Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County (MOVE-LA)
Conditions: HIV Prevention
Sponsor: University of California, Los Angeles

MOVE-LA Protocol 
Mobile Vehicle-Based Delivery of Lenacapavir PrEP in Los Angeles County 
Funded by: 
Gilead Sciences 
 
Principal Investigator: 
Risa Hoffman, MD, MPH 
Catherine Weaver, MD, FAAEM, 
Co-Investigators: 
FACEP 
Brian P. Zunner-Keating, MS, RN, 
PHNA-BC 
Raphael Landovitz, MD, MSc. 
 
Homeless Health Collaborative 
Kendal Wilkie, BSN, RN 
Nurse Supervisor: 
Project Manager: 
Daisy Walker, MPH, MA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 1.0 
April 8, 2026 

2 
 
TABLE OF CONTENTS 
Page 
SCHEMA ...................................................................................................................................................... 3 
1.0 
OBJECTIVES, OUTCOME VARIABLES, and ESTIMANDS ................................................... 5 
1.1 
Hypotheses ........................................................................................................................ 5 
1.2 
Primary Objectives and Outcome Measures ................................................................. 5 
1.3 
Secondary Objectives and Outcome Measures ........................................................... 6 
2.0 
INTRODUCTION ............................................................................................................................ 7 
2.1 
Background ........................................................................................................................ 7 
3.0 
STUDY DESIGN AND AIMS ........................................................................................................ 9 
4.0 
SELECTION AND ENROLLMENT OF PARTICIPANTS ........................................................ 10 
4.1 
Inclusion Criteria .............................................................................................................. 10 
4.2 
Exclusion Criteria ............................................................................................................ 10 
5.0 
CLINICAL AND LABORATORY EVALUATIONS .................................................................... 11 
5.1 
Schedule of Evaluations ................................................................................................. 11 
5.2 
Instructions for Evaluations ............................................................................................ 12 
5.3 
LEN Dosing ....................................................................................................................... 16 
5.4 
Counseling Prior to LEN initiation .................................................................................... 17 
6.0 
CLINICAL MANAGEMENT ........................................................................................................ 18 
6.1 
Precautionary Medications ............................................................................................ 18 
6.2 
Injection Technique ........................................................................................................ 19 
6.3 
Support for Second Oral Dose of Load .......................................................................... 20 
6.4 
Side Effect/Adverse Reactions ........................................................................................ 20 
6.5 
Follow-Up .......................................................................................................................... 21 
7.0 
STATISTICAL CONSIDERATIONS ........................................................................................... 21 
7.1 
Sample Size ..................................................................................................................... 21 
7.2 
Endpoints .......................................................................................................................... 21 
7.3 
Analyses ........................................................................................................................... 22 
8.0 
DATA COLLECTION AND MONITORING ............................................................................... 23 
8.1 
Records ............................................................................................................................ 23 
8.2 
Privacy .............................................................................................................................. 23 
8.3 
Confidentiality ................................................................................................................... 23 
8.4 
Reporting Protocol Deviations ....................................................................................... 24 

3 
 
SCHEMA 
 
MObile VEhicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County (MOVE-LA) 
 
DESIGN 
This study is a prospective cohort study of lenacapavir pre-exposure 
prophylaxis (LEN PrEP) in unstably housed people receiving health 
services from the Homeless Healthcare Collaborative’s (HHC) mobile 
program. Adults (≥18 years) being seen by the HHC team for routine 
health services will be screened for human immunodeficiency virus (HIV) 
risk and LEN eligibility. All individuals offered PrEP (regardless of 
decision to start LEN, other PrEP, or no PrEP) will be referred to research 
staff for survey completion, with those starting LEN also receiving 
assistance from staff for LEN initiation and continuation. 
DURATION 
All participants starting LEN will be followed for 52 weeks. 
SAMPLE SIZE 
100 adults receiving services from the HHC mobile program 
 
POPULATION 
For Aim 1 (Survey) Individuals being reached for mobile health services 
by the HHC mobile program that are at least 18 years old, able to provide 
informed consent, English- or Spanish-speaking, willing and able to 
comply with study procedures. For LEN, must be at-risk for HIV based on 
clinician assessment (based on CDC guidelines; includes any individual 
requesting PrEP, regardless of reported risk factors for HIV) and negative 
by both 4th generation HIV Ab/Ag testing and viral load prior within 14 
days prior to LEN injection. 
REGIMEN 
Lenacapavir (LEN PrEP) subcutaneous (927 mg, in two 1.5-ml 
injections) every 26 weeks (within a window of ±14 days). Participants 
will receive loading doses of two 300-mg tablets (600mg) of LEN on day 
1 and two 300-mg tablets (600mg) of LEN on day 2. 

4 
4 
 
 
SCHEMA (Cont'd) 
 
 
Aim 1: Uptake
(n≈100)
•Adults being seen by HHC mobile program and 
offered LEN will complete baseline survey 
(regardless of decision to start LEN, other PrEP, 
or no PrEP)
Aim 2:
Persistence
(n≈66)
• Individuals who initiate LEN PrEP will receive ongoing 
visits from HHC van every every 6 months for HIV 
testing, sexually transmitted infection (STI ) testing, and 
LEN injections
• At 26 and 52 weeks, surveys will be performed

MOVE-LA Protocol Version 1.0 
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1.0 
OBJECTIVES, OUTCOME VARIABLES, and ESTIMANDS 
 
1.1 
Hypotheses 
Primary Hypotheses: 
For the primary outcome of LEN PrEP uptake, the study will enroll ~100 individuals and 
hypothesize, based on preliminary data in a similar population, that approximately two-
thirds of those offered LEN PrEP will receive a first dose (n~66) within two weeks of 
baseline assessment and offer (uptake). 
Secondary Hypotheses: 
1) Factors associated with LEN PrEP uptake will include perceived HIV risk (higher vs 
lower), self-efficacy for health care (higher vs lower on a validated tool), education 
level (high school or more vs less than high school), transitional or encampment 
housing (vs unsheltered), and comorbidities (absence vs presence of substance use 
disorders and mental health conditions). 
2) Persistence at 52 weeks will be in the range of 50%-60%. Factors associated with 
persistence will be similar to uptake, with the strongest associations for degree of 
housing instability and comorbidities, such as substance use disorders. 
 
3) Mobile delivery of LEN PrEP will have high acceptability to clients. 
 
4) Common participant-reported barriers to use of mobile LEN PrEP will include 
competing life priorities (need for food, employment, shelter) and high level of 
mobility among the population within and outside of Los Angeles County (LAC); 
relationships between participants and community-based organizations working with 
HHC will help alleviate but not overcome barriers. 
5) The cost of adding LEN PrEP health services to the existing HHC mobile van 
program will be low and will result in a favorable cost per participant initiated on LEN 
PrEP and cost per participant persisting on LEN PrEP. 
 
6) LEN PrEP will be well-tolerated, with rare discontinuations due to side effects. 
7) The mobile van LEN PrEP delivery model will be feasible for HHC to implement and 
highly acceptable to staff, health system and public health leaders, and community 
organizations (as explored via the Theoretical Framework for Acceptability); relevant 
determinants of scalability and sustainability will include cost, perceived 
effectiveness, complexity of service delivery, and factors related to leadership and 
organizational capacity. 
 
8) AirTag uptake and acceptability with be high among participants; however, over time, 
AirTags are likely to be lost or discarded and become less useful for tracing beyond 
26 weeks of follow-up. 
1.2 
Primary Objectives and Outcome Measures 
 

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The primary objective is to characterize uptake of LEN PrEP among unstably housed 
people receiving health services via HHC’s mobile program. The primary outcome will be 
defined as receiving a first injection of LEN (along with both oral doses on days 1 and 2). 
All participants will have the option of directly observed therapy (DOT) for the second 
oral LEN dose. Those not receiving DOT will receive a phone call on the second day to 
confirm they have taken the dose and remind/prompt them to take it, if they have not. 
 
1.3 
Secondary Objectives and Outcome Measures 
1) Characterize predictors of uptake. Surveys will be performed at baseline to measure 
sociodemographic factors, HIV risk perception, PrEP knowledge, PrEP self-efficacy, 
and clinical factors. 
 
2) Describe LEN PrEP persistence at 26 weeks (defined as receiving a second injection 
of LEN on-time [+/- 14 days]). 
 
3) Evaluate LEN PrEP persistence at 52 weeks (defined as receiving a third injection of 
LEN on-time [+/- 14 days]). 
4) Understand acceptability of mobile LEN PrEP delivery. 
 
5) Characterize predictors of persistence at 26-and 52-weeks utilizing baseline survey 
data. 
 
6) Characterize barriers to LEN PrEP via a mobile delivery model of care. 
7) Describe satisfaction with LEN PrEP via a mobile delivery model of care. 
8) Describe costs and cost-outcome of mobile delivery of LEN PrEP. Costs will be 
collected from the health system perspective. The study will calculate the cost per 
person who initiates LEN and cost per person persisting on LEN PrEP over 52 
weeks, in a cost-outcome analysis. 
 
9) Characterize feasibility, acceptability, scalability, and sustainability of the mobile LEN 
PrEP delivery model using qualitative methods. The study will perform in-depth 
interviews with stakeholders including HHC leadership, field-based HHC staff, LAC 
public health leaders, and community leaders (n~25) to understand feasibility, 
acceptability, and service- and system-level factors hypothesized to be associated 
with scalability and sustainability of the program. 
 
10) Explore uptake and acceptability of AirTags for geolocation among participants 
enrolled in the study. This will be measured as proportion of individuals accepting an 
AirTag at enrollment, proportion keeping the AirTag through 26 and 52 weeks, and 
acceptability questions on surveys at baseline and at week 26 and 52. 

MOVE-LA Protocol Version 1.0 
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11) To describe tolerability of LEN PrEP, including frequency and severity of injection 
site reactions. This will be measured by phone calls with participants 48 hours after 
each injection as well as field-based clinical assessments for those who report 
moderate to severe reactions. The study will also describe the proportion of 
participants who discontinue LEN PrEP due to side effects. 
 
12) To describe real-world effectiveness of LEN PrEP for HIV prevention as measured 
by both rapid and lab-based 4th generation Ag/Ab testing done at 6 and 12 months. 
 
13) Describe whether providing an oral bridge of tenofovir-based PrEP is associated with 
improved uptake of LEN PrEP (relative to those not receiving oral PrEP as a bridge). 
 
2.0 
INTRODUCTION 
2.1 
Background 
 
HIV is a public health priority in LAC due to high incidence of infections (~1,600 
annually) (1). New infections are most common in people of Black and Latinx 
backgrounds, with significant “hot spots” in areas which also have a high prevalence of 
unstably housed people. In 2022, approximately 13% of newly diagnosed HIV cases in 
Los Angeles County were experiencing homelessness, a 36% increase over the prior 
period (2). 
 
Access to HIV prevention services for unstably housed people in LAC has been 
limited due to barriers in seeking care at health facilities. Unstably housed people 
face barriers including competing life priorities (such as seeking food, shelter, and 
employment), low health literacy, particularly around HIV prevention, and comorbidities 
such as substance use and mental health disorders. A mobile healthcare service that 
offers LEN PrEP is ideal to help overcome these barriers by providing a low-
complexity biomedical PrEP option in locations where unstably housed people 
congregate (i.e., shelters, encampments, community centers, and transitional housing 
facilities). The University of California, Los Angeles (UCLA) Health Homeless Healthcare 
Collaborative (HHC) was founded in January 2022 and currently operates six mobile 
vans, which deliver urgent care, primary care, behavioral health services, and 
medication-assisted treatment for substance use disorders. At least one mobile van is in 
the field offering services every day of the week, including weekends. The van is staffed 
by clinicians and community health workers, who link clients to social services. HHC 
recently began providing point-of-care HIV and STI testing and is well-positioned to 
integrate LEN PrEP into their program. 
 
Based on Andersen’s behavioral model (3) and using Proctor et al’s implementation 
outcomes (4), the investigators propose the following: 
Aim 1. Characterize uptake of LEN PrEP among unstably housed people in Los 
Angeles County receiving health services via HHC’s mobile program. People 
without HIV receiving health services via the HHC mobile unit (n~100) will be offered 
LEN PrEP. A baseline survey will be performed (sociodemographics, clinical information, 
HIV risk, PrEP knowledge, self-efficacy for health care, and acceptability of mobile PrEP 
offer). The primary outcome will be uptake, defined as receiving a first injection of LEN 

MOVE-LA Protocol Version 1.0 
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PrEP and both oral doses on days 1 and 2. All participants will have the option to 
receive an Apple AirTag to enable directly observed therapy (DOT) for the second 
oral LEN dose and for follow-up LEN PrEP injections. 
 
Aim 2. Evaluate LEN PrEP persistence through 52 weeks. Participants who initiate 
LEN PrEP (estimated n~66) will receive ongoing visits from the HHC mobile unit for STI 
testing every 3 months and HIV testing and LEN injections every 6 months. The study 
will estimate the share of initiators who receive LEN PrEP through week 52 
(“persistence” defined as completing the third dose on-time [+/-14 days]). Surveys will be 
performed with all individuals who can be reached at 52 weeks (both persisters and non-
persisters), to understand acceptability of mobile LEN PrEP, barriers to this care, and 
satisfaction with care. 
Aim 3. Understand costs, acceptability, feasibility, scalability, and sustainability of 
the mobile LEN PrEP delivery model. Costs will be collected from the health system 
perspective. The study will calculate the cost per person who initiates LEN PrEP, and 
cost per person persisting over 52 weeks. The investigators will additionally perform in-
depth interviews with stakeholders, including HHC leadership and van staff, public 
health leaders, and community leaders (n~25) to understand acceptability and feasibility 
of this model, and service- and system-level factors hypothesized to be associated with 
scalability and sustainability of the program. 
The study will collaborate with existing HHC community partners (Casa Milagrosa and 
the Santa Monica Salvation Army), which provide social services to HHC clients. This 
supportive scaffolding will increase success of the project and long-term sustainability of 
mobile LEN PrEP delivery. For feasibility, the study will focus on individuals with Medi-
Cal or other insurance at the time of screening (anticipated to be ~70% of the HHC 
population served); however, HHC provides referrals and navigation for obtaining 
insurance, and individuals without insurance will be linked to certified Medi-Cal 
enrollment counselors – and once insured, can be referred back to the study for LEN 
PrEP initiation. 
This project brings together experts in biomedical HIV prevention (Hoffman, Landovitz) 
and implementation science (Hoffman, Moucheraud), experts in the delivery of street 
medicine using a mobile van model (Weaver, Zunner-Keating), and a costing expert 
(Wagner). Dr. Hoffman is currently leading a project in collaboration with the LAC 
Department of HIV and STD Programs on mobile delivery of cabotegravir PrEP to 
unstably housed women in Los Angeles County. She has leveraged important lessons 
learned from this ongoing study for the design of this proposed work on LEN PrEP 
implementation in a similar context. Table 1 (Timeline in supplementary file) 
demonstrates how the project can be completed in 18 months. Table 2 (supplementary 
file) summarizes the key implementation science elements of the proposed project. The 
investigators anticipate 2 manuscripts from this project (see Timeline in supplementary 
materials) and will submit abstracts to national and international meetings (e.g., CROI, 
IAS, etc.). 
 
1- http://www.publichealth.lacounty.gov/dhsp/Dashboard.htm 
2- http://publichealth.lacounty.gov/dhsp/Reports/HIV/PEH%20Fact%20Sheet%20FINAL.pdf 

MOVE-LA Protocol Version 1.0 
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3- https://pubmed.ncbi.nlm.nih.gov/18580382/ 
4- https://pmc.ncbi.nlm.nih.gov/articles/PMC3068522 
 
3.0 
STUDY DESIGN AND AIMS 
The investigators will perform a prospective cohort study of unstably housed individuals with an 
elevated likelihood of acquiring HIV (see inclusion criteria) being offered LEN PrEP via HHC. 
Findings from this study will be generalizable to similar urban settings with a high HIV incidence 
and high prevalence of unstably housed individuals. 
 
Aim 1 (Uptake): Adults (≥18 years) being seen by the HHC team for routine health services will 
be screened for HIV risk and LEN eligibility (see inclusion/exclusion criteria). Those eligible will 
be offered a rapid HIV test (4th generation Ag/Ab), provided with counseling about HIV 
prevention, and offered LEN or referred to a facility for cabotegravir or oral PrEP. Those who 
select LEN will have blood drawn for lab-based 4th generation and quantitative viral load testing. 
All individuals offered PrEP (regardless of decision to start LEN, other PrEP, or no PrEP) will be 
referred to research staff for information about the study, eligibility determination, and informed 
consent. A baseline survey will be interview-administered in English or Spanish with a focus on 
sociodemographic characteristics, PrEP knowledge, HIV risk perception, self-efficacy for health 
care, and acceptability of the offer of LEN via the mobile van. Participants will be compensated 
for their time with a Visa gift card ($50). Those who accept LEN PrEP will be offered an Apple 
AirTag for geolocation for follow-up. An appointment will be scheduled for one week later to 
initiate LEN PrEP, which allows time for the medication to be delivered to the HHC dispensary 
and loaded on the van. For those with normal renal function (based on point-of-care creatinine 
testing or pre-existing labs available in the medical record), oral tenofovir-based PrEP will be 
offered as a bridge to LEN PrEP. 
Directly observed therapy (DOT) will be offered for the second dose of oral LEN if requested by 
the participant or at the discretion of the clinician (using a private vehicle and nurse/community 
health worker (CHW) team). In addition, all participants will be called 48 hours after the injection 
to ask about injection site reactions (ISRs). For those reporting moderate to severe reactions, an 
HHC team will do a field-based assessment and refer for higher level care, if needed. 
Aim 2 (Persistence): Individuals who initiate LEN PrEP (n~66) will receive ongoing visits from 
the HHC mobile health van every 6 months for HIV testing and LEN injections. Prior to each 
follow-up injection, a negative rapid 4th generation HIV Ag/Ab test will be required. STI 
screening will be offered at 3-month intervals either through the van or at brick-and-mortar 
health clinics (a list of clinics will be provided to all study participants initiating LEN). 
Persistence on LEN PrEP will be defined by receiving two additional on-time injections by 52 
weeks (+/- 14 days, or as indicated in the package insert). Baseline survey data will be used to 
understand predictors of LEN PrEP persistence. At 26 and 52 weeks, surveys will be performed 
for all participants (including non-persisters, if traceable) to understand acceptability, barriers to 
LEN PrEP, and satisfaction with care. The study will also characterize the proportion who 
transition to facility-based PrEP (LEN or other PrEP). Participants will be compensated with a 
Visa gift card ($50) for each survey. 
Aim 3 (Costs, Acceptability, Feasibility, Scalability, and Sustainability): Costs of the HHC mobile 
LEN PrEP delivery program will be collected during study implementation. The study will 
allocate the share of costs to LEN PrEP based on the proportion of time spent on this 

MOVE-LA Protocol Version 1.0 
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component of care, quantified using time logs and time-and-motion techniques. The 
investigators will also perform in-depth LAC public health leaders, and community leaders to 
understand feasibility and acceptability of the mobile program as well as service-level and 
system-level barriers and facilitators to scalability and sustainability of the program. The study 
will use Moucheraud et al’s framework for determinants of sustainability. 
 
4.0 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
4.1 
Inclusion Criteria 
4.1.1 Being reached for mobile health services by a UCLA HHC mobile van 
 
4.1.2 ≥18 years of age 
4.1.3 Able to provide informed consent 
 
4.1.4 English or Spanish-speaking 
4.1.5 Willing and able to comply with study procedures 
4.1.6 HIV unknown or negative status and HIV negative based on rapid 4th generation 
Ag/Ab test on the day of enrollment 
 
4.1.7 At-risk for HIV, based on clinician assessment (based on CDC guidelines; 
includes any individual requesting PrEP, regardless of reported risk factors for 
HIV) 
4.1.8 Pregnant and breastfeeding women/people can be offered LEN with counseling 
about benefits and risks. 
 
4.2 
Exclusion Criteria 
4.2.1 Any clinical or psychosocial condition or prior therapy that, in the opinion of the 
investigator, would make the participant unsuitable for the study or unable to 
comply with LEN PrEP 
 
4.2.2 On a strong CYP3A4 inducer at time of screening (given lack of dosing guidance 
in package insert). 
 
4.2.3 History or clinical evidence of cirrhosis or severe liver disease (jaundice, ascites, 
encephalopathy, etc.). 
 
4.2.4 End stage renal disease on dialysis (CrCl <15ml/min) 
 
4.2.5 Known hypersensitivity to the study drug, the metabolites, or formulation 
excipient 
4.2.6 BMI <35 kg/m2 (77 pounds) 
 

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4.2.7 On oral or other long-acting PrEP and unwilling to discontinue 
 
4.2.8 Already taking LEN for HIV prevention 
 
4.2.9 Known HIV diagnosis or positive 4th generation HIV Ab/Ag test (on day of 
enrollment) or subsequent lab-based confirmatory testing. Note: those who have 
a negative rapid HIV test on the day of the study and a subsequent positive lab-
based HIV test [which will be performed on all participants prior to the first dose 
of LEN] will be discontinued from the study and linked to care for antiretroviral 
therapy 
 
4.2.10 Do not have any active insurance, including Medi-Cal (those without insurance 
will be referred to an enrollment counselor and may be re-screened for the study 
once insurance is active) 
 
 
5.0 
CLINICAL AND LABORATORY EVALUATIONS 
 
5.1 
Schedule of Evaluations 
 
 
 
 
 
 
Screening 
/Enrollment 
LEN Initiation 
(+14 days 
after 
enrollment) 
LEN Oral load 
Follow-up 
(LEN injection 
+ 1day) 
Week 26 
(after LEN 
dose #1 +/- 
14 days) 
Week 52 (after 
LEN dose #2 
+/-14 days) 
Notes 
Brief medical 
history 
X 
 
 
 
 
 
Medication 
history 
X 
 
 
X 
X 
 
Targeted 
physical exam 
X 
 
 
X 
X 
 
Pregnancy Test 
(if indicated) 
X 
X 
 
X 
X 
Pregnant clients 
may be offered 
LEN with 
discussion of risks 
and benefits 
Hepatitis B 
Surface Ag, 
surface Ab, core 
Ab 
X* 
 
 
 
 
*Recommended, if 
starting oral PrEP 
as bridge to LEN 
Comprehensive 
metabolic panel 
X* 
 
 
 
 
*Consider if 
comorbidities or 
clinical concern 
based on medical 
history or exam 

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Rapid 4th 
generation HIV 
test 
X 
X 
 
X 
X 
 
Confirmatory 4th 
generation HIV 
test (laboratory) 
X 
 
 
X 
X 
 
HIV viral load 
(laboratory) 
X 
 
 
 
 
Repeat viral load 
testing if concern 
for acute HIV or if 
late for injection, 
prior to re-starting 
STI testing (RPR, 
GC/chlamydia all 
sites where 
sexually active, 
HCV as 
indicated) 
X 
 
 
X 
X 
STI testing will be 
offered every 12 
weeks with option 
of mobile testing 
by HHC or referral 
to facility-based 
services 
Phone for oral 
load dose #2 
 
 
X 
 
 
 
ISR Assessment  
 
X 
X 
X 
Will occur by 
phone 1-2 days 
after each 
injection 
Air Tag 
Distribution 
 
X 
 
 
 
Optional for those 
who opt-in for use 
at time of first 
injection 
Baseline Survey* 
X 
 
 
 
 
 
Follow-up 
Survey* 
 
 
 
X 
 
 
Endline Survey* 
 
 
 
 
X 
 
 
*Includes questions about HIV risk, substance use, and LEN acceptability, tolerability, satisfaction, and barriers to 
ongoing LEN PrEP 
 
 
5.2 Instructions for Evaluations 
 
Brief Medical History: At clinician discretion, with focus on conditions like latent or active 
tuberculosis, seizure disorder requiring medication, chronic kidney disease/end stage renal 
disease requiring dialysis, liver disease/cirrhosis, history of STIs, and recent risk for HIV 
exposure. At weeks 26 and 52 this will include recall related to any ISR experienced during the 
prior injection. 
 
Medication History: With focus on active prescriptions for medications that may have 
interactions with lenacapavir (CYP3A inducers). 
 
Drug class 
Interaction and management 
Antibiotics for treatment of 
tuberculosis (TB) 
Rifabutin 
Potential interaction, which requires dose adjustment 
Induction of CYP3A4 can substantially reduce LEN 

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Rifampicin 
Rifapentine 
concentrations which may result in loss of its prevention 
efficacy. 
Anticonvulsants 
Carbamazepine 
Phenobarbital 
Phenytoin 
Potential interaction, which requires dose adjustment 
Induction of CYP3A4 can substantially reduce LEN 
concentrations, which may result in loss of its prevention 
efficacy. 
Illicit/recreational 
Ketamine 
Potential interaction, which may persist after 
discontinuation of lenacapavir 
Ketamine concentrations may increase due to inhibition of 
CYP3A4 by LEN and may increase side-effects associated 
with ketamine, such as respiratory depression and 
hallucinations. 
Erectile dysfunction 
Avanafil 
Sildenafil 
Tadalafil 
Vardenafil 
Potential interaction, which may persist after 
discontinuation of lenacapavir 
Sildenafil, tadalafil and vardenafil concentrations may 
increase due to inhibition of CYP3A4 by LEN. 
Gender-affirming hormones 
Estradiol 
Conjugated estrogens 
Ethinylestradiol 
Medroxyprogesterone 
Micronized progesterone 
Testosterone 
No dose adjustment required. 
LEN is a moderate inhibitor of CYP3A4 and could potentially 
increase exposure of the gender-affirming hormone, 
although to an extent that does not require dose adjustment. 
Hormonal contraceptives 
Ethinylestradiol 
Etonogestrel 
Levonorgestrel 
Medroxyprogesterone 
Norethisterone 
Norgestrel 
No dose adjustment required. 
LEN is a moderate inhibitor of CYP3A4 and could potentially 
increase exposure of the contraceptive hormone, although 
to an extent that does not require dose adjustment. 
*Ref: WHO LEN Guidelines: https://www.who.int/publications/i/item/9789240111608 
 
 
Additional medications listed here:  

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Targeted Physical Exam: Focused on stigmata of end stage liver disease/cirrhosis and skin 
lesions that would pose an issue for LEN injection. At week 26 and 52, exam of prior injections 
sites for any evidence of nodule or abnormalities from ISR due to last injection 
 
Pregnancy Test: If indicated based on sex at birth and report of last menstrual period. Any 
participant who becomes pregnant while on LEN will be counseled on risks and benefits of 
continuation by a clinician and reported prospectively to the Antiretroviral Pregnancy Registry: 
https://www.apregistry.com/ (1-800-258-4263). 
 
Support for completion of oral load: The day after the first injection, each participant will 
receive a phone call to confirm they have taken the second dose of the oral load and support 
completion of the dose, if it has not yet been taken. If the participant does not have a phone, 
outreach will be undertaken by the community partner to assist with confirmation that load was 
completed. For clients who request in-person DOT of the second dose, a nurse/community 
health worker team will deliver this dose in a location agreed upon on the day of the injection. 

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ISR Assessment: 24-48 hours after each injection, participants will receive a phone call to 
assess for ISRs. For the first injection, this will be done at the same time as the phone call to 
support completion of the oral load. The assessment will used a standardized format for 
recording the type and extent of reaction (Table below). If the participant does not have a 
phone, the client will be given clear parameters for when to seek evaluation and the ISR type 
and extent will be assessed retrospectively at weeks 26 and 52. See below (section 6.0) for 
clinical management of ISRs. 
 
Standardized Data Collection for ISRs 
(Assessed by phone or in person 24-48 hours after injection at 
baseline, week 26, and week 48) 
Since the injection did you/are you experiencing any of the 
following (check all that apply 
Pain 
Swelling 
Redness 
Nodule/lump/bump 
Itching 
Bruising 
Other (Describe) 
Which best describes the how this/these symptoms affected you: 
No symptoms 
No or minimal problems with usual daily activities (equivalent to grade 
1) 
Some or moderate problems with usual daily activities (equivalent to 
grade 2) 
Unable to perform usual daily activities (equivalent to grade 3) 
Unable to perform basic self-care, or hospitalized due to injection site 
reaction (equivalent to grade 4) 
 
Baseline laboratories (at time of prescription) 
a. Rapid 4th generation HIV Ag/Ab test negative result (Note: this is the only result 
required to prescribe LEN) 
b. 4th generation HIV Ag/Ab (lab-based) drawn (Note: this should be negative within 
14 days before the first dose of LEN is given) 
c. HIV viral load (lab-based) drawn (Note: this should be negative within 14 days of 
the first dose of LEN. If not available and 4th gen testing is negative, LEN can be 
given and viral load drawn that day based on discretion of clinician.) 
d. RPR with reflex to FTA confirmation and titer 
e. Chlamydia and gonorrhea from all sites where sexually active (urine, rectal, oral); 
do not withhold offer of LEN to clients who decline but continue to encourage 
testing at follow-up interactions. If asymptomatic, send samples to lab; if 

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symptoms, perform point-of-care, if available (can be done with Roche test only 
with male urine and female vaginal swabs) 
f. 
Hepatitis C antibody with reflex (not required, recommended to screen and offer 
treatment) 
g. Comprehensive metabolic panel (not required, recommended particularly for 
people with comorbidities if indicated for other reasons) 
h. Pregnancy test, as indicated 
Can also consider if feasible and relevant for clinical context 
• 
CBC/diff 
• 
Hepatitis B surface antigen, (also hep B core antibody and hep B surface 
antibody to assess if vaccination needed, if feasible) 
Follow-up Laboratory monitoring at injection visits 
i. 
Every injection visit (assuming on-time injections +/-14 days) 
i. Rapid 4th generation HIV test (If negative, provide dose) 
ii. 4th generation HIV Ag/Ab test (lab-based) 
j. 
Every 3 months (strongly recommended, not required) 
i. STI testing (d and e above) 
ii. Pregnancy testing, as indicated 
iii. Assess for HCV risk factors and symptoms, optional testing if concern 
k. For late injections (>14 days late or >28 weeks since last injection), the decision 
to give LEN should be based on duration of lapse and risk of having acquired 
HIV in this period. If concern for HIV acquisition, confirmation of a lab-based HIV 
test should be received before re-starting injections using HIV 4th gen and HIV 
viral load. See below LEN dosing for late injections. 
i. Note - Viral load should be repeated if more than 14 days late for injection 
(more than 28 weeks since last injection) or if signs/symptoms of an HIV 
seroconversion event; or if recent high-risk exposure. 
 
Surveys (see Manual of Procedures for detailed procedures of surveys) 
Among all participants at baseline and among those who start LEN, additional timepoints of 
week 26 and week 52, brief surveys will be administered to record sociodemographics, HIV risk 
factors, medical conditions (including mental health and substance use disorders, detailed 
housing information, HIV and PrEP knowledge, HIV and LEN acceptability, barriers to HIV 
prevention/LEN care, and satisfaction with LEN and mobile delivery. At endline, surveys will be 
obtained for all participants who initiated LEN and can be reached at endline regardless of 
whether they have continued on LEN through 52 weeks. Participants will receive a $50 gift card 
for completion of each survey completed. 
 
5.3 LEN DOSING 
Dosing is based on the package insert as follows: 
 
 

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Oral bridging for planned missed LEN doses: Clients should be given oral PrEP and counseling 
about adherence. Baseline renal function and hepatitis B status are recommended as baseline 
for use or oral tenofovir-based PrEP. An adequate supply should be given until LEN can be 
resumed. 
 
Missed Day 2 oral load: If the day 2 loading dose of oral LEN is missed, it should be taken as 
soon as possible, and clients should be counseled on using barrier protection to reduce risk of 
HIV acquisition. 
 
Late or missed LEN injections: If more than 28 weeks have elapsed since last dose, the oral 
load of LEN should be resumed along with the injection, as in the Table above. 
 
Discontinuation of LEN: At time of planned discontinuation, clients should be counseled on use 
of condoms to prevent HIV transmission (to reduce the risk of HIV acquisition and LEN resistant 
virus) and STIs and encouraged to receive regular HIV and STI testing. Alternative types of 
PrEP should be discussed/offered, if appropriate. 
5.4 Counseling prior to LEN initiation 
• 
Discuss importance of keeping next injection appointment 
• 
Counsel on the possibility of pain, swelling, redness, or a small bump at the site of 
injection. This typically lasts 1-2 days. Symptoms can be self-managed with warm 
compresses or ice (10-20 minutes at a time) or Tylenol. Seek medical care for a more 
severe reaction. 
• 
Seek medical care for any unusual symptoms after injection (fever, nausea, vomiting, 
rash) 
• 
While there are no medications that cannot be taken while on LEN, there are some 
interactions that may result in higher or lower drug levels, particularly medications that 
are used to prevent and treat tuberculosis (TB) and seizures medications. Counseling 
should be provided to report use of LEN to other clinicians, emergency room/urgent care 
providers. All clients should be provided with a “prescription card” that can be presented 

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to any health care providers that includes name of the medication “Yeztugo or 
lenacapavir”, the date the last dose was due, and the date the next dose is due. Clients 
should be counseled to present this card at routine primary care, urgent care, 
emergency care, and/or specialty appointments. 
 
6.0 
CLINICAL MANAGEMENT 
 
6.1 Precautionary Medications 
There are no contraindicated medications, but drug interactions for strong CYP3A4 inducers 
(rifampin and related and various seizure medications except for Keppra) require dose 
adjustment; if medication list not available, ask if client takes anything for seizures or treatment 
or prevention of tuberculosis. If patient has a pharmacy, call pharmacy to verify medications. If 
cannot confirm, defer LEN prescription until medication list can be obtained. 
 
1. If on a 
CYP3A4 inducer 
would defer LEN 
and offer oral 
PrEP due to 
limited data 
2. If on LEN and 
needs to start a 
CYP3A4 inducer, 
LEN dose 
adjustment will 
be required as 
per Tables 4 
(strong inducer) 
and 5 (moderate 
inducer) from 
Package Insert 
below 

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6.2 Injection Technique: All clinicians administering LEN will be trained in administration of 
injections as outlined in the Package Insert (see figures 1 and 2 below from the insert). An initial 
training by a Gilead nurse will be provided to all HHC staff and subsequent training done after 
study launch will be done by an experienced staff person who was previously trained by Gilead 
and has experience with injections. 
 

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LEN is a subcutaneous injection. Note serious reactions have occurred with subdermal 
injections. Injections should be given in the abdomen but may be given in the thigh as an 
alternative. 
 
6.3 Support for second oral dose of load: 
A member of the HHC clinical team or study team will call each participant who receives a first 
LEN oral dose and injection on day 1 to support completion of the second oral dose. If 
participants do not have a phone or have preference for receiving in-person directly observed 
therapy (DOT) for the oral dose, a member of the clinical team will perform in person DOT on 
day 2. 
6.4 Side effect/adverse reactions 
The most common adverse reactions to LEN include injection site reactions (ISRs), headache, 
and nausea. As per standard of care, all clients will receive counseling prior to LEN 
administration on the possible side effects as well as instructions on managing the most 
common types of ISRs. All participants will be called on day 2 after the subcutaneous injection 
for DOT of the second oral dose and to assess for any side effects from the injection or other 
potential medication side effects. Individuals with minor ISRs will be counseled on symptomatic 
management. For any ISR that is described as severe, the participant will have the choice of 
seeking care at a brick-and-mortar health clinic nearby or a visit from HHC to their location for 
an assessment and clinical care, if feasible within a reasonable timeframe. Individuals with 
adverse reactions will receive frequent follow-up phone calls and/or mobile visits until the 
issue(s) are deemed sufficiently resolved by the treating clinician. The decision to discontinue 
LEN due to a reaction will be determined by the clinician and client based on shared decision 
making about risks and benefits. 
All side effects and adverse reactions such as ISRs will be recorded in an electronic case report 
phone created for this purpose. 

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6.5 Follow-up 
Support for continued clinical follow-up will be provided with reminder text messages and phone 
calls or via trusted contacts in community organizations. Participants will only be contacted via 
routes they consent to as part of the informed consent process. Apple AirTags will be offered to 
all participants who start LEN (at time of first injection) for geolocation for follow-up injections. 
AirTags will be labeled with unique IDs and data will only be visible to a limited number of highly 
trained study staff. 
7.0 STATISTICAL CONSIDERATIONS 
7.1 Sample Size 
 
The sample size is determined by the feasibility of enrollment over a 6-8-month period to 
allow for follow-up to evaluate persistence at 52 weeks. For the primary outcome of 
uptake, with a sample of ~100 offered LEN PrEP and an anticipated LEN PrEP uptake 
rate of approximately two-thirds (n~66), the study will achieve a margin of error of 9.2% 
in estimating the uptake rate. For the secondary outcome of persistence at 52 weeks, 
with an expected rate of 50-60%, this sample size will provide a margin of error of 11-
12% in estimating the persistence rate. 
7.2 Endpoints 
 
Primary Endpoint 
The primary endpoint is uptake of LEN PrEP among unstably housed people receiving 
health services via HHC’s mobile program. The primary endpoint will be defined as 
receiving a first injection of LEN and the oral load on days 1 and 2. This will be 
measured through records of LEN administration, which will include telephone 
confirmation (or DOT) of the second oral dose. The investigators will perform a 
sensitivity analysis that defines uptake based on the injection and day one oral dose 
only. The investigators will also use study records to describe the proportion of those 
offered LEN who declined all PrEP versus selected cabotegravir or oral PrEP and were 
referred to a facility for this care (as these will not be provided long-term by the HHC 
mobile van during the time of the study). 
Secondary Endpoints 
1) LEN PrEP persistence at 26 weeks defined as completing the second dose of LEN 
on-time (+/- 14 days or as defined in the package insert) based on records of drug 
administration. 
2) LEN PrEP persistence up to 52 weeks defined as receiving a third injection of LEN 
on-time (+/- 14 days or as defined in the package insert) based on records of drug 
administration. 
3) Acceptability of mobile LEN using survey questions based on the Theoretical 
Framework of Acceptability. 
4) Predictors of uptake based on surveys at baseline including sociodemographic 
factors, HIV risk perception, PrEP knowledge, self-efficacy, and clinical factors. 

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5) Predictors of persistence at 52 weeks based on surveys at baseline including 
sociodemographic factors, HIV risk perception, PrEP knowledge, self-efficacy, and 
clinical factors. 
6) Barriers to LEN PrEP via mobile delivery based on surveys at baseline, 26, and 52 
weeks (including non-persisters, if they can be reached). 
7) Satisfaction with LEN PrEP via mobile delivery based on surveys at 26, and 52 
weeks (including non-persisters, if they can be reached). 
8) Cost per person who initiates LEN PrEP and cost per person persisting over 52 
weeks. 
9) Qualitative data on feasibility, acceptability, scalability, and sustainability of the 
mobile LEN PrEP delivery model. 
10) Uptake and acceptability of AirTags for geolocation among participants enrolled in 
the study. Acceptability will be determined using survey questions based on the 
Theoretical Framework of Acceptability 
11) Tolerability of LEN PrEP, including frequency and severity of injection site reactions 
as measured by phone calls with participants 48 hours after each injection as well as 
field-based clinical assessments done for those who report moderate to severe 
reactions; proportion of participants who discontinue LEN PrEP due to side effects. 
12) Number of HIV infections that occur among participants while covered by LEN PrEP, 
as measured by both rapid and lab-based 4th generation Ag/Ab testing done at 6 and 
12 months among those who remain in care. 
13) LEN PrEP uptake by oral tenofovir-bridge status (those who accept versus those 
who do not, among those eligible for tenofovir-containing regimens) 
7.3 Analyses 
 
Statistical Analyses for Aim 1 (uptake): 
Descriptive statistics (mean, standard deviation, median, inter-quarter range) will be 
generated for baseline sociodemographic factors and clinical information to characterize 
the study population. The percentage of LEN PrEP uptake will be calculated defining 
uptake as receiving the first injection and both oral doses as the primary outcome. A 
sensitivity analysis will be performed in which uptake is defined as receiving the first 
injection and day 1 oral dose only (i.e., including participants in the ‘uptake’ group who 
could not be reached to confirm they took the second oral dose). Data from baseline 
surveys regarding barriers to care, acceptability of mobile LEN PrEP offer, HIV risk and 
risk perception, and self-efficacy for health care will also be summarized, and 
associations with LEN PrEP uptake will be explored using logistic regression models. 
 
Statistical Analyses for Aim 2 (persistence): 
The rate of LEN PrEP persistence over 52 weeks among participants initiating LEN will 
be estimated. Data from baseline and 52-week surveys will be summarized using 
descriptive statistics. A logistic regression model will be employed to examine predictors 
of persistence at 52 weeks using baseline data. 
 
Statistical Analyses for Aim 3 (cost and qualitative outcomes): 
Cost-outcome: The study will conduct a cost-outcome analysis focusing on the average 
cost per person initiating LEN PrEP, and the average cost per person persisting through 
52 weeks. The investigators will define the outcome of “persisted on LEN PrEP” by 

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including those with late doses and will perform a sensitivity analysis including only 
those who received injections on time (+/- 14 days). From the cost data collected, the 
study will estimate a total program cost. The study will report all cost data as means with 
95% confidence intervals and medians with interquartile ranges. Finally, the 
investigators will use the latest available data on HIV incidence in the populations of 
interest (by sex and gender), the efficacy of LEN PrEP (based on clinical trial data for 
each population), and this study’s cost data to estimate the number of HIV infections 
averted by this program and the cost per HIV infection averted. 
 
In-depth interviews: The interview guide will be informed by Sekhon’s Theoretical 
Framework of Acceptability and the Moucheraud et al framework for sustainability. Table 
4 (supplementary file) shows how the sustainability framework will be applied to the 
interview guide. The investigators will also ask about system components that would 
facilitate scale-up, such as what type of scaling up will be appropriate; how it will be 
organized and how fast it will be pursued; and how various environmental challenges 
and opportunities will be addressed. Interviews will last no more than one hour, and a 
$50 electronic gift card will be provided to those who participate. Interview recordings will 
be transcribed, and transcripts will be analyzed using standard qualitative analysis 
methods: a codebook will be developed deductively, and emergent codes will be 
included as relevant. With ~25 stakeholders, the study should have sufficient sample to 
achieve saturation of themes. If the study does not achieve saturation with this sample, 
the investigators will add additional key informants until saturation is achieved. 
 
8.0 DATA COLLECTION AND MONITORING 
8.1 Records 
Participants will be identified by the unique identification number (UID) created upon 
study enrollment and all personally identifiable information collected from participants will 
be stored under this UID. All personally identifiable information will be stored on UCLA 
encrypted computers or UCLA encrypted Box files and held separately from other data. 
Access to identifiers will be limited to key study personnel trained in management of 
these data. 
 
8.2 Privacy 
 
All study activities will be conducted in the privacy of the mobile van or in a private space 
at a brick-and-mortar building where the van is located on the day of service. Surveys 
will be conducted in the van or a private room, without other staff so that conversations 
cannot be heard by others. For study procedures conducted by telephone or text 
messages (i.e. appointment reminders, follow-up, etc.), participants will agree to their 
preferred modalities in the tracing form, which will be updated at each study visit, and 
only their preferred modalities will be used. 
 
8.3 Confidentiality 
 
All devices used by study personnel (phones, tablets, computers) will be encrypted, 
password protected and kept in locked offices when not in use. Any paper records will 

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be stored in locked cabinets in locked offices and will only be accessible by select 
members of the study team. Participants who have opted in to use an AirTag to support 
their ability to remain on LEN PrEP and be reached for on-time injections (in the case 
only that they are unable to be reached via other mechanisms on the tracing form) will 
be linked to the AirTag through a unique identification number (not the participant's 
name) that only key project staff will have access to geolocating via an encrypted study 
phone. Participants can decide at any time to return the AirTag or discard it. 
8.4 Reporting Protocol Deviations 
The principal investigator and personnel are responsible for identifying, and reporting 
deviations. Once protocol deviations are identified, corrective actions are to be 
developed by the site and implemented promptly. Protocol deviations will be sent to the 
UCLA IRB per their guidelines.