Clinical trial NCT04650269
Conditions: Harm Reduction HIV Infections Drug Use
Sponsor: University of Miami
Start date: 2021-03-04; Completion date: 2023-12-31
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.

Detailed description:

Arms: arm 1: Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.
Interventions: intervention 1: Biktarvy 50Mg-200Mg-25Mg Tablet intervention 2: HIV care
Intervention descriptions: intervention 1: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months intervention 2: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.

Protocol documents:
Prot_SAP_000.pdf: 
IRB Study Number: 20200793 
 
Page 1 of 10 
Revised: 4/25/22 
 
 
 
 
 
 
 
 
 
 
 
Implementation of onsite, rapid ART initiation among People Who Inject Drugs living 
with HIV at Syringe Services Program  
 
Protocol Version 2 
Protocol Version Date 4/25/22 
eProst ID Number 20200793 
PI Hansel Tookes 
NCT Number NCT04650269 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


IRB Study Number: 20200793 
 
Page 2 of 10 
Revised: 4/25/22 
1) Protocol Title: Implementation of onsite, rapid ART initiation among People Who Inject 
Drugs (PWID) living with HIV at Syringe Services Program (SSP) 
 
2) Objectives* 
 
Aim 1: To evaluate/assess the effectiveness and feasibility of same-day rapid initiation of 
ART for PWID living with HIV who utilize the SSP (SSP Rapid Initiation).   
Aim 2: To identify barriers to success of HIV care retention and treatment adherence among 
PWID preparing for entry into long-term HIV care.  
Aim 3: To compare adherence of patients in SSP Rapid Initiation after transition to a 
traditional healthcare clinic. 
 
3) Background* 
 
PWID experience extensive barriers to engagement in HIV care. Challenges in linkage 
to care, retention in care, and viral suppression in PWID are well documented, with 
estimates that less than half of PWID living with HIV in the U.S. are virally 
suppressed5,6. In the 2018 Miami outbreak investigation and public health response in 
PWID, we were able to support 100% of newly infected individuals in achieving viral 
suppression through a test-and-treat approach with intensive patient navigation and 
medication management; but faced challenges in initiating ART in previously diagnosed 
PWID, with only 53% achieving suppression. Reasons for this sub-optimal result could 
include recognized barriers to HIV care and retention within the Miami community, including 
drug use, mental illness, stigma and transportation issues7,8. Although Miller et al.9 recently 
reported that intensive and flexible patient navigation with psychosocial counseling was 
central to increased initiation of ART and viral suppression, the literature on evidence-based 
approaches to initiation of ART and retention in care for PWID is lacking.  
 
Why Test and Treat? Early HIV diagnosis and immediate ART initiation are essential to 
rapidly decrease viral load, reduce the impact of outbreaks, and improve quality of life among 
PWID10,11,12. Established Test and Treat paradigms have shown decreased time to virologic 
suppression, the ultimate goal of controlling HIV transmission among PWID and their sexual 
partners13. However, traditional healthcare systems may not be the ideal environment to 
initiate HIV care in PWID, a population so stigmatized by the healthcare system and society 
at-large that they often avoid care due to profound distrust and structural barriers. ART 
initiation at an SSP is potentially an ideal venue, bringing services to the patient and making 
healthcare easily accessible.  With SSPs just beginning in Florida, an SSP Rapid Initiation 
approach developed at the Miami IDEA SSP will enable new programs to rapidly implement 
pathways to rapid ART initiation.   
 
 
4) Inclusion and Exclusion Criteria* 
1) Adult (age>18 years); 2) positive rapid HIV test; 3) ability to provide informed consent; 
4) HIV RNA > 200; 5) creatinine clearance > 30 as measured by serum creatinine; 6) no 
allergy to bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) as indicated by 
patient history and self-reported allergies. Any other comorbidities that at the discretion 
of the investigator would prevent the participant from participating in the study. 
 


IRB Study Number: 20200793 
 
Page 3 of 10 
Revised: 4/25/22 
5) Study Design 
 
We plan to utilize a hybrid quasi-experimental design to test the effectiveness and 
implementation outcomes of successful delivery of rapid ART initiation intervention in an SSP 
(Figure 1). In addition, we will use a multi-method approach, collecting both quantitative and 
qualitative data on patients (n=50) accepting the rapid ART initiation protocol at the SSP, patients 
declining to engage in the rapid ART initiation protocol, and patients after transition to a 
traditional Ryan White clinic. To assess the effectiveness of the SSP Rapid Initiation, we will 
compare the percentage of PWID virally suppressed at 6 months post baseline at the SSP 
compared to at 6 months post transition to UM/Jackson Adult Outpatient HIV Clinic. Since this 
proposed study is in its pilot phase, this study will not be examining differential effects in 
treatment groups in the study, but rather provide preliminary data to support a future randomized-
controlled trial. Represented in the figure below, participants at the SSP will be tested for HIV 
using a rapid test, which when reactive will be confirmed using a second rapid HIV test from 
another manufacturer following a CDC-approved dual rapid HIV testing algorithm. If a patient 
tests positive, the patient will be offered immediate initiation onto ART at the SSP. Baseline labs 
(4th Generation HIV test, HIV viral load, CD4, HIV genotype, CBC, CMP, 
Gonorrhea/Chlamydia, RPR, HCV Antibody, HCV RNA, HbsAg, HBsAb, HAV Total) will be 
obtained and sent to the Miami-Dade County Health Department. Patients will have up to 7 days 
post HIV-positive test to start on ART (per definition of rapid ART initiation). The community 
advisory board and peer navigators at the SSP will assist in the SSP Rapid Initiation protocol 
design, execution, and process improvement.  Peers will work between the SSP and the Ryan 
White clinics.  Our experience with the 2018 HIV cluster in PWID in Miami taught us that 
medication management (i.e., pill lockers at the SSP, third party pickup of ART at ADAP by SSP 
staff, weekly medication drops to participants unable to access medications at the fixed site) was 
highly effective at supporting adherence in PWID living with HIV.   Peer navigators will conduct 
outreach to SSP Rapid Initiation participants, monitor appointments, and provide transport to 
healthcare services. This intensive linkage and active follow-up delivered by peer PWID living 
with HIV is essential to delivery of care to this population.  Peers will be tasked with helping 
participants with eligibility (e.g., Ryan White, Medicaid) and ADAP enrollment when they 
transition to the transitional HIV clinic.  This grant will enable them to have ongoing support in 
clinic after transition to the traditional healthcare environment for long-term care.  
Patients who decline engagement in ART after one week will be asked to partake in 
semi-structured interviews. Patients who accept will be initiated onto ART at the SSP. A 
medication adherence plan will be developed for each patient by SSP staff to optimize medication 
adherence. Quantitative and qualitative assessments exploring barriers and facilitators of HIV 
treatment adherence will be given at 1, 3, 6 and 12 months post treatment start date. In addition, 
HIV viral load will be measured at 1, 3, 6, 9 and 12 months post treatment start date to assess 
viral suppression.  
 
Figure 1. Conceptual Framework of SSP Rapid Initiation Pilot Study 


IRB Study Number: 20200793 
 
Page 4 of 10 
Revised: 4/25/22 
 
Quantitative Assessments of those accepting rapid ART 
Baseline assessment of participants will include socio-demographics, drug and sexual risk 
behaviors, HIV knowledge, and SSP utilization. If re-engaging: date of HIV diagnosis, previous 
HIV clinic attendance, previous ART exposure, and reason(s) for discontinuing ART. Follow-up 
assessments will include a side effect inventory, mental health screening, timeline follow-back on 
ART adherence, timeline follow-back on drug use.  
Qualitative Assessment of those accepting rapid ART 
Qualitative assessments will include patient perspectives on HIV diagnosis and living with HIV, 
including both HIV and PWID stigma. The interviews will explore which symptoms are most 
important to the patient, their experience with ART in the past and experience on BFTAF in the 
current study, and facilitators and barriers to ART adherence in the past and in the current study.  
These assessments will also include formative feedback on ART initiation at the SSP, medication 
management at the SSP, follow-up HIV care at the SSP, and barriers and facilitators to transition 
to a more traditional HIV clinic for long-term care. Those who are eligible for the study will be 
consented and asked to participate in a 30-minute interview conducted at the IDEA SSP for 
which they will receive $50 
Qualitative Assessment of those declining rapid ART 
In-depth interviews with PWID living with HIV who do not engage in treatment with 7 days of 
HIV test result will be conducted. We anticipate conducting 10 interviews, which is sufficient to 
achieve data saturation and will be conducted within 3 months post HIV test result. Inclusion 
criteria are: 1) 18 years of age or older; 2) enrolled in the IDEA SSP; 3) HIV positive rapid test 
result; 4) English or Spanish speaking, 5) declined rapid ART initiation at the SSP. Those who 
are eligible for the study will be consented and asked to participate in a 30-minute interview 
conducted at the IDEA SSP for which they will receive $25.  
     These semi-structured interviews will explore: 1) the role of key personal and structural 
barriers to engagement in HIV care (e.g., transportation, poverty, and stigma); 2) perceived 
benefit of engaging in rapid initiation of HIV care on personal health outcomes (i.e., viral 


IRB Study Number: 20200793 
 
Page 5 of 10 
Revised: 4/25/22 
suppression); 3) reasons for declining rapid ART initiation protocol (e.g., prior clinic experience, 
previous ART side effects), 4) recommendations for structuring the intervention to maximize 
participant engagement (e.g., physical location, hours of operation, duration, and frequency); 5) 
recommendations for intervention facilitator demographics and training; and 6) current 
knowledge, attitudes, and awareness regarding HIV treatment in PWID. All interviews will be 
audio-recorded and transcribed verbatim by an external transcription company. 
 
 
6) Arms and Interventions 
This single arm pilot study will assess the effectiveness of on site initiation of HIV care and 
followup at an SSP (fixed site or mobile exchange on outreach). The study is 1 year duration, and 
study visits are conducted at at 0, 1, 3, 6, 9 and 12 months as outlined above. The intervention is 
delivery of HIV care outside of a traditional healthcare clinic. The medication offered will be 
BFTAF, 50/200/25mg tablet to be administered orally. The intervention will include wraparound 
support by the peer navigator. Study visits will be conducted either at the IDEA Exchange fixed 
location, or on the mobile unit in the community (e.g. homeless encampments). The fixed site and 
mobile unit are equipped with private rooms for medical encounters. Medical visit with a 
provider and phlebotomy will be provided on site. 
 
7) Procedures Involved* 
  
Screening 
0 
1 
3 
6 
9 
12 
Lab 
Assessments 
HIV Rapid  HIV Ag/Ab Test 
HIV RNA 
HIV RNA 
HIV RNA 
HIV RNA 
HIV RNA 
  
  
HIV RNA 
CD4 count 
CD4 
CD4 
  
  
  
  
CD4 count 
CBC 
CBC 
CBC 
  
  
  
  
HIV genotype 
CMP 
CMP 
CMP 
  
  
  
  
CBC 
  
GC/CT 
GC/CT 
  
  
  
  
CMP 
  
RPR 
RPR 
  
  
  
  
GC/CT 
  
  
  
  
  
  
RPR 
  
  
  
  
  
  
  
HCV Ab 
  
  
  
  
  
  
  
HCV RNA 
  
  
  
  
  
  
  
HBsAg 
  
  
  
  
  
  
  
anti-HBs 
  
  
  
  
  
  
  
Anti-HAV Total 
  
  
  
  
  
Assessments 
Eligibility 
Baseline 
  
Quant/Qual  Quant/Qual    
Quant/Qual  
 
Participants at the SSP will be tested for HIV using a rapid test, which when reactive will be 
confirmed using a second rapid HIV test from another manufacturer following a CDC-
approved dual rapid HIV testing algorithm. Confirmatory testing no longer requires 
venipuncture. A 4th generation test will be sent as indiated below. The initiation of care, 
however, will not be delayed. If a patient tests positive on dual rapids, the patient will be 
offered immediate initiation onto ART at the SSP. If accepted, they will provide informed 
consent.  They will have an immediate HIV care visit with a provider in person or via 
encrypted Zoom technology. A prescription for BFTAF will be written and filed for the 
participant, and BFTAF will be provided on site. ART will be initiated immediately, and in 
the rare case that changes in dosing or ART based on lab values (e.g. creatinine) is needed, 


IRB Study Number: 20200793 
 
Page 6 of 10 
Revised: 4/25/22 
they will made once lab results return. This is now standard of care nationwide for rapid 
initiation. The care visit will be documented in UChart. Baseline labs (4th Generation HIV 
test, HIV viral load, CD4, HIV genotype, CBC, CMP, Gonorrhea/Chlamydia, RPR, HCV 
Antibody, HCV RNA) will be obtained and sent to the Miami-Dade County Health 
Department. Patients will have up to 7 days post HIV-positive test to start on ART (per 
definition of rapid ART initiation).  
 
Peer navigators will conduct outreach to SSP Rapid Initiation participants, monitor 
appointments, and provide transport to healthcare services. This intensive linkage and active 
follow-up delivered by peer PWID living with HIV is essential to delivery of care to this 
population.  A medication adherence plan will be developed for each patient by SSP staff to 
optimize medication adherence. Quantitative and qualitative assessments exploring barriers 
and facilitators of HIV treatment adherence will be given at 1, 3 and 6 months post treatment 
start date. In addition, HIV viral load will be measured at 1, 3, and 6 months post treatment 
start date to assess viral suppression. Peers will be tasked with helping participants with 
eligibility (e.g., Ryan White, Medicaid) and ADAP enrollment when they transition out of the 
trial to a traditional care environment. 
 
For each 30-minute interview conducted at the IDEA SSP, participants will receive $50. 
 
Qualitative Assessment of those declining rapid ART 
In-depth interviews with PWID living with HIV who do not engage in treatment with 7 days 
of HIV test result will be conducted. We anticipate conducting 10 interviews, which is 
sufficient to achieve data saturation and will be conducted within 3 months post HIV test 
result. Participants will be consented and asked to participate in a 30-minute interview 
conducted at the IDEA SSP for which they will receive $25. 
 
 
8) Primary Endpoints 
 
Study Aim 
Primary 
Outcome 
(Patient-Level) 
Definition 
Primary Outcome 
(Implementation) 
Definition 
Aim 1 
Viral Suppression  
HIV viral load 
<200 copies/ml at 
6 months post 
baseline 
Acceptability of Rapid 
Initiation of ART 
Number and 
percentage of 
PWID living with 
HIV that enter SSP 
Rapid Initiation  
Aim 2 
Treatment 
Adherence 
HIV Viral Load 
<200, pill counts, 
medication log, 
appointment 
attendance 
  
Barriers to Adherence 
Exploration of 
challenges to HIV 
treatment 
management at 
SSP 
Aim 3 
Viral Suppression 
HIV Viral Load 
<200, pill counts, 
medication log, 
appointment 
attendance 
 
Feasibility of peer 
navigation  
Exploration of 
challenges to HIV 
treatment 
management at 
traditional HIV 
clinic 


IRB Study Number: 20200793 
 
Page 7 of 10 
Revised: 4/25/22 
 
For this proposed study, we expect that ongoing, peer-driven patient navigation based at the 
SSP will result in patients’ remaining virally suppressed after transition to the UM/Jackson 
Adult Outpatient HIV Clinic. More importantly, based on the hybrid design, this study will 
lay the foundational groundwork to provide a proof of concept for HIV care at SSPs, 
including pertinent implementation information for future expansion sites in the state of 
Florida. We expect to uncover barriers and facilitators to implementation of rapid ART 
initiation at an SSP, including patient-level perspectives on improving delivery of care 
developed in the SSP Rapid Initiation among PWID Living with HIV protocol. 
 
Secondary outcomes: Time to viral suppression, or viral suppression at 1 month, will be 
assessed. Treatment adherence will be assessed both by follow-up viral load results (1, 3, 6, 
9, 12 months) as well as by medication management measures (e.g., PWID accessing meds 
weekly, pill counting by SSP staff) and attendance at clinic visits. Successful transition to 
HIV care at a Ryan White clinic will also be assessed.  The clinic-based peer patient 
navigator will assist in transition of patients to long-term care within six months of ART 
initiation. Ryan White clinic appointment attendance and successful re-enrollment in Ryan 
White/ADAP will be assessed.  
 
 
9) Data and Specimen Banking* 
 
For clinical data, we will use the UHealth’s electronic health record, UChart, which is locked 
under dual authentication.  
 
All data collected will be housed in the REDCap database system, which is locked under dual 
authentication by University of Miami Information Technology and then extracted for 
analysis by the principal investigator. Only study staff will have access to survey results. 
 
As for the in-depth interviews, sessions will be audio-recorded, transcribed by an external 
company, de-identified for analysis and stored on a password-protected computer in a secured 
office in the Don Soffer Clinical Research Center. Only study staff will have access to results. 
 
10) Data Management* 
 
Quantitative Data Analysis: Quantitative data will be analyzed using descriptive statistics 
and frequencies to present pilot data on rapid ART initiation at an SSP. Data will be 
presented as frequency tables, and viral suppression will be reported as a percentage 
suppressed at each time-point (1, 3, 6, 9, 12 months). All quantitative data will be stored 
and managed in REDCap and all analyses will be performed using SAS statistical 
software (Version 9.4; SAS Institute, Cary, NC). Categorical data will be analyzed using 
frequency of responses and continuous variables will be analyzed using means and 
standard deviations. 
 
Qualitative Data Analysis: Qualitative data collected from the in-depth interviews will be 
analyzed using general inductive methodology31, which allows for themes to be 
developed from the raw data based on a study objective/research question. A data 
codebook will be generated in an iterative process during transcript reading by the study 
team. All qualitative data analysis will be conducted using Dedoose (version 8.2.14, 
Sociocultural Research Consultants, Los Angeles, CA), a cross-platform software used 
for analyzing qualitative and mixed methods research. 


IRB Study Number: 20200793 
 
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Revised: 4/25/22 
 
 
11) Risks to Subjects* 
 
Study procedures: there is risk of discomfort to phlebotomy, but no risk above routine HIV care 
 
Study Drug: Serious risks of taking BFTAF includes serious drug reactions such as lactic 
acidosis, hepatomegaly with steatosis, hepatotoxicity, hepatitis B virus exacerbation, pancreatitis, 
nephrotoxicity, neutropenia, immune reconstitution syndrome, autoimmune disorders, suicidality, 
and angioedema. Common adverse reactions include diarrhea, headache, fatigue, 
hyperbilirubinemia, elevated CK, abnormal dreams, dizziness, insomnia, hypercholesterolemia, 
hyperamylasemia, neutropenia, LFTs elevated, nausea/vomiting, depression, rash, dyspepsia, 
abdominal pain, asthenia, increased creatinine, bone density loss, arthralgia/myalgia, cough, 
paresthesia, peripheral neuropathy, palmar-plantar hyperpigmentation, hypertriglyceridemia, 
hematuria, hyperglycemia, glycosuria, rhinitis and flatulence.  
 
12) Adverse Events and Serious Adverse Events 
 
AEs will be any of the common adverse reactions defined above. SAEs will include any 
hospitalization or death or disability that occurs with participants in the trial.  AEs will be 
reported to the IRB in continuing reviews. SAEs will be reported to the IRB within 24 hours.  
 
13) Potential Benefits to Subjects* 
 
The potential benefit to the PWID is that they will be able to access rapid on-site ART 
treatment initiation with few barriers, improving their overall health in the short and long 
term.  
 
14) Vulnerable Populations* 
 
This study will exclude children because the provider is board certified in Internal Medicine 
and only sees adult patients. Children will be rapidly referred to University of Miami 
Department of Pediatrics Test and Treat program. 
 
15) Setting 
 
The IDEA Syringe Services Program of the University of Miami Miller School of Medicine 
is the study site.  
 
16) Resources Available 
 
Dr. Hansel Tookes (Contact PI) is a board-certified internist and HIV physician with 
expertise in treating HIV among PWID. Dr. Tookes was the driving force behind the 
establishment of the IDEA SSP and serves as the PI of the UM Harm Reduction Research 
Group. Dr. Tookes has extensive knowledge regarding HIV prevention among PWID and has 
utilized community-based research approaches to improve health outcomes among this 
vulnerable population.  
 
Dr. David Serota (co-I) is a board-certified infectious disease specialist, internist and 
addiction medicine physician. He specializes in the treatment of severe infections in PWID. 


IRB Study Number: 20200793 
 
Page 9 of 10 
Revised: 4/25/22 
He has extensive knowledge regarding HIV prevention in this high priority community, and a 
leader in harm reduction in our community. 
 
 
Dr. David Forrest (co-I) is a medical anthropologist who brings expertise in advanced 
qualitative methods and research to inform HIV prevention among at-risk populations. Dr. 
Forrest is co-PI for the Miami-Dade site of the National HIV Behavioral Surveillance and has 
over 25 years of expertise conducting research among PWID. 
  
Dr. Tyler Bartholomew (co-I) has expertise conducting HIV and HCV implementation 
research among PWID, including the implementation and evaluation of HIV/HCV testing and 
linkage to care at the IDEA SSP.  
 
Dr. Katrina Ciraldo (co-I) is a board certified Family Medicine and Addiction Medicine 
specialist. She specializes in womens health with a focus on pregnant women with substance 
use disorders who are experiencing homelessness. Dr. Ciraldo has extensive knowledge in 
addiction medicine and innovator in the harm reduction community.  
 
Dr. Teresa Chueng (co -I) is finishing her Infections Disease clinical fellowship at Jackson 
Memorial Hosptial and will start her appointment as Assistant Professor of Clinical Medicine 
in the Division of Infectious Diseases at the University of Miami Miller School of Medicine 
in July 2022. Dr. Chueng provides expertise in clinicial infectious disease, including HIV, 
hepatitis C, and infections related to injection drug use.  
 
 
17) Prior Approvals 
 
Funding agency approval: none 
 
18) Recruitment Methods 
Recruitment will be through the IDEA SSP participants with regular usage of SSP services 
(at least 1 visit per month). All PWID with a negative rapid HIV screen will be offered 
participation in this study. 
 
Local Number of Subjects 
We intend to recruit 50 PWID living with HIV and currently not engaged in ART treatment 
to assess the SSP Rapid Initiation pilot program. Since this is a pilot, there were no statistical 
considerations made with determining sample size. We expect that 20% of those approached 
to participate will decline. Those who decline will be asked to participate in a brief qualitative 
assessment to explore patient-level factors for declining treatment (N=10). 
 
19) Confidentiality 
The REDCap surveys will be anonymous and do not solicit protected health information or 
any identifying information. If results of this survey are reported to any agency, or in journals 
or at scientific meetings, data will be de-identified and presented in aggregate. In addition to 
the research staff, the following entities may review information collected as part of this 
survey activity:  1) Office of Human Research Protections (OHRP), 2) University of Miami 
Human Subjects Research Office, and 3) professionals who may be evaluating this survey 
activity 
 


IRB Study Number: 20200793 
 
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Revised: 4/25/22 
The in-depth interviews audios and transcripts will be stored in a password-protected file that 
will be stored on University of Miami secure network.  Audio will be deleted immediately 
after transcription.  
 
In order to secure the data, all staff will be trained on confidentiality via the CITI program 
including Human Subjects Research and Good Clinical Practice 
 
20) Provisions to Protect the Privacy Interests of Subjects  
All data will be stored on the PI’s password protected computer and data will only be shared 
via secured access Sharepoint with other members of the research team. The computer is 
secured by UM IT, kept in a locked office in the Soffer Clinical Research Center. Qualitative 
data will be transcribed and stored on the PI’s computer and shared only with the research 
team. Audio will be deleted immediately following transcription. Copies of the informed 
consent with patient signature will be stored in a locked filing cabinet within the PI’s keycard 
secured office.  
 
21) Consent Process 
Written consent will be obtained at the IDEA SSP by study staff.  
 
(See attached consent documents for reference) 
 
22) Process to Document Consent in Writing 
Writtten consent (provided both in English and in Spanish) will be obtained using e-consent 
in REDCap. REDCap e-Consent Framework provides standardized tools to obtain consent 
and store consent documentation with a certification screen and a storage function which 
automatically generates a “hard-copy” PDF of the signed form.