ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000570987

Ethics application status

Approved

Date submitted

31/03/2020

Date registered

15/05/2020

Date last updated

11/04/2024

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 Sidama, Ethiopia: A cluster randomized trial and economic evaluation of Teach-Test-Link-Trace model trial protocol

Secondary ID [1]

None

Universal Trial Number (UTN)

Not registered

Trial acronym

The TTLT trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Public Health

Epidemiology

Acquired immune deficiency syndrome (AIDS / HIV)

Condition category

Condition code

Infection

Acquired immune deficiency syndrome (AIDS / HIV)

Public Health

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]

Treatment: Devices

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

(i) Proportion of individuals who will know their HIV status (UNAIDS 1st 90)

Timepoint [1]

this will be measured using community based cross-sectional survey at enrolment of the trial through HIVST and H2H.

Primary outcome [2]

(ii) Proportion of individuals who will be linked to HIV care (UNAIDS 2nd 90)

Timepoint [2]

this will be measured at 0 month (enrolment at ART) through extracting their linkage of care from clinical registry (prospective cohort).

Primary outcome [3]

(iii) Proportion of individuals who will achieve virological suppression (UNAIDS 3rd 90)

Timepoint [3]

this will be measured at 6 months through extracting viral counts from clinical registry (prospective cohort).

Secondary outcome [1]

(i) Health related quality of life (HRQoL)

Timepoint [1]

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]

(ii) HIV related stigma

Timepoint [2]

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]

(iii) Adherence to ART

Timepoint [3]

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]

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]

at the end of the intervention i.e. six months.

Secondary outcome [5]

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]

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

Sex

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

15/06/2024

Actual

Date of last participant enrolment

Anticipated

15/11/2024

Actual

Date of last data collection

Anticipated

15/04/2025

Actual

Sample size

Target

5440

Accrual to date

Final

Recruitment outside Australia

Country [1]

Ethiopia

State/province [1]

Sidama

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Torrens University Australia

Address

Sturt Rd, Bedford Park SA 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

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]

11 Hindmarsh Square Adelaide South Australia 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/04/2020

Approval date [1]

14/07/2020

Ethics approval number [1]

HREC/20/SAC/97

Ethics committee name [2]

Institute of Review Board at Mekelle University

Ethics committee address [2]

Ayder, Mekelle, Ethiopia

Ethics committee country [2]

Ethiopia

Date submitted for ethics approval [2]

04/06/2020

Approval date [2]

Ethics approval number [2]

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 Sidama, SouthEthiopia. 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

Dr Hailay Abrha Gesesew

Address

Torrens University Australia
88 Wakefield St, Adelaide SA 5000, Australia

Country

Australia

Phone

+61 466816002

Fax

[email protected]

Contact person for public queries

Name

Dr Hailay Abrha Gesesew

Address

Torrens University Australia
88 Wakefield St, Adelaide SA 5000, Australia

Country

Australia

Phone

+61466816002

Fax

[email protected]

Contact person for scientific queries

Name

Dr Hailay Abrha Gesesew

Address

Torrens University Australia
88 Wakefield St, Adelaide SA 5000, Australia

Country

Australia

Phone

+61466816002

Fax

[email protected]

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 June 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 [email protected].

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7477	Study protocol	Is under process for publication

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Peer-led HIV care and the UNAIDS 90-90-90 treatment targets in Tigrai, Ethiopia: A cluster randomised trial and economic evaluation of teach-test-link-trace model (TTLT) trial protocol.	2021	https://dx.doi.org/10.1136/bmjopen-2020-043943

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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