Trial Outcomes & Findings for HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting (NCT NCT06282328)

Results Overview

The primary objective of the study is to estimate the prevalence of previously unknown HIV infection (new HIV infection) in the hospital setting among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or with presence of behavioral risk factors

Recruitment status

COMPLETED

Target enrollment

300 participants

Primary outcome timeframe

Baseline

Results posted on

2026-03-30

Participant Flow

Overall 300 participants enrolled and completed the study. No screening failures.

Participant milestones

Participant milestones
Measure	HIV Diagnostic Test Bedside rapid capillary HIV test
Overall Study STARTED	300
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Each participant may have no HIV-ICs, HIV-ICs from a single group, HIV-ICs from two groups, or HIV-ICs from all three groups. HIV-ICs comprise a predefined set of clinical conditions into three groups: group 1 includes AIDS-defining conditions; group 2 includes conditions associated with an undiagnosed HIV prevalence above the recommended testing threshold; and group 3 includes conditions for which failure to identify HIV infection may have important implications for clinical management.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV Diagnostic Test n=300 Participants Bedside rapid capillary HIV test
Age, Continuous	54 years n=4 Participants
Sex: Female, Male Female	114 Participants n=4 Participants
Sex: Female, Male Male	186 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	300 Participants n=4 Participants
HIV-IC HIV-IC Group 1	38 Participants n=4 Participants • Each participant may have no HIV-ICs, HIV-ICs from a single group, HIV-ICs from two groups, or HIV-ICs from all three groups. HIV-ICs comprise a predefined set of clinical conditions into three groups: group 1 includes AIDS-defining conditions; group 2 includes conditions associated with an undiagnosed HIV prevalence above the recommended testing threshold; and group 3 includes conditions for which failure to identify HIV infection may have important implications for clinical management.
HIV-IC HIV-IC Group 2	215 Participants n=4 Participants • Each participant may have no HIV-ICs, HIV-ICs from a single group, HIV-ICs from two groups, or HIV-ICs from all three groups. HIV-ICs comprise a predefined set of clinical conditions into three groups: group 1 includes AIDS-defining conditions; group 2 includes conditions associated with an undiagnosed HIV prevalence above the recommended testing threshold; and group 3 includes conditions for which failure to identify HIV infection may have important implications for clinical management.
HIV-IC HIV-IC Group 3	8 Participants n=4 Participants • Each participant may have no HIV-ICs, HIV-ICs from a single group, HIV-ICs from two groups, or HIV-ICs from all three groups. HIV-ICs comprise a predefined set of clinical conditions into three groups: group 1 includes AIDS-defining conditions; group 2 includes conditions associated with an undiagnosed HIV prevalence above the recommended testing threshold; and group 3 includes conditions for which failure to identify HIV infection may have important implications for clinical management.

PRIMARY outcome

Timeframe: Baseline

The primary objective of the study is to estimate the prevalence of previously unknown HIV infection (new HIV infection) in the hospital setting among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or with presence of behavioral risk factors

Outcome measures

Outcome measures
Measure	HIV Diagnostic Test n=300 Participants Bedside rapid capillary HIV test
Prevalence of HIV Infection	6 Participants

SECONDARY outcome

Timeframe: Baseline

The number/categories of HIV-IC will be assessed. HIV-IC will be defined according to ECDC HIV-IC guidelines

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

The number/type of behavioral risk factors will be assessed. Presence of behavioral risk factors for HIV infection will be evaluated by means of a questionnaire designed for the trial

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

CD4+ lymphocytes (cells/microL) will be assessed among people with HIV infection at time of diagnosis

Outcome measures

Outcome measures
Measure	HIV Diagnostic Test n=6 Participants Bedside rapid capillary HIV test
CD4+ Lymphocytes	540 cells/microL Interval 199.0 to 760.0

SECONDARY outcome

Timeframe: Baseline

HIV-RNA levels (copies/mL) will be assessed among people with HIV infection at time of diagnosis

Outcome measures

Outcome measures
Measure	HIV Diagnostic Test n=6 Participants Bedside rapid capillary HIV test
HIV-RNA	1,130,000 copies/mL

Adverse Events

HIV Diagnostic Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Silvia Nozza

IRCCS San Raffaele Scientific Institute

Phone: +0039 0226437934

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place