An observational study in HIV Infections, sponsored by Columbia University. Completed at 1 site in Rwanda. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Columbia University · Observational
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.
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.
4,342 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 1,588 is above the median of 200 across 731 observational studies indexed under HIV Infections.
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Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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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.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 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.
Time frame: From baseline to 6 months after initial HIV diagnosis
Plan to share: Yes — Individual Participant Data (with removal of personally identifiable data) will be made available concurrently with the release of the final report to a dedicated website where requests for data can be submitted.
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.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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