PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 99 |
| Updated: | 11/9/2018 |
| Start Date: | November 13, 2018 |
| End Date: | November 30, 2024 |
| Contact: | Stephen A Migueles, M.D. |
| Email: | smigueles@niaid.nih.gov |
| Phone: | (301) 496-7090 |
PREVAIL VIII: A CoHOrt Clinical, Viral, and, ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)
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.
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.
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.
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.
- 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 future research testing,
including genetic testing.
4. Willingness to be followed by a participant tracker.
5. Willingness to be referred for clinical care at a preferred treatment and care clinic
if not already enrolled in care.
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
We found this trial at
2
sites
Bethesda, Maryland 20892
Phone: 301-496-7090
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