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临床试验/NCT03659253
NCT03659253已完成不适用

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)

Gadjah Mada University8 个研究点 分布在 1 个国家目标入组 827 人开始时间: 2017年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
827
试验地点
8
主要终点
Proportion of virologically suppressed

研究概览

简要总结

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)

详细描述

Description of the Each Proposed Interventions After the qualitative research, literature reviews, thorough discussions, and based on practical/ logistic considerations, there are five specific interventions that have been chosen. Each of the intervention will be presented here in the same format, i.e. rationale of the intervention, aims of the intervention, study site and key population, description of the intervention, and evaluation of the intervention.

  1. ORAL FLUID BASED TESTING (SELF-TESTING) AS A STRATEGY TO OVERCOME BARRIERS OF TESTING AMONG MSM IN BALI, INDONESIA While in Indonesia facility-based HIV testing and counselling (HTC) has been available widely, studies including the HATI qualitative research found that people still worry about stigma, visibility, and social discrimination. Also some reports mentioned lack of privacy and lengthy waiting time for the result impede people to access facility based testing. Public health effort to increase testing coverage and treatment uptakes is urgently needed. Home based testing kit including oral saliva test for HIV has been available in the international market that could bring more control to the communities in finding out their HIV status. A number of studies have reported that the self-testing strategy is accepted and in many cases preferred, however there is still limited study to evaluate its effectiveness in increasing HTC and treatment uptake.

The aim of intervention : To test whether oral fluid self-testing will increase the uptake HTC in MSM and increase the number of HIV+ve MSM who are aware of their status in Bali, Indonesia Description of intervention The current HIV testing practices in Indonesia is happen in two major settings: VCT clinic settingand Mobile testing; both procedure need the health provider team in minimum consist of a doctor, a nurse, a lab technician/analyst and outreach staffs.

The intervention will be different to above practices as it will add or introduce a new option of HIV diagnosis using oral fluids rapid test that could be conducted by the clients themselves (self-testing).

  1. The second year intervention will introduce provider supervised and unsupervised self-testing as an option for early HIV diagnosis among MSM community in Denpasar Bali Indonesia.
  2. The intervention will be delivered by outreach workers of Kerti Praja Foundation (YKP) in Denpasar Bali. Currently there are 8 outreach workers for MSM in Denpasar. The main task of the outreach staff would be delivering health communication and education around self-testing procedures, distribute the kits to participants who received the test, supervised the test when participants choose to have supervised test, collect the used kits, conduct follow up counselling procedure of the test results including for participants who choose to have unsupervised or home-based test, and conduct referral of reactive result participants to the VCT clinics for confirmatory test and ART services.
  3. Potential subjects will be approached in the outreach setting conducted by outreach workers during a standard outreach works. Every MSM will be offered HTC at VCT clinics or mobile VCT available near to their living or working areas. If the client refuse, outreach worker will offer self-testing option.
  4. Steps that will take place if potential subject received the intervention i. Subjects will be given detailed information on how to use the test kit in a standardised information (brochure or video) and counselling session for the use of self-testing kit.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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;
  • 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
  • Well informed and agree to receive ARV
  • SMS Reminder :
  • Age: ≥ 16 years old
  • New HIV positive patients initiating ARV
  • Owning a mobile phone with reliable reception
  • Willing to report to research team whenever changing their phone number during the intervention period.
  • Motivational Interviewing :
  • Inclusion criteria for the intervention are:
  • PWID with HIV positive;
  • ARV naïve or have ever received treatment but lost to follow up;
  • 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
  • 16 years old or older

排除标准

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

结局指标

主要结局

Proportion of virologically suppressed

时间窗: 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

次要结局

  • Quantify and comparing other components of the HIV treatment cascade/continuum of care(12 months)
  • Assess behavioural aspects of Test and Treat Strategy(12 months)
  • Number of participants that virologically suppressed(12 months)
  • Assess the safety and acceptability of early ART Initiation(12 months)

研究者

发起方
Gadjah Mada University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanri Wijayanti Subronto, MD

MD,PhD,Sp.PD-KPTI,FINASIM

Gadjah Mada University

研究点 (8)

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