NCT05063487

Evaluation of HIV-1 Recent Infection Testing in Rwanda

Evaluating the Impact of HIV-1 Recent Infection Testing on Incremental HIV Testing Yield and Adverse Events Linked to Return of Recent Infection Testing Results in Rwanda

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,588 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The rapid test for recent HIV infection (RTRI) assay can distinguish between people who are recently-infected and those who are long-term HIV cases. This may help guide efforts to identify ongoing HIV transmission and direct prevention or treatment efforts. But, more research is needed on the impact of RTRI on the number of HIV+ individuals that can be identified through testing. Furthermore, not much is known about the impact that returning RTRI results may have on the occurrence of intimate partner violence. A primary objective of this study is to compare the HIV testing yield among contacts of people newly diagnosed with HIV by recency testing result. The investigators will abstract routinely collected data from participant medical records and registers. In addition, a second primary objective of this study is to assess the incidence of intimate partner violence associated with the return of recency testing results among those classified as testing recent versus long-term. Index study participants newly diagnosed with HIV will be interviewed at the initial enrollment visit following HIV diagnosis and during follow-up visits at 1, 2, and 6-months using a health-related quality of life instrument and intimate partner violence questionnaire. Participants will be recruited from 60 high-volume facilities across all provinces in Rwanda during the evaluation period.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-29
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2021-10-01
• Last updated: 2023-08-31

Locations

1 site across 1 country: Rwanda