NCT03659253

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

Completed NA Last updated 5 February 2020

What this trial tests

NA trial testing Oral Fluid Based Self Testing in HIV/AIDS in 827 participants. Completed in 31 December 2019.

Timeline

22 November 2017

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Gadjah Mada University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	827
Start date	22 November 2017
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	4 locations across Indonesia

Drugs / interventions tested

• Oral Fluid Based Self Testing
• Simplified ART Initiation
• CBO AND BROTHEL-BASED ART SERVICE
• SMS REMINDER
• MOTIVATIONAL INTERVIEWING

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Gadjah Mada University

Who can join

Adults 16 to 50, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antiretroviral adherence for adolescents growing up with HIV: understanding real life, drug delivery and forgiveness.
   Foster C, Ayers S, Fidler S. · · 2020 · cited 30× · PMID 32523693 · DOI 10.1177/2049936120920177
2. Motivational Interviewing as an Intervention to Improve Antiretroviral Treatment Initiation Among People who Inject Drugs (PWID): A Pilot Study in Jakarta and Bandung, Indonesia.
   Sukmaningrum E, Ayu AP, Wongso LV, Handayani M, et al · · 2024 · cited 2× · PMID 37259929 · DOI 10.2174/2589977515666230531154629
3. Acceptability of a pilot motivational interviewing intervention at public health facilities to improve the HIV treatment cascade among people who inject drugs in Indonesia.
   Wongso LV, Rahadi A, Sukmaningrum E, Handayani M, et al · · 2024 · PMID 38561793 · DOI 10.1186/s12954-024-00989-w