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Evaluation of HIV-1 Recent Infection Testing in Rwanda

NCT05063487 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1588

Last updated 2023-08-31

No results posted yet for this study

Summary

The study is a longitudinal, observational cohort study of people who are newly-diagnosed with HIV who consent to recency testing and participate in index testing services, and their disclosed contacts.

The study will evaluate the impact of recency testing on HIV positive yield of index testing among the contacts of newly diagnosed people living with HIV and the incidence of adverse events or social harm as a result of returning recency results among newly diagnosed people living with HIV.

Conditions

  • HIV Infections

Interventions

OTHER

Return of recent classification

As part of routine HIV case-based surveillance in Rwanda, blood samples are collected for recency testing on the Rapid Test for Recent Infection (RTRI) assay and viral load testing for all newly diagnosed people living with HIV. Results of a recent classification (i.e., having acquired an HIV infection within the last year) will be returned to study participants during a scheduled 1-month visit following initial HIV diagnosis.

OTHER

Return of long-term classification

As part of routine HIV case-based surveillance in Rwanda, blood samples are collected for recency testing on the Rapid Test for Recent Infection (RTRI) assay and viral load testing for all newly diagnosed people living with HIV. Results of a long-term classification (i.e., having acquired an HIV infection more than one year ago) will be returned to study participants during the scheduled 1-month visit following initial HIV diagnosis.

Sponsors & Collaborators

Principal Investigators

  • Suzue Saito, PhD · Columbia University

  • Gallican Rwibasira, MD · Rwanda Biomedical Centre

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Rwanda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063487 on ClinicalTrials.gov