HIV Infections
Conditions
Keywords
HIV, point of care testing, nucleic acid testing
Brief summary
This project (NCT04880200) 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.
Interventions
DIAGNOSTIC_TESTPOC 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.
Sponsors
University of Washington
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
For the aim #3 RCT, we will randomize participants 1:1 to the POC NAT intervention arm and to standard of care. The intervention will include a SAMBA test and adherence counseling intervention developed by the study team to accompany delivery of test results. The study team will train participating primary care providers (PCPs) in delivery of the adherence counseling intervention. Study staff will discuss the study, obtain informed consent, and, for participants randomized to POC NAT, perform SAMBA and provide results to the PCP. Study staff will perform venipuncture, ensure that individual laboratory NAT is performed, and administer a brief CASI. PCPs will deliver the POC NAT result and adherence counseling intervention to patients during their visit. Participants will be asked to sign an ROI that allows the study to share POC NAT results with the PCP and allows the study staff to obtain outcomes measures from clinical patient data for longitudinal follow up.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Viral Suppression | 1 year | Participants achieving an undetectable viral load during 1 year of follow up |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoanne D Stekler, MD
University of Washington
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.5 years |
| HIV-1 RNA level at study visit (Laboratory NAT) Detectable (>40 copies/mL) | 32 Participants |
| HIV-1 RNA level at study visit (Laboratory NAT) Missing | 11 Participants |
| HIV-1 RNA level at study visit (Laboratory NAT) Undetectable (<40 copies/mL) | 55 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 3 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 53 Participants |
| Race/Ethnicity, Customized Hispanic or Latinx | 27 Participants |
| Race/Ethnicity, Customized Multiracial | 10 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race/Ethnicity, Customized Unknown/refused | 1 Participants |
| Race/Ethnicity, Customized White | 45 Participants |
| Sex/Gender, Customized Female | 12 Participants |
| Sex/Gender, Customized Male | 69 Participants |
| Sex/Gender, Customized Not specified | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 97 |
| other Total, other adverse events | 0 / 97 | 0 / 97 |
| serious Total, serious adverse events | 0 / 97 | 0 / 97 |
Outcome results
None listed