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

NCT03659253 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 827

Last updated 2020-02-05

No results posted yet for this study

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
  • World Health Organization

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03659253 on ClinicalTrials.gov