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

MRC/UVRI and LSHTM Uganda Research Unit

Status: Unknown

Conditions: Acute Human Immunodeficiency Virus Type I Infection

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT05372510

RGAO190401

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.