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

May 10, 2022 updated by: Dr. Andrew Obuku, MRC/UVRI and LSHTM Uganda Research Unit

A Pilot Study to Evaluate the Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.

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 Overview

Status

Recruiting

Conditions

Acute Human Immunodeficiency Virus Type I Infection

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ANDREW OBUKU, PhD
Phone Number: +256772623473
Email: Andrew.Obuku@mrcuganda.org

Study Contact Backup

Name: FREDDIE KIBENGO, MD
Phone Number: +256772435251
Email: Freddie.Kibengo@mrcuganda.org

Study Locations

Uganda
- - Masaka, Uganda
    - Recruiting
    - MRC/UVRI & LSHTM, Uganda Research Unit,Masaka station
    - Contact:
      
      FREDDIE KIBENGO, MD
      
      Phone Number: +256772435251
      
      Email: Freddie.Kibengo@mrcuganda.org
    - Contact:
      
      DOREEN ASIO, Bachelors
      
      Phone Number: +256772425404
      
      Email: Doreen.Asio@mrcuganda.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any females and males between 18years - No limit.

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To measure the number of individuals who are Genexpert HIV Viral load assay positive and Alere Determine HIV-1/2 Negative. Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MRC/UVRI and LSHTM Uganda Research Unit

Collaborators

International AIDS Vaccine Initiative

Investigators

Principal Investigator: ANDREW OBUKU, PhD, MRC/UVRI & LSHTM Uganda Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)