Differentiated Service Delivery for Antiretroviral Therapy

NCT04383769 | Completed

• 1 other identifier: DSD-ART
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

questionnaires survey 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.

5,000 participants:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• N/A

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead

Study Sites (1)

3. Swing Dic,

Chon Buri, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nittaya Phanuphak, MD,Ph.D

  Institute of HIV Research and Innovation (IHRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: December 15, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2023
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

TH (1)