Evaluation of HIV-1 Recent Infection Testing in Rwanda

Completed

• Conditions: HIV Infections
• Interventions: Other: Return of recent classification; Other: Return of long-term classification

• Registration Number: NCT05063487
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2021-07-29
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-10-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1588

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recent HIV Infection	Return of recent classification	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).
Long-Term HIV Infection	Return of long-term classification	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).

Primary Outcome Measures

Name	Time	Method
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	From baseline to 6 months after initial HIV diagnosis	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.
The HIV positive yield of index testing among the contacts of people newly diagnosed with HIV that test recent versus long-term.	From baseline to 6 months after initial diagnosis	We will compare the number of HIV positive contacts that are linked to HIV recent vs. long-term index cases newly diagnosed with HIV.

Trial Locations

Locations (1)

Rwanda Biomedical Centre, Ministry of Health; 🇷🇼 Kigali, Rwanda