Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-17

Study Completion Date

2022-12-31

Brief Summary

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It is only between peak viremia and viral setpoint in natural acute HIV-1 infection that the immune response overwhelms viral replication resulting in a plasma viral load decline. The aim will be to characterize these immune responses, how they develop and their progeny. This will require the need to identify HIV-1 infected individuals before peak viremia and follow them to post viral setpoint.

This protocol describes a pilot study to evaluate the feasibility of identifying, enrolling and following acute and early HIV-1 infected individuals from voluntary counselling and testing centres in Masaka, Bukomansimbi, Kalungu, Lwengo, Sembababule and Lyantonde districts.

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Detailed Description

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Conditions

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Acute Human Immunodeficiency Virus Type I Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Females and males.
* Able and willing to provide informed consent.
* Willing to undergo HIV testing using GeneX pert Viral Load assay.
* Able and willing to provide accurate locator information for tracking purposes and willing to be contacted by study staff.
* Willing to complete interviewer administered questionnaires on risk factors and if infected, questions related to the route and timing of exposure.

Exclusion Criteria

Has any condition that in the opinion of the principal investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives.

* Participation in a current clinical trial unless approved by the investigators and IAVI medical monitor.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No