Madison Clinic
Seattle, Washington, 98104, United States
Location status: Recruiting
Location contact
Joanne Stekler
CONTACT
NCT Number: NCT04880200
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98104, United States
Location status: Recruiting
Joanne Stekler
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Participants will be enrolled for up to 6 months
We will compare time to virologic suppression among participants randomized to the two arms.
Time frame: 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.
Time frame: Participants will be enrolled for up to 6 months
We will report on the limit of detection of the SAMBA test, using the plasma HIV RNA level as gold standard, and the agreement (kappa) of SAMBA and plasma HIV RNA level, dichotomized at 1000 copies/mL
Contact information is provided by the study sponsor or research team.
Lauren Violette
CONTACT
Lisa Niemann
CONTACT
University of Washington
Other
The GAIN (Greater Access and Impact With NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests (NATs)
Acronym: GAIN
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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