers caring for patients in sub-cohort 3 will be interviewed to explore: the
impact of COVID-19 on work routines; the impact of COVID-19 on quality of care and HIV/TB medicine supplies;
mitigating actions taken or recommended; concerns with COVID-19 exposure at HIV/TB clinics; concerns with
increased COVID-19 susceptibility among HIV and TB patients. A preliminary healthcare worker interview guide (to be
piloted) is included in our attachments. Each healthcare worker interview will take ~30-60 min.

Patient and healthcare worker questionnaire interviews will be conducted in private locations at health facilities by
trained research assistants using a semi-structured interview guide. Interviews will be recorded, transcribed and
translated from Indonesian to English. Translated texts will be independently coded using NVivo and thematically
analysed.

*Patient structured diaries - structured diaries will be used to measure total costs incurred by a sample of TB and HIV
affected patients who contribute to the patient questionnaire study. We will assess the incidence and intensity of
catastrophic health expenditure. Questions will include demographic and socio-economic characteristics, healthcare
facility visits, health payments and coping strategies. A structured diary, pre-tested in other settings, will be used to
collect data on out-of-pocket payments on TB and HIV care over a 12-month period. A preliminary diary template is
included in our attachments. Two-monthly follow-up phone calls will be made to encourage diary-keepers.
4. Clinical Trials

N/A

Date: November 2020

5. Sample Size (Maximum of 250 Words)

The total sample size for the project is:

Cohort: 1,000 (HIV)/10,000 (TB)
Interviews: 30 patients and 30 health workers
Total: 11,060 participants

Individual steps of the TB and HIV cascades will be formally compared pre- and post-COVID using chi-square tests,
logistic regression or survival analysis methods as appropriate. To indicate the power of the study, consider one key
element of the cascade, the rate at which people who start treatment are retained in treatment (HIV) or have
successfully completed (TB) at 1 year. In the two cities around 1000 newly diagnosed patients with HIV started
treatment in cohort 1, with around 40% no longer retained at one year.[1] If we assume COVID results in fewer new
HIV diagnoses, so 800 people starting treatment in the third cohort (i.e. during-COVID-19 outbreak), then we would
have over 98% power to detect an increase in proportion not retained to 50%, and 80% power to detect an increase to
47% (2-alpha=5%). Over 10,000 people started TB treatment in cohort 1, with a treatment success rate of 60%.
Assuming 8,000 people start TB treatment in the post-COVID cohort, we will have near 100% power to detect a
decreased treatment success rate of 55%, and over 90% a decrease to 57.5%. Interviews: A purposive sample of
about 30 patients and 30 health workers in the third cohort will be interviewed. The final sample size to be determined
by data saturation.[2]

1) Health profile of Bandung dinkes.bandu ng. go.id/dashboard.php?page=profildinas & Yogyakarta:

kesehatan.jogjakota.go.id/ berita/id/189/profil-kesehatan-dinas-kesehatan-kota-yogyakarta-2019-data-tahun-2018/
2) Glaser B et al. (1967) The Discovery of Grounded Theory: Strategies for Qualitative Research. Chicago: Aldine.

6. Research Participants (Maximum of 500 words)

Cohort study
Inclusion criteria:
*TB and/or HIV positive patient
*Any age
Exclusion criteria:
*None

Patient questionnaires
Inclusion criteria:
*TB and/or HIV positive patient
*Contributed to sub-cohort 3
*Experiencing disruptions to care as identified by clinic staff
Exclusion criteria:
*Aged <18

Health worker questionnaires

Inclusion criteria:
*Carer of patients in sub-cohort 3
Exclusion criteria:
*None

Patient structured diaries

Inclusion criteria:
*TB and/or HIV positive patient
*Contributed to patient questionnaire study
*Experiencing disruptions to care as identified by clinic staff
Exclusion criteria:
*Aged <18

7. Recruitment of participants

Date: November 2020

Patients will be emailed/mailed a letter of invitation (see patient interview and diary invitation letters in supporting
documents) by a member of the health service who is not a member of the research team. A copy of the PISCF will be
attached. All patients will be advised that a member of the research team will contact them via phone to discuss their
involvement in the research. A maximum of two phone call attempts will be made after invite letters are sent. A
mechanism to allow patients to opt-out of receiving the phone call is also included in the recruitment materials.

Healthcare workers will be emailed/mailed a letter of invitation (see healthcare worker interview invitation letter in
supporting documents) by a member of the health service who is not a member of the research team. A copy of the
PISCF will be attached. All healthcare workers will be advised that a member of the research team will contact them
via phone to discuss their involvement in the research. A maximum of two phone call attempts will be made after invite
letters are sent. A mechanism to allow healthcare workers to opt-out of receiving the phone call is also included in the
recruitment materials.

Reminder letters will not be sent to individuals who do not respond to the initial invitation or follow up phone calls.

On the day of their interview, the research team will go through the research study and ask participants to provide
written consent by signing the consent form. Those that sign consent forms are to be provided with another copy of the
PISCF for their information.

8. Consent

We are seeking a waiver of consent for participants contributing de-identified medical records data due to the
negligible likelihood of harm, impracticality of seeking consent (records from ~11,000 patients will be included), and
unlikeliness of participants not consenting if they were asked. Interviewees and diary-keepers will be given a copy of
our PISCF (see patient-questionnaire, patient-diary, and healthcare worker versions attached) via email/letter and in
hardcopy during their initial contact with the research team. They will be informed about the research objectives and
free to ask questions and/or choose to participate. If they agree to participate, interviewees and diary-keepers will be
asked to sign a hardcopy of the PISCF before returning it to the research team on the day of their scheduled interview.
No money will be paid except to cover travel costs for those who may need to return to the clinic for their interview.
This written consent process is appropriate for our data collection method and participant group because participants
will be completing the data collection in person, so written consent can be obtained at the time of data collection. All
data will be de-identified to protect participant confidentiality. Electronic data will be kept on secure servers at
Universitas Gadjah Mada and UNSW accessible only to the research team. Important findings from the research will
be made publicly available via conferences (such as the STD & HIV World Congress, Health Systems Global
Conference, International Conference on TB), open access publications, webinars, community meetings, policy briefs,
and stakeholder meetings. The possibility of commercial exploitation resulting from this study is negligible. A waiver of
consent is not prohibited by State, federal, or international law.

9. Reimbursement of Expenses or Incentives to Participate

Travel costs of patients who need to return to the clinic for an interview will be reimbursed. The transport cost dictated
by the Ministry of Finance standard will be provided (between Rp 50,000 – 150,000) depending on distance travelled
and mode of transport. No other money will be paid to participants.

Date: November 2020

10. Risks to participants

We anticipate the following discomforts to HIV and TB patient interviewees and diary keepers:
 anxiety induced by providing answers related to home finances and/or HIV or TB care during an interview or
when completing structured diary
Patients will be advised of this risk and told they may skip questions they do not wish to answer and go to the next
question or stop immediately. If they become upset or distressed as a result of participation, the research team will be
able to arrange for counselling or other appropriate support. Alternatively, a number of free contactable support
services are available. e.g. Yogyakarta Clinical Psychologist Association. Any counselling or support will be provided
by qualified staff who are not members of the research team. This counselling will be provided free of charge.
The benefit of participating in this study outweighs this potential risk of discomfort because the study will be used to
design strategies to safeguard the continuity of care for TB and HIV patients in the near and medium term.
11. Privacy and Confidentiality

Data will be collected in PISCFs and electronic databases, and as audio recorded interviews, transcripts and
structured diaries. UNSW will receive electronic copies of all data.

Direct identifiers (e.g. name, address, photograph) will be removed from all stored data. Identifying information will be
replaced with a unique patient identification code. The master list for the de-identification will be stored separately to
the de-identified data.

Audio recordings will be transcribed by the research team. Structured diary and PICSF hardcopies will be scanned
and scans will be electronically stored. Data from the structured diaries will be coded and entered into a de-identified
electronic database.

All hardcopy and electronic data will be retained for a minimum of 5 years after publication of the main study results.

Data Storage Platform

The data collected for this research will be:
 Sensitive

Electronic data will be stored on the following UNSW Data will also be stored using alternative methods at
supported data storage platform(s): OneDrive UGM (Indonesia) and LSHTM (UK)

Date: November 2020

Complete the Data Storage Table: Define how data collected will be stored
Data Type Campus/Location/ Building/Server/ How is data stored How is access Data Retention
Platform Name Platform Name securely restricted Period
Hard Copies UGM Tropmed center, PISCFs, transcripts, Locked cabinet 5 years after
UGM and structured will only be publication of the
diaries will be accessible by main study results
stored in a locked investigators
cabinet
Electronic Copies UGM UGM server Password protected Passwords will 5 years after
servers will be used only be known publication of the
UNSW Kensington UNSW OneDrive at all institutes to investigators main study results

Audio/Visual UGM UGM server Password protected Password will 5 years after
servers will be used only be known publication of the
UNSW Kensington UNSW OneDrive at all institutes to investigators main study results

12. Data Sharing

Data will not be used for future research purposes or shared with other researchers.

13. Publications and Dissemination of Results

Key stakeholders targeted by this research include: Provincial/District Health Offices; community networks supporting
TB and HIV patients; TB and HIV funding and implementing agencies; academics and analysts measuring quality of
care; TB and HIV patients and their families.

Dissemination activities and outputs will include:

- Sharing policy-briefs to inform and engage local and national stakeholders (3 policy briefs - at the start, mid-way and
end of the study).
- Engaging members of the COVID-19 Taskforce by presenting our results at quarterly meetings (CI Ahmad is a
committee member).
- Informing members of the study Advisory Committee (chaired by Heads of the Sub-directorates for AIDS and STIs,
and TB and including representatives from the District/City Health Offices) about findings so they may act as
champions for the research (4 face-to-face or virtual meetings)
- Raising awareness about the research through an end-of-study dissemination event with key stakeholders (1
meeting in final 2 months of the study)
- Attending 'musrenbang' (community discussions for development planning) at the district level to seek feedback on
research recommendations (2 meetings per study site)
- Share and promote findings at conferences such as the STD & HIV World Congress, Health Systems Global
Conference, International Conference on TB (5-6 people to attend 1 conference each)
- Share and promote uptake of findings and survey tools through open access publications (approx 6) and webinars
(approx 3).

Study findings will be presented in aggregate or as de-identified data and will not jeopardise participant confidentiality.

Date: November 2020