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Effect of COVI Soup on BMI, Immunological and Haematological Parameters Among People Living With HIV in Kakamega County Kenya - Trial PACTR202307740330512

Access comprehensive clinical trial information for PACTR202307740330512 through Pure Global AI's free database. This Not Applicable trial is sponsored by Masinde Muliro University of Science and Tachnology and is currently Not yet recruiting. The study focuses on Infections and Infestations.

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PACTR202307740330512
Not Applicable
Not yet recruiting
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202307740330512
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Effect of COVI Soup on BMI, Immunological and Haematological Parameters Among People Living With HIV in Kakamega County Kenya
An Open Parallel Randomized Control Trial on Effect of COVI Soup on BMI, Immunological and Haematological Parameters Among People Living With HIV in Kakamega County Kenya

Study Focus

Sponsor & Location

Masinde Muliro University of Science and Tachnology

Masinde Muliro University of Science and Technology

Kenya

Timeline & Enrollment

Not Applicable

Jan 01, 1900

Jan 01, 1900

Summary

Coronavirus Disease 2019 (COVID 19) has rapidly spread around the world with approximately 37.9 million People Living with HIV (PLWH) at risk of infection with Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2). The pandemic has the potential to lead to serious negative health outcomes for PLWH. Lack of effective antiretroviral treatment (ART) against SARS-CoV-2 impede the current measures to fight the disease threatening immuno-compromised individualsโ€™ lives. Supportive therapy plays a major role for the patients to fight this pandemic. The main objective of this study is to determine the effect of Covi soup on BMI, Immunological and Hematological parameters among PLWH. Specific objectives are to determine the effect of Covi soup on; Body Mass Index (BMI); CD4+ cell count; Viral Load (VL) and Hematological parameters. This will be an Open Randomized Control Trial (RCT) conducted in Kakamega County Teaching and Referral Hospital (KCTRH) Comprehensive Care Centre (CCC) from August to November 2023. Purposive sampling will be used to select the study area and study site while systematic random sampling will be used to select the study participants. Block randomization will be used to place participants in either treatment group or control group. Approximately 48,752 are PLWH in Kakamega County. A RCT formula will be used to determine the sample size of 60 participants assuming 30 participant for treatment group and 30 for control group. Treatment group will receive standard care alongside Covi soup while the control group will exclusive receive standard care. Data will be collected using researcher administered questionnaire and laboratory report forms. Data will be keyed in Statistical Packages for Social Sciences (SPSS) and analyzed using paired t-test to determine the effect of Covi soup on BMI, CD4+ cell count, VL and Hematological parameters.

ICD-10 Classifications

Certain infectious and parasitic diseases
Other infestations
Infestation, unspecified
Other specified infestations
Other infectious diseases

Data Source

Pan Africa Clinical Trials Registry

PACTR202307740330512

Non-Device Trial