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

MRC/UVRI and LSHTM Uganda Research Unit100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Acute Human Immunodeficiency Virus Type I Infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts