Differentiated Service Delivery for Antiretroviral Therapy

Study Overview
=================
Brief Summary
-----------------
This study is a prospective observational cohort. The target study population is PLHIV who receive ART at hospitals and community-based organizations (CBOs) in Chiang Mai, Ubon Ratchathani, Chonburi, and Songkhla. Participants will receive ART service in the same standard as in the hospital setting. Secondary data will be collected from the medical records already existed in the hospital and CBO systems.

Detailed Description
-----------------
DSD-ART service at the Hospital Medical examination: All clients who receive ART service at the hospital and agree to participate in the research project will be interviewed to collect personal information and receive physical and laboratory examination in order to assess eligibility in research participation. If ineligible, the clients will be referred to the standard of care. Preparation and DSD-ART service offer: PLHIV who are eligible to participate in the research will receive counselling to assess the supports the clients need and will be offered various models of DSD-ART service. The clients may choose the model that is most suitable to their lifestyle.

Official Title
-----------------
Differentiated Service Delivery for Antiretroviral Therapy

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Other: questionnaires survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thai citizenship Age ≥ 18 HIV positive Received ART for at least 6 months at a participating hospital (Except for After hour ART clinic model that will allow participants who receive ART less than 6 months into service) Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 5,000 participants:<br>2,500 are PLHIV receiving standard care in the hospital and 2,500 are PLHIV receiving care in DSD-ART model Inclusion criteria: Thai citizenship Age ≥ 18 HIV positive Received ART for at least 6 months at a participating hospital (Except for After hour ART clinic model that will allow participants who receive ART less than 6 months into service) One of the following: Accept DSD-ART, OR Already receiving DSD-ART, OR Decline DSD-ART and will continue standard ART service at the hospital. | Other: questionnaires survey<br>* data will be collected from the medical records already existed in the hospital and community-based organization (CBO) systems and entered into case report form (CRF). The expected number of participants is 5000. For each participant, the data will be collected prospectively for 24 months and retrospectively up to 5 years from the screening date. This study has no intervention and will not alter ART services whether be standard or DSD-ART at hospitals.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differentiated service delivery for antiretroviral therapy (DSD-ART) | 1. To assess retention among people living with HIV (PLHIV) in various models of differentiated service delivery for antiretroviral therapy (DSD-ART) Hypothesis: The proportions of PLHIV with high ART retention in each DSD-ART model are similar and not inferior to standard-of-care historical data | 5 years |