HIV InfectionsNCT05063487
Evaluation of HIV-1 Recent Infection Testing in Rwanda
An observational study of HIV Infections, run by Columbia University at 1 site in Rwanda.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Return of recent classification and Return of long-term classification
- How many people
- 1,588 participants
- Where
- 1 siteRwanda
- Study dates
- 29 Jul 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Return of recent classification, Return of long-term classification
- Keywords
- HIV Infections, HIV-1, Rapid Test for Recent Infection, RTRI, recent infection, newly diagnosed people living with HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return of recent classificationOther
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 classificationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Return of recent classification | |
| 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). Receives: Other: Return of long-term classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to 6 months after initial HIV diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start29 Jul 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health, Rwanda
- Responsible party
- Principal investigator, Suzue Saito, Columbia University
- Investigators
- Suzue Saito, PhD, Principal investigator, Columbia UniversityGallican Rwibasira, MD, Principal investigator, Rwanda Biomedical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063487
- Sponsor's protocol ID
- AAAT5637
- Other IDs
- GG014256-18
- Status last verified
- Aug 2023
- First submitted
- 13 Sep 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Poirot E, Reid G, Saito S, Irabona JC, Kamanzi C, Maliwa V, Mugisha V, Remera E, Sangwayire B, Kayirangwa E, Malamba S, Cain M, Hegle J, Justman J, Behel S, Rwibasira GN; Rwanda HIV Recency Evaluation Study Team. Self-reported Intimate Partner Violence Before and After Return of Recency Test Results: Findings from the Rwanda HIV Recency Evaluation Study. AIDS Behav. 2026 Jul 21. doi: 10.1007/s10461-026-05236-w. Online ahead of print.
PubMed 42479394
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05063487
- Acronym / sponsor ID
- AAAT5637
- Conditions
- HIV Infections
- Keywords
- HIV Infections, HIV-1, Rapid Test for Recent Infection, RTRI, recent infection, newly diagnosed people living with HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,588 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health, Rwanda
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recent HIV Infection | – | Other: Return of recent classificationPersons ≥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 | – | Other: Return of long-term classificationPersons ≥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). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Return of recent classificationAs 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. | Other | Recent HIV Infection |
| Return of long-term classificationAs 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. | Other | Long-Term HIV Infection |
Primary outcome
The HIV positive yield of index testing among the contacts of people newly diagnosed with HIV that test recent versus long-term.
Time frame: 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.
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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 42479394Poirot E, Reid G, Saito S, Irabona JC, Kamanzi C, Maliwa V, Mugisha V, Remera E, Sangwayire B, Kayirangwa E, Malamba S, Cain M, Hegle J, Justman J, Behel S, Rwibasira GN; Rwanda HIV Recency Evaluation Study Team. Self-reported Intimate Partner Violence Before and After Return of Recency Test Results: Findings from the Rwanda HIV Recency Evaluation Study. AIDS Behav. 2026 Jul 21. doi: 10.1007/s10461-026-05236-w. Online ahead of print.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzue Saito, PhD principal investigator
Columbia University
Gallican Rwibasira, MD principal investigator
Rwanda Biomedical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Columbia University at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The HIV positive yield of index testing among the contacts of people newly diagnosed with HIV that test recent versus long-term. (time frame: From baseline to 6 months after initial diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.