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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: Return of recent classification; Other: Return of long-term classification

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.

• Study Type: Observational
• Enrollment (Actual): 1588

Contacts and Locations

• Study Contact: Name: Suzue Saito, PhD; Phone Number: 212-304-7130; Email: ss1117@cumc.columbia.edu

Study Locations

• Rwanda
  • Kigali, Rwanda
    • Rwanda Biomedical Centre, Ministry of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population are persons ≥15 years of age who are newly diagnosed with HIV during HIV testing services (i.e., a previously undiagnosed HIV case) and who provide informed consent for their blood to be tested for recent HIV infection.

Description

Inclusion Criteria:

• Aged ≥15 years
• Be newly diagnosed with HIV
• Ability to speak and understand English or Kinyarwanda
• Consented to be part of both case-based surveillance (CBS) (which includes PNS) and recency surveillance under the separate, approved CBS protocol.
• Give voluntary written informed consent for data collection via semi-structured interview and survey instruments
• Give voluntary written informed consent for use of routinely collected data
• Be female if they are received at the facility at the same time as their partner (for intimate partner violence objective only).

Exclusion Criteria:

• Opt out or do not consent, or are unable to consent to participate in semi-structured interviews and completion of survey instruments
• Have a history of testing HIV positive (i.e., not newly diagnosed with HIV)
• Report antiretroviral drug (ARV) use for HIV management at any point during the HIV testing service (HTS) visit

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Recent HIV Infection; Persons ≥15 years of age who are newly-diagnosed with HIV, consent to participate in case-based surveillance and recency testing and test recent on the rapid test for recent infection (RTRI).	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.
Long-Term HIV Infection; Persons ≥15 years of age who are newly-diagnosed with HIV, consent to participate in case-based surveillance and recency testing and test long-term on the rapid test for recent infection (RTRI).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The HIV positive yield of index testing among the contacts of people newly diagnosed with HIV that test recent versus long-term.	We will compare the number of HIV positive contacts that are linked to HIV recent vs. long-term index cases newly diagnosed with HIV.	From baseline to 6 months after initial diagnosis
The incidence of intimate partner violence associated with the return of recency testing results among people newly diagnosed with HIV that test recent versus long-term	We will compare the incremental change in intimate partner violence resulting from the return of recency testing results between 2 and 6 months, adjusting for baseline and 1 month follow-up.	From baseline to 6 months after initial HIV diagnosis

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Centers for Disease Control and Prevention; Ministry of Health, Rwanda
• Investigators: Principal Investigator: Suzue Saito, PhD, Columbia University; Principal Investigator: Gallican Rwibasira, MD, Rwanda Biomedical Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: HIV-1; HIV Infections; Rapid Test for Recent Infection; RTRI; recent infection; newly diagnosed people living with HIV
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; HIV Infections; Infections; Communicable Diseases
• Other Study ID Numbers: AAAT5637; GG014256-18 (Other Grant/Funding Number: CDC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual Participant Data (with removal of personally identifiable data) will be made available concurrently with the release of the final report to a dedicated website where requests for data can be submitted.
• IPD Sharing Time Frame: Individual Participant Data will be made publicly available approximately six months after the final data set is made available to investigators.
• IPD Sharing Access Criteria: A de-identified dataset will be made available publicly to a dedicated website. Requestors of Individual Participant Data will submit requests and data will be released to all bona fide. requesting institutions and individuals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No