Differentiated Service Delivery for Antiretroviral Therapy

Sponsor

Thai Red Cross AIDS Research Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT04383769

Collaborator

(none)

5,000

Enrollment

Location

Anticipated Duration (Months)

69.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Other: questionnaires survey

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 Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Differentiated Service Delivery for Antiretroviral Therapy

Actual Study Start Date :

Dec 15, 2019

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 15, 2025

Arms and Interventions

Arm	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: 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 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.

Arm

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: 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

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	3. Swing Dic,	Chon Buri		Thailand

Sponsors and Collaborators

Thai Red Cross AIDS Research Centre

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thai Red Cross AIDS Research Centre

ClinicalTrials.gov Identifier:

NCT04383769

Other Study ID Numbers:

DSD-ART

First Posted:

May 12, 2020

Last Update Posted:

Jul 9, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Jul 9, 2021