Recruiting

HIV Point-of-Care Tests

Sponsor:

University of Washington

Code:

NCT04880200

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

POC NAT & Adherence Intervention

Study Details

Brief summary:

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.

Conditions

HIV Infections

Study ID

NCT04880200

Start date

Jan 3, 2022

Status verified date

Apr, 2023

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Persons who are HIV-positive and seeking care at Madison Clinic.
  • 18 years of age or older
  • Patient's provider is willing to deliver adherence intervention
  • Patient is getting a laboratory RNA viral load test that day.
  • Able to read and speak English

Exclusion Criteria:

  • Patients of unknown HIV status
  • Patients who have participated in the study before

Study Design

Enrollment

932 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

POC NAT & Adherence Intervention

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lisa Niemann

206 744-8887niemal@uw.edu

Lauren Violette

206 616-5234lvio@uw.edu

Locations

Madison Clinic

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

University of Washington

Last update posted

Apr 28, 2023

Last verified

Apr, 2023

Keywords

  • HIV
  • point of care testing
  • nucleic acid testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2023-04-28.