Clinical trial NCT05063487: Evaluation of HIV-1 Recent Infection Testing in Rwanda
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV Infections
HIV-1
Rapid Test for Recent Infection
RTRI
recent infection
newly diagnosed people living with HIV
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Ministry of Health, Rwanda
First posted: 2021-10-01
Enrollment: 1588
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: The HIV positive yield of index testing among the contacts of people newly diagnosed with HIV that test recent versus long-term.
timeFrame: From baseline to 6 months after initial diagnosis
measure: 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
timeFrame: From baseline to 6 months after initial HIV diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Rwanda Biomedical Centre, Ministry of Health
Study officials:
affiliation: Columbia University
name: Suzue Saito, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rwanda Biomedical Centre
name: Gallican Rwibasira, MD
role: PRINCIPAL_INVESTIGATOR
References: