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

NCT03659253 | Completed DMC

• 1 other identifier: The HATI Project HIV Phase 2
• Study Type: interventional
• Target: 827
• Locations: 1 country
• Sites: 4

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. 1.Increase uptake of HIV testing
2. 2.Increase uptake of HIV treatment initiation
3. 3.Reduce time from testing to treatment initiation
4. 4.Increase percentage of treatment adherence
5. 5.Reducing loss to follow-up on ART
6. 6.Improve treatment outcomes (virological suppression)
7. 7.Oral fluid-based testing (self-testing) as a strategy to overcome barriers of testing
8. 8.Simplification of ART initiation
9. 9.CBOs and Brothel-based ART service
10. 10.SMS reminders to increase treatment adherence
11. 11.Motivational Interviewing Approach to increase treatment uptake \& adherence

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Proportion of virologically suppressed

  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

  12 months

Secondary Outcomes (4)

• Quantify and comparing other components of the HIV treatment cascade/continuum of care

  12 months

• Assess the safety and acceptability of early ART Initiation

  12 months

• Assess behavioural aspects of Test and Treat Strategy

  12 months

• Number of participants that virologically suppressed

  12 months

Study Arms (6)

Oral Fluid Based Self Testing

EXPERIMENTAL

All study participants that received intervention and meet inclusion criteria intervention that will be offered OFT

Diagnostic Test: Oral Fluid Based Self Testing; Procedure: Simplified ART Initiation; Behavioral: SMS REMINDER

Control Group

NO INTERVENTION

All HIV Patients in the clinic that not received any intervention

Simplified ART Initiation

EXPERIMENTAL

All study participants that received intervention and meet inclusion criteria intervention that will be offered SAI

Procedure: Simplified ART Initiation

CBO AND BROTHEL-BASED ART SERVICE

EXPERIMENTAL

All patients coming to brothel or Community Based Organization services will be offered to get tested and received ART

Procedure: Simplified ART Initiation; Procedure: CBO AND BROTHEL-BASED ART SERVICE; Behavioral: SMS REMINDER

SMS Reminder

EXPERIMENTAL

All patients that recently found HIV Positive "HIV Naive" offered to get SMS Reminder

Procedure: Simplified ART Initiation; Behavioral: SMS REMINDER; Procedure: MOTIVATIONAL INTERVIEWING

Motivational Interviewing

EXPERIMENTAL

PWID in Jakarta and Bandung that recently found HIV Positive or lost to follow up ARV offered MI intervention

Procedure: MOTIVATIONAL INTERVIEWING

Interventions

Oral Fluid Based Self Testing DIAGNOSTIC_TEST

The intervention will introduce provider supervised and unsupervised self-testing as an option for early HIV diagnosis among MSM community in Denpasar Bali Indonesia.

Also known as: OFT

Oral Fluid Based Self Testing

Simplified ART Initiation PROCEDURE

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.

Also known as: SAI

CBO AND BROTHEL-BASED ART SERVICE; Oral Fluid Based Self Testing; SMS Reminder; Simplified ART Initiation

CBO AND BROTHEL-BASED ART SERVICE PROCEDURE

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.

Also known as: CBO ART SERVICE

CBO AND BROTHEL-BASED ART SERVICE

SMS REMINDER BEHAVIORAL

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.

CBO AND BROTHEL-BASED ART SERVICE; Oral Fluid Based Self Testing; SMS Reminder

MOTIVATIONAL INTERVIEWING PROCEDURE

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

Also known as: MI

Motivational Interviewing; SMS Reminder

Eligibility Criteria

• Age: 16 Years - 50 Years
• Gender Eligibility Details: Female Male Transgender
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• OFT :
• Refused HTC testing at clinic or outreach setting?
• Aged 18 years and over;
• Not known to be HIV-infected;
• Self-reported anal sex with a man in the last 12 months;
• SAI \& CBO
• WHO clinical stage 1 and 2
• Age \< 50 years old
• Free of Tuberculosis suspicion (based on TB screening form)
• Not suffering from uncontrolled hypertension (blood pressure more than 140 mmHg) and or diabetes (clinical history based on patients interview)
• BMI above 18.5 kg/m2
• ARV naïve
• Well informed and agree to receive ARV
• SMS Reminder :
• Age: ≥ 16 years old

You may not qualify if:

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

Sponsors & Collaborators

• Gadjah Mada University: lead
• Udayana University: collaborator
• Hasan Sadikin General Hospital: collaborator
• Yayasan Kertipraja: collaborator
• World Health Organization: collaborator
• Sardjito Hospital Yogyakarta: collaborator
• Universitas Katholik Atmajaya: collaborator
• Universitas Padjadjaran: collaborator
• Kirby Institute: collaborator

Study Sites (4)

Yayasan Kerti Praja

Denpasar, Bali, 80223, Indonesia

Location

Dr. Sardjito Hospital, Yogyakarta Indonesia

Yogyakarta, DI Yogyakarta, 55281, Indonesia

Location

Atma Jaya HIV-AIDS Research Centre

Jakarta, DKI Jakarta, 12930, Indonesia

Location

Hasan Sadikin Hospital, Bandung, Indonesia

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yanri W Subronto, PhD

  Gadjah Mada University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD,Sp.PD-KPTI,FINASIM

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 6, 2018
• Study Start: November 22, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (4)