PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)

NCT03733093 | Completed

• 2 other identifiers: 99991901419-I-N014
• Study Type: observational
• Target: 1,377
• Locations: 1 country
• Sites: 4

Brief 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. ...

Conditions

HIV

Keywords

HIV; Opportunistic Diseases; Tuberculosis; AIDS; Sexually Transmitted Infection; Natural History

Outcome Measures

Primary Outcomes (2)

• Description of disease course

  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

  Description of major social/demographic, clinical, immunologic, and virologic characteristics of HIV disease in the study population at baseline.

  Baseline

Secondary Outcomes (1)

• ARV Genotypic Resistance Mutations

  1 year

Study Arms (1)

1

HIV Positive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cohort of individuals currently receiving or initiating care for HIV infection in Margibi and Montserrado Counties, Liberia.

You may qualify if:

• 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.

You may not qualify if:

• Individuals meeting the following criterion will be excluded from study participation:
• \. 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

C.H. Rennie Hospital

Kakata, Liberia

Location

John F. Kennedy (JFK) Medical Center

Monrovia, Liberia

Location

Redemption Hospital

Monrovia, Liberia

Location

Duport Road Clinic

Paynesville, Liberia

Location

MeSH Terms

Conditions

Tuberculosis; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen A Migueles, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 7, 2018
• Study Start: August 22, 2019
• Primary Completion: December 31, 2025
• Study Completion: January 8, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-01-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (4)