HIV InfectionsGAINNCT04880200
Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests
A study testing POC NAT & Adherence Intervention in people with HIV Infections, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- POC NAT & Adherence Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 31 May 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients of unknown HIV status
- Patients who have participated in the study before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
- Conditions
- HIV Infections
- Being tested
- POC NAT & Adherence Intervention
- Keywords
- HIV, point of care testing, nucleic acid testing
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC NAT & Adherence InterventionDiagnostic 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 group | Role | What they receive |
|---|---|---|
| POC NAT & Adherence Intervention | Experimental | 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. Receives: Diagnostic Test: POC NAT & Adherence Intervention |
| Standard of Care | No intervention | These participants will receive the clinical standard of care during their visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Viral Suppression
Participants achieving an undetectable viral load during 1 year of follow up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Mar 2022
- Primary completion23 Dec 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Joanne Stekler, MD MPH, University of Washington
- Investigators
- Joanne D Stekler, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880200
- Sponsor's protocol ID
- STUDY00010387
- Other IDs
- 6 U01 PS 005196-01-01, 6U01PS005196
- Acronym
- GAIN
- Status last verified
- Mar 2026
- First submitted
- 27 Apr 2021
- Last updated
- 17 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Intellectual property and data generated will be administered in accordance with UW and CDC policies. Final determinations for data sharing will be based on guidelines for use determined by the Publication Committee. Data obtained during this project will be available at the end of the funding cycle or within a year of publication of major findings, whichever is later. Requests for data or specimens must be made in writing, and human subjects approval must be obtained prior to data transfer. Data will be provided from the Data Center electronically, stripped of identifying information. Investigators receiving data will be asked to sign an agreement stipulating that they will (1) use data only for not-for-profit research purposes (unless negotiated otherwise with the Publication Committee); (2) not attempt to identify any individual participant; (3) secure data using appropriate technology and not share data with anyone else; and (4) destroy data after analyses are completed.
Publications
Niemann LA, Violette LR, Cornelius-Hudson A, Murphy M, Capili C, Dai M, Wagner A, Frey S, Dhanireddy S, Taylor SE, Hoover KW, Stekler JD. Feasibility, Acceptability, and Test Performance of Point-of-Care Nucleic Acid Tests for HIV Testing and Viral Load Monitoring in the United States: Prospective Longitudinal Mixed-Methods Study. JMIR Res Protoc. 2026 Jul 23;15:e84625. doi: 10.2196/84625.
PubMed 42492499
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04880200
- Acronym / sponsor ID
- GAIN / STUDY00010387
- Conditions
- HIV Infections
- Keywords
- HIV, point of care testing, nucleic acid testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Posted 17 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| POC NAT & Adherence Intervention | Experimental | Diagnostic Test: POC NAT & Adherence InterventionThese 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. |
| Standard of Care | No intervention | –These participants will receive the clinical standard of care during their visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients of unknown HIV status
- Patients who have participated in the study before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POC NAT & Adherence InterventionThe 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. | Diagnostic test | POC NAT & Adherence Intervention |
Primary outcome
Achievement of Viral Suppression
Time frame: 1 year
Participants achieving an undetectable viral load during 1 year of follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42492499Niemann LA, Violette LR, Cornelius-Hudson A, Murphy M, Capili C, Dai M, Wagner A, Frey S, Dhanireddy S, Taylor SE, Hoover KW, Stekler JD. Feasibility, Acceptability, and Test Performance of Point-of-Care Nucleic Acid Tests for HIV Testing and Viral Load Monitoring in the United States: Prospective Longitudinal Mixed-Methods Study. JMIR Res Protoc. 2026 Jul 23;15:e84625. doi: 10.2196/84625.
- Individual participant dataSharing planned: Yes. Intellectual property and data generated will be administered in accordance with UW and CDC policies. Final determinations for data sharing will be based on guidelines for use determined by the Publication Committee. Data obtained during this project will be available at the end of the funding cycle or within a year of publication of major findings, whichever is later. Requests for data or specimens must be made in writing, and human subjects approval must be obtained prior to data transfer. Data will be provided from the Data Center electronically, stripped of identifying information. Investigators receiving data will be asked to sign an agreement stipulating that they will (1) use data only for not-for-profit research purposes (unless negotiated otherwise with the Publication Committee); (2) not attempt to identify any individual participant; (3) secure data using appropriate technology and not share data with anyone else; and (4) destroy data after analyses are completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne D Stekler, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POC NAT & Adherence Intervention in people with HIV Infections, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of Viral Suppression (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04880200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.