Greater Access and Impact through Point-of-Care Nucleic Acid Testing: Protocol for the GAIN Study (Preprint)

<sec> <title>BACKGROUND</title> Accurate HIV testing is important for individual and population level health for persons with and without HIV. With shorter window periods than serologic point-of-care (POC) tests and faster turnaround than laboratory-based nucleic acid testing (NAT), POC NATs could be valuable tools in improving early detection of HIV. Furthermore, semi-quantitative POC NAT could provide real-time monitoring for persons with HIV (PWH). There have been limited evaluations of POC NAT implementation in the United States to date. </sec> <sec> <title>OBJECTIVE</title> This paper describes protocols and procedures to evaluate acceptability and feasibility of POC NAT implementation in a clinical and community setting in Seattle, Washington. </sec> <sec> <title>METHODS</title> The Greater Access and Impact through POC NAT (GAIN) Study was a CDC-funded study that enrolled participants at a Ryan White-funded, hospital-based clinic (Madison Clinic) and a community site (Seattle’s LGBTQ+ Center, formerly Gay City). Persons seeking HIV testing, non-occupational post-exposure prophylaxis (nPEP) or pre-exposure prophylaxis (PrEP) who enrolled at either site received standard-of-care plus the SAMBA II HIV-1 Qualitative Whole Blood Test (SAMBA Qual) and a back-up pooled (1:10) laboratory HIV NAT. PWH enrolled at Seattle’s LGBTQ+ Center (the Center) received standard-of-care STI testing plus the SAMBA II HIV-1 Semi-Quantitative Whole Blood Test (SAMBA Semi-Q) and laboratory viral load. PWH from Madison Clinic were recruited into a randomized clinical trial (RCT) to compare the clinical standard-of-care versus the addition of the SAMBA Semi-Q (backed up by the U.S. Food and Drug Administration (FDA) approved laboratory NAT). Participants randomized to receive the POC NAT also received a brief adherence counseling intervention delivered by their physician who was trained by the study team. All participants completed a demographic survey during their study visit and contributed prospective data via electronic medical records. Subsets of participants from each group were invited to complete an online, in-depth acceptability survey after their study visit and an individual interview. Finally, patient flow was observed in Madison Clinic to assess how POC testing impacted timing of patient clinic visits. </sec> <sec> <title>RESULTS</title> From January 2022 to December 2024, 734 participants completed 754 GAIN research visits. Of those visits, 491 visits were completed by 489 participants seeking HIV testing and/or PrEP at the Center and 61 visits were completed by 43 participants seeking HIV testing, PEP and/or PrEP at Madison Clinic. Seven PWH were enrolled at the Center and 194 PWH were enrolled in the Madison Clinic RCT. In-depth acceptability surveys were completed by 193 participants, and 41 interviews were conducted. Time and motion observations made in 2021 and 2023 were collected on 47 patients. </sec> <sec> <title>CONCLUSIONS</title> The GAIN Study protocol described here is an important evaluation of POC NAT implementation in the United States in community and clinical care settings for HIV diagnosis and viral load monitoring. Results will be reported elsewhere. </sec> <sec> <title>CLINICALTRIAL</title> NCT04880200 </sec>