NCT05953844

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 12, 2023

Last Update Submit

July 12, 2023

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Extent of adherence to antiretroviral treatment

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

    6 MONTHS

Secondary Outcomes (1)

  • factors influencing adherence to ART

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HIV +ve adults identified and listed by the HIV/AIDS National program in Assiut governorate.

You may qualify if:

  • HIV +ve adults identified and listed by the HIV/AIDS National program in Assiut governorate.
  • Aged 18 years old and more.

You may not qualify if:

  • prisoners children patients aged less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 16079372RESULT

  • 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.

    PMID: 18425859RESULT

  • 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.

    PMID: 15076819RESULT

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

    PMID: 10860902RESULT

  • 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 available.

    PMID: 11416722RESULT

  • 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.

    PMID: 3945130RESULT

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

    PMID: 24495293RESULT

  • 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 antiretroviral treatment in the UK: cross-sectional and longitudinal analyses. Lancet Public Health. 2016 Nov;1(1):e26-e36. doi: 10.1016/S2468-2667(16)30002-0.

    PMID: 28299369RESULT

  • 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):157-159. doi: 10.24875/AIDSRev.19000028.

    PMID: 31386650RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Heba sayed

CONTACT

01015544483white_heart198788@yahoo.com

Omaima Elgibaly

CONTACT

01223971259Oelgibaly@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 20, 2023

Study Start

September 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

July 20, 2023

Record last verified: 2023-07