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临床试验/CTRI/2024/08/072599
CTRI/2024/08/072599招募中不适用

A retrospective analysis of adherence rate and associated factors in a Tenofovir, Lamivudine, and Dolutegravir based regimen in People Living with HIV

Government Medical College, Patiala1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年8月27日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
1) Adherence rate in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen.

研究概览

简要总结

A retrospective analysis of adherence rate and associated factors in a Tenofovir, Lamivudine, and Dolutegravir based regimen in People Living with HIV

Introduction:

Dolutegravir, a key component of the TLD regimen, has a high barrier to resistance and is well-tolerated by patients. Despite these advantages, adherence to ART remains a critical challenge that affects treatment outcomes. Thus, we plan to conduct a retrospective analysis to explore adherence rates to the Tenofovir, Lamivudine, and Dolutegravir regimen among People Living with HIV (PLHIV) and associated factors at the ART Centre, Government Medical College and Rajindra Hospital, Patiala.

**Aims & Objectives:**The primary objective of the research includes determining the adherence rate and identifying factors associated with adherence in PLHIV on the TLD regimen. The secondary objective includes comparing adherence between different age groups, genders, socio-economic classes, and WHO Clinical Stages in PLHIV on the TLD regimen.

Materials and Methods:

It is a retrospective study of PLHIV who are registered at the ART Centre at Government Medical College & Rajindra hospital, Patiala and initiated on TLD regimen. Medical records for all patients fulfilling the inclusion and exclusion criteria will be reviewed on a retrospective basis for a duration of three consecutive months. Data will be collected on a predesigned semi structured case record form and will be analyzed using appropriate statistical tests.

Clinical Significance:

By elucidating factors contributing to adherence and its impact on treatment outcomes, this study seeks to inform targeted interventions aimed at enhancing adherence and optimizing HIV care delivery.

Key words: Dolutegravir, Adherence, HIV, TLD regimen

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients above the age of 18 years 2) Patients diagnosed with HIV 3) PLHIV registered at ART Centre in Government Medical College and Rajindra Hospital, Patiala 4) Treatment naïve PLHIV initiated on Tenofovir 300 mg, Lamivudine 300 mg, Dolutegravir 50 mg, fixed-dose combination regimen 5) PLHIV on TLD with a minimum of 2 drug refills irrespective of follow-up period.

排除标准

  • Records with incomplete data on ART adherence 2) PLHIV not on Tenofovir 300 mg, Lamivudine 300 mg, Dolutegravir 50 mg, fixed-dose combination regimen 3) PLHIV whose ART regimen was switched during the study period.

结局指标

主要结局

1) Adherence rate in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen.

时间窗: Medical records for all patients put on anti-retroviral therapy fulfilling the inclusion and exclusion criteria will be reviewed on a retrospective basis for a duration of three consecutive months. | All visits that the patient has completed within a period of one year from date of initiation of ART will be considered.

2) Factors associated with adherence in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen.

时间窗: Medical records for all patients put on anti-retroviral therapy fulfilling the inclusion and exclusion criteria will be reviewed on a retrospective basis for a duration of three consecutive months. | All visits that the patient has completed within a period of one year from date of initiation of ART will be considered.

次要结局

  • 1) Adherence between different age groups in people living with HIV on Tenofovir, Lamivudine, and Dolutegravir regimen.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sharwani Vijayshree Lal

Government Medical College, Patiala

研究点 (1)

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