Evaluation of HIV-1 Recent Infection Testing in Rwanda

NCT ID: NCT05063487

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1588 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2022-10-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Return of recent classification

Intervention Type: 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.

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).

Return of long-term classification

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Ministry of Health, Rwanda

OTHER_GOV

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Suzue Saito

Associate Research Scientist in ICAP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzue Saito, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Gallican Rwibasira, MD

Role: PRINCIPAL_INVESTIGATOR

Rwanda Biomedical Centre

Locations

Rwanda Biomedical Centre, Ministry of Health

Kigali, , Rwanda

Countries

Rwanda

Other Identifiers

GG014256-18

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAT5637

Identifier Type: -

Identifier Source: org_study_id