Evaluation of HIV-1 Recent Infection Testing in Rwanda

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063487
• Other study ID #: AAAT5637
• Secondary ID: GG014256-18
• Status: Completed
• Start date: July 29, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: August 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1588
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Rwanda	Rwanda Biomedical Centre, Ministry of Health	Kigali

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention, Ministry of Health, Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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