HIV/AIDSNCT03485599
Prevalence,Knowledge and Attitude of HIV /AIDS in Luxor
An observational study of HIV/AIDS, run by Assiut University at 1 site in Egypt.
Trial summary
Human immunodeficiency virus infection is a global pandemic problem. About 35.3 million infected people in the world, so causing a great social, economical, political and cultural problems worldwide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- ELIZA , Westron blot
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2019to Apr 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community based cross sectional study will be done in Luxor,Data will be collected by physicians at the mobile Voluntary Confidential Counseling and Testing centers apart of National strategic plan , blood samples will be taken by laboratory technician,diagnostic tests will be done.
Who may be able to join
- 1-People living in Luxor. 2 Subjects of high risk groups as men have sex with men, children street, female sex workers.
- 3-People clinically diagnosed as HIV/AIDS. 4-People in contact with HIV/AIDS patients.
Who cannot join
- 1 - Subjects outside Luxor 2- People refused to consent 3- Mentally disordered patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine
Asyut, 71111
Amira El Gazar, lecturer, 01008194433, Elgazzar44@yahoo.com
About this study
Human immunodeficiency virus infection is a global pandemic problem. About 35.3 million infected people in the world, so causing a great social, economical, political and cultural problems worldwide.
In 1986 Egypt's first AIDS case was discovered , since then the number of infected cases cases are increasing.According to United Nations 2016 statistics, there are about 11,000 infected people living with Human immunodeficiency virus in Egypt.
Read the detailed description
Human immunodeficiency virus is a lentivirus that causes the infection and over time leading to Acquired immunodeficiency syndrome.
The virus spread primarily by unprotected sex including vaginal, anal and oral sex, contaminated blood transfusions, infected needles, and from mother to child during pregnancy, delivery, or from milk during breastfeeding.
In 1986 Egypt's first AIDS case was discovered , since then the number of infected cases cases are increasing.According to United Nations 2016 statistics, there are about 11,000 infected people living with Human immunodeficiency virus in Egypt.
According to the National Aids Program, the primary mode of transmission is heterosexual intercourse, followed by homosexual intercourse , renal dialysis , and blood transfusion Others include street children, prisoners, and refugees, female sex workers, men have sex with men, and injecting drug users.
Human immunodeficiency virus related stigma and discrimination is a great barrier to effectively fighting the disease epidemic.
This study will assess prevalence, knowledge, attitudes of Human immunodeficiency virus and Acquired immunodeficiency syndrome people in Luxor Governorate in Upper Egypt.
- Conditions
- HIV/AIDS
- Being tested
- ELIZA , Westron blot
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELIZA , Westron blotDiagnostic test
Blood sample will be taken then rapid test by ELIZA will be done if positive then confirmatory test by Westron blot will be done
| Study group | Role | What they receive |
|---|---|---|
| HIV infected people | Blood samples will be taken and rapid HIV test by ELIZA will be done ,for positive cases Westron blot done Receives: Diagnostic Test: ELIZA , Westron blot |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge score
Questionnaire to define knowledge score of HIV/AIDS through an interview
Measured: 20 mintues
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study startJan 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zienab Gamea, Assiut University
- Investigators
- Hisham Zayan, Assistant, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485599
- Sponsor's protocol ID
- PKHIVL
- Status last verified
- Mar 2018
- First submitted
- 21 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cohen MS, Hellmann N, Levy JA, DeCock K, Lange J. The spread, treatment, and prevention of HIV-1: evolution of a global pandemic. J Clin Invest. 2008 Apr;118(4):1244-54. doi: 10.1172/JCI34706.
PubMed 18382737Abstracts from the 38th annual meeting of the society of general internal medicine. J Gen Intern Med. 2015 Apr;30 Suppl 2(Suppl 2):45-551. doi: 10.1007/s11606-015-3271-0. No abstract available.
PubMed 25869016Getnet MK, Damen HM. Level of stigma among female sex workers: comparison of two surveys of HIV behavioral data, Ethiopia. Afr Health Sci. 2011 Dec;11(4):543-9.
PubMed 22649433
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence,Knowledge and Attitude of HIV /AIDS in Luxor
- ClinicalTrials.gov ID
- NCT03485599
- Acronym / sponsor ID
- PKHIVL
- Conditions
- HIV/AIDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 2 Apr 2018 (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.
Human immunodeficiency virus infection is a global pandemic problem. About 35.3 million infected people in the world, so causing a great social, economical, political and cultural problems worldwide.
In 1986 Egypt's first AIDS case was discovered , since then the number of infected cases cases are increasing.According to United Nations 2016 statistics, there are about 11,000 infected people living with Human immunodeficiency virus in Egypt.
Detailed description
Human immunodeficiency virus is a lentivirus that causes the infection and over time leading to Acquired immunodeficiency syndrome.
The virus spread primarily by unprotected sex including vaginal, anal and oral sex, contaminated blood transfusions, infected needles, and from mother to child during pregnancy, delivery, or from milk during breastfeeding.
In 1986 Egypt's first AIDS case was discovered , since then the number of infected cases cases are increasing.According to United Nations 2016 statistics, there are about 11,000 infected people living with Human immunodeficiency virus in Egypt.
According to the National Aids Program, the primary mode of transmission is heterosexual intercourse, followed by homosexual intercourse , renal dialysis , and blood transfusion Others include street children, prisoners, and refugees, female sex workers, men have sex with men, and injecting drug users.
Human immunodeficiency virus related stigma and discrimination is a great barrier to effectively fighting the disease epidemic.
This study will assess prevalence, knowledge, attitudes of Human immunodeficiency virus and Acquired immunodeficiency syndrome people in Luxor Governorate in Upper Egypt.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV infected people | – | Diagnostic Test: ELIZA , Westron blotBlood samples will be taken and rapid HIV test by ELIZA will be done ,for positive cases Westron blot done |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community based cross sectional study will be done in Luxor,Data will be collected by physicians at the mobile Voluntary Confidential Counseling and Testing centers apart of National strategic plan , blood samples will be taken by laboratory technician,diagnostic tests will be done.
Key inclusion criteria (2 listed)
- 1-People living in Luxor. 2 Subjects of high risk groups as men have sex with men, children street, female sex workers.
- 3-People clinically diagnosed as HIV/AIDS. 4-People in contact with HIV/AIDS patients.
Key exclusion criteria (1 listed)
- 1 - Subjects outside Luxor 2- People refused to consent 3- Mentally disordered patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELIZA , Westron blotBlood sample will be taken then rapid test by ELIZA will be done if positive then confirmatory test by Westron blot will be done | Diagnostic test | HIV infected people |
Primary outcome
knowledge score
Time frame: 20 mintues
Questionnaire to define knowledge score of HIV/AIDS through an interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Results publication: PubMed 18382737Cohen MS, Hellmann N, Levy JA, DeCock K, Lange J. The spread, treatment, and prevention of HIV-1: evolution of a global pandemic. J Clin Invest. 2008 Apr;118(4):1244-54. doi: 10.1172/JCI34706.
- Results publication: PubMed 25869016Abstracts from the 38th annual meeting of the society of general internal medicine. J Gen Intern Med. 2015 Apr;30 Suppl 2(Suppl 2):45-551. doi: 10.1007/s11606-015-3271-0. No abstract available.
- Results publication: PubMed 22649433Getnet MK, Damen HM. Level of stigma among female sex workers: comparison of two surveys of HIV behavioral data, Ethiopia. Afr Health Sci. 2011 Dec;11(4):543-9.
- 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.
Hisham Zayan, Assistant study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Assiut University at 1 site in Egypt.
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 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hisham Zayan, Assistant (01223971409, hishamzayan@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge score (time frame: 20 mintues). 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 NCT03485599, which also lists 3 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 2 Apr 2018.