PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men
Phase: NA
Conditions: Risk Reduction
Sponsor: University of California, San Francisco

Protocol Number MH122286 
 
 
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PI: MATTHEW A. SPINELLI 
Clinical Research Protocol 
PREP POINT-OF-CARE BRIEF-INTERVENTION FOR ADHERENCE AMONG 
YOUNG MSM (PREP2-BAY) 
Protocol Number: 
MH122286 
Version Date: 
10/07/22 
Investigational Product: 
Point-of-Care Urine Tenofovir Test 
IND Number: 
Non-Significant Risk Device (FDA 10/3/2019) 
Development Phase: 
Pre-submission 
Principal Investigator: 
Matthew A. Spinelli MD, MAS 
995 Potrero Ave, Ward 84 
San Francisco, CA 94110 
Funding Organization: 
US National Institute of Mental Health 
Study Contact: 
Name: Matthew A. Spinelli MD, MAS 
 
Telephone: 
415-502-1765 
Fax: 
 
770-796-5059 
E-mail: 
matthew.spinelli@ucsf.edu 
 
Approval: 
 
 
 
PI Signature (Name and Title)  
 
Date 
 
 
 
10/07/22

Protocol Number MH122286 
 
 
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I have read the protocol specified below. In my formal capacity as Investigator, my duties 
include ensuring the safety of the study subjects enrolled under my supervision and 
providing the study team with complete and timely information, as outlined in the protocol.  
It is understood that all information pertaining to the study will be held strictly confidential 
and that this confidentiality requirement applies to all study staff at this site. Furthermore, 
on behalf of the study staff and myself, I agree to maintain the procedures required to carry 
out the study in accordance with accepted GCP principles and to abide by the terms of this 
protocol. 
 
Protocol Number:  MH122286 
 
Protocol Title:  PREP POINT-OF-CARE BRIEF-INTERVENTION FOR ADHERENCE 
AMONG YOUNG MSM (PREP2-BAY) 
 
Protocol Date:  10/07/22 
 
 
 
 
Investigator Signature  
 
Date 
Matthew A. Spinelli 
Print Name and Title 
 
10/07/22

Protocol Number MH122286 
 
 
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LIST OF ABBREVIATIONS 
Add all other abbreviations referenced in the protocol and delete any not referenced in 
the protocol. 
AE 
adverse event 
CFR 
Code of Federal Regulations 
CRF 
case report form 
DSMB 
Data Safety Monitoring Board 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HIV 
Human immunodeficiency virus 
ICF 
informed consent form 
IRB 
Institutional Review Board 
PI 
Principal Investigator 
PK 
Pharmacokinetic 
POC 
Point-of-care 
SAE 
serious adverse experience 
SOC 
Standard-of-care 
TAF 
tenofovir alafenamide 
TDF 
tenofovir disoproxil fumarate 
TFV 
TFV-DP 
Tenofovir 
Tenofovir-diphosphate 
YMSM 
young men who have sex with men 

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PROTOCOL SYNOPSIS 
TITLE 
PREP POINT-OF-CARE BRIEF-INTERVENTION FOR 
ADHERENCE AMONG YOUNG MSM (PREP2-BAY) 
PI 
Matthew Spinelli, MD, MAS 
FUNDING 
ORGANIZATION 
U.S. National Institute of Mental Health 
NUMBER OF SITES 
Study procedures performed remotely (over video chat) at University 
of California, San Francisco and University of Miami 
RATIONALE 
Young men who have sex with men (YMSM; ages 18-30 years) have 
rising HIV incidence in the United States. Pre-exposure prophylaxis 
(PrEP) is a highly effective medication prevent HIV infection, both at 
the individual and population level. However, in several clinical trials 
and demonstration projects among YMSM, a majority of participants 
had adherence to PrEP sufficiently low to compromise efficacy 
throughout the study. Unfortunately, pill-counts and self-reported 
adherence have limitations in this population, and therapeutic drug 
monitoring using previously available methods requires expensive 
equipment and specialized staff, meaning it cannot be implemented at 
the point-of-care (POC). We have developed a novel POC test to 
measure urine drug-levels to PrEP for the first time, providing the 
opportunity to target and enhance adherence counseling during a 
routine clinical visit. Substantial knowledge gaps on the correct 
counseling approach and framing of the drug-level feedback message 
must be addressed to use this strategy to improve adherence among 
YMSM. This study will use a mixed methods approach to test the 
central hypothesis that an intervention leveraging a POC urine 
bioassay to detect PrEP adherence can both target and enhance 
adherence counseling. Brief interventions are a motivational 
interviewing (MI) counseling approach with wide uptake by primary 
care providers for substance use prevention and medical therapy 
adherence. PrEP2-BAY proposes a brief intervention be used as the 
framework for POC drug-level feedback among YMSM using PrEP. 
This study will test the acceptability and preliminary impact on long-
term adherence, measured through hair tenofovir levels, of the brief 
intervention in a pilot randomized controlled trial among YMSM. 
This proposed research plan has the goal of optimizing PrEP’s impact 
through a novel adherence support intervention. The findings of this 
proposal will lead to a R01 application to test a POC bioassay-
enhanced adherence brief intervention among YMSM in a multi-city 
trial, with the goal of reducing the burden of HIV among MSM. 
STUDY DESIGN 
This is a randomized, unblinded, open-label pilot study 

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PRIMARY 
OBJECTIVE 
To test the acceptability to participants and impact on a longer-term 
metric of adherence among participants (assessed via tenofovir levels 
in hair) of implementing POC urine tenofovir testing and providing 
adherence feedback and motivational interview-based counseling 
among YMSM in the U.S. 
NUMBER OF 
SUBJECTS 
60 participants, 40 in the intervention arm and 20 in the standard-of-
care arm 
SUBJECT 
SELECTION 
CRITERIA 
Inclusion Criteria: 
1. Age 18-30 years. 
2. Primary sexual partners are male sex at birth  
3. Able to understand, read, and speak English.  
4. Currently taking TDF/FTC-based, daily PrEP and planning to 
continue for at least 3 months 
5. Willing to provide a hair sample 
Exclusion Criteria: 
1. Any health condition that may interfere with participation or the 
ability to provide informed consent, including any debilitating or 
life-threatening conditions  
2. Currently enrolled in another HIV intervention study.  
3. Known to be HIV-infected. 
POC TESTING 
Urine tenofovir testing by lateral flow assay performed at each of 2 
counseling sessions approximately 2-3 months apart 
CONTROL 
Participants will continue to receive standard of care at their PrEP 
clinic without the PrEP2-BAY adherence counseling intervention 
DURATION OF 
SUBJECT 
PARTICIPATION 
AND DURATION OF 
STUDY 
Participants will be enrolled in the study for a maximum of 3 months, 
including the enrollment period and 3 months of study follow-up. 
PRIMARY ENDPOINT 
• 
Acceptability: Number of participants indicating satisfied or very 
satisfied with the intervention  
• 
Description: Number of participants reporting to be "satisfied" or 
"very satisfied" about their overall experience on a five-point 
Likert scale. 
• 
Time Frame: 3 months 
SECONDARY 
ENDPOINTS 
• 
Change in tenofovir levels in hair from baseline and after 3 
months of follow-up 
PLANNED INTERIM 
ANALYSES  
When approximately 50% of patients have completed all study 
procedures, an interim analysis of all data will be conducted by an 

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independent DSMB. Serious adverse events will be monitored by the 
committee on an ongoing basis throughout the study. 
STATISTICS 
Primary Analysis Plan 
Acceptability will be the primary outcome for this pilot randomized 
controlled trial, and will be assessed via tabulation of survey results 
with graded answers in the intervention arm. Frequency distributions 
of the Likert scale will be summarized. Advantages and disadvantages 
of the bioassay enhanced brief adherence intervention will be 
tabulated, including manually reviewing and assigning open-ended 
responses under the “other” option to appropriate pre-specified 
categories. We will use a threshold of ≥75% reporting that they were 
at least somewhat satisfied with the full PrEP2-BAY intervention.  
 
After analysis of the quantitative results, we will explore mechanisms 
of acceptability using a sequential explanatory mixed methods 
approach. Qualitative interviews from the participants and providers 
will be performed, a debrief report will be prepared, and audio 
recordings will be professionally transcribed. Coding and analysis will 
be performed in the Dedoose cloud-based analysis platform to 
facilitate collaboration and comparison of coding transcripts. At least 
10% of transcripts will be double-coded and compared among the 
analytic team and inter-coder agreement will be calculated. 
Inconsistent results will be reviewed by coders until consensus on 
codes and themes is reached. 
 
Preliminary impact on adherence as assessed by hair tenofovir levels 
(long-term adherence): The first adherence analysis will include use 
of a mixed effects logistic regression model to estimate the effect of 
the intervention vs. SoC arm on optimal vs. sub-optimal adherence 
(<700 fmol/punch) equivalent to at least 4-times weekly average 
dosing over the prior three months. We will include a random 
intercept term to account for within-person correlation over two 
timepoints; and time points will be included as a categorical variable 
to account for systematic changes over time. We will also analyze 
continuous tenofovir-diphosphate levels between intervention and 
SoC arms using a censored-mixed effects linear regression with 
logarithmically transformed levels of tenofovir in hair.  
Rationale for Number 
of Subjects 
We will assess sample size based on the primary endpoint of 
acceptability, with a threshold of ≥75% reporting that they were at 
least somewhat satisfied with the full PrEP2-BAY counseling 
intervention. We will base our estimate of acceptability on a similar 
intervention performed among Los Angeles MSM (PATH-PrEP),1 
which was ~>90% acceptable. Using an estimate of PrEP2-BAY being 
somewhat acceptable for 90% of the 40 individuals in the intervention 

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arm, we would have 82% power to detect acceptability of 75% or less 
with a one-sided alpha of 0.015. 
 

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1 
BACKGROUND 
Adherence challenges in YMSM threaten to compromise PrEP’s effectiveness. Men 
who have sex with men (MSM) are the only risk group in the U.S. who have not 
experienced decreased HIV incidence, with increasing incidence specifically demonstrated 
among young MSM (YMSM).2-5 PrEP with adequate adherence is highly effective, both at 
the individual and population level.6-9 A recent analysis demonstrates that, among sexually 
active US MSM, the proportion eligible for PrEP has jumped from 24.7% in 2015 to 45% 
today with an update in practice guidelines.10 Indeed, rising numbers of U.S. MSM have 
initiated PrEP, with up to 50% of MSM having tried PrEP in the prior year in some 
districts, including San Francisco.11,12 PrEP expansion is a critical component of the newly-
launched End the HIV Epidemic campaign in the U.S.13 However, poor adherence can 
compromise PrEP’s effectiveness in the populations at greatest risk. Data from two U.S. 
PrEP demonstration projects has shown that up to 66-78% of YMSM exhibit low PrEP 
adherence.14,15 Furthermore, a drop-off in adherence may herald future PrEP 
discontinuation, meaning that new non-adherence may be a critical period for intervention 
in individuals who remain at risk.16 Although some stop PrEP due to decreasing HIV risk, 
many who stop PrEP remain at risk of HIV:17 in a Montreal clinic, the HIV incidence after 
stopping PrEP was as high as the placebo arm of the iPrEx trial.18  
Objective adherence monitoring effectively identifies adherence challenges. 
Pharmacologic metrics of adherence, where drug levels are measured in a biomatrix such 
as dried blood spots, plasma or hair, predict the efficacy of PrEP better than other measures 
such as self-reported adherence.7,19-24 The low correlation between self-report and 
pharmacologic metrics was seen not just in randomized trials, but also in open label studies 
after the efficacy of PrEP was known.25 Among YMSM in particular, the U.S. 
demonstration projects for young and adolescent MSM (Adolescent Trials Network (ATN) 
studies) demonstrated that self-reported adherence and electronic pill-cap monitoring (via 
Wisepill) both had low correlation and accuracy when compared to pharmacologic 
measures of adherence (drug levels in hair and dried blood spots, DBS),25 echoing findings 
in other populations.6,7,22,23,26 As a result, pharmacologic metrics of adherence are now 
often included in PrEP roll-out projects and demonstration studies to aid in outcome 
interpretation.6,22,27,28 
Point-of-care (POC) urine adherence screening is now feasible and scalable. 
Previously available methods to measure drug levels for pharmacologic monitoring, no 
matter which biomatrix tested, required expensive spectrometry-based equipment, usually 
liquid chromatography/tandem mass spectrometry (LC-MS/MS) machines. Moreover, LC-
MS/MS-based methods require long turn-around times and personnel with specialized 
training. A point-of-care (POC) method to measure drug levels in urine using a low-cost 
(<$2), easy-to-perform, rapid turnaround (<2 minutes) antibody-based assay has recently 
been developed for tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)-based PrEP.29-
31 Urine collection is noninvasive and preferred among youth over blood sampling.32,33 
Furthermore, POC adherence monitoring could be performed on urine specimens already 
collected for gonorrhea and chlamydia infection STI screening as part of routine PrEP care 
for MSM,11 requiring few changes in procedures and minimal time to implement in clinical 
settings. 

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Monitoring and feedback on adherence metrics or clinical outcomes can be used to 
enhance adherence counseling across multiple disease states. Patients adhere to life-
saving cardiovascular and diabetes medications approximately 50% of the time.34 
Monitoring and feedback of disease outcomes is used to motivate adherence across 
prevention and treatment of a variety of disease states, such as prediabetes/ diabetes, 
prehypertension/hypertension, obesity, and heart failure (hemoglobin A1c and glucose; 
blood pressure recordings; weight; remote pulmonary artery pressure monitoring 
respectively).35-41 Furthermore, objective adherence monitoring is now performed for 
several conditions;42-47 examples include urine drug-level testing for anti-hypertensive 
medications in resistant hypertension, leading to subsequent improvements in medication 
adherence and blood pressure,44,48 and remote monitoring of insulin delivery and 
carbohydrate entry with insulin infusion pumps among adolescents with type 1 diabetes, 
leading to improved adherence and glycemic control.49-51 Finally, studies have utilized 
objective adherence monitoring, including drug-level measurement, to enhance 
motivational interviewing-based adherence counseling to improve adherence in severe 
mental illness, substance use, asthma, obstructive sleep apnea, and HIV treatment.52-58 
Real-time adherence feedback, contextualized through counseling, can be used to 
interpret and motivate adherence to PrEP. In the iPrEx-Open Label Extension (OLE) 
study conducted among MSM and transwomen, plasma TFV levels were analyzed and 
feedback was provided at a later visit.59 Many with low adherence noted that feedback 
encouraged them to improve their adherence, while those with high adherence felt that the 
result motivated them to maintain their adherence.59 However, participants reported that 
adherence feedback would have less impact on their behavior without contextualization 
through counseling.59 A demonstration project in Los Angeles MSM therefore included 
MI-based counseling with plasma TFV-level feedback. The study demonstrated high 
acceptability, with a trend towards improved adherence among those who received their 
drug-levels.1 MSM found drug-level feedback with MI-based counseling highly acceptable, 
particularly when contextualized as “level of HIV protection,” with participants competing 
to achieve the highest drug level result.1,60 Finally in HPTN 082, a study of drug-level 
feedback using lab-based TFV-diphosphate monitoring in DBS among young African 
women on PrEP, long delays in receiving results limited acceptability, with the 
investigators recommending use of POC drug level testing in future studies.61,62 Based on 
the evidence available, (1) drug-level feedback should be supported by counseling to 
contextualize results and motivate improved adherence; and (2) drug-level feedback should 
be provided as close as possible to the visit before recall of recent adherence and 
motivation waned. 59,60,63 However, POC objective adherence metrics have not been 
available until now.29,30 
A POC bioassay-enhanced PrEP adherence brief intervention is promising and 
feasible for busy clinical settings. Motivational interviewing (MI)-based techniques to 
improve medication adherence are effective and have been embraced by primary care and 
HIV providers for prevention and treatment of chronic conditions.64,65 Brief interventions 
are structured MI-based strategies most widely used for substance use interventions,66 but 
have since been adapted to interventions to improve medication adherence. 64,66-68 To our 
knowledge, brief interventions have not yet been adapted to PrEP use. These brief 
interventions have 3 basic steps (1) screen for adherence challenges and provide adherence 
feedback, (2) enhance motivation, and (3) strategize and jointly set goals to improve 

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adherence.66 Due to their efficacy, simplicity to learn and teach, and ability to be performed 
in short clinical encounters, brief interventions have received widespread uptake among 
primary care providers.64,69 Brief interventions have been adapted for use with adherence 
monitoring (step 1 above) using the metrics of self-reported adherence and electronic pill-
cap monitoring systems.64,70,71 However, given greater accuracy of therapeutic drug 
monitoring (TDM)25 to monitor PrEP adherence and the predictive ability of TDM to 
identify individuals at risk of HIV due to low adherence,6,72 a brief intervention triggered 
and informed by a POC adherence metric could both improve adherence and prevent HIV 
infections. 
 
Preliminary Data: Below, I present preliminary data on (1) adherence in YMSM at SFCC; 
(2) validation of the urine POC immunoassay; (3) barriers to adherence reported by SFDPH 
PrEP users and medical providers; and (4) a conceptual model of PrEP adherence and 
proposed mechanisms of behavior change via PrEP2-BAY.  
 
YMSM have adherence challenges and a drop-off in adherence heralds future PrEP 
discontinuation. In an analysis of data from the U.S. PrEP Demonstration Project,28 
conducted between October 2012 and February 2015, for which SFCC was the largest site, 
we examined short-term adherence to PrEP using emtricitabine-triphosphate (FTC-TP) 
levels in dried blood spots (DBS). FTC-TP assesses adherence in the prior week similar to 
urine tenofovir (TFV) measurement.73,74 We found that 25% of participants had 
undetectable FTC-TP levels over the study duration, and a drop-off in short-term adherence 
heralded future PrEP discontinuation (adjusted hazard ratio: 6.3; 95% Confidence Interval 
(CI): 3.8-10.2).16 FTC-TP levels predicted future discontinuation more strongly than long-
term adherence metrics (e.g. TFV-diphosphate levels in DBS).16 Younger (age<30) vs. 
older MSM had 2.5-fold higher odds of low FTC-TP (95% CI: 1.7-3.9).  
 
The POC urine immunoassay is sensitive, specific, and highly correlated with gold-
standard metrics; low adherence via the assay identified MSM at risk of future HIV 
seroconversion. Samples from a directly observed therapy (DOT) study (n=30) ,where 
TDF/FTC was given to HIV-
uninfected volunteers at 2, 4 and 7 
doses per week, were used to 
compare urine TFV levels by the 
novel immunoassay with levels 
derived from the analytic gold 
standard, LC-MS/MS (R01 AI143340 PI: Gandhi). The novel immunoassay was sensitive 
(94%), specific (99%), and the correlation was high (0.92, p<0.001).29 A cut-off of 1,500 
ng/ml accurately classified 98% of patients who took a dose within the last 24 hours as 
adherent. The immunoassay has now been developed, validated against LC-MS/MS 
concentrations with high sensitivity and specificity, and packaged into a POC test with this 
cut-off (Fig. 1).31  Finally, in a secondary data analysis of a large PrEP demonstration 
project, the iPrEx-OLE study, we found that low vs. high urine TFV was associated with 
14-fold higher odds of future HIV seroconversion (95% CI: 1.3-1197).72   
 
Fig. 1: First Point-of-care Urine Tenofovir Test  

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Barriers to PrEP adherence in YMSM could be amenable to counseling; drug-level 
feedback can further enhance adherence counseling. To assess barriers to non-
adherence that could potentially be amenable to counseling, we analyzed preliminary data 
from the PrEP Persistence Study 
(R01 MH109320 PI Buchbinder) 
using the situated-Information-
Motivation-Behavioral Skills model 
(sIMB).75,76 The PrEP Persistence 
study performed in-depth interviews 
among 28 PrEP users (50% age<30) 
and 18 PrEP providers to assess 
barriers and facilitators of PrEP 
persistence (continued 
PrEP use over time).77 
YMSM, in particular, 
reported that (1) 
additional information about 
addressing missed doses and 
adherence necessary for protection 
would be helpful; (2) they 
experienced difficulty finding 
motivation for daily pill-taking in 
the context of other obligations and 
stressors; and (3) they were “taking 
a daily medication for the first 
time,” and thereby, could have used 
additional support in developing a 
pill-taking routine. In a presentation 
of preliminary data regarding the 
POC adherence test to the SFDPH 
Bridge HIV community advisory 
group (CAG), members felt that 
drug-level feedback would enrich adherence counseling if delivered supportively. One 
CAG member stated, “It shows my doctor values my protection [from HIV] so much that 
they are double-checking that the medication is in my body” (Fig. 2).   
 
We have developed a preliminary conceptual model of PrEP adherence among 
YMSM. Guided by factors in our preliminary data and literature review, our conceptual 
model (Fig. 3) is based on the situated Information-Motivation-Behavioral Skills model78 
(sIMB; previously applied to HIV therapy75,79 and more recently to PrEP adherence among 
MSM and YMSM80-82). We posit that the PrEP2-BAY intervention (presented in the yellow 
box) can foster pill-taking by enhancing adherence information (via drug-level feedback 
and discussion of timing of HIV protection based on adherence1,59); motivation (through 
MI components including: (1) assessing readiness for behavioral change; (2) discussing 
sources of support and restating motivation to improve83-85); and behavioral skills (setting a 
Fig. 2: Themes and illustrative quotes from preliminary data 
Developing motivation for adherence is a challenge  
“Remembering to take the pill, on top of work, school, you know, it 
sometimes feels like a lot and I’m trying to stay…motivated” (age 19) 
 
Behavioral skills support PrEP adherence 
 
“I got into a routine, so I knew I was consciously doing it. I would put one 
in my coin pocket so that I had one on me…like a backup plan” (age 27) 
 
Drug-level feedback, if real-time, is motivating  
Fig. 3: Adapted situated Information Motivation Behavioral Skills (sIMB) 
Model for PrEP Adherence and how PrEP2-BAY could address these factors 

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joint follow-up plan, specifying a reminder, cueing, or strategy, and agreeing on a follow-
up time with the provider by phone or in-person65,81,86).  
 
In summary, preliminary data reveal the need for additional PrEP adherence support among 
YMSM. In addition to receiving support for psychosocial challenges, YMSM report that 
interventions which enhance motivation to take PrEP and encourage the development of 
pill-taking strategies, which is the focus of PrEP2-BAY, are likely to be successful. Prior 
studies of drug-level feedback to support adherence reveal a need to (1) contextualize 
results and motivate improvement with counseling and (2) provide information on drug 
levels in real-time. 
 
2 
STUDY RATIONALE 
There are three important aspects that support the implementation of this pilot randomized 
controlled trial: (1) we will assess implementation of the first POC metric for assessing 
PrEP adherence objectively among MSM for the first time; (2) we will develop the first 
brief intervention for PrEP adherence; and (3) we will develop adherence support tailored 
specifically for YMSM, a population with rising HIV incidence in the U.S. 
 
1. We will use the first POC objective adherence assessment to support PrEP 
adherence among YMSM. Although pharmacologic metrics of adherence have been 
previously used to enhance and target adherence counseling, no clinically-validated POC 
metric for PrEP adherence has existed until now.29-31 This novel easy-to-perform POC 
urine assay will permit drug-level adherence feedback to be delivered in the context of 
routine PrEP clinical visits by the patient’s clinician, before memory and motivation to 
improve on recent adherence patterns has waned. This approach has the potential to be 
adapted to other PrEP strategies, such as tenofovir alafenamide (TAF),87,88 as well as to 
HIV treatment and the management of other chronic diseases. 
2. We will adapt an adherence screening and brief intervention to PrEP. This study 
will adapt an MI-based brief intervention widely used in primary care settings for other 
disease states for use in PrEP. Brief interventions have been effective in other contexts to 
support medication adherence64 and have high uptake among primary care providers.66,89 
Given that brief interventions are simple to learn and quick to perform, they have the 
potential for scalability and adoption across a variety of primary care and sexual health 
clinic settings. However, to our knowledge, no brief intervention has yet been developed 
for PrEP adherence. 
3. We will develop an adherence tool specifically tailored for YMSM. YMSM are a 
population with rising HIV incidence.2-4 YMSM have unique medical and sexual health 
needs in the context of negotiating independence from caregivers, exploring sexual 
identity, and if interested in PrEP, often taking a medication for the first time.90 We will 
develop a counselling tool specifically developed for YMSM’s sexual health needs and 
goals and enroll YMSM ages 18 and older to fully explore the tool among adolescents. 
 

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3 
STUDY OBJECTIVES 
3.1 
Primary Objective 
The primary objective is to assess the acceptability of the PrEP2-BAY intervention over a 
three-month period, implemented over two counseling sessions in concert with PrEP 
adherence feedback among YMSM using PrEP. 
3.2 
Secondary Objectives 
The secondary objective is to assess the impact of the PrEP2-BAY intervention on long-
term PrEP adherence (using tenofovir levels in hair) over a three-month period. 
4 
STUDY DESIGN 
4.1 
Study Overview 
 
We will conduct a 3-month pilot study of the PrEP2-BAY intervention to assess its 
accessibility and the preliminary impact on adherence. Participants will be randomized 2:1 
to the additional PrEP2-BAY adherence intervention vs. continued standard of care at their 
PrEP clinic.28 We will assess the acceptability of the intervention through surveys and 
interviews. Finally, we will assess preliminary impact on long-term adherence through 
measurement of tenofovir levels in hair compared from baseline to month 3 across study 
arms.  
5 
CRITERIA FOR EVALUATION 
5.1 
Primary Endpoint 
Acceptability will be the primary outcome for this pilot randomized controlled trial, and 
will be assessed via tabulation of survey results with graded answers in the intervention 
arm. We will use a threshold of ≥75% reporting that they were at least somewhat satisfied 
with the full PrEP2-BAY intervention. After analysis of the quantitative results, we will 
explore mechanisms of acceptability using a sequential explanatory mixed methods 
approach.  
 
5.2 
Secondary Endpoint 
 
Preliminary impact on adherence as assessed by tenofovir hair levels (long-term 
adherence): Change in tenofovir levels in hair from baseline and after 3 months of follow-
up will compared between the intervention and standard of care arm.  

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6 
SUBJECT SELECTION 
6.1 
Study Population 
We will recruit 60 YMSM (ages 18-30), who are male sex at birth, through advertisements 
on social networks who are currently using PrEP who are willing to give urine and hair 
biospecimens and to enroll in the PrEP2-BAY trial. We will obtain written informed 
consent from participants prior to enrollment in the study. 
6.2 
Inclusion Criteria 
1. Age 18-30 years. 
2. Primary sexual partners are male sex at birth  
3. Able to understand, read, and speak English.  
4. Currently taking TDF/FTC-based, daily PrEP and planning to continue for at least 3 
months 
5. Willing to provide a self-collected hair sample 
6.3 
Exclusion Criteria 
1. Any health condition that may interfere with participation or the ability to provide 
informed consent, including any debilitating or life-threatening conditions  
2. Currently enrolled in another HIV intervention study. 
3. Known to be HIV-infected  
 
7 
CONCURRENT MEDICATIONS 
The participant may continue to use concomitant medications as recommended by the 
primary PrEP provider. The study will not provide PrEP medication and will not review 
PrEP safety labs. The study will provide additional PrEP adherence counseling only in the 
intervention arm, and the standard of care arm will receive no changes to the current PrEP 
care that they are receiving outside of the study. Concomitant medications will not be 
collected as they are not expected to impact interpretation of study results. 
8 
RANDOMIZATION 
8.1 
Method of Assigning Subjects to Treatment Groups 
Up to 60 eligible participants will be randomly assigned to the PrEP2-BAY adherence 
counseling intervention or to continue standard of care with study assessments only in a 2:1 
ratio using a Stata-based computer-generated randomization scheme developed by the 
study statistician, which will be integrated into the Redcap study tracking forms. 
8.2 
Blinding 
Due to the intervention involving an adherence counseling intervention, all procedures will 
be open-label and no blinding will occur. 

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9 
STUDY PROCEDURES AND GUIDELINES 
9.1 Recruitment and Consent: 
This study involves two video (Zoom)/phone research visits for each of the 60 participants. 
Potential participants who are interested in participating in the study will contact the 
recruitment website/email address provided on recruitment notices on social networks. 
First, the study coordinator(s) will evaluate participants for eligibility for the study as per 
the inclusion criteria above. All participants will be informed of the purpose of the study, 
risks and discomforts involved, potential benefits, etc. Participants will be given as much 
time as necessary to consider study participation and are offered the opportunity to review 
the consent form on their own to provide adequate time to consider participation. The study 
team will engage the potential participant in a dialogue, using open-ended questions about 
the nature of the study or the experimental treatment, the risks and benefits of participating, 
and the voluntary nature of participation. Potential participants will be asked or shown a 
series of questions to assess their understanding of the study purpose, procedures, risks and 
benefits, as well as the voluntary nature of participation. Informed consent will occur 
remotely using the phone/zoom, and the signature via Docusign.  
Randomization 
Randomization will occur in the screening/enrollment visit after the informed consent 
procedures are performed. Eligible participants will be randomly assigned to the PrEP2-
BAY adherence counseling intervention or to continue standard of care with study 
assessments only in a 2:1 ratio using a Stata-based computer-generated randomization 
scheme. 
 
9.2 Hair Sample Collection 
Prior to the Month 0 visit, hair collection instructions will be sent to the participant. 
Instructions will be provided and will be reviewed with the participant at the Month 0 visit. 
All participants will self-collect (at home) hair samples using a pair of scissors at study 
enrollment and at three months and will place them in a pre-addressed and prepaid 
envelope to be sent back to the UCSF HAL. Approximately 50 strands of hair will be 
collected (less than is lost from the scalp in a day). Home collected hair specimens will be 
used for measurement of tenofovir, a marker of long-term adherence to PrEP. Participants 
will send the hair sample via the mail to the UCSF Hair Analytic Lab for analysis. No other 
analyses will be performed on this sample and it will be destroyed after analysis. 
 
 
Screening/ 
Enrollment 
Month 
0 
Month 
3 
Assess eligibility 
√ 
 
 
Informed consent 
√ 
 
 
Randomization 
√ 
 
 

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9.3 Urine Sample Collection 
and Analysis (Intervention Arm 
Only) 
 
Prior to the Month 0 visit, urine 
test kits will be sent to all 
participants in the intervention 
arm. Urine samples will be 
collected by the participant before 
or during the video visit only for 
participants in the intervention 
arm. Urine is collected with a 
volume of at least 5mL into a 
urine collection cup provided to the participant. The urine may be collected at the 
beginning of the urine stream (no need for clean catch). The participant will be provided 
instructions on how to complete the urine test, and may discuss any questions with the 
research coordinator at the time of enrollment/first study visit  
The participant will be provided a $50 cash or gift card reimbursement for completion of 
all study procedures at each visit, including the survey and urine collection. 
Reimbursement may be provided via an e-gift card or check.  
 
Device for Tenofovir Testing 
We obtained pre-trial consultation advice from the Food and Drug Administration’s 
(FDA's) Center for Devices and Radiological Health (CDRH) regarding the our use of the 
novel point of care urine tenofovir assay in PrEP2-BAY and verified that the urine 
tenofovir assay is not Investigational Device Exempt (IDE) because we are returning test 
results to participants in the intervention arm of the trial. Per FDA regulations (21516 CFR 
812), the alternative determinations applicable to our studies are either Nonsignificant Risk 
(NSR) or Significant Risk (SR). Under FDA 21 CFR 812.3(m), a Significant Risk (SR) 
device is defined as an investigational device that “Is intended as an implant and presents a 
potential for serious risk to the health, safety, or welfare of a subject; is purported or 
represented to be for use supporting or sustaining human life and presents a potential for 
serious risk to the health, safety, or welfare of a subject; Is for a use of substantial 
importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing 
impairment of human health and presents a potential for serious risk to the health, safety, or 
welfare of a subject; or otherwise presents a potential for serious risk to the health, safety, 
or welfare of a subject.” The urine assay does not meet these criteria as it is noninvasive 
and merely tests levels of tenofovir in urine samples. Although test results will be shared 
with patients, which excludes it from the exempt category, no clinical decisions will be 
made based on the results. While the assay will be used to measure medication adherence, 
the collection of adherence information does not present a potential for serious risk to the 
health, safety, or welfare of the subject. Therefore the urine assay meets the criteria under 
the IDE. 
Hair TFV Levels 
 
√ 
√ 
POC Urine Testing 
(intervention arm 
only) 
 
√ 
√ 
PrEP2-BAY 
Counseling 
Intervention 
(intervention arm 
only) 
 
√ 
√ 
Online 
questionnaire 
 
√ 
√ 

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Nonsignificant Risk Medical Device study with additional details provided here: 
The non-invasive urine assay will be used to detect the absence or presence of tenofovir 
(the metabolite of TDF) in urine to improve adherence counseling. TDF is used in HIV 
treatment regimens worldwide and is also the only agent (in combination with 
emtricitabine) approved for pre-exposure prophylaxis (PrEP) worldwide. The threshold of 
the assay was designed to distinguish between people who have taken TDF within the prior 
four days (“adherent”) versus those who have not (“non-adherent”) taken TDF within the 
prior four days. Participants who are considered “adherent” by the assay in the intervention 
arm of PUMA will be informed of the result and continue to receive standard adherence 
counseling. Participants who are considered “non-adherent” by the assay will receive 
enhanced adherence counseling with positive messaging (detailed below). 
The antibody that was developed against tenofovir for this novel assay is highly selective. 
As above, the assay has been demonstrated to have very high sensitivity and specificity in 
our recently concluded clinical validation studies against both the gold standard of 
measuring drug levels, LC-MS/MS, and the laboratory-based method of performing 
immunoassays (enzyme-linked immunosorbent assay or ELISA). Therefore, this test has a 
very low rate of false positivity and we have designed it to have a very low false negative 
rate. In the unlikely situation of false positive results (where the results indicate “adherent” 
when the participant is not taking their medication), participants will continue to receive 
standard adherence counseling. In the very unlikely event of false negative results (where 
the results indicate “non-adherent” when the participant is taking their medication) the 
participant will receive enhanced adherence counseling (which does not meet the definition 
of “significant risk”) in the intervention arm of PUMA. Therefore, participant access to 
standard adherence counseling will not be affected by a false positive result. We do not 
anticipate any adverse consequences for participants who receive enhanced adherence 
counseling due to being wrongly classified as non-adherent (a very rare event). The 
feedback and adherence counseling will be delivered in a supportive non-judgmental 
manner. 
The FDA confirmed with our study team on October 3, 2019 that they approve the NSR 
designation of the urine device (Email dated October 3, 2019 from Kellie B. Kelm PhD, 
Acting Director, Division of Chemistry and Toxicology Devices | OHT7: Office of In Vitro 
Diagnostics and Radiological Health, Office of Product Evaluation and Quality, CDRH | 
Food and Drug Administration states “Since the therapies that will be given are approved, 
given at approved doses and the adherent patients get standard adherence counseling and 
the non-adherent patients get enhanced adherence counseling with positive messaging, the 
impact of a false negative and false positive are minimal. We would agree these studies 
using an investigational device appear to be non-significant risk”. This designation of NSR 
for the urine assay by the FDA is attached. Finally, the study staff at will follow the 
abbreviated requirements at 21 CFR 812.2(b), which require devices to be clearly labeled 
as investigational, under study, and marked clearly to specify that no clinical decisions 
should be based on the outcome of the results. All research participants in PrEP2-BAY will 
signed written informed consent forms prior to participation and will cite the urine test as 
investigational. 
 

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9.4 Adherence Counseling Session (Intervention Arm Only) 
Participants in the PrEP2-BAY intervention arm will complete two individually delivered 
sessions via zoom designed to enhance intrinsic motivation and self-efficacy for 
maintaining adherence to PrEP and addressing the intersection of substance use and HIV 
risk. Session 1 focuses on supporting efforts of participants to continue taking PrEP 
adequately to achieve protection from HIV infection. Session 2 focuses on addressing the 
intersection of substance use and HIV risk. Counseling sessions will also reflect on results 
of the urine test collected and analyzed immediately prior to the session by the participant. 
The counselling intervention manual is also attached. 
 
9.5 Survey Collection 
The quantitative survey will be performed and collected using Redcap software either on 
the participants phone or home computer. The participant identification number will be 
inputted into the survey to allow linking of the survey to the participant’s urine sample. The 
survey will take 20-30 minutes to complete and contains approximately 100 questions. The 
survey will be completed by the participant after each research visit.  
 
9.6 In-depth Interviews 
In-depth interviews will be conducted among 20 YMSM to assess acceptability, as well as 
to explore mechanisms by which the intervention motivated changes in adherence. We will 
use purposive sampling among participants in the intervention arm, with a goal to include 
15 individuals who reported adherence challenges and 5 who did not report adherence 
challenges, as well as achieve a racially/ethnically and geographically diverse sample of 
respondents. Participants will receive an additional $50 reimbursement for completing an 
interview. 
 
9.7 Early Termination of Study Participation 
Participants may voluntarily withdraw from the study for any reason at any time. The site 
investigators, with the approval of the Protocol Team, withdraw participants before their 
scheduled termination visit to protect their safety or staff safety, and/or if participants are 
unable or unwilling to comply with study procedures. Participants also may be withdrawn 
if the study sponsors, government or regulatory authorities (including the OHRP and US 
FDA), or IRB terminate the study prior to its planned end date. Study staff will record the 
reason(s) for all withdrawals in participants’ study records.  
 
9.8 Risks to Participants 
There is potential for loss of confidentiality in all research, but risk to participants will be 
minimized by training all staff in the ethical conduct of research. Data for the participants 
in this study will be obtained from the medical record, or from behavioral questionnaires 
administered (via tablet or personal electronic device).  

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If data related to illicit drug use were disclosed due to a loss of confidentiality, there could 
be risk of criminal justice involvement.  
There is no substantial risk for urine collection or performance of the urine point of care 
test.  
Participants may feel slight pulling at the scalp when using scissors to collect a hair sample. 
Participants will be asked questions about their sexual behavior that may make them feel 
uneasy. Participants do not have to answer any question that they do not want to and can 
stop answering the questions at any time. Participants may also become embarrassed, 
worried, or anxious when being counseled about PrEP. 
Strict protection of the data will be maintained through using password protected databases 
There may be risks of discrimination or other personal problems from being in this study. 
The most common risks we know about are family or friends worrying, getting upset or 
angry, or assuming that you are HIV-infected and treating you unfairly as a result. The 
study staff will take the same steps to protect participant privacy. The participant may be 
embarrassed or feel uncomfortable with some of the questions that are asked during the 
study. The participant does not have to answer any questions that make them 
uncomfortable. 
 
9.10 Benefits to the Subject or Future Benefits 
The participant may receive no immediate benefits from the research study. It is possible 
that the participant may improve their PrEP adherence behavior, which could lead to 
decreased HIV risk. The participant may also feel satisfaction at having contributed to 
knowledge within a health field.  
Prior to conducting any study-related activities, written informed consent and the Health 
Insurance Portability and Accountability Act (HIPAA) authorization must be signed and 
dated by the subject. If appropriate, assent must also be obtained prior to conducting any 
study-related activities. 
10 Data management and analysis 
 
10.1. Data management 
 
Questionnaire data will be collected online using Redcap and stored in password-protected 
databases. All study staff will be trained in Good Clinical Practice (GCP) and will have 
received additional training about maintaining confidentiality. 
 
All assessments (questionnaires, CRFs) will be identified by only a coded number to 
maintain participant confidentiality. All study staff will be trained in Good Clinical 
Practice (GCP), Human Subjects Protection (HSP) and will have received additional 
training about maintaining confidentiality. Only study staff will have access to 
individually identifiable study data. 

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Audio-recorded qualitative interviews will be recorded onto digital media using a portable 
recorder that records directly into computer readable format and can be transferred from 
the recorder and stored in an encrypted volume that is then stored on a secure computer 
or burned on a DVD which will be stored in a locked cabinet. The data will be 
transferred via USB cable to a password-protected, encrypted volume created on a 
laptop computer. Only study personnel will have access to the password. A copy of the 
encrypted volume would be stored on secured servers at one of the research institutions 
for study team members at different research sites to access. The encrypted volume will 
be opened (mounted) only when it is being used for analysis purposes.  At all other 
times, the encrypted volumes containing the data will remain closed (dismounted) and 
thereby encrypted. Because the data are stored in an encrypted format, the risk of 
unauthorized access is very low.  
 
10.2 Statistical Analysis 
Acceptability, the primary outcome, will be assessed through tabulation of survey results 
and in-depth interviews. We will use a threshold of ≥75% reporting that the full PrEP2-
BAY intervention was at least somewhat acceptable on a 5-point Likert scale, and then 
explore potential mechanisms through in-depth interviews using a sequential 
explanatory mixed methods approach.91 For the interviews, we will analyze transcripts 
using the codebook and theoretical model developed in Aim 2, applying it to a subset of 
transcripts. We will seek 90% agreement among coders prior to applying codes to the 
entire set of interviews. We will use code reports to organize findings into emergent 
themes and discuss these as a group and with the HIV prevention community advisory 
group.  
Preliminary impact (adherence) will be assessed via a long-term adherence metric, namely 
DBS TFV-DP levels. We will use mixed effects logistic regression for high adherence 
(at least 4 times weekly dosing; TFV-DP≥700 fmol/punch) comparing the interaction of 
adherence by intervention arm with time. Random intercepts will accommodate paired 
adherence levels. As an additional adherence outcome, we will examine continuous 
DBS TFV-DP levels using censored mixed-effects linear regression in a similar fashion. 
10.3 Qualitative Data analysis 
Recordings of the in-depth interviews (IDIs) will be analyzed using software for qualitative 
analysis. Interviewers will complete a debrief report promptly following each interview 
to capture results relevant to the study objectives.  Debrief reports will also include an 
assessment of whether the interview merits additional in-depth analysis. Debriefing 
reports have been shown to be of sufficiently high quality to use as a primary source.92 
Debrief reports and selected transcripts will be reviewed for emergent themes and 
results relevant to the study objectives.  Team members will create summary reports 
based on this analysis for use in providing feedback and suggestions in achieving study 
goals, and to contribute to manuscript development. Debrief reports will be reviewed 
promptly in order to provide feedback and suggestions for subsequent interviews..  
 

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11. Safety Monitoring and Clinical Data Review 
 
11.1. Safety Monitoring and Clinical Data Review  
A multi-tiered safety review process will be followed for the duration of this study. Close 
cooperation between the PI, investigators, study coordinator, statistician, and other 
study team members will be necessary to monitor participant safety and to respond to 
occurrences of toxicity in a timely manner. The research team will have regularly 
scheduled meetings during the period of study implementation, and additional ad hoc 
calls will be convened if required. 
 
11.2 Reporting Requirements for this Study  
This study will follow safety reporting requirements as outlined by the UCSF IRB. All 
adverse events that are definitely, probably, or possibly related, AND serious or 
unexpected, will be reported to the IRB within 5 working days of PI awareness. All AEs 
meeting these criteria will be reported to the study PI within 48 hours of site awareness, 
to allow ample time for IRB notification. The NIH Project Officer will be provided 
copies of these reports at the time of IRB reporting and informed of any actions taken by 
the IRB as a result of such events. 
 
Serious adverse events are any AEs that result in any of the following outcomes: 
• 
Death, 
• 
Life-threatening adverse experience, 
• 
Inpatient hospitalization or prolongation of existing hospitalization, 
• 
Persistent or significant disability/incapacity, 
• 
Congenital anomaly/birth defect, or cancer, or 
• 
Any other experience that suggests a significant hazard, contraindication, side effect 
or precaution that may require medical or surgical intervention to prevent one of the 
outcomes listed above 
Unexpected AEs are those that exceed the nature, severity or frequency described in the 
current IRB Application including the protocol, consent form and investigator brochure 
(when applicable). An unexpected AE also includes any AE that meets any of the 
following criteria: 
• 
Results in subject withdrawal from study participation, 
• 
Due to an overdose of study medication, or 
• 
Due to a deviation from the IRB approved study protocol 
 
In addition, all SAEs will be reported to the study team within 72 hours of recognition by 
study staff. 

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11.3 Data Safety Monitoring Board (DSMB) 
We will form a dedicated DSMB for PrEP2-BAY.  Membership will include a researcher 
with experience in conducting trials to address PrEP uptake and persistence; a clinician 
with expertise in HIV treatment and prevention, including PrEP adherence measures; a 
biostatistician with expertise in PrEP intervention trials; and a community member.  
 
The purpose of the DSMB will be:  
• To ensure the safety of trial participants  
• To preserve validity and integrity of research data  
• To facilitate the availability of timely as well as reliable findings to the broader clinical 
community  
 
The DSMB will meet by teleconference every 6 months, and more frequently as needed. 
No DSMB members will be permitted to have any financial interest related to the 
outcome of the trial. Individuals on the DSMB will be required to disclose in writing to 
the NIH project officer of any potential conflicts of interest, actual or implied.  
 
The DSMB will review the PrEP2-BAY protocol prior to launch of the trial, and monitor 
follow-up to identify unexpected events that change the known risks to participation. 
The DSMB may make recommendations to continue, modify, or terminate the trial 
based on their findings. Recommendations will be made in writing to the PI and the 
NIMH Program Officer.  
 
The DSMB report will contain a brief description of the trial, baseline socio-demographic 
characteristics of participants (total and by group), status of recruitment, retention, and 
disposition of study participants (total and by group), description of any quality 
assurance or regulatory issues, a report of AEs and SAEs (including social harms) (total 
and by study group), and the status of outcome data. Protocol compliance will be 
evaluated by reviewing: the expected recruitment rate, study drop-outs and reasons for 
leaving the study, data quality assurance reports, overall data flow procedures, 
questionnaires completed and CRFs entered; protocol  deviations; protocol violations; 
missing data; staff omissions; subject refusal to provide data.  The outcome data report 
will include outcome data analyzed by group, with calculation of p-values at the 
direction of the DSMB, and include all primary and secondary outcome variables.  
 
11.4 Social Impact Reporting 
 

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Although the study site will make every effort to protect participant privacy and 
confidentiality, it is possible that participants' involvement in the study could become 
known to others, and that a negative social impact may result (e.g. participants could be 
perceived as being HIV-infected or at "high risk" for HIV infection). For example, 
participants could be treated unfairly, or could have problems being accepted by their 
families and/or communities. In the event that a participant reports a negative social 
impact, every effort will be made by study staff to provide appropriate care and 
counseling to the participant as necessary, and/or referral to appropriate resources for 
the safety of the participant. Staff will provide such care and counseling in accordance 
with standardized guidance.   
 
12. Laboratory Specimens and Biohazard Containment 
 
Hair specimens will be collected at screening and at the month 3. Specimens will be 
collected via home mailer and shipped to the UCSF Hair Analytical Laboratory. There is 
no risk of bloodborne pathogen transmission via hair samples. 
 
13. Administrative Procedures 
 
13.1. Training 
Recruiters and staff who collect data will complete CITI GCP and HSP training, as well as 
protocol specific training. Trained qualitative interviewers will conduct the in-depth 
interviews and code the responses. 
 
13.2. Confidentiality  
All staff are required to sign an oath of confidentiality and receive annual training on 
maintaining confidentiality, privacy, and handling questions about study participants 
from friends, employees, and insurance companies. Study staff will discuss any privacy 
concerns the participant may have regarding the need to contact them, via phone or e-
mail, and contact methods will be tailored accordingly. A participant’s involvement in 
this study will not be divulged without the subject’s written permission, except as 
necessary for monitoring by the sponsor and/or its contractors; other government and 
regulatory authorities, and/or the local IRBs. 
Information collected from subjects will be handled in the most confidential manner 
possible. All data will be coded by a subject number. Personal identifier records will be 
kept in a password protected computer files and double-locked cabinet at the study site, 
and any forms with identifying information will be stored separately from other study 
data. Digital audio recordings will be encrypted and stored on password protected 
computers until destroyed. Transcripts of the recordings will be transcribed in such a 
way as to not have any identifying information present. Interviews will take place by 

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videoconferencing (zoom). Questionnaires and surveys will not include any personal 
identifiers. 
 
13.3. Informed Consent 
The informed consent process will conform to local IRB consent standards. Informed 
consent will be obtained electronically via DocuSign, before any study procedures are 
initiated. Potential participants will receive a copy of the informed consent form and the 
Experimental Subject’s Bill of Rights, and a study staff member will offer to review the 
form with the participant, and answer any questions the participant may have. 
 
14. References: 
 
1. 
Landovitz RJ, Beymer M, Kofron R, et al. Plasma Tenofovir Levels to Support 
Adherence to TDF/FTC Preexposure Prophylaxis for HIV Prevention in MSM in 
Los Angeles, California. J Acquir Immune Defic Syndr. 2017;76(5):501-511. 
2. 
Balaji AB, An Q, Smith JC, et al. High Human Immunodeficiency Virus Incidence 
and Prevalence and Associated Factors Among Adolescent Sexual Minority Males-
3 Cities, 2015. Clin Infect Dis. 2018;66(6):936-944. 
3. 
Maulsby C, Millett G, Lindsey K, et al. HIV among Black men who have sex with 
men (MSM) in the United States: a review of the literature. AIDS Behav. 
2014;18(1):10-25. 
4. 
Wejnert C, Hess KL, Rose CE, et al. Age-Specific Race and Ethnicity Disparities in 
HIV Infection and Awareness Among Men Who Have Sex With Men--20 US 
Cities, 2008-2014. J Infect Dis. 2016;213(5):776-783. 
5. 
Singh S, Song R, Johnson AS, McCray E, Hall HI. HIV Incidence, Prevalence, and 
Undiagnosed Infections in U.S. Men Who Have Sex With Men. Ann Intern Med. 
2018;168(10):685-694. 
6. 
Grant RM, Anderson PL, McMahan V, et al. Uptake of pre-exposure prophylaxis, 
sexual practices, and HIV incidence in men and transgender women who have sex 
with men: a cohort study. Lancet Infect Dis. 2014;14(9):820-829. 
7. 
Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV 
prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587-
2599. 
8. 
McCormack S, Dunn DT, Desai M, et al. Pre-exposure prophylaxis to prevent the 
acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase 
of a pragmatic open-label randomised trial. Lancet. 2016;387(10013):53-60. 
9. 
Grulich AE, Guy R, Amin J, et al. Population-level effectiveness of rapid, targeted, 
high-coverage roll-out of HIV pre-exposure prophylaxis in men who have sex with 
men: the EPIC-NSW prospective cohort study. Lancet HIV. 2018;5(11):e629-e637. 
10. 
Weiss KM, Prasad P, Ramaraju R, Anderson EJ, Jenness S. Estimated PrEP 
eligibility in a national sexual network study of U.S. MSM. Conference on 
Retroviruses and Opportunistic Infections. Seattle. 2019 March 4-7  [# 971]. 

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11. 
Centers for Disease Control and Prevention. HIV Infection Risk, Prevention, and 
Testing Behaviors Among Men Who Have Sex With Men—National HIV 
Behavioral Surveillance, 23 U.S. Cities, 2017. HIV Surveillance Special Report 22 
Web site.  Accessedhttps://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. 
Published February 2019. Accessed March 11 2019. 
12. 
Enanoria W, Scheer S, Hsu L, Buckman A. San Francisco HIV Epidemiology 
Annual Report 2017. San Francisco Department of Public Health HIV 
Epidemiology Section 2018. 
13. 
Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV 
Epidemic: A Plan for the United States. JAMA. 2019;321(9):844-645. 
14. 
Hosek SG, Landovitz RJ, Kapogiannis B, et al. Safety and Feasibility of 
Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With 
Men Aged 15 to 17 Years in the United States. JAMA Pediatr. 2017;171(11):1063-
1071. 
15. 
Hosek SG, Rudy B, Landovitz R, et al. An HIV Preexposure Prophylaxis 
Demonstration Project and Safety Study for Young MSM. J Acquir Immune Defic 
Syndr. 2017;74(1):21-29. 
16. 
Spinelli MA, Glidden DV, Anderson PL, et al. Short-Term Adherence Marker to 
PrEP Predicts Future Non-Retention in a Large PrEP Demo Project: Implications 
for Point-of-Care Adherence Testing. J Acquir Immune Defic Syndr. 2019 doi: 
10.1097/QAI.0000000000002005. [Epub ahead of print]. 
17. 
Krakower D, Maloney KM, Powell VE, et al. Patterns and clinical consequences of 
discontinuing HIV preexposure prophylaxis during primary care. J Int AIDS Soc. 
2019;22(2):e25250. 
18. 
Greenwald Z, Beuachemin M, Benomar K, et al. High seroconversion rates 
following PrEP discontinuance in a Montreal clinic. Conference on Retroviruses 
and Opportunistic Infections Boston. 2018.  March 4-7 [#1038]. 
19. 
Liu AY, Yang Q, Huang Y, et al. Strong relationship between oral dose and 
tenofovir hair levels in a randomized trial: hair as a potential adherence measure for 
pre-exposure prophylaxis (PrEP). PLoS One. 2014;9(1):e83736. 
20. 
Anderson PL, Glidden DV, Liu A, et al. Emtricitabine-tenofovir concentrations and 
pre-exposure prophylaxis efficacy in men who have sex with men. Sci Transl Med. 
2012;4(151):151ra125. 
21. 
Anderson PL, Liu AY, Castillo-Mancilla JR, et al. Intracellular Tenofovir-
Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots following 
Directly Observed Therapy. Antimicrob Agents Chemother. 2018;62(1). 
22. 
Marrazzo JM, Ramjee G, Richardson BA, et al. Tenofovir-based preexposure 
prophylaxis for HIV infection among African women. N Engl J Med. 
2015;372(6):509-518. 
23. 
Koss CA, Bacchetti P, Hillier SL, et al. Differences in Cumulative Exposure and 
Adherence to Tenofovir in the VOICE, iPrEx OLE, and PrEP Demo Studies as 
Determined via Hair Concentrations. AIDS Res Hum Retroviruses. 2017;33(8):778-
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