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

Not Applicable

Recruiting

• Conditions: HIV Infections
• Interventions: Diagnostic Test: POC NAT & Adherence Intervention

• Registration Number: NCT04880200
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-10
• Study Start: 2022-01-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 932

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POC NAT & Adherence Intervention	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.

Primary Outcome Measures

Name	Time	Method
Time to viral suppression	Participants will be enrolled for up to 6 months	We will compare time to virologic suppression among participants randomized to the two arms.

Secondary Outcome Measures

Name	Time	Method
Participation	Participants will be enrolled for up to 6 months	We will use descriptive statistics to report on the proportion of Madison primary care providers (PCP)s willing to participate in the RCT and the proportion of patients who agree to study enrollment.

Trial Locations

Locations (1)

Madison Clinic; 🇺🇸 Seattle, Washington, United States