Differentiated Service Delivery for Antiretroviral Therapy

February 15, 2023 updated by: Thai Red Cross AIDS Research Centre
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Chon Buri, Thailand
        • 3. Swing Dic,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Data officer will collect secondary data regarding ART refill, laboratory test, counseling, doctor visit for HIV-related conditions, such as adverse drug reaction, opportunistic infections, and comorbidities, from the medical records already existed in the hospital and community-based organization systems and entered into the case report form. The identity of the clients will be untraceable since UL, which is a unique letter code assigned to each participant using Thai initials and date of birth translated into English alphabets, will be used as an individual identifier. The data will be collected prospectively for 24 months and retrospectively for up to 5 years from the screening date.

Description

Inclusion Criteria:

  1. Thai citizenship
  2. Age ≥ 18
  3. HIV positive
  4. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
5,000 participants:

2,500 are PLHIV receiving standard care in the hospital and 2,500 are PLHIV receiving care in DSD-ART model

Inclusion criteria:

  1. Thai citizenship
  2. Age ≥ 18
  3. HIV positive
  4. 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)

  5. One of the following:

    1. Accept DSD-ART, OR
    2. Already receiving DSD-ART, OR
    3. Decline DSD-ART and will continue standard ART service at the hospital.
Other: questionnaires survey
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differentiated service delivery for antiretroviral therapy (DSD-ART)
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thai Red Cross AIDS Research Centre

Investigators

  • Principal Investigator: Nittaya Phanuphak, MD,Ph.D, Institute of HIV Research and Innovation (IHRI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2019

Primary Completion (Actual)

December 15, 2022

Study Completion (Anticipated)

December 15, 2025

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSD-ART

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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