HIV InfectionsNCT05953844
Adherence to Antiretroviral Therapy in HIV Infected Individuals in Assiut Governorate, Egypt
An observational study of HIV Infections, run by Assiut University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV +ve adults identified and listed by the HIV/AIDS National program in Assiut governorate.
Who may be able to join
- HIV +ve adults identified and listed by the HIV/AIDS National program in Assiut governorate.
- Aged 18 years old and more.
Who cannot join
- prisoners children patients aged less than 18 years old
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of adherence to antiretroviral treatment
report on the extent of adherence to treatment by HIV +ve patients in Assiut Governorate.
Measured: 6 MONTHS
Secondary outcomes (1)
factors influencing adherence to ART
identification of factors influencing adherence to ART among HIV infected individuals in Assiut Governorate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Sayed Sabra, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953844
- Sponsor's protocol ID
- HIV/AIDs
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16079372Haynes 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.
PubMed 18425859DiMatteo 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.
PubMed 15076819Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis. 2000 Jun;30 Suppl 2:S171-6. doi: 10.1086/313849.
PubMed 10860902Bangsberg 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.
PubMed 11416722Morisky 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.
PubMed 3945130Schaecher KL. The importance of treatment adherence in HIV. Am J Manag Care. 2013 Sep;19(12 Suppl):s231-7.
PubMed 24495293Burch 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.
PubMed 28299369Abdulrahman 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.
PubMed 31386650
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Antiretroviral Therapy in HIV Infected Individuals in Assiut Governorate, Egypt
- ClinicalTrials.gov ID
- NCT05953844
- Acronym / sponsor ID
- HIV/AIDs
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV +ve adults identified and listed by the HIV/AIDS National program in Assiut governorate.
Key inclusion criteria (2 listed)
- HIV +ve adults identified and listed by the HIV/AIDS National program in Assiut governorate.
- Aged 18 years old and more.
Key exclusion criteria (1 listed)
- prisoners children patients aged less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extent of adherence to antiretroviral treatment
Time frame: 6 MONTHS
report on the extent of adherence to treatment by HIV +ve patients in Assiut Governorate.
1 secondary outcome
factors influencing adherence to ART
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Results publication: PubMed 16079372Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Results publication: PubMed 18425859Haynes 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.
- Results publication: PubMed 15076819DiMatteo 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.
- Results publication: PubMed 10860902Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis. 2000 Jun;30 Suppl 2:S171-6. doi: 10.1086/313849.
- Results publication: PubMed 11416722Bangsberg 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.
- Results publication: PubMed 3945130Morisky 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.
- Results publication: PubMed 24495293Schaecher KL. The importance of treatment adherence in HIV. Am J Manag Care. 2013 Sep;19(12 Suppl):s231-7.
- Results publication: PubMed 28299369Burch 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.
- Results publication: PubMed 31386650Abdulrahman 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba sayed (01015544483, white_heart198788@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of adherence to antiretroviral treatment (time frame: 6 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953844, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.