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Completed

NCT Number: NCT05063487

Evaluation of HIV-1 Recent Infection Testing 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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rwanda Biomedical Centre, Ministry of Health

Kigali, Rwanda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Return of recent classification

Other

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

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Ministry of Health, Rwanda

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2021
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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