Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT04880200
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • POC NAT & Adherence Intervention — DIAGNOSTIC_TEST
    The POC NAT test will be the SAMBA Semi-Q HIV test. The adherence intervention will be developed by study staff and tailored for delivery along with the POC NAT results.

Study Details

This project will develop, implement, and evaluate models for use of point-of-care nucleic acid testing (POC NAT) among HIV-negative persons seeking HIV testing, PEP, and PrEP and HIV-positive persons in community and clinical settings. Study aims #1 and #2 will evaluate the sensitivity and specificity of a qualitative POC NAT in persons not known to be HIV-positive and will determine the impact of its use on PrEP uptake and persistence among persons testing HIV-negative and on time to HIV continuum of care outcomes among persons testing HIV-positive. Aim #3 will implement a POC NAT-tailored behavioral intervention to evaluate impact on time to virologic suppression among PLWH receiving ART. Aim #4 will quantify the acceptability and feasibility of implementation of POC NAT in community and clinical settings and collect cost and related data for cost-effectiveness analyses. Finally, in Aim #5, a distinct but related study will compare the sensitivity, specificity, and agreement of multiple POC NATs over a range of HIV RNA levels.

Key Dates

Start date
Jan 3, 2022
Status verified
Apr 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
932 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: POC NAT & Adherence Intervention
    These participants will receive the POC NAT test during their study visit. The result will be conveyed to their provider, who will deliver the result and an adherence intervention.
  • No Intervention: Standard of Care
    These participants will receive the clinical standard of care during their visit.

Primary Outcome Measure

Time to viral suppression [ Time Frame: Participants will be enrolled for up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Madison ClinicSeattleWashington98104
Joanne Stekler

Find similar trials in Seattle, WA

By condition
HIV
By specialty
Infectious disease
By research site
Madison Clinic· Seattle, WA

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