HIVNCT03733093
PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in Liberia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- How many people
- 1,377 participants
- Where
- 4 sitesLiberia
- Study dates
- 22 Aug 2019to 8 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cohort of individuals currently receiving or initiating care for HIV infection in Margibi and Montserrado Counties, Liberia.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Liberia4 sites
C.H. Rennie Hospital
Kakata
John F. Kennedy (JFK) Medical Center
Monrovia
Redemption Hospital
Monrovia
Duport Road Clinic
Paynesville
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- HIV
- Keywords
- HIV, Opportunistic Diseases, Tuberculosis, AIDS, Sexually Transmitted Infection, Natural History
- Medical subject headings
- Tuberculosis, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV Positive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of disease course
Description of the course of HIV disease in the study population as a whole or by subgroup.
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start22 Aug 2019
- Primary completion31 Dec 2025
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,377 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephen A Migueles, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733093
- Sponsor's protocol ID
- 999919014
- Other IDs
- 19-I-N014
- Status last verified
- 16 Oct 2026
- First submitted
- 6 Nov 2018
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)
- ClinicalTrials.gov ID
- NCT03733093
- Acronym / sponsor ID
- 999919014
- Conditions
- HIV
- Keywords
- HIV, Opportunistic Diseases, Tuberculosis, AIDS, Sexually Transmitted Infection, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,377 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –HIV Positive |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cohort of individuals currently receiving or initiating care for HIV infection in Margibi and Montserrado Counties, Liberia.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
ARV Genotypic Resistance Mutations
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. De-identified data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A Migueles, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in Liberia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Liberia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of disease course (time frame: Months 1,3,6,12,18,24,30,36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.