Differentiated Service Delivery for Antiretroviral Therapy

NCT ID: NCT04383769

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-15

Study Completion Date

2023-12-15

Brief Summary

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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

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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.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

questionnaires survey

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thai Red Cross AIDS Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nittaya Phanuphak, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Institute of HIV Research and Innovation (IHRI)

Locations

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3. Swing Dic,

Chon Buri, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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DSD-ART

Identifier Type: -

Identifier Source: org_study_id

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