COVID-19 Recovery Study: Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV

  • STATUS
    Recruiting
  • End date
    Jun 11, 2022
  • participants needed
    315
  • sponsor
    Johns Hopkins University
Updated on 19 July 2021
HIV Vaccine

Summary

This observational study will prospectively characterize the long-term symptoms and side effects of COVID-19 in cohorts of people living with and without HIV. This will be achieved through a series of remote study visits involving completing surveys about health history, symptoms, mood, quality of life and changes in health, and up to two blood draws from home through the use of a mobile phlebotomy service.

Description

This is a prospective observational study being conducted to learn about late (2+ weeks or more) effects of COVID-19 in people living with and without HIV. The investigators plan to do this by studying people who have COVID-19 and people who have not had COVID-19, and by studying people living with HIV and people who are HIV-negative. The investigators will investigate the average duration of symptoms after COVID-19, how these symptoms affect quality of life, and what medical complications are common after COVID-19 in people with and without HIV.

Participation involves:

  • Participant completion of surveys about themselves, their health history, their quality of life and mood in the recent past, and about COVID-19 or HIV if the participant has a history of either infection. The investigators will ask participants to answer questions in up to 5 follow-up surveys over the course of a year about their symptoms, mood, quality of life, and changes in health. Participants will also complete a series of short tests of thinking, memory, and reaction speed at certain follow-up surveys.
  • Up to two visits to the participant's home (or an acceptable location of their choosing) by a phlebotomist. The phlebotomist will collect about 3.5 tablespoons of blood, as well as measure height, weight, and vital signs when laying down and standing up.

This is a fully remote study and all study activities can be done from home or another location of the participant's choosing.

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, HIV Infections, Severe Acute Respiratory Syndrome Coronavirus 2, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment No intervention
Clinical Study IdentifierNCT04958889
SponsorJohns Hopkins University
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults 18 years of age or older
Living within the contiguous 48 states
Groups 1 and 3: self-reported HIV infection
Groups 2 and 4: self-reported HIV negative

Exclusion Criteria

Inability to communicate by telephone in English or Spanish
Inability to complete required study events
A first or only diagnosis of COVID-19 5 or more months prior to first contact with participant
Groups 3 and 4: diagnosis of cOVID-19 ever, or participant suspects they had COVID-19 at any time regardless of whether they were tested
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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