An observational study in HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 4 sites in Liberia. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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:
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.
...
Resources for management of HIV-positive individuals are extremely limited in the West African country of Liberia, and many knowledge gaps exist about the nature of the HIV epidemic in this country. While the prevalence is likely low compared to other regions in Sub-Saharan Africa, the burden of disease is likely high given the current state of the Liberian health care system, despite attempts to improve HIV treatment services and coverage. The Ebola epidemic of 2014-2016 created tremendous strain on a health care system already weakened by years of civil strife, and it is suspected that care for many HIV-positive individuals was disrupted by this event. Currently, clinicians do not have regular access to measurements of CD4 levels or viral loads, making management of people living with HIV in Liberia difficult. While there is some access to antiretroviral (ARV) medications through the National AIDS and Sexually Transmitted Infection (STI) Control Program, several details, including the extent of this access and the impact on disease outcomes, remain unknown. This cohort study will examine these basic factors; attempt to characterize major social/demographic, clinical, immunologic, and virologic features of HIV/AIDS; and investigate the course of HIV disease, including rates of hospitalization, frequencies of ARV regimen modifications, and incidence of certain opportunistic diseases, STIs, other co-infections, and non-AIDS comorbidities among those who are enrolled. Study participants will attend periodic study visits over 3 years. Clinical information will be collected, as will blood and urine samples for clinical and research tests. This protocol is not designed to estimate the prevalence of HIV infection; however, it provides a unique opportunity to generate quality data to understand the course and epidemiology of HIV and AIDS in Liberia. It also provides an opportunity to contribute to the quality and impact of HIV prevention, treatment, and care programs in Liberia.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 1,377 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
cohort of individuals currently receiving or initiating care for HIV infection in Margibi and Montserrado Counties, Liberia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals of any age and gender must meet all of the following criteria to be eligible for study participation:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV Positive
Description of disease course
Description of the course of HIV disease in the study population as a whole or by subgroup.
Time frame: 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.
Time frame: Baseline
ARV Genotypic Resistance Mutations
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.
Time frame: 1 year
Plan to share: No — De-identified data will be shared
No publications or documents are linked to this record.
Ran from Aug 2019 to primary completion in Dec 2025, 76 months.
Of 122 non-industry observational studies under Tuberculosis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's 76 months is above that.
Counting every sponsor, half of 134 studies reached it within 36 months; a quarter within 21 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID) →