- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03733093
PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)
Background:
There are many people living with human immunodeficiency virus (HIV) infection in Liberia. Most experts consider HIV an epidemic there. Researchers want to collect health data from Liberians with HIV over several years. This may help HIV prevention and treatment programs in Liberia.
Objective:
To learn more about how HIV affects people in Liberia.
Eligibility:
People with HIV in Liberia
Design:
Participants will be screened with a blood sample.
Participants will visit the study clinic about 10 times over 3 years. They will need to return to the clinic after some visits to get test results. The visits will be closer together during the first part of the study and less frequent later.
At each study visit, participants will:
- Have a brief physical exam
- Answer questions about how they are feeling and what medicines they are taking
- Have blood taken from an arm vein by a needle
- Give urine samples
Participants ages 12 years or older may be asked questions about HIV risk behaviors. These include sex practices and drug use. Participants ages 18 years or older may be asked how their
HIV infection makes them feel emotionally.
Participants may be asked to join a research substudy. This will be about tuberculosis (TB) testing in people with HIV. For this substudy, participants will have a TB skin test. A small amount of liquid will be injected under the skin on the arm.
Participants will return to the clinic a few days later. The test area will be checked. They will get their test results.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Kakata, Liberia
- C.H. Rennie Hospital
-
Monrovia, Liberia
- John F. Kennedy (JFK) Medical Center
-
Monrovia, Liberia
- Redemption Hospital
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Paynesville, Liberia
- Duport Road Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
Individuals of any age and gender must meet all of the following criteria to be eligible for study participation:
- HIV infection confirmed by HIV-1/2 enzyme-linked immunosorbent assay (ELISA) and confirmatory test or positive assay for HIV-1 pVL.
- Ability to provide informed consent.
- Willingness to allow storage of biological samples for research testing.
- Willingness to be followed by a participant tracker.
EXCLUSION CRITERIA:
Individuals meeting the following criterion will be excluded from study participation:
1. Any condition that, in the opinion of the investigator, would compromise the safety of the study subject or staff, or would prevent proper conduct of the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
1
HIV Positive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of disease course
Time Frame: Months 1,3,6,12,18,24,30,36
|
Description of the course of HIV disease in the study population as a whole or by subgroup.
|
Months 1,3,6,12,18,24,30,36
|
Characteritics of study population
Time Frame: Baseline
|
Description of major social/demographic, clinical, immunologic, and virologic characteristics of HIV disease in the study population at baseline.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ARV Genotypic Resistance Mutations
Time Frame: 1 year
|
Determine ARV genotypic resistance mutations within 1 year of study initiation on stored samples from a subset of participants with HIV-1 pVL >1000 copies/mL at baseline (+/- ART) or at other early study timepoints.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stephen A Migueles, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999919014
- 19-I-N014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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