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HIV Awal (Early) Testing & Treatment Indonesia Project Intervention Phase

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ClinicalTrials.gov Identifier: NCT03659253
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
Udayana University
Hasan Sadikin General Hospital
Yayasan Kertipraja
World Health Organization
Sardjito Hospital Yogyakarta
Universitas Katholik Atmajaya
Universitas Padjadjaran
Kirby Institute
Information provided by (Responsible Party):
Yanri Wijayanti Subronto, MD, Gadjah Mada University

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.

HATI Project is an implementation research designed, of which consisted of phase I as observation of available standard practice and data collection and phase II implementation of intervention of intervention designed based on the results of phase I.

The first year observation study showed that there are poor cascade of HIV care. The first is the low coverage of HIV test uptake. Along the HIV test and treatment cascade there are substantial reductions.

Furthermore, In the qualitative analysis we found several reasons for the study population for not coming to the ARV sites after being diagnosed with HIV, e.g. social and administrative reasons such as not possessing ID card and unsuited hospital opening hours, etc. Another important finding was the requested laboratory testing by the physicians prior to ART initiation, such as Levels of Haemoglobin, serum transaminases, creatinine, and chest X-ray (manuscript in preparation).

The aims of the proposed interventions are:

  1. Increase uptake of HIV testing
  2. Increase uptake of HIV treatment initiation
  3. Reduce time from testing to treatment initiation
  4. Increase percentage of treatment adherence
  5. Reducing loss to follow-up on ART
  6. Improve treatment outcomes (virological suppression)

There are five interventions proposed:

  1. Oral fluid-based testing (self-testing) as a strategy to overcome barriers of testing
  2. Simplification of ART initiation
  3. CBOs and Brothel-based ART service
  4. SMS reminders to increase treatment adherence
  5. Motivational Interviewing Approach to increase treatment uptake & adherence

Study sites of the intervention will be conducted in Denpasar (Bali), Yogyakarta (Special Region of Yogyakarta), Bandung (West Java), and Jakarta

The study population for the intervention phase are the same with the first year observational study, i.e.: Female sex workers (FSW), Gay men and other men who have sex with men (MSM), Waria (or transgender) and People who inject drugs (PWID)


Condition or disease Intervention/treatment Phase
HIV/AIDS Diagnostic Test: Oral Fluid Based Self Testing Procedure: Simplified ART Initiation Procedure: CBO AND BROTHEL-BASED ART SERVICE Behavioral: SMS REMINDER Procedure: MOTIVATIONAL INTERVIEWING Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 (Intervention Phase)
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Oral Fluid Based Self Testing
All study participants that received intervention and meet inclusion criteria intervention that will be offered OFT
Diagnostic Test: Oral Fluid Based Self Testing
The intervention will introduce provider supervised and unsupervised self-testing as an option for early HIV diagnosis among MSM community in Denpasar Bali Indonesia.
Other Name: OFT

Procedure: Simplified ART Initiation
In this intervention, there will be a change in the clinical practice of ART initiation. In the current practice, clients are asked to perform full pre-ART laboratory examination (complete blood count, liver and renal function tests) before decision of ART initiation. In this intervention, the study participants who are already confirmed as HIV positive and meet specific clinical criteria (see below) will initiate ART (antiretroviral therapy) immediately (after clients' approval) without having to perform full pre-ART laboratory examination. Here, laboratory criteria for initiating ART will be simplified and specific laboratory examination, I.e. creatinine test will be delayed in two weeks after ART initiation.
Other Name: SAI

Behavioral: SMS REMINDER
HATI SMS reminder: short message services as reminders to inform ART patients when to take medication, visit the clinics (1 week before the next visit) and remind if they miss clinic appointment.

No Intervention: Control Group
All HIV Patients in the clinic that not received any intervention
Experimental: Simplified ART Initiation
All study participants that received intervention and meet inclusion criteria intervention that will be offered SAI
Procedure: Simplified ART Initiation
In this intervention, there will be a change in the clinical practice of ART initiation. In the current practice, clients are asked to perform full pre-ART laboratory examination (complete blood count, liver and renal function tests) before decision of ART initiation. In this intervention, the study participants who are already confirmed as HIV positive and meet specific clinical criteria (see below) will initiate ART (antiretroviral therapy) immediately (after clients' approval) without having to perform full pre-ART laboratory examination. Here, laboratory criteria for initiating ART will be simplified and specific laboratory examination, I.e. creatinine test will be delayed in two weeks after ART initiation.
Other Name: SAI

Experimental: CBO AND BROTHEL-BASED ART SERVICE
All patients coming to brothel or Community Based Organization services will be offered to get tested and received ART
Procedure: Simplified ART Initiation
In this intervention, there will be a change in the clinical practice of ART initiation. In the current practice, clients are asked to perform full pre-ART laboratory examination (complete blood count, liver and renal function tests) before decision of ART initiation. In this intervention, the study participants who are already confirmed as HIV positive and meet specific clinical criteria (see below) will initiate ART (antiretroviral therapy) immediately (after clients' approval) without having to perform full pre-ART laboratory examination. Here, laboratory criteria for initiating ART will be simplified and specific laboratory examination, I.e. creatinine test will be delayed in two weeks after ART initiation.
Other Name: SAI

Procedure: CBO AND BROTHEL-BASED ART SERVICE
The CBOs involved in this intervention are Kebaya and Vesta. Kebaya is an CBO working for Transgender (TG) community. It serves as community gathering place for TG and others, as HIV testing site on regular bases, and also as shelter for homeless HIV patients. The proposed intervention Is that HATI Project will provide HIV testing and treatment in the community, CBO and brothel in collaboration with nearby Puskesmas.
Other Name: CBO ART SERVICE

Behavioral: SMS REMINDER
HATI SMS reminder: short message services as reminders to inform ART patients when to take medication, visit the clinics (1 week before the next visit) and remind if they miss clinic appointment.

Experimental: SMS Reminder
All patients that recently found HIV Positive "HIV Naive" offered to get SMS Reminder
Procedure: Simplified ART Initiation
In this intervention, there will be a change in the clinical practice of ART initiation. In the current practice, clients are asked to perform full pre-ART laboratory examination (complete blood count, liver and renal function tests) before decision of ART initiation. In this intervention, the study participants who are already confirmed as HIV positive and meet specific clinical criteria (see below) will initiate ART (antiretroviral therapy) immediately (after clients' approval) without having to perform full pre-ART laboratory examination. Here, laboratory criteria for initiating ART will be simplified and specific laboratory examination, I.e. creatinine test will be delayed in two weeks after ART initiation.
Other Name: SAI

Behavioral: SMS REMINDER
HATI SMS reminder: short message services as reminders to inform ART patients when to take medication, visit the clinics (1 week before the next visit) and remind if they miss clinic appointment.

Procedure: MOTIVATIONAL INTERVIEWING

The approach used in this intervention is an individual counselling with a MI approach, as it is considered a brief form of therapy have been known to be effective in improving HIV treatment adherence.

The sessions will be held from 3 to up to 10 MI counselling over 6-month period of intervention. The goal of this intervention is to help PWID gain an understanding of their medication-taking behaviors and the actions necessary to successfully maintain a high level of adherence

Other Name: MI

Experimental: Motivational Interviewing
PWID in Jakarta and Bandung that recently found HIV Positive or lost to follow up ARV offered MI intervention
Procedure: MOTIVATIONAL INTERVIEWING

The approach used in this intervention is an individual counselling with a MI approach, as it is considered a brief form of therapy have been known to be effective in improving HIV treatment adherence.

The sessions will be held from 3 to up to 10 MI counselling over 6-month period of intervention. The goal of this intervention is to help PWID gain an understanding of their medication-taking behaviors and the actions necessary to successfully maintain a high level of adherence

Other Name: MI




Primary Outcome Measures :
  1. Proportion of virologically suppressed [ Time Frame: 12 months ]
    Proportion of people from each key population who are virologically suppressed 12 months after HIV diagnosis. Analyses will be conducted separately for each key affected population


Secondary Outcome Measures :
  1. Quantify and comparing other components of the HIV treatment cascade/continuum of care [ Time Frame: 12 months ]

    To quantify and compare other components of the HIV treatment cascade/continuum of care, including

    • Uptake of HIV testing and retesting
    • Clinical and immunological stage at time of HIV diagnosis
    • Uptake of ART and time to initiation of treatment
    • ART adherence and retention in care

  2. Assess the safety and acceptability of early ART Initiation [ Time Frame: 12 months ]

    To assess the safety and acceptability of early ART initiation, including :

    • ART toxicity
    • Short term incidence of AIDS and mortality in those who do and do not initiate ART
    • Proportion failing on first-line ART by virological criteria
    • Emergence of resistance mutations in those failing first-line ART
    • For those who decline immediate ART, reasons for refusal and barriers to initiation of ART

  3. Assess behavioural aspects of Test and Treat Strategy [ Time Frame: 12 months ]

    To assess behavioural aspects of a T&T strategy, including :

    • Impact of ART initiation on risk behaviour
    • Impact of enhanced community-based intervention package on risk behaviour

  4. Number of participants that virologically suppressed [ Time Frame: 12 months ]
    Total number of virologically suppressed individuals from each key affected population



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female Male Transgender
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

OFT :

  1. Refused HTC testing at clinic or outreach setting?
  2. Aged 18 years and over;
  3. Not known to be HIV-infected;
  4. Self-reported anal sex with a man in the last 12 months;

SAI & CBO

  1. WHO clinical stage 1 and 2
  2. Age < 50 years old
  3. Free of Tuberculosis suspicion (based on TB screening form)
  4. Not suffering from uncontrolled hypertension (blood pressure more than 140 mmHg) and or diabetes (clinical history based on patients interview)
  5. BMI above 18.5 kg/m2
  6. ARV naïve
  7. Well informed and agree to receive ARV

SMS Reminder :

  1. Age: ≥ 16 years old
  2. New HIV positive patients initiating ARV
  3. Owning a mobile phone with reliable reception
  4. Willing to report to research team whenever changing their phone number during the intervention period.

Motivational Interviewing :

Inclusion criteria for the intervention are:

  1. PWID with HIV positive;
  2. ARV naïve or have ever received treatment but lost to follow up;
  3. HATI participants in first phase (regardless the ARV status) and referred by outreach worker/health care provider for adherence counselling because of low level of ARV adherence
  4. 16 years old or older

Exclusion Criteria:

  • Known HIV Positive
  • Refuse to be included in the intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659253


Contacts
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Contact: Yanri W Subronto, PhD +62 811 255 030 yanrisubronto@gmail.com
Contact: Nurhayati H Kawi, Master +6281287396154 hati.study@gmail.com

Locations
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Indonesia
Yayasan Kerti Praja Recruiting
Denpasar, Bali, Indonesia, 80223
Contact: D.N Wirawan, Prof    +62 811 394 306    ykpdps@dps.centrin.net.id   
Principal Investigator: Pande Januraga, PhD         
Dr. Sardjito Hospital, Yogyakarta Indonesia Recruiting
Yogyakarta, DI Yogyakarta, Indonesia, 55281
Contact: Yanri Subronto, PhD    +62 811 255 030    yanrisubronto@gmail.com   
Principal Investigator: Yanri Subronto, PhD         
Atma Jaya HIV-AIDS Research Centre Recruiting
Jakarta, DKI Jakarta, Indonesia, 12930
Contact: Evi Sukmaningrum, PhD    +62 856 1400 456    evi.sukmaningrum@gmail.com   
Principal Investigator: Evi Sukmaningrum, PhD         
Hasan Sadikin Hospital, Bandung, Indonesia Recruiting
Bandung, Jawa Barat, Indonesia, 40161
Contact: Rudi Wisaksana, PhD    +62 819 105 63 062    rudiw98@gmail.com   
Principal Investigator: Rudi Wisaksana, PhD         
Sponsors and Collaborators
Gadjah Mada University
Udayana University
Hasan Sadikin General Hospital
Yayasan Kertipraja
World Health Organization
Sardjito Hospital Yogyakarta
Universitas Katholik Atmajaya
Universitas Padjadjaran
Kirby Institute
Investigators
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Principal Investigator: Yanri W Subronto, PhD Gadjah Mada University

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Responsible Party: Yanri Wijayanti Subronto, MD, MD,PhD,Sp.PD-KPTI,FINASIM, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT03659253     History of Changes
Other Study ID Numbers: The HATI Project HIV Phase 2
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No