Evaluation of HIV-1 Recent Infection Testing in Rwanda

NCT05063487 | Completed

• 2 other identifiers: AAAT5637GG014256-18
• Study Type: observational
• Target: 1,588
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV Infections; HIV-1; Rapid Test for Recent Infection; RTRI; recent infection; newly diagnosed people living with HIV

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Return of recent classification OTHER

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.

Recent HIV Infection

Return of long-term classification OTHER

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.

Long-Term HIV Infection

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Centers for Disease Control and Prevention: collaborator
• Ministry of Health, Rwanda: collaborator

Study Sites (1)

Rwanda Biomedical Centre, Ministry of Health

Kigali, Rwanda

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Suzue Saito, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Gallican Rwibasira, MD

  Rwanda Biomedical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist in ICAP

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 1, 2021
• Study Start: July 29, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Individual Participant Data will be made publicly available approximately six months after the final data set is made available to investigators.
• 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.

Locations

RW (1)