HIV Awal (Early) Testing & Treatment Indonesia Project Intervention Phase
NCT03659253 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 827
Last updated 2020-02-05
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)
Conditions
Interventions
- 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.
- 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.
- 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.
- 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
Sponsors & Collaborators
-
Udayana University
collaborator OTHER -
Hasan Sadikin General Hospital
collaborator OTHER -
Yayasan Kertipraja
collaborator UNKNOWN - collaborator OTHER
-
Sardjito Hospital Yogyakarta
collaborator UNKNOWN -
Universitas Katholik Atmajaya
collaborator UNKNOWN -
Universitas Padjadjaran
collaborator OTHER -
Kirby Institute
collaborator OTHER_GOV -
Gadjah Mada University
lead OTHER
Principal Investigators
-
Yanri W Subronto, PhD · Gadjah Mada University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-22
- Primary Completion
- 2019-12-31
- Completion
- 2019-12-31
Countries
- Indonesia
Study Locations
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