Adherence to Antiretroviral Therapy in HIV Infected Individuals in Assiut Governorate, Egypt

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05953844
Collaborator
(none)
278
21

Study Details

Study Description

Brief Summary

Egypt is a HIV low prevalence country but between 2010 and 2019 newly infected cases have more than quadrupled, and the rise continues at an alarming pace. Maintaining over 95% adherence level among the PLHIV in developing countries is a crucial issue to maintain viral suppression, to minimize HIV related morbidity and mortality. The present study aims to identify the level of adherence and the factors influencing adherence to ART in Assiut Governorate. To the best of our knowledge, no previous studies on adherence to antiretroviral therapy and its associated factors in HIV infected individuals were done in Egypt.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Egypt is a HIV low prevalence country but between 2010 and 2019 newly infected cases have more than quadrupled, and the rise continues at an alarming pace. According to the WHO country profile in 2021, 65% of people living with HIV (PLHIV) know their status, there is no statistic on viral load suppression, or the level of adherence to treatment among those who are under care.

    To achieve optimal results from Antiretroviral therapy (at least 95%), high levels of patient adherence to ART is essential. Therefore, enhancing ART coverage is a principal strategy to end HIV/AIDS.

    Medication adherence, which can be defined as the extent to which a patient's medicine-taking behavior corresponds with agreed instructions from a health care provider, is essential for realizing the potential benefits of most medication-based treatment. Many patients, especially those with chronic diseases, experience difficulties in adhering to a recommended treatment plan. Medication non-adherence, with average rates of those affected being between 30 and 50%, is a major challenge in the real-life treatment of these patients .

    Despite several advances in ART for human immunodeficiency virus in the last decades, non-adherence continues to be a critical phenomenon in the treatment of these patients. Not only short-term virological response will be poor, but low drug concentrations also dramatically accelerate development of drug-resistance. So, maintaining over 95% adherence level among the PLHIV in developing countries is a crucial issue to maintain viral suppression, to minimize HIV related morbidity and mortality.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    278 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Adherence to Antiretroviral Therapy in HIV Infected Individuals in Assiut Governorate, Egypt
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Extent of adherence to antiretroviral treatment [6 MONTHS]

      report on the extent of adherence to treatment by HIV +ve patients in Assiut Governorate.

    Secondary Outcome Measures

    1. factors influencing adherence to ART [6 months]

      identification of factors influencing adherence to ART among HIV infected individuals in Assiut Governorate.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • HIV +ve adults identified and listed by the HIV/AIDS National program in Assiut governorate.

    Aged 18 years old and more.

    Exclusion Criteria:
    • prisoners children patients aged less than 18 years old

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heba Sayed Sabra, doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05953844
    Other Study ID Numbers:
    • HIV/AIDs
    First Posted:
    Jul 20, 2023
    Last Update Posted:
    Jul 20, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2023