A study to find out the effect of Covid Vaccine in patients living with HIV/AIDS in central Kerala and to identify different types of SARS CoV2 viruses affecting these patients

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease,

Registration Number: CTRI/2021/10/037337

Lead Sponsor: ICMR

Brief Summary: PLHIV are at risk of adverse outcomes of SARS CoV-2 infection. Immune suppression, indicated by a low CD4 T-cell count (<200/Âµl) is found to be associated with risk for severe disease in PLHIV and COVID-19 vaccination evidently prevents severe disease. The assessment of real world effectiveness of these vaccines in PLHIV and determination of cut off value of CD4 count for severe COVID-19 and determining the genomic variants of SARS CoV 2 virus in PLHIV is imperative. Novelty: There is paucity of literature on effectiveness of COVID vaccine and estimates of cut off value of CD4 counts in PLHIV, which can determine their priority for vaccination. The study entails the identification of SARS CoV 2 variants in PLHIV.Objectives:

a) To determine the real world effectiveness of COVID-19 vaccines in PLHIV

b) To estimate the cut off of CD4 count level for severe Covid-19 and to study the variants of SARS CoV 2 virus in PLHIV

Methods:

Ambidirectional cohort study would be conducted among 910 PLHIV in the support groups of Thrissur and Palakkad districts, Kerala with a follow up of one year. Sociodemographic details, COVID infection and vaccination details, baseline CD4 count and NP swab for RT-PCR testing would be collected at enrollment and follow-up.

Expected outcomes:

a) Vaccine effectiveness of COVID-19 vaccines among PLHIV

b) Cut off value of CD4 count that could predict severity of COVID-19 in PLHIV

c) Proportion of different SARS CoV-2 variants infecting PLHI

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 910

Inclusion Criteria

PLHIV above 18 years of age.

Exclusion Criteria

Any participant not able to communicate coherently or is non-ambulatory (mentally ill, dementic, bedridden, unconscious & comatose).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaccine effectiveness of COVID-19 vaccines among PLHIV	12 months

Secondary Outcome Measures

Name	Time	Method
1) Cut off value of CD4 count that could predict severity of COVID-19 in PLHIV	2)Proportion of different SARS CoV-2 variants infecting PLHI

Trial Locations

Locations (1): JubIee Mission Medical College and Research Institute
🇮🇳
Thrissur, KERALA, India
JubIee Mission Medical College and Research Institute
🇮🇳Thrissur, KERALA, India
Dr Joe Thomas
Principal investigator
9447960010
covidjmmcri@gmail.com