Differentiated Service Delivery for Antiretroviral Therapy

Completed

• Conditions: HIV Infections
• Interventions: Other: questionnaires survey

• Registration Number: NCT04383769
• Lead Sponsor: Thai Red Cross AIDS Research Centre

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.

Study Timeline

• Study Start: 2019-12-15
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Primary Completion: 2021-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
5,000 participants:	questionnaires survey	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.

Primary Outcome Measures

Name	Time	Method
differentiated service delivery for antiretroviral therapy (DSD-ART)	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

Trial Locations

Locations (1)

3. Swing Dic,; 🇹🇭 Chon Buri, Thailand