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NCT04383769 Clinical Trial

Differentiated Service Delivery for Antiretroviral Therapy

HIV Infections Clinical Trial

Official title:
Differentiated Service Delivery for Antiretroviral Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04383769
Other study ID # DSD-ART
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 15, 2019
Est. completion date December 15, 2025

Study information
Verified date February 2023
Source Thai Red Cross AIDS Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5000
Est. completion date December 15, 2025
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Thailand 3. Swing Dic, Chon Buri

Sponsors (1)
Lead Sponsor Collaborator
Thai Red Cross AIDS Research Centre

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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