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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05953844
• Other study ID #: HIV/AIDs
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Heba sayed
• Phone: 01015544483
• Email: white_heart198788[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 278
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

Abdulrahman SA, Ganasegeran K, Rampal L, Martins OF. [Conceptual Framework for Investigating and Influencing Adherence Behavior among HIV-Positive Populations: An Applied Social Cognition Model]. AIDS Rev. 2019 Aug 6;21(3):23-27. doi: 10.24875/AIDSRev.190 — View Citation

Bangsberg DR, Perry S, Charlebois ED, Clark RA, Roberston M, Zolopa AR, Moss A. Non-adherence to highly active antiretroviral therapy predicts progression to AIDS. AIDS. 2001 Jun 15;15(9):1181-3. doi: 10.1097/00002030-200106150-00015. No abstract availabl — View Citation

Burch LS, Smith CJ, Anderson J, Sherr L, Rodger AJ, O'Connell R, Geretti AM, Gilson R, Fisher M, Elford J, Jones M, Collins S, Azad Y, Phillips AN, Speakman A, Johnson MA, Lampe FC. Socioeconomic status and treatment outcomes for individuals with HIV on a — View Citation

Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis. 2000 Jun;30 Suppl 2:S171-6. doi: 10.1086/313849. — View Citation

DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004 Mar;42(3):200-9. doi: 10.1097/01.mlr.0000114908.90348.f9. — View Citation

Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3. — View Citation

Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007. — View Citation

Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available. — View Citation

Schaecher KL. The importance of treatment adherence in HIV. Am J Manag Care. 2013 Sep;19(12 Suppl):s231-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of adherence to antiretroviral treatment	report on the extent of adherence to treatment by HIV +ve patients in Assiut Governorate.	6 MONTHS
Secondary	factors influencing adherence to ART	identification of factors influencing adherence to ART among HIV infected individuals in Assiut Governorate.	6 months