Clinical trial NCT03429842: HIV Awal (Early) Testing & Treatment Indonesia Project Observational Phase
Official title: HIV Awal (Early) Testing & Treatment Indonesia Project Implementing 'Test and Treat' Strategies for HIV Treatment and Prevention in Key Populations in Indonesia: a Prospective Implementation Research Study (Phase 1 - Observational Phase)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Department of Foreign Affairs and Trade (DFAT), Australia
name: Kirby Institute
name: Hasan Sadikin General Hospital
name: Sardjito Hospital Yogyakarta
name: Yayasan Kerti Praja
name: Udayana University
name: Universitas Padjadjaran
name: Universitas Katholik Atmajaya
First posted: 2018-02-12
Enrollment: 2071
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adults from the following three key population groups:

i) Gay men and other men who have sex with men (MSM) ii) Female sex workers, including brothel and non-brothel based sex workers (FSW) iii) Waria (transgender people)

Brief summary: This study will be one of the first to systematically evaluate strategies to improve the implementation of a T\&T strategy in a concentrated epidemic in Asia.

While large controlled randomized trials assessing the efficacy of T\&T at the community level are underway, they are being run in the generalised epidemic settings of Africa with the population HIV prevalence above 15%. Findings on implementation of T\&T strategy from such settings will not be readily applicable to concentrated epidemics. This study will run in parallel with the trials so that the key implementation data in concentrated epidemic settings are available in a timely fashion. Finally, the study aims to develop capacity in implementation research in Indonesia.

In line with principles of implementation science, the components of the intervention package will be designed from extensive discussions with all stakeholders including affected communities. This will ensure that the intervention is acceptable, feasible and could be integrated in to larger policy framework beyond the study. Further, the study will utilize and explore the role of primary care centres (Puskesmas) in providing 'Test and Treat' services. The success of T\&T strategy based on primary care model will be critical for the wider penetration of services to the key affected populations.

It will generate key data on critical steps in the cascade of care and show how current prevention services might enhance the uptake of HIV testing and immediate treatment. The study will identify which programmatic areas, under current resources, need strengthening for a larger scale implementation of T\&T for HIV treatment and prevention.

This will be a prospective implementation research study assessing the impact of enhanced community based interventions, on the uptake of HIV treatment and retention in care among key populations as part of a T\&T strategy in three urban settings in Indonesia. The enhanced package of interventions will be introduced in a series of steps over time.

This phase 1- Pre-implementation of the enhanced intervention package (Year 1) Current standard practices for HIV treatment and care will be observed ('business as usual'), utilising a comprehensive data collection system at each participating site. In accordance with current national guidelines, all HIV positive participants will be offered immediate ART initiation after being diagnosed as HIV positive.

Detailed description: Purpose

The principal aims of the HATI study are:

1. To evaluate interventions aimed at increasing HIV testing and immediate antiretroviral therapy (ART), also known as the test and treat (T\&T) strategy, in key populations in Indonesia;
2. To develop capacity in implementation research in Indonesia through training and the active participation of local researchers as investigators on the study.

The study will be conducted in two phases:

i) Phase 1 -observing current practice (year 1) ii) Phase 2 - after implementation of an enhanced intervention package (years 2 and 3)

Primary research objective

The primary objectives are to assess the impact of enhanced community based intervention compared with current practice, on:

1. Total number of virologically suppressed individuals from each key population (at the end of year 1 and year 4);
2. Proportion of people from each key population who are virologically suppressed 12 months after HIV diagnosis.

Analyses will be conducted separately for each key population

Secondary research objectives

1. To quantify and compare the HIV treatment cascade/continuum of care.
2. To assess safety of early ART and acceptability of early ART initiation.
3. To assess behavioural aspects of a T\&T strategy, including impact on risk behaviours.

Research capacity building objectives

1. To enhance the capacity of senior local researchers as research leaders.
2. To increase the research skills and experience of early career researchers.

Study population

The study population will include adults from the following three key population groups:

i) Gay men and other men who have sex with men (MSM) ii) Female sex workers, including brothel and non-brothel based sex workers (FSW) iii) Waria (transgender people)

Study Design This will be a prospective implementation research study assessing the impact of enhanced community based interventions, on the uptake of HIV treatment and retention in care among key populations as part of a T\&T strategy in three urban settings in Indonesia. The enhanced package of interventions will be introduced in a series of steps over time.

Phase 1- Pre-implementation of the enhanced intervention package (Year 1) Current standard practices for HIV treatment and care will be observed ('business as usual'), utilising a comprehensive data collection system at each participating site. In accordance with current national guidelines, all HIV positive participants will be offered immediate ART initiation after being diagnosed as HIV positive.

Phase2-a - Partial implementation of the enhanced package of interventions (Year 2) The components of an enhanced intervention package will be implemented selectively across the participating service delivery sites. The allocation of enhanced intervention package components across sites will be determined after the content of the package is developed in year 1 (see below for details describing how this package will be developed). Allocations will be made so as to allow for comparison between intervention and non-intervention exposure for each key population group.

Phase 2-b - Full implementation of the enhanced package of interventions (Years 3-4) The full implementation package will be implemented across all participating sites. Study outcomes for each phase will be compared. Participants will be followed up for a minimum of 12 months. The total study observation period will be 4 years.

In addition, during the first year of the study formative research will be conducted to inform the development of an enhanced package of interventions to increase the uptake of HIV testing and treatment, improved treatment adherence and treatment outcomes (virological suppression). This formative research will include focus group discussions and interviews with people from key populations, service providers, and other key stakeholders. The enhanced package will be designed such that it is locally relevant, acceptable to affected communities and deemed likely to be sustainable beyond the study by stakeholders.

Study sites The study will be undertaken in three urban locations in Bali, West Java and Yogyakarta. At each location a service providing HIV treatment will be designated as the Primary (Principal) Site; each Primary Site will be affiliated with a tertiary academic institution and will be responsible for overseeing the study activities in that location. A number of Satellite Sites will also be included in the study and will be involved in participant recruitment and/or follow-up.

Recruitment of HIV positive participants and sample size Eligible HIV positive individuals will be invited to enter the study following a positive HIV test during Phase 1 (year 1) and Phase 2 (years 2 and 3). The target total sample size across all three locations is 600 HIV positive MSM and 600 HIV positive FSW, with the aim to recruit, on average, 200 individuals from each population in each year .

Due to the considerably smaller overall waria population size there will be no specified target for the HIV positive waria sample.

HIV positive MSM, FSW and waria will be recruited at all locations. It is anticipated that recruitment is likely to be slower in Phase 1 (year 1) when no strategies in addition to current practice will be implemented to increase HIV testing; it is also anticipated that certain locations may recruit greater or fewer participants from each key population group. HIVpositive participants will be followed for the duration of the HATI study as far as possible.

Data on HIV testing among key populations Individuals from key populations receiving HIV test at participating study sites during Years 1-3 and who are found to be HIV-negative will not be recruited to the cohort in this study. De-identified data HIV testing among people from key populations will be analysed in order to examine patters in HIV testing during the study period.

Participant procedures Phase 1 :In line with a government directive on HIV treatment for people from key populations, all HIV positive participants will be offered immediate access to ART irrespective of CD4 count,. Linkage to HIV treatment and care, clinical management (including diagnostics) will be conducted as per routine practice. Costs borne by patients will remain as per current practices with exception of CD4 testing, which will be provided to study participants at no cost to them. Viral load testing at the time of being offered or starting treatment and every six months thereafter at no cost to the participant. Resistance testing will be done on virological failure, at no cost to the participant. A short behavioural questionnaire will be administered to all HIV positive participants at entry to the study and then every 12 months.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosis HIV Positive individual during the study observation period
* Aged 16 years and over
* Fow FSW : Had sex in exhange for money or a gft in the last 12 months or
* For MSM : Ever had sex with a man/waria
* For Waria : Identify as waria.

Exclusion criteria for all participants

* Unable to provide informed consent to enroll in the study
* Attending clinician judges that participation in the study would adversely affect individual.

Primary outcomes:
measure: Rates of virological suppression under current practice
timeFrame: 12 months
Secondary outcomes:
measure: Uptake of HIV testing
timeFrame: 24 months
measure: Linkage between HIV testing and care
timeFrame: 24 months
measure: Uptake of ART among FSW, MSM and waria
timeFrame: 24 months
measure: Retention in treatment
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Universitas Udayana
name: Dewa N Wirawan, Prof
role: PRINCIPAL_INVESTIGATOR
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