- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06852430
Factors Associated With Advanced HIV and Poor Nutrition Among People Living With HIV
Factors Associated With Advanced HIV Disease and Poor Nutrition Among People Living With HIV: A Hospital-based Study
Aim of the work:
- To determine the frequency of advanced HIV among PLWH in Assiut University Hospital.
- To assess the nutritional patterns and frequency of poor nutrition among PLWH.
- To evaluate factors associated with advanced HIV disease and poor nutrition among PLWH.
Study Overview
Status
Detailed Description
Human immunodeficiency virus (HIV) is an RNA virus that attacks the human body's immune system, which results, in advanced cases, in expression of opportunistic infections (1). HIV infection represents a global public health burden (2, 3). In Egypt, in 2022, about 34,000 people (<0.1%) were positive for HIV (4). There is 25-30% annual increase of newly confirmed HIV cases in Egypt over the last 10 years (5).
The WHO defines advanced HIV disease as having CD4+ T-cell count <200 cell/mm3 or having an acquired immune deficiency syndrome (AIDS)-related infection (stage 3 or 4 of HIV infection) regardless of the CD4+ T-cell count (1).
The WHO reported, in 2022, that 630,000 people living with HIV (PLWH) died from AIDS-related diseases worldwide (which is 51% fewer than those in 2010) (2, 3, 6). In Egypt, the AIDS-related deaths increased from <100 PLWH in 1990 to <1000 PLWH in 2021 (5).
PLWH are usually malnourished due to opportunistic infections, poor food intake, changes in metabolic activity or chronic illnesses. Malnutrition leads to more impairment of the immune system and further disease progression (7).
According to 2023 Global Hunger index, Egypt is at a moderate level of food insecurity, ranking 57 out of 125 countries. 14.4% of the Egyptian population are food insecure (8).
In Egypt, there is lack of data about the frequency of advanced HIV disease and the nutritional status among PLWH and associated factors. Monitoring these factors could help in early treatment of HIV infection, prevention of further virus transmission and enhancement of the nutritional pattern among PLWH.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Salma Hussein Badry, Resident doctor
- Phone Number: +201123254745
- Email: Salma.16266321@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- (1) Newly diagnosed people living with HIV (PLWH), (2) Patients previously diagnosed with HIV but non-compliant to treatment.
Exclusion Criteria:
- (1) PLWH compliant on ART, (2) PLWH who refuse to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
People living with Advanced HIV disease
Factors associated with advanced HIV disease
|
|
People with Early HIV disease
Factors associated with early HIV disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Factors associated with advanced HIV disease and poor nutrition among people living with HIV disease.
Time Frame: Febraury 2025 to December 2026
|
To study factors associated with advanced HIV disease and poor nutrition among people living with HIV
|
Febraury 2025 to December 2026
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Haidi KaramAllah Ramadan, Assisstant professor, Assiut University
- Principal Investigator: Ehab Fawzy Abdou, Professor, Assiut University
Publications and helpful links
General Publications
- Boutros S, Skordis J. HIV/AIDS surveillance in Egypt: current status and future challenges. East Mediterr Health J. 2010 Mar;16(3):251-8.
- Rezazadeh L, Ostadrahimi A, Tutunchi H, Naemi Kermanshahi M, Pourmoradian S. Nutrition interventions to address nutritional problems in HIV-positive patients: translating knowledge into practice. J Health Popul Nutr. 2023 Sep 8;42(1):94. doi: 10.1186/s41043-023-00440-z.
- Ghazy RM, Al Awaidy S, Taha SHN. Trends of HIV indicators in Egypt from 1990 to 2021: time-series analysis and forecast toward UNAIDS 90-90-90 targets. BMC Public Health. 2023 Apr 1;23(1):625. doi: 10.1186/s12889-023-15490-5.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- Advanced HIV, poor nutrition
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
-
Study Protocol
Information identifier: 042025201171
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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