Instacare: A Prospective Study of Clinical Outcomes Following Rapid ART Initiation Among Persons With HIV and Out of Care
Conditions: Hiv, HIV Infections
Sponsor: University of California, San Diego

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UCSD Human Research Protections Program 
New Biomedical Application 
RESEARCH PLAN 
1. 
PROJECT TITLE 
InstaCare: A Prospective Study of Clinical Outcomes Following Rapid ART Initiation Among Persons with HIV 
and Out of Care 
2. 
PRINCIPAL INVESTIGATOR  
Susan Little, MD - Professor of Medicine 
University of California San Diego – Department of Medicine, Division of Infectious Diseases 
3. 
FACILITIES 
The study will be conducted at:  
1)The UCSD AVRC-Antiviral Research Center, 220 Dickinson Suite A, San Diego, CA 92103 and  
2) The UCSD Owen Clinic, 3rd Floor Medical Offices South, 4168 Front St, San Diego, CA 92103. 
4. 
ESTIMATED DURATION OF THE STUDY 
3 years 
5. 
LAY LANGUAGE SUMMARY OR SYNOPSIS (no more than one paragraph) 
The human immunodeficiency virus (HIV) continues to cause significant illness and death in the USA despite 
availability of effective treatment. People who are aware of their HIV status, but who are out of care and not on 
medications, are therefore at risk of developing HIV related health problems. In addition, people with HIV who 
are out of care are at greater risk of transmitting HIV compared to people on HIV treatment with suppressed levels 
of virus in plasma. To date, there are no interventions that have been shown to successfully link this “out of care” 
population back into care and successfully maintain viral suppression. 
This study will test a strategy of providing immediate HIV therapy drugs, linkage to care, and a randomized 
intervention (60-minutes for health or diet and nutrition session). The goal of the study is to demonstrate that the 
60-Minutes-for-Health intervention improves the rate of viral suppression at 24 weeks. 
The use of rapid antiretroviral therapy (rapid ART), defined as the initiation of ART within 7 days of HIV 
diagnosis, has been associated with improved rates of linkage to care, retention in care and virological suppression 
after 1 year among persons newly diagnoses with HIV. In addition, the behavioral intervention, “60-Minutes-for-
Health”, was shown in a pilot study to improve retention in care among PWH-OOC. We aim to undertake a study 
to evaluate the feasibility of providing rapid-ART to people who are aware of their HIV status, but have been out 
of care at the time they re-engage in care. In addition, study participants will be randomized to either the “60-
Minutes-for-Health” intervention or a 60 minute diet and nutrition control session.  
6. 
SPECIFIC AIMS 
AIM 1. To compare the proportion of persons with HIV and out of care (PWH-OOC) undergoing rapid-ART 
initiation that are on ART with VL ≤50 copies/mL at week 24 between those randomized to 60-Minutes-for Health 
vs. a time-and-attention control session at baseline.  
AIM 2. To compare the proportion of participants in care at week 24 between those randomized to 60-Minutes-for 
Health vs. a time-and-attention control session at baseline.  
AIM 3. To compare the role of genotypic susceptibility scores (GSS) derived from HIV Genosure archive resistance 
testing as a predictor of achieving virologic suppression on rapid ART among PWH-OOC.  
AIM 4. To determine the acceptability of rapid ART among PWH-OOC using quantitative surveys and focus groups 
on patient-reported outcomes and perspectives at week 4. 

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7. 
BACKGROUND AND SIGNIFICANCE 
HIV continues to cause substantial morbidity and mortality in the USA with over 38,000 new diagnoses in 20171. 
Historically, the majority of HIV transmissions in the USA were thought to arise from persons who were HIV 
infected but unaware, or who had acute HIV infection2,3. However, more recent data suggests the dynamics of 
HIV transmission in parts of the US are changing. Fewer than 60% of PWH are retained in care and achieve viral 
suppression4. As a consequence, over 40% of HIV transmissions in the US are now estimated to arise from PWH 
and aware of their diagnosis but out-of-care (PWH-OOC)5. Local data from San Diego County support a similar 
shift in regional transmission dynamics6. Using National HIV Behavioral Surveillance data applied to local 
prevalence, San Diego County estimates that 90% of PWH are aware of their diagnosis and that the number of 
new diagnoses have declined by 21% (data through 2017)6. However, despite these encouraging data, the HIV 
Care Continuum in San Diego also demonstrates that among those diagnosed with HIV infection, only 75% have 
been linked to care, and of these only 60% have achieved viral suppression7. Together, these data suggest that 
strategies to engage and treat PWH-OOC may play a vital role in preventing transmission of HIV5.  
Delays between re-linkage to care and initiation of ART may represent a missed opportunity for immediate 
engagement resulting in some loss to follow up. Rapid ART initiation, generally defined as ART initiation <7 days 
from diagnosis8, has been shown to improve linkage, retention and viral suppression rates compared to standard of 
care ART in persons newly diagnosed with HIV in low and middle income countries 9-12. In the U.S., rapid ART 
initiation has been associated with shorter time to virologic suppression than historically treated persons13. To 
date, no studies have investigated rapid ART among PWH-OOC14, many of whom have been previously engaged 
in the healthcare system, but were unable to sustain engagement15. Our group has successfully implemented rapid 
ART among persons newly diagnosed with HIV16. We propose to leverage this expertise to evaluate rapid ART 
among PWH-OOC. 
Multiple brief, single-session, POC interventions have successfully changed complex HIV-related behaviors in 
other areas17-27. Most of these interventions range from 15-60 minutes long and are delivered in clinic settings by a 
variety of people (e.g. lay health educators, outreach workers, nurses). Significant changes in behavioral outcomes 
include reductions in condomless sex17,18, decreased incidence of sexually transmitted infections19,20,24, increased 
odds of HIV testing21, returning for HIV test results22, and improvements in ART adherence23. Most follow-up 
periods were 6 months or less, though one study observed significant changes over 12 months19. All but one23 
intervention integrated evidence-based motivational interviewing (MI)28 and/or social cognitive theories (e.g. 
Information Motivation Behavioral Skills model29) to inform the interventions’ delivery and content. MI promotes 
behavior change by eliciting the individual’s own motivation for change and solutions to overcome their perceived 
barriers to change28. Social cognitive theory targets the conversation around behavioral determinants most 
proximal to change (i.e. correct misinformation driving decisions to avoid HIV care, build motivation by 
improving ART attitudes, or increase behavioral skills to navigate structural barriers like transportation29). 
Preliminary Data 
Rapid ART. The UCSD NIH-funded Primary Infection Resource Consortium (PIRC) is the largest, most 
intensively studied and well-characterized cohort of people identified with acute and early HIV infection in the 
U.S.. Since December 2014, the PIRC has implemented a rapid ART program16,30 in an effort to improve uptake 
of ART and time to virologic suppression10,12,13. Since this program began, 66 of the 69 (95.7%) participants 
diagnosed with acute and early HIV infection have initiated rapid ART with an integrase-based treatment regimen, 
with a median time from HIV diagnosis to ART start of 1 day (IQR 0-6 days). The proportion with VL 
suppression at 12 and 24 weeks was 80% and 98%, respectively.  
“60-Minutes-for Health”: To date, there are no interventions with a strong evidence base to effectively re-engage 
PWH-OOC31.  “60-Minutes-for Health” is a brief, low resource, single session, theory-based behavioral 

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intervention for PWH-OOC29,32. In a pilot randomized controlled trial (by Co-I Smith), “60-Minutes-for Health”, 
was found to be acceptable and feasible and was associated with improved retention in HIV care at both 12- and 
24-month follow-up among participants randomized to the intervention (87.5% and 62.5% respectively) compared 
to a time-and-attention control (62.5% and 25.0% respectively)32. 
8. 
PROGRESS REPORT 
N/A 
9. 
RESEARCH DESIGN AND METHODS 
The overall strategy is to perform a feasibility study of rapid ART initiation among PWH-OOC who are 
randomized (1:1) to an unblinded behavioral intervention “60-Minutes-for Health”, compared to a 60 minute time-
and-attention control session focused on diet and nutrition.  
Individuals eligible for participation will be enrolled and followed for 48 weeks. They will be offered a same day 
(or within 1 week) appointment to enable the initiation of ART within 7 days of contact. Eligible individuals, after 
completing informed consent, will start ART for HIV with Bictegravir/Emtricitabine/tenofovir alafenamide 
(B/F/TAF) or appropriate alternative therapy if B/F/TAF is not thought to be an optimal regimen. Individuals will 
undergo computer-generated randomization (1:1) to onsite 60-Minutes-for Health intervention vs an onsite theory-
based time-and-attention control session focused on diet and nutrition. After completion of the intervention 
participants will receive standard-of-care case management services between day 0 and week 4. A 60-day supply 
of B/F/TAF or alternative will be provided for participants of both study arms. The timeline of visits and study 
interventions is summarized in Table 1. 
Table 1. Schedule of Evaluations 
Study Assessment 
Baseline 
(Day 0) 
Wk 
1 
Wk 
2 
Wk 
4 
Wk 
4-8 
Wk 
12 
Wk 
24 
Wk 
36 
Wk 
48 
Assessments 
Eligibility checklist 
X 
 
 
 
 
 
 
 
 
Informed Consent/HIPAA 
X 
 
 
 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
 
 
 
Release of information4 
X 
 
 
X 
 
 
X 
 
X 
Limited history5 
X 
 
 
 
 
 
 
 
 
Concomitant medications 
X 
 
 
 
 
 
 
 
 
Baseline Risk Assessments 
X 
 
 
 
 
 
 
 
 
Follow-up Risk Assessments 
 
 
 
X 
 
 
X 
 
X 
Linkage to Care Assessment 
X 
 
 
X 
 
X6 
X 
X6 
X 
STI Treatment/Referral 
Tracking7 
X 
 
 
 
 
 
 
 
 
Targeted physical examination 
X 
 
 
 
 
 
 
 
 
Historical ART assessment 
X 
 
 
 
 
 
 
 
 
ART Adherence Monitoring 
 
X 
X 
X 
 
 
X 
 
X 
Adverse Event Monitoring 
X 
X 
X 
X 
 
 
X 
 
X 
Ensure Provision of ART 
X8 
X 
X 
X8 
 
 
 
 
 
ART acceptability survey 
 
 
 
X 
 
 
 
 
 
Behavioral Services 
60 Min Intervention vs. Control 
X 
 
 
 
 
 
 
 
 
Case Management 
X 
X6 
X6 
X 
 
 
 
 
 
Telephone follow-up 
 
X 
X 
 
 
 
 
 
 

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Focus Group (optional) 
 
 
 
 
X 
 
 
 
 
Laboratories 
INSTI HIV Rapid Test9 
X 
 
 
 
 
 
 
 
 
HIV Ultra RNA PCR 
X 
 
 
 
 
 
X 
 
X 
CD4/CD8 Panel 
X 
 
 
 
 
 
 
 
 
GC/CT NAT (x3 sites) 
X 
 
 
 
 
 
 
 
 
Syphilis EIA 
X 
 
 
 
 
 
 
 
 
w/reflex to titer and TP-PA 
X 
 
 
 
 
 
 
 
 
Comprehensive Metabolic Panel 
X 
 
 
 
 
 
 
 
 
CBC w/diff 
X 
 
 
 
 
 
 
 
 
HepBsAg 
X 
 
 
 
 
 
 
 
 
HIV Genosure archive resistance 
test (w/Integrase) 
X3 
 
 
 
 
 
 
 
 
Urine Pregnancy test1 
X 
 
 
 
 
 
 
 
 
Specimen Collection 
Plasma Bank 
X 
 
 
 
 
 
 
 
 
PBMC for cell pellet 
X 
 
 
 
 
 
 
 
 
Stipends 
Study stipend2 
X 
 
 
X 
X 
 
X 
 
X 
1 In women any time pregnancy is suspected 
2Compensation rates: Day 0 [$20]; Survey Wk 4 [$20]; Focus Group [$50]; Wk 24 [$50]; Wk 48 [$75].  
3Sample is banked for future analysis 
4Baseline and at any time a new care provider is identified 
5Medical history, STI, HIV and Hepatitis 
6Phone call, email, text message, WhatsApp message, Facebook Messenger, and other participant-approved methods will be 
used to contact participant 
7Complete for participants who test positive for Syphilis, Gonorrhea and/or Chlamydia at their Day 0 visit 
8Study-provided ART will be dispensed at week 0 and 4 
9For participants without documentation of HIV positive test results 
Antiretroviral Therapy (ART) drugs: Drugs proposed for use in the study are currently standard of care for 
PWH and are all FDA approved. For participants without a clinical history or documented evidence of integrase 
inhibitor resistance, a regimen of bictegravir, emtricitabine & tenofovir alafenamide (B/F/TAF) will be offered. 
For individuals with evidence of integrase inhibitor resistance, an alternative ART regimen will be determined, 
based on prior treatment regimens – in collaboration with the participants primary care physician. 
Clinical assessments: All subjects will undergo history and physical examination at baseline (Day 0) for the 
purposes of documenting features consistent with HIV infection, subject demographics, income, insurance status 
and employment status. Adverse event monitoring and reporting will start at baseline and continue at each study 
visit. Serious adverse events, grade 2 rashes, and all grade 3 or 4 adverse events will be reported in line with the 
International Conference on Harmonization (ICH) guidelines.  
Laboratory Assessments 
HIV Monitoring Laboratories – All subjects will have an HIV rapid test performed on Day 0 on confirm HIV 
status if documentation of HIV status is not available to determine study eligibility. HIV related laboratories 
including: viral load (6 ml) and CD4 cell counts (3 ml). A 6 ml blood sample will be banked for future HIV drug 
resistance testing to assess ART resistance mutations (HIV GenoSure Archive).  HIV viral load testing will be 
repeated at weeks 24 and 48. 

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Hepatitis Laboratories: Blood (6 ml) will be collected to test for hepatitis B virus surface Ag. If subjects are 
identified as HBV, they will be referred for case management to provide linkage to care and treatment. 
STI screening will occur at Baseline (Day 0) as defined in Table 1. Urine, throat and rectal swab specimens will 
be sent for GC/CT NAT and blood will be sent for RPR (syphilis). Testing for syphilis will involve collection of 6 
ml of blood. All patients will be informed of their STI test results. If any STIs are identified, notification will 
occur by phone or in person, and referral will be made to subject’s primary medical doctor or to a public health 
clinic for treatment. Negative STI results will be provided via participants preferred method of communication 
(text, e-mail, or phone). STI reporting will be completed according to state requirements.   
Safety Laboratories: A urine pregnancy test will be performed at any time during study participation that 
pregnancy is suspected. 
Biological Specimens 
Plasma and peripheral blood mononuclear cells (PBMC) – whole blood will be collected for blood plasma and 
PBMC (20 mL) for cryopreservation.  
The total blood drawn for the screening and first four (4) study visits (12 weeks) is approximately 50 ml.  
Additional study assessments: Linkage and retention in care – the number of HIV care visits ≥90 days apart 
between enrolment and 24 weeks (visit window 24 weeks + 12 weeks); the number of HIV care visits ≥90 days 
apart between enrolment and 48 weeks (visit window 48 weeks + 12 weeks). The time between enrolment and 
first HIV primary care visit. 
Baseline, follow-up and focus group assessments: Participants will take structured surveys. Answers will be 
recorded into Redcap. We will use validated survey instruments of known determinants predicting engagement in 
HIV care: (a) unmet need addressing current and past 6-month structural barriers (i.e., housing and food stability, 
transportation),  (b) substance use assessed by the Drug Abuse Screening Test (DAST) and AUDIT-C,  (c) mental 
health symptoms related to depression (CESD-10) and anxiety (GAD-7), (d) antiretroviral (ART) medication 
regimen and overall ART adherence, (e) HIV care beliefs scale, (f) internalized HIV stigma, (g) resilience, (f) HIV 
affect skills, (g) sexual risk behavior and (h) the Engagement in HIV care index. Participants in the focus group 
will be reminded to not state anything in the focus group visit that they would not want to be heard outside of the 
group. 
Experimental study aspects: Experimental aspects of the study are listed here: 
• Rapid initiation of ART among PWH-OOC: Rapid ART among PWH with newly diagnosed infection is 
widely used though the use among PWH-OOC, while used in some physicians’ clinical practice, is not 
currently established standard of care and would be considered experimental 
• 60-Minutes-for Health: this is a psychological intervention which seeks to correct factors underlying 
decisions to delay or avoid HIV care and strengthen abilities to overcome HIV care utilization barriers. This 
is achieved through assistance identifying and reducing misinformation guiding HIV care attendance 
decisions; enhancing motivation to maintain HIV care via personal health goals; building skills for coping 
with negative feelings related to living with HIV; and increasing self-efficacy for navigating structural 
barriers and maintaining HIV care amidst competing priorities. The session will be provided by staff HIV 
testers (trained by Dr Smith, Co-I) 
Pregnancy: Participants that are pregnant at time of enrolment to the study will be eligible to participate. US HIV 
guidelines indicate all individuals without contraindication should start ART immediately and so rapid-ART for 
pregnant participants falls within established guidelines. B/F/TAF is not standard of care for pregnant individuals 
and so ART regimens will be selected after discussion between investigators and according to national guidelines. 

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Pregnant individuals will be assisted in establishing care with HIV providers with experience in treating HIV in 
pregnancy and will assist with establishment in care with obstetrics providers with HIV expertise if not done prior 
to enrolment. The schedule of evaluations will remain the same for pregnant participants. 
Data collection: data collection will be performed at each visit according to the schedule of evaluations and 
entered into the Research Electronic Data Capture (REDCap) data management system. Participants will be 
requested to provide release of information (ROI) to allow capture of HIV primary care visit data, primary care 
visit details (clinical notes) and HIV viral load for the duration of the study (48 weeks).  
Primary outcomes are:  
• the proportion of individuals with HIV VL ≤50 copies/ml at week 24; and  
• the number of clinical care visits ≥90 days apart between study enrollment and week 24 (window +12 
weeks).  
Secondary outcomes are:  
• the self-reported initiation of ART;  
• the proportion of participants with HIV VL ≤50 at week 48;  
• the proportion of participants with ≥2 clinical care visits >90 days apart between enrollment and week 48;  
• to compare discrete genotypic susceptibility score (derived from banked archive genotype at enrolment) 
between individuals with and without virologic suppression at week 24 and 48; and  
• to assess the acceptability of rapid ART through quantitative surveys at week 4 and among four focus 
groups help between week 4-8. 
Statistical considerations: Based on preliminary data from the 60-Minutes-for-Health pilot study, we expect a 
difference of 30% in the proportion of participants with suppressed viral load at week 24 between study groups. 
Assuming a loss to follow-up of 20% and a 70% rate of viral suppression in the intervention arm, we will need to 
enroll 124 individuals to detect a significant difference (p<0.05) in suppression (≥30%) between the two groups. 
The proportion of participants with the primary and secondary outcomes will be compared using Fisher’s exact 
test between intervention groups. 95% confidence intervals for the overall proportion of PWH-OOC that are on 
ART with HIV VL≤50 copies/ml and the overall proportion that are in care at week 24 will be compared to the 
analogous proportions among acute and early HIV (AEH) participants undergoing rapid ART initiation. 
Comparison with this historical cohort will be performed using Fisher’s exact test. 
Collaboration with other Academic Research Groups studying Rapid ART: Coded data, that have been 
stripped of identifiers, from HIV infected participants may be shared with research investigators in the U.S. and 
abroad, to better understand the acceptability and durability of Rapid ART and to gain a better understanding of 
this treatment strategy in all populations. InstaCare investigators will maintain the codebook in order to access 
identifiers to link data sets outside of the InstaCare research study.  
Collaborations with other rapid ART investigators and collaborators are anticipated that will utilize InstaCare data 
and will involve the statistical, modeling, and inference needs of specific projects. The needs of these studies are 
expected to range from traditional biostatistical design and analyses needs (e.g., formulation of testable 
hypotheses, power calculations, and multivariate regressions), to novel analytical techniques (next generation 
sequence analysis, phylogenetics, and molecular epidemiology), which are increasingly crucial for 
interdisciplinary biomedical research. Summary data only will be shared with Gilead - consistent with materials 
prepared for publication. No individual-level data will be shared. 
10. HUMAN SUBJECTS 

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We will enroll 124 participants in this study. Prospective participants will be identified through a number of 
means to ensure an equitable representation of PWH-OOC: 
1. Potential subjects from UCSD Owen Clinic that fulfill the entry criteria will be contacted and offered an 
appointment for study recruitment 
2. Subjects identified in the UCSD emergency department HIV screening program will be contacted and offered 
an appointment for study recruitment 
3. San Diego Public Health Department (SDPHD) has implemented routine evaluations of their local HIV 
surveillance data in conjunction with other data to identify PWH who may be OOC33. This Data to Care 
program results in the evaluation of ~ 250 new cases per year in San Diego (~20-21 PWH-OOC a month), 
many of whom are found to be viremic and out-of-care. Once located, SDPHD will offer immediate 
transportation vouchers (Lyft) to and from the AVRC to expedite study enrollment and rapid ART start. 
4. If after 12 weeks enrollment falls below ~7/month we will initiate an additional social media campaign 
(Facebook and Instagram). We will use the existing UCSD AVRC platform to promote study participation and 
work within our existing partnerships with local gay bars to increase our social media reach. 
Inclusion Criteria:  
• 18 years of age or older;  
• documented HIV infection status (or rapid HIV will be repeated);  
• out-of-care defined as not seen in HIV provider clinic for ≥6 months AND not receiving ART for ≥1 month 
(by self-report); 
• available for follow-up according to schedule of evaluations. 
Exclusion Criteria:  
• Co-morbid condition(s) that in the opinion of the investigator could limit the participant’s ability to comply 
with the visit schedule or safely initiate rapid ART (e.g. psychiatric comorbidities or suspected central 
nervous system opportunistic infection);  
• Prior ART regimens that in the opinion of the investigator precludes selection of a treatment option likely to 
result in virologic suppression (e.g. documented treatment failure on INSTI based regimen and multiple prior 
NRTI, NNRTI and PI regimens or documented resistance mutations likely to result in treatment failure) 
• Participants that are unable to speak sufficient English or Spanish to consent to the study will be excluded 
11. RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH 
Candidates for participation will be recruited through avenues listed in item 10. In situations where clinical data 
for a subject already exists on UCSD health electronic records, reasonable pre-screening will be undertaken to 
assess eligibility. A recruitment/educational flyer (Appendix X) is included and will be posted in area clinics, 
shelters, foodbanks, etc to outreach to potential participants. The text and imagery from the same flyer may also be 
used as part of a social media outreach effort if we are not reaching our enrollment goals with our initial print 
media outreach efforts. 
For the purposes of pre-screening ONLY:  A request for partial waiver of consent is requested.   
The investigator believes the pre-screening to be used for recruitment meets the following requirements for this 
request per 46 CFR 46.116: 
1. The (pre-screening) research involves no more than minimal risk to the participants; 

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2. The waiver or alteration will not adversely affect the rights and welfare of the participants; 
3. The (pre-screening) research could not practicably be carried out without the waiver or alteration; and 
4. Whenever appropriate, the participants will be provided with additional pertinent information after 
participation. 
Recruitment procedures will also involve the review of participant records by designated study personnel (e.g., 
investigators and/or study coordinators) in order to identify potentially eligible participants.  
Since Protected Health Information (PHI) will be accessed via the study team’s record database prior to contacting 
the potential participant about the research study, we are requesting a partial waiver of HIPAA authorization for 
access to PHI for purposes of pre-screening only.   
Standard HIPAA authorization to collect research data from the participant's medical record will be obtained at the 
time of informed consent. 
A brief subset of preliminary eligibility criteria such as age, diagnosis, co-morbid conditions and prior treatment, 
will be reviewed by study personnel to determine participants’ preliminary eligibility for the research study. No 
written record of this information will be created. The study coordinator will then approach the participant to 
further discuss the research study with the participant and ask whether they would like to participate in the study.  
Eligibility may be formally determined at the time of counseling, but any research-specific screening procedures 
will only be performed after informed consent is obtained.  
For the partial waiver of individual authorization for pre-screening recruitment purposes ONLY of individual 
HIPPA/Protected Health Information. The following conditions apply:  
1. The (pre-screening) research involves no more than minimal risk, since we will not perform any procedure and 
the probability and magnitude of harm or discomfort anticipated in the research are not greater than those 
ordinarily encountered in daily life. 
2. Granting of waiver for recruitment purposes only will not adversely affect privacy rights and welfare of the 
individuals whose records will be used. as no written record of the potential participants’ information will be 
created. 
3. The pre-screening could not practicably be conducted without a waiver. Obtaining consent from all 
participants prior to determining eligibility would lead to a high screen fail rate, and as a result, place an 
increased burden on participants 
4. The pre-screening could not practicably be conducted without use of PHI. 
5. The privacy risks are reasonable relative to the anticipated benefits of research. 
6. An adequate plan to protect identifiers from improper use and disclosure is included in Item 16.  
7. Participant identifiers/sensitive information shall be removed/destroyed as soon as they are no longer needed 
and in accordance with AVRC policy. The investigators have procedures in place to periodically review 
collected participant identifiers/sensitive information to ensure it is still required to satisfy a particular purpose 
or carry out a function. 
8. The participants’ PHI will not be re-used or disclosed for other purposes. 
Recruitment to the study will occur through two routes: the first is through identification of UCSD Owen Clinic 
subjects eligible for recruitment and the second is through referral of participants from the emergency department, 
SDPHD or through social media campaign to the AVRC. Recruitment to the study will be performed by a named 

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member of the study team. 
UCSD Owen Clinic: 
• Participants will be prospectively identified by Owen Clinic and an appointment made at Owen Clinic for re-
establishment of care 
• At this visit, a study team member will attend UCSD Owen Clinic, assess the subject for eligibility and if 
eligible perform consent for the study, HIPAA consent and ROI. 
AVRC: 
• Participants identified through the UCSD emergency department, SDPHD or media campaign will be 
contacted by the study coordinator and offered an appointment at the AVRC within 7 days. Free Lyft 
transport will be provided by the study coordinator 
• At the AVRC, the project manager will assess the subject for eligibility and if eligible perform consent for 
the study, HIPAA consent and ROI. 
After completion of consent, HIPAA and ROI, the study coordinator will request relevant data from the subject’s 
primary care provider. For subjects under the care of a UCSD provider, one of the study investigators will access 
the subject’s clinical record to abstract relevant information (comorbidities, ART treatment history, HIV resistance 
assays (genotypes, phenotypes), substance use history, social documentation, baseline laboratory values including 
HIV VL) 
12. INFORMED CONSENT 
This protocol, the informed consent document and any subsequent modifications will be reviewed and approved 
by the UCSD Institutional Review Board responsible for oversight of the study. Written informed consent will be 
obtained from the participant by a member of the study staff. At the time potential participants contact us 
regarding the study, any questions they may have will be answered by a member of the study staff. If the potential 
participant is still interested in participating, the day 0 study visit will continue or be scheduled within 7 days. The 
participant will be informed of the time that needs to be allotted for their first visit in which the informed consent 
will be administered. 
Individuals unable to speak English will not be excluded from participating in a study. The approved informed 
consent and any subsequent versions will be translated into Spanish and on a case-by-case situation any other 
language that is deemed necessary. The translated informed consents will be submitted to the IRB for approval. 
The consent process will include a qualified translator in the participant’s native tongue. If a qualified UCSD 
translator is not available the Cyrom Language Line will be utilized as they have certified medical interpreters. 
The interpreter will sign and date at the end of the approved informed consent unless the Cyrom interpreter is 
utilized. In this situation, the study staff member involved in the consent process will document translator’s name, 
ID#, and date of the translation at the end of the approved informed consent. 
The informed consent process will describe the purpose of the study, the procedures to be followed, and the risks, 
and benefits of participation. This information will be explained to the study participant in a face-to-face setting 
by the individual consent the participant. Participants will be encouraged to ask questions throughout the consent 
process and encouraged to discuss their participation with trusted advisors, such as family members, close friends, 
etc.  Participants will be allotted sufficient time to consider whether or not to participate in the research study. 
After allowing the potential participant time to read the informed consent the study staff and/or investigator will 
answer and address any questions or concerns the participant may have. Once all questions and concerns have 
been addressed and the participant wishes to participate, they will be asked to sign the informed consent. 
Also, during the consent process, the informed consent process will be documented in the study CRF.  A copy of 

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the consent form will be given to the participant. 
13. ALTERNATIVES TO STUDY PARTICIPATION 
Participants may choose not to join this study. Persons who are HIV infected and out of care will be referred to an 
HIV care provider treatment and support services. 
14. POTENTIAL RISKS 
Potential risks to participants in the study are listed below: 
Personal Questions Risks: Participants will be asked about personal issues during this study. These types of 
personal questions could make them uncomfortable.  
Risks of Blood Draws: The subject may experience temporary discomfort from the blood draws. The needle 
sticks may cause local pain, bleeding, bruising and swelling, as well as lightheadedness, dizziness and rarely, 
blockage of the vein, fainting and/or a local infection. 
Waiting for Test Results: Subject may experience anxiety while waiting for test results. 
Stored Samples Containing DNA:  blood and cells containing genetic materials will be stored.  The blood and 
cells will be identified only be an identification number.  However, there is an inherent risk of inadvertent 
disclosure of identity because DNA can be used to identify an individual.  
Unknown Risks: There may be unknown risks that are unforeseen, or at this time cannot be predicted.  Subjects 
will be informed of any new risks that arise during the study. 
Reporting Requirements: Per California law, we will report information about known or reasonably suspected 
incidents of abuse or neglect of a child, dependent adult or elder including physical, sexual, emotional, and 
financial abuse or neglect. If any investigator has or is given such information, he or she is required to report such 
information to the appropriate authorities.  
Loss of Confidentiality: Study participation involves use of personal health information (PHI) including HIV 
status. As with all studies there is a risk of loss of confidentiality. Loss of confidentiality could lead to difficulty 
with employment, including situations where blood borne viruses preclude employment. The ability to obtain 
health insurance or life insurance may be compromised in situations where loss of confidentiality occurs. The 
likelihood of loss of confidentiality, while potentially serious, is believed unlikely. 
UC San Diego Health System participates in a health information exchange (HIE) associated with the 
implementation of the federal Affordable Care Act (ACA). The HIE shares portions of participants medical 
records in a “view only” format with other doctors outside UCSD to help improve the participants’ overall 
medical care. Clinical research tests that are performed at UCSD, including records from this research study, will 
be shared on the HIE.  This means that through the participant’s participation in this study, some doctors outside 
UCSD who might be participating in their overall medical care will see some portions of the participants’ medical 
records, including but not limited to lab results. If participants do not agree to allow the study staff to share their 
research records for this study on the HIE, they may not participate in this study.  
15. RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES 
Procedures taken to minimize risks to subjects are listed below: 
• Loss of confidentiality: see section 16. 
• Initiation of an ineffective HIV treatment regimen: The risk of using ineffective regimens will be minimized 
through obtaining as clear a history of prior ART regimens from the participant as possible, including using 
drug identification charts as standard. The proposed primary regimen (B/F/TAF) has a high barrier to 
resistance and resistance to this regimen in San Diego country is thought to be rare. The proposed study 

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follow-up timetable would be expected to rapidly identify cases of resistance allowing for regimen alteration 
in a timely manner. 
• Phlebotomy will be undertaken by experienced practitioners to minimize discomfort. 
Quality Assurance Monitoring and Record Availability: The AVRC quality assurance team will perform an on-
site review of individual participant records, including: consent forms, CRFs, and laboratory specimen records. 
Monitoring will ensure protection of study participants, compliance with the protocol, and accuracy and 
completeness of records. The quality assurance team will also inspect regulatory files to ensure requirements are 
being met. Quality assurance monitoring will occur when 10 participants are enrolled and then at 6-month 
intervals during the remainder of study conduct. Participants will be monitored clinically and will be given the 24-
hour number to call for emergencies. Participant will be informed to call at any time for adverse experience during 
study participation. This will be recorded in the research notes.  
All deviations from protocol or unanticipated problems involving risk (UPR) to subjects, as defined by the UCSD 
UPR fact sheet, will be reported to the UCSD IRB within 10 days. Problems or events that do not fulfill the 
definition of a UPR will be summarized in a table and submitted to the IRB in a timely manner. 
At year 1 and year 2 of full recruitment, the study team (PI, Co-Is) will review the data acquired and progress of 
the study. Details of virological failure will be reviewed for inadvertent initiation of an ineffective HIV treatment 
regimens. 
16. PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND 
MANAGEMENT 
Privacy: Recruitment to the study will take place in a private room either at Owen Clinic or via a direct telephone 
call to the individual. Discussion of the study and informed consent will take place in a private clinic room either 
in UCSD Owen Clinic or at the AVRC to ensure participants can ask questions about the study. The initial visit 
will include a physical exam which will be undertaken in the same private room by an experienced practitioner. 
Confidentiality: Case report forms will be stored in locked secure cabinets at the AVRC. Only authorized persons 
will have access to the case report forms (PI, Co-Is, study coordinators). Information gathered as part of this study 
will be recorded on REDCap data management system supported by the UCSD Clinical and Translational 
Research Institute (CTRI) and the San Diego Supercomputer Center (SDSC) for IT and HIPAA compliant data 
and server support. Data entry will use coded numbers where possible. Access to the records on REDCap will be 
restricted to essential study staff. For analysis of data, only records with all PHI removed will be downloaded from 
REDCap. Electronic data will be stored on REDCap indefinitely. Laboratory samples taken as part of this study 
will be labeled with coded identifier thereby reducing the chance of loss of confidentiality from blood draws. 
All members of the study team have undergone the CITI Biomedical Human Research and Good Clinical Practice 
training along with UCSD HIPAA training. 
It is reasonably foreseeable that study participants may report information that ethically could require action. The 
most likely of these is suicidal ideation or thoughts of harming others. In instances where a clinician deems there 
to be a real and imminent threat, this will be reported to the subject’s primary care provider and/or will escort the 
subject for assessment at UCSD emergency department. In cases where a threat is deemed real and imminent but 
the subject refuses emergency department assessment, then the study team will alert the police for assistance. 
17. POTENTIAL BENEFITS 
There is no guarantee that participants will directly benefit from being in this study or upon completion of the 
study. However, what is learned from this study may help other people who are infected with HIV. 
18. RISK/BENEFIT RATIO 

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Overall the risks of participation in the study are thought to be low as discussed above. The therapy offered for 
rapid ART is already established standard of care for individuals with a new diagnosis of HIV and have shown 
benefit in this population. The behavioral intervention was not associated with adverse events in a pilot study 
performed at UCSD and so it is reasonable to assume that the risk associated with this is low.  
Given the low risk of the study and the possibility of improved re-engagement in care of PWH-OOC, it is 
reasonable to expect the risk/benefit ratio of the study is favorable. 
19. EXPENSE TO PARTICIPANT 
No additional expenses to the participant are expected through their participation in the study. Every effort will be 
made through our case-management team to facilitate insurance coverage and linkage with care. Travel expenses 
will be available to all participants who are unable to cover their own travel expenses. 
20. COMPENSATION FOR PARTICIPATION 
Participants will receive compensation for attending the following visits: 
1. Screening visit - $20 
2. Completing the week 4 quantitative survey - $20 
3. Participating in a focus group - $50 
4. Attendance at week 24 study visit - $50 
5. Attendance at week 48 study visit - $75 
The most a participant can receive for study participation is $215.  
Subjects will be able to park free while visiting our clinic in the parking slots allocated for our patients.  Should a 
subject express a need for a meal, ride share, taxi or bus fare, we will provide transportation and/or meal vouchers 
to the subject by way of our patient discretionary funds. 
21. PRIVILEGES/CERTIFICATIONS/LICENSES AND RESEARCH TEAM RESPONSIBILITIES 
Drs. Susan Little (PI), David Smith, and Thomas Martin currently have privileges at UCSD Medical Center in the 
Department of Medicine; Division of Infectious Disease and are licensed and certified by the State of California to 
perform all the medical procedures discussed in the protocol at UCSD. In addition to having privileges with UCSD 
Medical Center, Dr. Susan Little has privileges at the VA Medical Center.  
Dr. Little will serve as the main PI and accept responsibility for all aspects of the protocol and the overall conduct of 
the study. The co-investigators will serve as after-hours/research study doctor(s) on-call, in Dr. Little’s absence.  
Dr Laramie Smith PhD is an assistant professor at UCSD. Dr Smith will have access to subject data, which includes 
identifiers, as part of her role in providing the intervention 60-Minutes-for-Health. 
Helene Le and Joseph Lencioni, MABMH will serve as the regulatory affairs administrators for this study.  
The AVRC nurses (NP: Aurora Verduzco-Gonzalez; RNs: Alina Burgi, Stephanie Solso and Steven Hendrickx) will 
be involved with the consent process and study visits. The study nurses are all licensed by the State of California.   
DeeDee Pacheco, DeLys Brooks, Christopher Houston, Rebecca Gonzalez, and Jessica Lloyd will perform all lab 
duties for this study.  
Liliana Harkness, Audrey Sanchez and Kelly Walsh will serve as staff research associates and assist the study nurse 
in performing study procedures.  
Leticia Muttera PharmD and Niamh Higgins, PharmD are our site pharmacists and will assist with the immediate 
ART procedures.  

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Tara Tenenbaum and Audrey Sanchez will be responsible for QA/QC of study related data. 
Support of the statistical portion of this study will come from Christy Anderson, MS Department of Medicine. These 
data will include PHI information. 
Miriam Zuazo and George Lara are case managers and will assist with the linkage to care procedures.  
Marvin Hanashiro and David Vance are the outreach coordinators for this study.  They will help with recruitment of 
new subjects.  
22. BIBLIOGRAPHY 
1. 
Centers for Disease Control and Prevention (CDC). HIV Surveillance Report, 2017. Atlanta, GA: U.S. 
Department of Health & Human Services; 2018. 
2. 
Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware 
that they are infected with the virus in the USA. AIDS 2006;20:1447-50. 
3. 
Skarbinski J, Rosenberg E, Paz-Bailey G, et al. Human immunodeficiency virus transmission at each step of 
the care continuum in the United States. JAMA internal medicine 2015;175:588-96. 
4. 
Centers for Disease Control and Prevention (CDC). HIV Incidence: Estimated Annual Infections in the U.S., 
2010-20162019 February 2019. 
5. 
Li Z, Purcell DW, Sansom SL, Hayes D, Hall HI. Vital Signs: HIV Transmission Along the Continuum of 
Care - United States, 2016. MMWR Morb Mortal Wkly Rep 2019;68:267-72. 
6. 
Getting 2 Zero: Stop HIV. County of San Diego Health and Human Services Agency, 2018. (Accessed April 
7, 2019, at https://insight.livestories.com/s/v2/gtz-outcomes/dbbb69ec-199c-4a9a-8f8f-40b7a9bdade4/.) 
7. 
Macchione N, Wooten W, Waters-Montijo K, McDonald E. HIV/AIDS Epidemiology Report - 2016. San 
Diego, CA: County of San Diego Health and Human Services Agency Public Health Services; 2018. 
8. 
Mateo-Urdiales A, Johnson S, Smith R, Nachega JB, Eshun-Wilson I. Rapid initiation of antiretroviral 
therapy for people living with HIV. Cochrane Database Syst Rev 2019;6:CD012962. 
9. 
Rosen S, Maskew M, Fox MP, et al. Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: 
The RapIT Randomized Controlled Trial. PLoS Med 2016;13:e1002015. 
10. Koenig SP, Dorvil N, Devieux JG, et al. Same-day HIV testing with initiation of antiretroviral therapy versus 
standard care for persons living with HIV: A randomized unblinded trial. PLoS Med 2017;14:e1002357. 
11. Amanyire G, Semitala FC, Namusobya J, et al. Effects of a multicomponent intervention to streamline 
initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial. Lancet HIV 
2016;3:e539-e48. 
12. Labhardt ND, Ringera I, Lejone TI, et al. Effect of Offering Same-Day ART vs Usual Health Facility 
Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With 
HIV in Lesotho: The CASCADE Randomized Clinical Trial. JAMA 2018;319:1103-12. 
13. Coffey S, Bacchetti P, Sachdev D, et al. RAPID antiretroviral therapy: high virologic suppression rates with 
immediate antiretroviral therapy initiation in a vulnerable urban clinic population. AIDS 2019;33:825-32. 
14. Krentz HB, Vu Q, Gill MJ. The Impact of "Churn" on Plasma HIV Burden Within a Population Under Care. 
Open Forum Infect Dis 2019;6:ofz203. 
15. Mugavero MJ, Lin HY, Willig JH, et al. Missed visits and mortality among patients establishing initial 
outpatient HIV treatment. Clinical infectious diseases : an official publication of the Infectious Diseases 

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Society of America 2009;48:248-56. 
16. Hoenigl M, Chaillon A, Moore DJ, et al. Rapid HIV Viral Load Suppression in those Initiating Antiretroviral 
Therapy at First Visit after HIV Diagnosis. Scientific reports 2016;6:32947. 
17. Belcher L, Kalichman S, Topping M, et al. A randomized trial of a brief HIV risk reduction counseling 
intervention for women. Journal of consulting and clinical psychology 1998;66:856-61. 
18. Wolfers ME, de Wit JB, Hospers HJ, Richardus JH, de Zwart O. Effects of a short individually tailored 
counselling session for HIV prevention in gay and bisexual men receiving Hepatitis B vaccination. BMC 
Public Health 2009;9:255. 
19. Jemmott LS, Jemmott JB, 3rd, O'Leary A. Effects on sexual risk behavior and STD rate of brief HIV/STD 
prevention interventions for African American women in primary care settings. Am J Public Health 
2007;97:1034-40. 
20. Crosby R, DiClemente RJ, Charnigo R, Snow G, Troutman A. A brief, clinic-based, safer sex intervention 
for heterosexual African American men newly diagnosed with an STD: a randomized controlled trial. Am J 
Public Health 2009;99 Suppl 1:S96-103. 
21. Simbayi LC, Kalichman SC, Skinner D, et al. Theory-based HIV risk reduction counseling for sexually 
transmitted infection clinic patients in Cape Town, South Africa. Sex Transm Dis 2004;31:727-33. 
22. Outlaw AY, Naar-King S, Parsons JT, Green-Jones M, Janisse H, Secord E. Using motivational interviewing 
in HIV field outreach with young African American men who have sex with men: a randomized clinical trial. 
Am J Public Health 2010;100 Suppl 1:S146-51. 
23. Safren SA, Otto MW, Worth JL, et al. Two strategies to increase adherence to HIV antiretroviral medication: 
life-steps and medication monitoring. Behav Res Ther 2001;39:1151-62. 
24. Milam J, Richardson JL, McCutchan A, et al. Effect of a brief antiretroviral adherence intervention delivered 
by HIV care providers. J Acquir Immune Defic Syndr 2005;40:356-63. 
25. Eaton LA, Huedo-Medina TB, Kalichman SC, et al. Meta-analysis of single-session behavioral interventions 
to prevent sexually transmitted infections: implications for bundling prevention packages. Am J Public 
Health 2012;102:e34-44. 
26. Rollnick S, Miller WR. What is Motivational Interviewing? Behavioural and Cognitive Psychotherapy 
1995;23:325-34. 
27. Amico KR. A situated-Information Motivation Behavioral Skills Model of Care Initiation and Maintenance 
(sIMB-CIM): An IMB Model Based Approach to Understanding and Intervening in Engagement in Care for 
Chronic Medical Conditions. Journal of Health Psychology 2011:1-11. 
28. Miller JC. Spread of infectious disease through clustered populations. Journal of the Royal Society, Interface 
/ the Royal Society 2009;6:1121-34. 
29. Smith LR, Fisher JD, Cunningham CO, Amico KR. Understanding the behavioral determinants of retention 
in HIV care: a qualitative evaluation of a situated information, motivation, behavioral skills model of care 
initiation and maintenance. AIDS Patient Care STDS 2012;26:344-55. 
30. Amico KR, Miller J, Schairer C, Gianella S, Little SJ, Hoenigl M. I wanted it as soon as possible: a 
qualitative exploration of reactions to access to same-day ART start among participants in San Diego's ART-
NET project. AIDS Care 2019:1-7. 

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31. Higa DH, Crepaz N, Mullins MM, Prevention Research Synthesis P. Identifying Best Practices for 
Increasing Linkage to, Retention, and Re-engagement in HIV Medical Care: Findings from a Systematic 
Review, 1996-2014. AIDS Behav 2016;20:951-66. 
32. Smith LR, Amico KR, Fisher JD, Cunningham CO. 60 Minutes for health: examining the feasibility and 
acceptability of a low-resource behavioral intervention designed to promote retention in HIV care. AIDS 
Care 2018;30:255-65. 
33. Centers for Disease Control and Prevention (CDC). Sexually Transmitted Disease Surveillance 2016. 
Atlanta, Georgia: U.S. Department of Health and Human Services; 2017 September 2017. 
23. FUNDING SUPPORT FOR THIS STUDY 
This is an investigator sponsored research (ISR) project supported by Gilead Sciences, Inc.  
24. BIOLOGICAL MATERIALS TRANSFER AGREEMENT 
None.  
25. INVESTIGATIONAL DRUG FACT SHEET AND IND/IDE HOLDER 
None.  
26. IMPACT ON STAFF 
The AntiViral Research Center (AVRC) is an HIV/AIDS research facility.  The nurses and other study personnel 
assigned to this study are funded by the grant. 
27. CONFLICT OF INTEREST 
Gilead Sciences, Inc. paid a one-time consulting fee and travel reimbursement in the $500 - $9,999 range to Susan 
Little, M.D. (PI).  She provided consulting to Gilead in the form of a single lecture given on 12/6/19 at the Gilead 
HIV Advisory Program - "Rapid Start: Implementation Insights", which took place on December 5-6, 2019 In 
Foster City, CA. A 700-U and Addendum Form has been submitted to the CTO and COI office.  Dr. Little stated 
that she intends to keep her interest and obligations separate from those of the sponsor by: “I am willing to provide 
infrequent educational updates, sponsored by Gilead, to other researchers (as with the lecture given on 12/6/19) 
related to my own research interests. I will not embark on any greater level of financial relationship with this study 
sponsor (i.e., speaker’s bureau) while engaged in studies sponsored by the same entity.” 
Dr. Thomas Martin has no conflict of interest with the study sponsor funding this study.  In addition, no other 
study staff member or study investigator has a conflict of interest with the study sponsor funding this study.  
28. SUPPLEMENTAL INSTRUCTIONS FOR CANCER-RELATED STUDIES 
None.  
29. OTHER APPROVALS/REGULATED MATERIALS 
None.  
30. PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY ASSESSMENT 
Not applicable – The participants enrolling/participating in this study will have the ability to: 
• 
Understand, i.e., the ability to comprehend the disclosed information about the nature and purpose of 
the study, the procedures involved, as well as the risks and benefits of participating versus not 
participating; 
• 
Appreciate, i.e., the ability to appreciate the significance of the disclosed information and the potential 
risks and benefits for their own situation and condition; 
• 
Reason, i.e., the ability to engage in a reasoning process about the risks and benefits of participating 
versus alternative, and  

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• 
The ability to express a choice about whether or not to participate.