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Completed
NCT03733093
PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)
Conditions: HIV
Sex: All
Healthy volunteers: No
Enrollment: 1377
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Location: C.H. Rennie Hospital Kakata
Summary
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.
...
Eligibility Criteria
* INCLUSION CRITERIA:
Individuals of any age and gender must meet all of the following criteria to be eligible for study participation:
1. HIV infection confirmed by HIV-1/2 enzyme-linked immunosorbent assay (ELISA) and confirmatory test or positive assay for HIV-1 pVL.
2. Ability to provide informed consent.
3. Willingness to allow storage of biological samples for research testing.
4. 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.
Source: ClinicalTrials.gov (NCT03733093). StuddyBuddy aggregates publicly available trial information.