PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03733093|
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : August 22, 2019
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.
To learn more about how HIV affects people in Liberia.
People with HIV in Liberia
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|Official Title:||PREVAIL VIII: A CoHOrt Clinical, Viral, and, ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)|
|Estimated Study Start Date :||August 27, 2019|
|Estimated Primary Completion Date :||November 30, 2023|
|Estimated Study Completion Date :||December 31, 2025|
- 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.
- 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 awhole or by subgroup.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733093
|Contact: Stephen A Migueles, M.D.||(301) firstname.lastname@example.org|
|C.H. Rennie Hospital||Recruiting|
|Contact: Kumblytee Johnson +2310770185606 email@example.com|
|John F. Kennedy (JFK) Medical Center||Recruiting|
|Contact: James Moses, M.D. +231886659910 firstname.lastname@example.org|
|Contact: Mark Kieh +231886088723 email@example.com|
|Duport Road Clinic||Recruiting|
|Contact: Dehkontee Gayedyu-Dennis, M.D. +231886538810 firstname.lastname@example.org|
|Principal Investigator:||Stephen A Migueles, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|