The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Sponsor: University of California, San Francisco

ID: IN-US-342-5516 
The No One Waits Study: acceptability and feasibility of community-based point-of-diagnosis 
HCV treatment 
 
Document date: September 17, 2023 
 
 

Study design 
The NOW study is a nonrandomized, single-arm, open-label, phase 4 study evaluating the 
feasibility, acceptability, and safety of a point-of-diagnosis HCV treatment model at a non-
medical community site in San Francisco (NCT03987503).  
 
From July 2020 to October 2021, the study team screened participants for HCV infection using 
the OraQuick® HCV Rapid Antibody (Ab) test and for HIV infection using the Alere Determine™ 
HIV-1/2 Ag/Ab Combo with a fingerstick blood sample. Those who tested HIV positive without a 
prior diagnosis were referred to clinical care. For participants with a reactive HCV Ab result, on-
site venipuncture was performed for HCV RNA quantification and reflex genotype testing as well 
as hepatitis B surface antigen (HBsAg) testing. Participants returned in one week for in-person 
HCV RNA results and were offered same-day initiation of HCV treatment if their HCV RNA was 
detectable and they met eligibility criteria. Participants self-selected, rather than randomized, to 
receiving the intervention (starting HCV treatment at the HCV diagnosis visit). The study team 
provided medication through an investigator-initiated grant from Gilead Sciences and dispensed 
it to participants. Consented participants were given a 14-day starter pack of sofosbuvir 400 mg 
and velpatasvir 100 mg (SOF/VEL) and took their first dose on day of enrollment. (Figure 1).  
 
Participants  
Participants were identified through: (1) flyers and study cards posted in neighborhoods and 
venues frequented by PWID; (2) referrals from service organizations; (3) street-outreach to 
PWID and people experiencing homelessness; and (4) lists of participants in the investigators’ 
previous research studies who gave contact permission for future research.  
 
Eligibility was assessed and consent obtained at two time-points: (1) HCV screening and (2) HCV 
treatment (Figure 2). For HCV screening, eligible participants were 18 years or older and 
reported either injecting drugs in their lifetime or having a blood transfusion in or before 1992.  
Second, participants with confirmed HCV viremia were assessed for eligibility at their HCV RNA 
results disclosure. Clinical exclusion criteria included: positive HBsAg, untreated HIV, history of 
hepatic decompensation, prior treatment with an NS5A-inclusive DAA regimen for more than 2 
weeks (unless there was evidence of prior SVR12 with HCV reinfection), pregnancy or 
breastfeeding, current medication use incompatible with SOF/VEL or sofosbuvir-velpatasvir-
voxilaprevir (SOF/VEL/VOX), or a life expectancy of < 12 months as assessed by the study 
clinician.  
 
Late study exclusion criteria were considered based on pre-treatment labs (drawn at study 
entry): albumin <3.0 g/dL, hemoglobin <8.0 g/dL (women) or <9.0g/dL (men), platelets <50,000, 
creatinine clearance (estimated by Cockcroft-Gault) <30 ml/min, aspartate aminotransferase or 
alanine aminotransferase > 10 x upper limit of normal (ULN), total bilirubin >1.5 times ULN, or 
INR >1.5 times ULN. For participants with genotype 3 and suspected cirrhosis based on FIB-4 
>3.25, NS5A resistance associated substitution testing was performed using a pre-treatment 
sample to assess for the presence of the Y93H mutation; if detected, patients were switched to 
SOF/VEL/VOX. 
 

Persons not meeting eligibility criteria or who declined enrollment received harm reduction 
counseling and referrals to community-based medical clinics for HCV and medical care needs.  
 
Study enrollment and follow-up procedures. After written informed consent, participants 
completed a research questionnaire, a blood draw for pre-treatment labs (complete blood 
count [CBC], comprehensive metabolic panel [CMP] and prothrombin time; hepatitis B surface 
antibody and hepatitis B core antibody if no prior clinical documentation), received clinical 
assessment via staff-assisted telemedicine, received a 14-day SOF/VEL starter pack, and were 
observed taking the first SOF/VEL dose by the staff. The study pharmacy team submitted 
documentation to authorize participants’ transition to insurance provided SOF/VEL treatment. If 
insurance-provided medication was delayed or not authorized, participants received study-
issued SOF/VEL until insurance provided SOF/VEL was attained or for the duration of treatment.  
 
The study team scheduled follow-up visits every two weeks during the 12 weeks of treatment 
and at 4- and 12-weeks post-treatment. At each follow-up study visit, participants picked up 
medication and completed research questionnaires. For patients who missed follow-up study 
visits, medication pickup or delivery was arranged. Clinical assessments conducted via staff-
assisted telemedicine at the end of treatment. Additionally, participants were offered clinical 
consults with a clinician at treatment weeks four and eight and 12-weeks post treatment. For all 
telemedicine visits, staff set up the telemedicine technology on a computer provided by the 
study and introduced the clinician. The telemedicine visit was led by a physician or clinical nurse 
practitioner. 
 
Enrollment and follow-up questionnaires collected demographics, physical and emotional 
health, current living context, healthcare access, sexual and drug use behaviors, and medication 
adherence. Study blood draws were obtained at treatment mid-point and completion and at 
≥least 12-weeks post-treatment. We approach research participation as a form of specialized 
work and consulted our community advisory board to determine suitable compensation1,2. 
Participants received reimbursement ranging from $20 to $60 per visit, with a total potential 
compensation of up to $325 USD over the course of the 10 study visits.  
Research site 
The study was conducted at: (1) a fixed community space located in a neighborhood close to 
public transit and social service organizations, in an area where PWID were known to 
congregate; and (2) a mobile medical van parked in the neighborhood with the highest 
percentage of African American and Black people in San Francisco and few city-supported social 
or medical service organizations. In 2018 and 2019, Black/African-American San Franciscans 
made up approximately a quarter of HCV cases reported despite being only about 5% of the 
overall population.3 Study procedures at the mobile site were discontinued in January 2021 due 
to COVID-19 and participants were rolled over to the fixed site. Both sites had private spaces for 
interviews and clinical research activities. Wrap-around services, including food, harm reduction 
supplies, COVID information and vaccination, were also available. Site staff were trained in HIV 
and HCV testing and disclosure counseling, harm reduction, ethical human research practices 
and de-escalation methods.  
 

Study materials were refined in partnership with local advocacy organizations and members of 
the target population. The study protocol was approved by the University of California, San 
Francisco Institutional Review Board (protocol number 19-27751). 
 
Endpoint measures 
Acceptability, feasibility, and safety of HCV treatment were assessed for all participants who 
received the intervention, starting HCV treatment (defined as receiving at least one dose of 
study drug) at the HCV status disclosure visit. The primary treatment feasibility outcome 
measure was treatment response defined as undetectable HCV RNA at least 12 weeks post-
treatment (SVR12). SVR12 was calculated by intention-to-treat (ITT group), defined as those 
who initiated treatment, and per-protocol (PP group) defined as those who completed a 12-
week course of DAA therapy. Participants with undetected HCV RNA after treatment completion 
who subsequently developed HCV viremia with an HCV genotype different from their pre-
treatment genotype within 12 weeks of DAA completion were considered to have post-
treatment reinfection within 12 weeks and were classified as not achieving SVR12. Secondary 
treatment feasibility endpoints were undetectable HCV RNA at treatment completion. Primary 
acceptability endpoints included treatment initiation at time of HCV RNA result disclosure and 
treatment completion. Safety endpoints were treatment discontinuation because of late 
exclusion criterion or adverse event.  
 
Statistical analyses 
All acceptability and safety results and secondary outcomes were summarized with descriptive 
statistics. Treatment initiation was evaluated among all participants with current HCV infection 
meeting eligibility who returned for their HCV RNA results disclosure visit. Treatment response 
was evaluated among those who initiated treatment (ITT group, N=87) and those who 
completed DAA therapy (PP group, N=69. Point estimates and two-sided 95% confidence 
intervals were also calculated for primary endpoints. Significance assessments were conducted 
using appropriate statistical tests, with p-values calculated using either the Wilcoxon rank-sum 
test for continuous or ordinal data, or chi-squared tests and Fisher's exact test for categorical 
data, based on the nature of the variables and data distribution. All analyses were performed 
using STATA software version 15.4 
 
References  
1. 
Davidson P, Page K. Research participation as work: comparing the perspectives of 
researchers and economically marginalized populations. Am J Public Health. Jul 
2012;102(7):1254-9. doi:10.2105/ajph.2011.300418 
2. 
Abadie R, Brown B, Fisher CB. "Money Helps": People who inject drugs and their 
perceptions of financial compensation and its ethical implications. Ethics & behavior. 
2019;29(8):607-620. doi:10.1080/10508422.2018.1535976 
3. 
San Francisco Department of Public Health (SFDPH). Hepatitis C Infection Surveillance 
Report 2018-2019. 2021. Accessed December 2022. https://endhepcsf.org/wp-
content/uploads/2021/07/SFDPH-Hepatitis-C-Infection-Surveillance-Report-2018-2019.pdf 
4. 
Stata Statistical Software: Release 15. StataCorp LLC; 2017.