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Trial registered on ANZCTR


Registration number
ACTRN12620000570987p
Ethics application status
Submitted, not yet approved
Date submitted
31/03/2020
Date registered
15/05/2020
Date last updated
15/05/2020
Date data sharing statement initially provided
15/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of peer educators on human immunodeficiency viruses (HIV) testing, treatment linkage and viral suppression
Scientific title
Peer-led HIV care and the UNAIDS 90-90-90 treatment targets in Tigrai, Ethiopia: A cluster randomized trial and economic evaluation of Teach-Test-Link-Trace model trial protocol
Secondary ID [1] 300906 0
None
Universal Trial Number (UTN)
Not registered
Trial acronym
The TTLT trial
Linked study record
No

Health condition
Health condition(s) or problem(s) studied:
Public Health 316841 0
Epidemiology 316842 0
Acquired immune deficiency syndrome (AIDS / HIV) 316843 0
Condition category
Condition code
Infection 315049 315049 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Public Health 315165 315165 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in the study is called a TTLT model. TTLT model is a new program in which peer educators counsel about HIV (teach), perform house-to-house HIV testing (test) through pinprick HIV testing (H2H) or OralQuick HIV self-testing (HIVST), link HIV positive patients to HIV care (link) and trace lost patients house-to-house (trace). Peer educators will then 'link' them to HIV treatment and follow them to remain in the care. The peer educators will 'trace' if people who started treatment lost from the care. In general, the over all trial has the following phases. Phase 1 will assess the acceptability of the TTLT model using a cross-sectional survey. We will measure acceptability from participants using Sekhon and colleagues’ theoretical framework of acceptability of healthcare interventions. Phase 2 will assess effectiveness of the TTLT model through comparing intervention and control groups for six months. For baseline data, we assess the proportion of individuals who self-report to know their HIV status. The intervention groups will receive one of the three home-based interventions provided by peer educators: (i) demonstrate and distribute OralQuick HIV self-testing kits (HIVST), (ii) perform pinprick HIV testing (H2H), and (iii) offer participants a choice to either receive HIVST or H2H. The peer educators will refer all individuals of the three intervention groups to nearby health facilities for confirmatory test if the test result is positive. Peer educators will also conduct a follow up as part of the intervention (at 0, 3 and 6 months after of the antiretroviral therapy) to those who will be diagnosed with HIV through HIVST or H2H and linked with HIV care. The control group will receive the standard care in which nurses counsel and refer eligible household members to nearby health facilities to access existing HIV testing services. The primary outcomes of the interventions are proportion of individuals who know of their HIV status (first 90), link to HIV care and treatment (second 90) and meet virological suppression (third 90). We will perform process evaluation of the trial through qualitative interviews in phase 3, economic evaluation for cost-effectiveness analysis in phase 4, and a sustainability exit strategy using nominal group technique in phase 5.
Intervention code [1] 317294 0
Treatment: Devices
Intervention code [2] 317295 0
Treatment: Other
Intervention code [3] 317296 0
Early detection / Screening
Comparator / control treatment
standard of care: Nurses will provide HIV counselling and refer to near by health facilities for testing and receiving HIV care and treatment.
Control group
Active

Outcomes
Primary outcome [1] 323352 0
(i) Proportion of individuals who will know their HIV status (UNAIDS 1st 90)
Timepoint [1] 323352 0
this will be measured using community based cross-sectional survey at enrolment of the trial through HIVST and H2H.
Primary outcome [2] 323425 0
(ii) Proportion of individuals who will be linked to HIV care (UNAIDS 2nd 90)
Timepoint [2] 323425 0
this will be measured at 0 month (enrolment at ART) through extracting their linkage of care from clinical registry (prospective cohort).
Primary outcome [3] 323426 0
(iii) Proportion of individuals who will achieve virological suppression (UNAIDS 3rd 90)
Timepoint [3] 323426 0
this will be measured at 6 months through extracting viral counts from clinical registry (prospective cohort).
Secondary outcome [1] 381629 0
(i) Health related quality of life (HRQoL)
Timepoint [1] 381629 0
this will be measured through facility based cross-sectional survey using the 31 items WHO-QoL-BREF Tigrigna version at 3 and 6 months after ART initiation.
Secondary outcome [2] 381906 0
(ii) HIV related stigma

Timepoint [2] 381906 0
this will be measured through facility based cross-sectional survey using 12 items HIV related stigma scale translated to Tigrigna at 3 and 6 months after ART initiation and qualitative interviews.
Secondary outcome [3] 381907 0
(iii) Adherence to ART
Timepoint [3] 381907 0
this will be measured through facility based cross-sectional survey using 8 items Morisky scale translated to Tigrigna at 3 and 6 months after ART initiation.
Secondary outcome [4] 381908 0
Cost-effectiveness of the intervention: This will be assessed using economic evaluation. Specifically, we will record all resources which will be used by those randomized to each study arm, and then cost each resource use item to estimate the total costs. We will collect financial and economic data to undertake a cost consequence in which the costs associated with HIV counselling, testing, linking and tracing will be estimated for control and experimental groups. Costs of HIV treatment will also be estimated for both groups. Differences in costs between the groups will be presented alongside differences in the primary and secondary outcomes.
Timepoint [4] 381908 0
at the end of the intervention i.e. six months.
Secondary outcome [5] 381909 0
quality of the intervention: We will collect data for safety endpoints and other issues related to the quality of the interventions. In-depth interviews will be conducted by experienced and trained research assistants at the end of the baseline survey and 6 months visit time. Baseline in-depth interviews aim at exploring experiences with HIVST, H2H and peer educators. AT 6-months follow up, experiences with peer educators in retention in care and challenges to HIV care continuum will be explored. In particular, we will ask additional questions to participants in the HIVST study arms about their experiences with the HIVST kit, associated adverse effects such as violence, unintentional disclosure and self-harm. We will also ask all participants about perceived likelihood of using HIVST in the future and if they would be happy to be tested by peer educators during home-based HIV testing. Furthermore, we will ask participants in the intervention arm about their experiences with the peer educators. All in-depth interviews in the process evaluation will be audio-recorded.
Timepoint [5] 381909 0
at the end of the trial i.e. six months

Eligibility
Key inclusion criteria
The population in the intervention phase will include individuals aged 18 years and above who will report negative HIV status in three months’ time before data collection.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
HIV positive people will be excluded from the testing intervention. However, if the peer educators found them not linked to care, they will refer them to link to care.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequencing generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Quantitative data analysis
We will apply intention-to-treat data analysis, and in two stages. Firstly, a cluster-level analysis where we will describe the socio-demographic characteristics of the study participants by study arms and compare using t-test, which also helps us to check for any imbalance. Furthermore, we will apply first-stage regression analysis, without considering the clustering of the data or the intervention effect. Secondly, an individual level analysis where we will perform a mixed-effects multilevel logistic regression model to consider the clustering effect by villages, and to adjust for confounding bias at the individual level. We will systematically assess missed values and apply necessary treatments. For example, we will compare complete case analysis results with imputed missing data through sensitivity analysis. We will develop the analysis plan before unblinding the data.

Qualitative data analysis
We will analyze the qualitative data using thematic framework analysis. Initially, we will familiarize with each interview and then transcribe the audiotaped interviews so as to identify significant statements from the transcripts. We will then develop a codebook to develop codes, subsequent sub-themes and themes inductively and deductively. We will use NVivo to perform open coding for the illustrative quotes. Finally, we will develop a working analytical framework, perform charting data into the framework matrix, and subsequently interpreting the data.

Cost-effectiveness analysis and cost utility analysis
We will present the cost differences between the trial groups alongside differences in the primary and secondary endpoints. Sensitivity analyses will be undertaken to describe the uncertainty around the mean study results. We will also analyse the cost utility analysis described through the number of life years saved adjusted to the account of loss of quality or for disability (quality-adjusted life years (QALYs) or disability-adjusted life years (DALYs) for the secondary outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22458 0
Ethiopia
State/province [1] 22458 0
Tigrai

Funding & Sponsors
Funding source category [1] 305355 0
Government body
Name [1] 305355 0
National Health and Medical Research Council (NHMRC)
Address [1] 305355 0
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 305355 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 305727 0
None
Name [1] 305727 0
Address [1] 305727 0
Country [1] 305727 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305687 0
Southern Adelaide Clinical Health Research Ethics Committee (SAC HREC), Adelaide, Australia; and the institutional review board (IRB) of Mekelle University, Mekelle, Ethiopia
Ethics committee address [1] 305687 0
11 Hindmarsh Square Adelaide South Australia 5000
Ethics committee country [1] 305687 0
Australia
Date submitted for ethics approval [1] 305687 0
22/04/2020
Approval date [1] 305687 0
Ethics approval number [1] 305687 0
Ethics committee name [2] 305688 0
Institute of Review Board at Mekelle University
Ethics committee address [2] 305688 0
Ayder, Mekelle, Ethiopia
Ethics committee country [2] 305688 0
Ethiopia
Date submitted for ethics approval [2] 305688 0
04/06/2020
Approval date [2] 305688 0
Ethics approval number [2] 305688 0

Summary
Brief summary
Background: This trial describes a cluster randomized trial designed to evaluate the acceptability and effectiveness of a new intervention program called teach-test-link-trace (TTLT) model. TTLT model is a new program in which peer educators counsel about HIV (teach), perform HIV testing (test) through pinprick house-to-house HIV testing (H2H) or OralQuick HIV self-testing (HIVST), link HIV positive patients to HIV care (link) and trace lost patients house-to-house (trace).

Methods: The TTLT model is a 4-arm cluster randomized trial to be conducted in 40 villages in Tigrai, Northern Ethiopia. The trial has five phases as follows: Phase 1 will assess the acceptability of the TTLT model using a cross-sectional survey. We will measure acceptability from participants using Sekhon and colleagues’ theoretical framework of acceptability of healthcare interventions. Phase 2 will assess effectiveness of the TTLT model through comparing intervention and control groups. For baseline data, we assess the proportion of individuals who self-report to know their HIV status. The intervention groups will receive one of the three home-based interventions provided by peer educators: (i) demonstrate and distribute OralQuick HIV self-testing kits (HIVST), (ii) perform pinprick HIV testing (H2H), and (iii) offer participants a choice to either receive HIVST or H2H. The peer educators will refer all individuals of the three intervention groups to nearby health facilities for confirmatory test if the test result is positive. Peer educators will also conduct a follow up as part of the intervention (at 0, 3 and 6 months after of the antiretroviral therapy) to those who will be diagnosed with HIV through HIVST or H2H and linked with HIV care. The control group will receive the standard care in which nurses counsel and refer eligible household members to nearby health facilities to access existing HIV testing services. The primary outcomes of the interventions are proportion of individuals who know of their HIV status (first 90), link to HIV care and treatment (second 90) and meet virological suppression (third 90). We will perform process evaluation of the trial through qualitative interviews in phase 3, economic evaluation for cost-effectiveness analysis in phase 4, and a sustainability exit strategy using nominal group technique in phase 5. To analyse the quantitative studies, we will apply descriptive and inferential statistical analyses, and qualitative studies will employ thematic framework and content analyses. Ethics approvals will be sought from Flinders University of South Australia and Mekelle University of Northern Ethiopia.

The registration for the trial is the intervention phase.
Trial website
Under development
Trial related presentations / publications
Not yet
Public notes
None

Contacts
Principal investigator
Name 101230 0
Dr Hailay Abrha Gesesew
Address 101230 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 101230 0
Australia
Phone 101230 0
+61 8 72218475
Fax 101230 0
Email 101230 0
hailay.gesesew@flinders.edu.au
Contact person for public queries
Name 101231 0
Dr Hailay Abrha Gesesew
Address 101231 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 101231 0
Australia
Phone 101231 0
+61 8 72218475
Fax 101231 0
Email 101231 0
hailay.gesesew@flinders.edu.au
Contact person for scientific queries
Name 101232 0
Dr Hailay Abrha Gesesew
Address 101232 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 101232 0
Australia
Phone 101232 0
+61 8 72218475
Fax 101232 0
Email 101232 0
hailay.gesesew@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data of selected variables will be available for the general public as per request. Variables include age, sex, residence (rural/urban), income quintiles, HIV testing history, acceptability of TTLT strategy, HIV status, treatment linkage, CD4 cells, WHO (World Health Organization) clinical stage, and viral load.
When will data be available (start and end dates)?
Individual data will be available from January 2024 and no end date has been determined.
Available to whom?
De-identified data of selected variables will be available for the general public as per request.
Available for what types of analyses?
quality check up and further descriptive or inferential statistical analyses (not decided at this stage).
How or where can data be obtained?
Contact the chief investigator, Dr Hailay Abrha Gesesew, through hailay.gesesew@flinders.edu.au.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 7477 0
Study protocol
Citation [1] 7477 0
Is under process for publication
Link [1] 7477 0
Email [1] 7477 0
Other [1] 7477 0
Attachment [1] 7477 0
Summary results
No Results