Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)
Phase: NA
Conditions: HIV/AIDS
Sponsor: San Diego State University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM 
(PrEParate) 
Study Protocol and Statistical Analysis Plan  
NCT04048382 
August 2, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
 
Using a randomized controlled trial design, a pilot test of the PN intervention will be conducted 
in collaboration with the Family Health Centers of San Diego (FHCSD), a federally qualified health 
center.17  Bilingual research assistants will recruit 60 young adult Latino MSM at-risk for HIV in San 
Diego County, California; this sample size is well within the bounds of recommendations for pilot trials.     
18 After a research assistant obtains informed consent, participants will complete baseline surveys, and 
then the research assistant will individually randomize each participant to 1 of 2 conditions: usual care 
plus written information (UC) or PN. At 3- and 6-month follow-up, participants will be asked to 
complete surveys. Individuals randomized to PN will also be asked to participate in a key informant 
interview at 6-months. Participants’ electronic health records (EHR) will be reviewed at 6-month 
follow-up to assess their engagement in the PrEP continuum. The study methods and PN intervention 
will be reviewed for feasibility and acceptability, as well as preliminary impact of the PN intervention in 
preparation for a future full-scale efficacy trial. In addition, the pilot test will evaluate preliminary 
impact on seven PrEP continuum-related primary outcomes (i.e., scheduled and attended PrEP 
consultation; PrEP prescription received; PrEP prescription filled; PrEP initiated; self-reported PrEP 
adherence; and PrEP follow-up medical appointment attended). Analyses will be performed under the 
intent-to-treat (ITT) principle. Participants will be compensated with a $50 gift card to an online retailer 
at each of the three assessment time points (baseline, 3-month follow-up, 6-month follow-up). (See 
Appendices 1-3 for informed consents and WHO Trial Registration Data Set) 
Patient and Public Involvement 
As suggested by Intervention Mapping, a Participatory Planning Group (PPG) of program 
stakeholders guided the design of the PN intervention. The PPG includes a consultant and HIV expert, 
potential program implementers, young Latino MSM, and community members who interact with or 
deliver services to people who may benefit from the intervention. The PPG was instrumental in helping 
us develop the intervention materials and recruitment approaches. This group will continue to meet on 
an as needed basis (with compensation for their time) and will assist with dissemination of research 
findings both in the community and in peer-reviewed publications and presentations. 
Setting 
 
The pilot RCT will take place in San Diego County, California. In 2017, San Diego had an 
estimated population of 3,337,685 people,19 33.9% of whom identified as Hispanic and 50.3% identified 
as male. Between 2012 and 2014, it was estimated that 3.9% of San Diego County’s population 
identified as a sexual minority.20 Our study is being conducted in partnership with FHCSD, which is San 
Diego’s largest federally qualified health center, providing care to more than 140,834 patients in 2018. 
FHCSD delivers comprehensive healthcare in 42 sites throughout San Diego County. Each site provides 
a wide range of health care services to sexual and gender minority patients. Although we are partnering 
with FHCSD on this study, participants are recruited throughout San Diego County and obtain health 
care in various health systems, centers, and practices in the community. 
Inclusion/Exclusion Criteria  
The following criteria are required for study inclusion: 1) age 18 to 29 years; 2) identifies as 
male; 3) identifies as gay/bisexual or reports having sex with men in past 12 months; 4) identifies as 
Latino/Hispanic; 5) self-reports being HIV-uninfected; 6) resides in San Diego County, California; 7) 
speaks English or Spanish; 8) is willing and able to provide informed consent; and 9) reports at least one 
HIV risk factor as informed by Centers for Disease Control and Prevention (CDC) guidelines.21 MSM 
are at elevated risk for HIV if they report one of the following: 1) an HIV-positive sexual partner; 2) 
diagnosis of a bacterial sexually transmitted infection (STI) within the past 12 months; 3) engaging in 

3 
 
condomless anal sex with a non-monogamous partner in the past 12 months; 4) engaging in commercial 
sex work in the past 12 months; 5) injection of illicit drugs and sharing of injection equipment in the 
past 12 months; or 6) engaging in drug treatment for injection drug use in the past 12 months. 
Individuals will be excluded if they self-report being HIV-positive. The intervention is designed to meet 
the needs of MSM who self-report their gender identity as male, but other gender identities are allowed 
in the study. If a potential participant indicates that their gender identity is not “male” (e.g., trans-
gender, non-binary, gender fluid), then the participant will be informed that the study was designed for 
cis-male MSM; and will then be invited to determine whether they feel that they will benefit from the 
study based on their gender identity. Participants who previously were prescribed or are currently taking 
PrEP will be included in the study. Participants are not required to seek care at FHCSD to be included in 
the study. 
Recruitment  
Non-probability (convenience) sampling will be used to recruit participants within the greater 
San Diego area via a variety of methods, including through FHCSD outreach and HIV/STI testing 
programs, a Spanish language Latino MSM support group, gay-friendly events, such as Pride, and 
flyering local LGBT community centers, gay-identified/friendly coffee shops, gyms, and bars. We will 
also utilize online recruitment methods, including targeted ads through Facebook and Instagram, and use 
of geolocation social networking mobile applications tailored to sexual minority men (e.g., Grindr, 
Scruff, Jack’d). Potential participants recruited using flyering or targeted ads will be requested to contact 
study personnel via email or telephone. A bilingual member of the study team will contact each potential 
participant via telephone to explain the study and screen for inclusion. The bilingual research assistants 
will be native Spanish speakers who are bilingual in English and Spanish; they will have some 
university education and research experience. If a potential participant screens positively for the study, 
an in-person baseline visit will be scheduled, in which the inclusion/exclusion criteria will be assessed in 
further detail. Reasons for non-participation of potential participants will be documented.   
Randomization  
The research coordinator will use the Randomizer for Clinical Trial computer application to 
randomize each participant to either UC or PN via an iPad22 immediately following the baseline survey 
data collection. Randomizer for Clinical Trial will implement a blocked randomization sequence (in 
blocks of 4 participants) to balance randomization across the arms of the study. The randomization 
sequence will be concealed from all members of the study team prior to randomization.   
Usual Care Intervention  
Immediately following randomization, the research team member will provide participants 
randomized to UC the CDC’s 2-page PrEP Information Sheet in the participant’s preferred language 
(either English or Spanish). This 2-page booklet includes the following information: 1) overview of 
PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and 
adhering to PrEP. Participants will also be provided with both verbal and written information regarding 
available sexual health and HIV prevention services, including PrEP, at FHCSD. Comprehensive HIV-
prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal 
cost.  
PN Intervention  
Based on extensive formative research and using Intervention Mapping,23 the study team 
developed, pre-tested, and produced the PN intervention materials. The produced PN intervention 
includes an introductory module, five educational modules (HIV prevention, PrEP introduction, PrEP 
efficacy, PrEP side effects, and PrEP adherence), and a module focused on decision support. Patient 
education is facilitated using infographics, palm cards, and a decision support tool. The educational 

4 
 
modules are designed to be delivered as needed in addition to personalized strategies to improve access 
and decrease barriers to PrEP initiation and adherence. The intervention also consists of barrier 
reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.  
Two part-time Spanish-English bilingual peer lay navigators hired by FHCSD will provide the PN 
intervention during the study. Navigators were hired based on their familiarity, as well as cultural and 
linguistic competence, with the intended audience, young Latino MSM. The study team will train the 
patient navigators using training manuals developed in formative research and via the Patient Navigation 
Research Program training approach.24   
Following patient randomization, the research coordinator will notify the patient navigators 
regarding the patient’s assignment to PN. A patient navigator will contact the participant to schedule the 
first in-person meeting at a time and location of the participant’s convenience. The navigators will 
provide services to patients using PN intervention manuals and materials the team has developed (see 
Figure 1 for examples of PN services provided at each level of PrEP continuum). Services will generally 
focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing 
PrEP-related healthcare; 2) increasing each patient’s knowledge, attitudes, and self-efficacy for initiating 
and adhering to PrEP; 3) improving communication between the patient and healthcare team through 
appointment scheduling and reminders; and 4) sexual risk reduction counseling. PNs do not meet 
participants at their homes but at any safe location to conduct the intervention (e.g., private rooms in a 
library, clinic, or community outreach center). Meeting locations are coordinated between the 
participants and the PNs. PNs communicate with participants via text, phone call, and 
videoconferencing, based on the participant’s preference.  
The FHCSD HIV Services Program Manager will provide day-to-day supervision of the patient 
navigators and will meet with each navigator weekly and document successes and challenges to PN 
intervention implementation through a weekly written report. The study staff also provide weekly 
supervision and will rate patient navigators’ delivery of the intervention, via audio recordings, using an 
intervention fidelity monitoring form.  
Data Collection  
 
Survey and Interview Data Collection. Following informed consent, the research coordinator 
will administer self-report baseline surveys using Qualtrics in-person in the participant’s preferred 
language of Spanish or English, assess time required to complete surveys, and note any participant 
difficulty in answering survey items. Participants will be asked to complete 3- and 6-month follow-up 
surveys using a mixed mode approach, consisting of an initial Qualtrics (online) survey followed by an 
emailed survey if the Qualtrics survey is not completed. At baseline, 3-month follow-up, and 6-month 
follow-up, participants will be asked to complete measures of PrEP knowledge, PrEP awareness, PrEP 
attitudes, PrEP barriers, PrEP efficacy beliefs, PrEP adherence, PrEP initiation, sexual behaviors, beliefs 
about medications, medication self-efficacy, mental health, substance use, and social support (see Table 
1 for information regarding study surveys, including evidence of their validity and reliability). Self-
report demographic information will be obtained at baseline. Self-report s     urveys assessing client 
satisfaction with PrEP-related healthcare services25 will be      administered at 3-month and 6-month 
follow-up. Those randomized to PN will complete a self-report survey assessing satisfaction with the 
interpersonal relationship with the patient navigator26 at 3-months and 6-months. In addition, all 
participants randomized to PN will be contacted by telephone at 6-months to complete a key informant 
telephone interview to assess acceptability of the intervention; these key informant interviews will be 
conducted by members of the assessment team and not by PNs.      
Measures were chosen following a literature review of existing validated instruments, and 
psychometrically validated instruments were chosen when possible. However, as PrEP was only recently 

5 
 
recommended for the prevention of HIV, there are few validated surveys measuring constructs related to 
PrEP. For these constructs, the team created new measures, adapting from existing scales when possible. 
Surveys not available in Spanish were translated using a dual panel approach.27-29 

6 
 
 
Table 1: Description and Timing of Surveys and Health Record Data Collection 
Construct 
Description of Measure 
Source 
BL 
3
m 
6
m 
6m 
EHR 
PrEP 
Knowledge 
16-item self-report measure of knowledge related to PrEP, 
including use and effectiveness. Data are collected using a Likert 
scale. 
Team 
developed  
X X X 
 
PreP 
Awareness 
One survey question assessing awareness of PrEP Categorical 
data are collected.  
 
Team 
developed  
X X X 
 
PrEP 
Adherence 
2-item self-report survey assessing ability to take PrEP over the 
past 7 days, and frequency (%) with which PrEP was taken over 
the past 7 days. Data are collected using a Likert scale. 
Team 
developed  
X X X 
 
PrEP Attitudes 
10-item PrEP Stigma and Positive Attitudes Measure assessing 
personal opinions about PrEP and people who use PrEP; 16 
additional items assessing general attitudes and beliefs about 
PrEP use, provider comfort and medical mistrust related to PrEP 
use, side-effect concerns about PrEP use, disclosure concerns 
and social norms related to PrEP use, and sexual risk concerns 
about PrEP use. Data are collected using a Likert scale. 
Mustanski et 
al., 2018; 
Pulsipher et al., 
2016 
X X X 
 
PrEP Barriers 
5 survey items related to concerns about PrEP use, efficacy, and 
stigma; 5 additional items assessing potential access barriers to 
obtaining PrEP, including lack of health insurance coverage, 
difficulty finding a provider, and cost of PrEP. Data are collected 
using a Likert scale. 
Golub et al., 
2012; Pulsipher 
et al., 2016 
X X X 
 
PrEP Efficacy 
Beliefs 
2-item measure of beliefs regarding the efficacy of PrEP, Data 
are collected using a Likert scale. 
Pulsipher et al., 
2016 
X X X 
 
Medication 
Self-Efficacy 
4 items assessing self-efficacy to adhere to PrEP; adapted for 
PreP use from the Self-Efficacy for Appropriate Medication Use 
Scale (SEAMS). Data are collected using a Likert scale.  
Adapted from 
Risser, 
Jacobson, & 
Kripalani, 2007 
X X X 
 
Beliefs about 
Medicines  
Items from the Beliefs about Medicines Questionnaire (BMQ), 
including the BMQ-Specific subscale, a 10-item scale assessing 
representations of medications, and the BMC-General subscale, 
an 8-item subscale assessing beliefs about medicines. Data are 
collected using a Likert scale.  
Horne, 
Weinman, & 
Hankins, 1999 
X X X 
 
Sexual 
Behaviors  
3 items measuring over the past 3 months the total number of 
male anal sex partners, number of partners in which condoms 
were not used exclusively, and the HIV status of partners.  Data 
are collected using numeric text entries.   
 
X X X 
 
Mental health  
21 item Depression, Anxiety, Stress Scale (DASS-21) measuring 
depression, anxiety, and stress over the past week.  Data are 
collected using a Likert scale. 
Lovibond & 
Lovibond, 1995 X X X 
 
Substance use 
15 items measuring drug, alcohol, and tobacco use over the past 
month. Data are collected using a Likert scale. 
Team 
developed  
X X X 
 
Social support  
8-item PROMIS Informational and 7-item Emotional Support 
Scales, respectively, measuring perceived sources of support 
over the past month. Data are collected using a Likert scale. 
Hahn et al., 
2014 
X X X 
 
Patient 
Satisfaction 
with PrEP-
related services 
8-item Client Satisfaction Questionnaire (CSQ-8) measuring of 
satisfaction with PrEP-related health care services received Data 
are collected using a Likert scale.  
Attkisson & 
Greenfield, 
2004  
 
X X 
 
Satisfaction 
with 
Interpersonal 
For participants randomized to PN intervention only; 9-item 
measure of satisfaction with care provided by a patient 
navigator. Data are collected using a Likert scale. 
Jean-Pierre et 
al., 2012  
 
 
X X 
 

7 
 
Relationship 
with Navigator  
 
PN Intervention 
Acceptability 
For participants randomized to PN, brief telephone key 
informant interview assessing acceptability of the PN 
intervention. Data are qualitative.  
Team 
developed 
 
 
X 
 
PrEP Initiation 
Up to 10 survey items assessing whether patient had received a 
prescription for PrEP, decided to fill a PrEP prescription, and 
taken at least one dose of PrEP since the start of the study. 
Categorical data are collected.  
Team 
developed  
X X X 
 
Demographic 
Characteristics 
Demographic items (e.g., age, race, gender, sexual orientation, 
relationship status, country of origin, U.S. citizen status, primary 
language, education level, employment status, income, health 
insurance status) have categorical response options. Age data are 
collected with numeric text entry. 
 
X 
 
 
 
Medical 
Characteristics  
Comorbid medical conditions, medications prescribed, history of 
STI testing 
 
 
 
 
X 
PrEP-Related 
Health Care 
Received 
Date(s) appointment scheduled for PrEP consultation; Date 
attended appointment for PrEP consultation; Date(s) health care 
provider wrote PrEP prescription(s); Date the first follow-up 
PrEP appointment(s) scheduled; Date(s) of follow-up medical 
appointment attended; Data recorded in EHR regarding 
adherence and discontinuation; other data regarding PrEP-related 
health care  
Team 
developed 
 
 
 
X 
Abbreviations: BL = baseline; 3m = 3 month follow/up appointment; 6m = 6 month follow-up appointment; EHR = 
electronic health record; STI= sexually transmitted infection; PN = patient navigation 
 
 
MEMS Device Data Collection. At baseline and 3-month follow-up, all participants will 
be asked if they have obtained a prescription for PrEP. Those who indicate that they have been 
prescribed PrEP and have taken at least one pill will be asked to track their PrEP adherence via a 
Medication Event Monitoring System (MEMS) device.30 A MEMS device is a standard 
prescription bottle that includes a larger lid containing a MEMS monitoring cap. During the 
baseline or at a 3-month follow-up visit, the research coordinator will give participants a MEMS 
device with instructions for its use. Participants will be instructed to place all PrEP pills into a 
MEMS container so when a pill is removed, the device will record date and time of removal of 
the medication dose using a small microcircuit. A medication “event” is removal of bottle 
closure, followed by replacement of closure. A study staff member will collect MEMS devices 
from participants in-person at the 3- and/or 6- month follow-up and connect them to a MEMS® 
Reader, which transfers data to a secured server via a secured web platform. Timing adherence 
will be calculated as percentage of time each participant took PrEP as prescribed by determining 
number of doses of PrEP taken at 24-hour intervals for a once daily PrEP regimen and dividing it 
by number of days adherence was monitored with MEMS.  
 
Medical Record Data Collection. We will collect the following data from electronic 
health records (EHRs) 6 months following study enrollment after obtaining a written release of 
information: 1) date(s) initial appointment to speak to a health care provider regarding PrEP was 
scheduled; 2) date participant attended an initial appointment to discuss PrEP; 3) dates and 
number of prescriptions written for PrEP by a health care provider; 4) date the first follow-up 
visit related to PrEP was scheduled; and 5) dates the participant attended follow-up appointments 
related to PrEP. We will document EHR data regarding PrEP initiation and adherence, barriers to 
PrEP adherence, exams and laboratory tests required to obtain an initial or follow-up PrEP 

8 
 
prescription, side effects attributed to PrEP, diagnosis and treatment of illness during the study, 
prescription medications, comorbid health conditions, and history of STI testing. We will also 
note whether the EHR indicates that participants decided to cease taking PrEP and the date of 
discontinuation.  
PN Intervention Encounter Data. Using an approach developed by the Patient 
Navigation Research Program (PNRP),31 patient navigators will record process data related to the 
PN services provided, including: 1) number of encounters; 2) length of time of each encounter; 
3) barriers experienced by patients; and 4) actions taken to reduce barriers. The patient 
navigators will also be asked to keep detailed qualitative notes regarding telephone, text, and in-
person encounters with participants, including participants’ progress in the PrEP continuum, 
successes in implementing the PN intervention, and challenges in implementing the PN 
intervention. 
 
Feasibility Evaluation. A feasibility evaluation will examine areas critical to success of 
a larger research study. First, we will evaluate recruitment strategies by assessing the number of 
individuals eligible for the study, number with whom we could establish contact, number who 
agreed to participate or did not, reasons for non-participation and ineligibility, and difficulty with 
implementing the randomization process. Second, we will assess methods of data collection 
including participant time burden for completing baseline surveys, participant difficulty in 
answering survey questions, difficulty of using MEMS, reliability of surveys, number and types 
of missing survey data, timing of follow-up data collection, and rates of completion of follow-up 
surveys. Third, we will examine feasibility and processes of delivering the PN intervention by 
assessing the actions taken by the patient navigators and frequency and type of encounters. Data 
will be examined descriptively to identify areas for improvement of the study or PN intervention 
methods before a larger research study is initiated.  
 
Acceptability Evaluation. An extensive acceptability evaluation will examine how both 
individuals randomized to the PN intervention and those involved in implementing the program 
reacted to the intervention.32 Data will be collected for the acceptability evaluation using 
multiple quantitative and qualitative methods, including patient navigator encounter logs, patient 
navigator client notes, patient navigator supervisor notes, participant surveys, and participant key 
informant interviews. Quantitative acceptability data will be collected from pilot test participants 
at the 6-month follow-up using validated surveys assessing satisfaction with PrEP-related 
healthcare25 and Interpersonal Relationship with the Navigator,26 as well as from the patient 
navigators through the PN intervention encounter logs. Qualitative data will be collected from 
pilot test participants at the 6-month follow-up via 3 open-ended survey questions assessing the 
aspect of the PN intervention participants liked the best, the aspect of the PN intervention 
participants liked the least, and one thing that could be changed about the PN intervention25 as 
well as via a brief telephone key informant interview conducted by a trained bilingual research 
coordinator. The semi-structured key informant interviews will be conducted in the participant’s 
preferred language and will use a 28-item standardized interview guide designed using Sekhon et 
al.’s theoretical framework of acceptability.33 Interviews will last approximately 45 minutes and 
will be recorded, transcribed verbatim, and translated (if necessary) into English. In addition, 
both the patient navigators and the supervisor of the patient navigators will record observations 
regarding the implementation of the PN intervention, including success and challenges.  
Monitoring 
Consistent with NIMH requirements, a data monitoring committee is not required given this is 
not a phase III clinical trial and because of the low-risk nature of this exploratory study.  

9 
 
Statistical Analysis Plan 
 
Qualitative data. Qualitative data (key informant interviews, navigator qualitative notes, 
supervisor notes) will be saved in a text file to import into NVivo34 for analysis. The study PIs 
will review the qualitative data using a content analysis technique, which identifies emergent 
themes occurring during discussion. Code mapping35 will be used to develop a preliminary set of 
codes (themes) corresponding to each potential strength of the PN intervention as well as every 
potential aspect for improvement. Then, the co-PIs will independently code the remaining data 
and meet to discuss and achieve consensus in coding. Once coded, the data will be summarized 
by theme. These data will be used to modify the PN intervention, if necessary, or will provide 
further indication that the PN intervention should be tested in a larger scale study. 
Quantitative data.  All quantitative data will be summarized descriptively to determine 
aspects of the PN intervention that worked well and potential areas of improvement of the PN 
intervention. Our biostatistician will be blinded to intervention assignment for participants and 
will conduct statistical analyses using SAS 9.4.36 Univariate statistics will be conducted for 
outcomes measured at baseline and 6-month follow-up to describe sample characteristics 
between the two groups (UC versus PN). Attrition in the two groups will be compared. 
Characteristics of individuals with missing values and individuals with no missing values will be 
studied. Multiple imputation technique will be implemented and sensitivity analysis will be 
conducted to assess if missing data is at random. Assumptions of statistical tests will be 
evaluated. For assessing preliminary impact, the primary outcomes are seven behaviors 
associated with the PrEP care continuum (i.e., appointment scheduled for PrEP consultation; 
appointment attended for PrEP consultation; PrEP prescription received; PrEP prescription filled; 
PrEP initiated; self-reported PrEP adherence over the past seven days; and PrEP follow-up 
medical appointment attended).  
 
To test the preliminary impact of the intervention, a series of logistic regression models 
will be conducted, with each of the 6 binary PrEP continuum primary outcome variables set as a 
criterion: 1) appointment scheduled for PrEP consultation; 2) appointment attended for PrEP 
consultation; 3) PrEP prescription received; 4) PrEP prescription filled; 5) PrEP initiated; and 6) 
PrEP follow-up medical appointment attended. In addition, we hypothesize that receipt of the PN 
intervention will be associated with increased self-reported PrEP adherence over the past seven 
days (also a primary outcome variable). To test the preliminary impact on the two measures of 
self-reported PrEP adherence, we will conduct two linear regression analyses with intervention 
group assignment entered as the independent variable and each measure of PrEP adherence 
entered as the dependent variable. Potential demographic variables (e.g., age) will be assessed 
for inclusion in the models as well. Finally, linear mixed models will be conducted to examine 
changes in 1) barriers to PrEP-related care; 2) PrEP knowledge, 3) PrEP efficacy beliefs; 4) 
medication beliefs, 5) PrEP attitudes; and 6) medication self-efficacy. Linear mixed models 
allow us to account for the dependence of the repeated measures. Different covariance structures 
will be implemented and the information criterion such as AIC or BIC will be used for model 
selection. We hypothesize that participants randomized to PN will have greater engagement in 
PrEP continuum behaviors compared to participants randomized to UC. Since data analyses are 
exploratory, and there is not adequate statistical power to evaluate efficacy of the PN 
intervention, these tests can only provide information regarding data trends and effect sizes. If 
the study and PN intervention methods are found to be feasible and acceptable, a larger study 
with adequate statistical power will be conducted to appropriately evaluate the efficacy of the PN 
intervention.  

10 
 
References 
1. Healthy People 2020. 2020 Topics and Objectives: HIV 2016 [updated January 5, 2017. 
Available from: https://www.healthypeople.gov/2020/topics-
objectives/topic/hiv/objectives accessed January 5, 2017. 
2. AIDS.gov. National HIV/AIDS Strategy: Overview  [cited 2017 January 5]. Available from: 
www.aids.gov/federal-resources/national-hiv-aids-strategy/overview/ accessed January 5, 
2017. 
3. Centers for Disease Control and Prevention. HIV and Gay and Bisexual Men 2018 [Available 
from: www.cdc.gov/hiv/pdf/group/msm/cdc-hiv-msm.pdf accessed February 2, 2019. 
4. Smith DK, Van Handel M, Wolitski RJ, et al. Vital signs: Estimated percentages and numbers 
of adults with indications for preexposure prophylaxis to prevent HIV acquisition--United 
States, 2015. MMWR Morb Mortal Wkly Rep 2015;64(46):1291-5. doi: 
10.15585/mmwr.mm6446a4 [published Online First: 2015/11/26] 
5. Centers for Disease Control and Prevention. Diagnoses of HIV infection in the United States 
and dependent areas, 2014. HIV Surveillance Report 2015;26:1-123. 
6. 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):151ra25-51ra25. doi: 10.1126/scitranslmed.3004006 
7. Pulsipher CA MJ, Plant A, Curtis P, Holloway IW, Leibowitz AA. Addressing PrEP 
dispartities among young gay and bisexual Men in California: California HIV/AIDS 
Research Program, 2016:41. 
8. Golub SA, Gamarel KE, Rendina HJ, et al. From efficacy to effectiveness: facilitators and 
barriers to PrEP acceptability and motivations for adherence among MSM and 
transgender women in New York City. AIDS Patient Care STDS 2013;27(4):248-54. doi: 
10.1089/apc.2012.0419. 
9. Bauermeister JA, Meanley S, Pingel E, et al. PrEP awareness and perceived barriers among 
single young men who have sex with men in the United States. Curr HIV Res 
2013;11(7):520. doi: 10.2174/1570162x12666140129100411 
10. Ayala G, Makofane K, Santos G-M, et al. Access to basic HIV-related services and PrEP 
acceptability among men who have sex with men worldwide: barriers, facilitators, and 
implications for combination prevention. J Sex Transm Dis 2013;2013 doi: 
10.1155/2013/953123 
11. Kimball D, Rivera D, Gonzales M, et al. Medical Mistrust and the PrEP Cascade Among 
Latino Sexual Minority Men. AIDS and behavior 2020 
12. Rivera DB, Brady JP, Blashill AJ. Traditional Machismo, Caballerismo, and the Pre-
Exposure Prophylaxis (PrEP) Cascade Among a Sample of Latino Sexual Minority Men. 
The Journal of Sex Research 2020:1-8. 
13. The spectrum of engagement in HIV prevention: Proposal for a PrEP cascade. 7th 
International conference on HIV treatment and prevention adherence; 2012; Miami 
Beach, Florida. 
14. Braschi CD, Sly JR, Singh S, et al. Increasing colonoscopy screening for Latino Americans 
through a patient navigation model: a randomized clinical trial. J Immigr Minor Health 
2014;16(5):934-40. doi: https://doi.org/10.1007/s10903-013-9848-y 

11 
 
15. Enard K, Nevarez L, Hernandez M, et al. Patient navigation to increase colorectal cancer 
screening among Latino Medicare enrollees: A randomized controlled trial. Cancer 
Causes Control 2015;26(9):1351-59. doi: 10.1007/s10552-015-0620-6. 
16. Wilson FA, Villarreal R, Stimpson JP, et al. Cost-effectiveness analysis of a colonoscopy 
screening navigator program designed for Hispanic men. J Cancer Educ 2015;30(2):260-
67. doi: 10.1007/s13187-014-0718-7. 
17. Family Health Centers of San Diego. Welcome to gay men's health service 2015 [Available 
from: gaymenshealth.org/ accessed February 11, 2019. 
18. Whitehead AL, Julious SA, Cooper CL, et al. Estimating the sample size for a pilot 
randomised trial to minimise the overall trial sample size for the external pilot and main 
trial for a continuous outcome variable. Stat Methods Med Res 2015;25(3):1057-73. doi: 
10.1177/0962280215588241 
19. United States Census Bureau. QuickFacts: San Diego County, California; California 2019 
[Available from: 
https://www.census.gov/quickfacts/fact/table/sandiegocountycalifornia,ca/PST045218 
accessed April 13, 2019. 
20. Newport F, Gates G. San Francisco Metro Area Ranks Highest in LGBT Percentage 2015 
[Available from: http://www.gallup.com/poll/182051/san-francisco-metro-area-ranks-
highest-lgbt-percentage.aspx accessed June 1 2016. 
21. US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the 
United States-2014: A Clinical Practice Guideline 2014 [cited 2014. Available from: 
www.cdc.gov/hiv/pdf/prepguidelines2014.pdf accessed January 5 2017. 
22. Randomizer for Clinical Trial [program]. Fontenay Sous Bois, France: Medsharing, Inc., 
2016. 
23. Bartholomew LK, Parcel GS, Kok G, et al. Planning health promotion programs: An 
intervention mapping approach. Third ed. San Francisco, California: Jossey-Bass 2011. 
24. Calhoun EA, Whitley EM, Esparza A, et al. A national patient navigator training program. 
Health Promot Pract 2008 doi: 1524839908323521 [pii] 
10.1177/1524839908323521 [published Online First: 2009/01/01] 
25. Attkisson CC, Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client 
Satisfaction Questionnaire-8. In: Maruish ME, ed. The use of psychological testing for 
treatment planning and outcomes assessment. 3rd ed. Mahwah, New Jersey: Lawrence 
Erlbaum Associates 2004. 
26. Jean-Pierre P, Fiscella K, Winters PC, et al. Psychometric development and reliability 
analysis of a patient satisfaction with interpersonal relationship with navigator measure: 
A multi-site patient navigation research program study. Psychooncology 2012;21(9):986-
92. doi: 10.1002/pon.2002 
27. McKenna SP, Doward LC. The Translation and Cultural Adaptation of Patient-Reported 
Outcome Measures. Value Health 2005;8(2):89-91. doi: 10.1111/j.1524-
4733.2005.08203.x 
28. Swaine-Verdier A, Doward LC, Hagell P, et al. Adapting quality of life instruments. Value 
Health 2004;7:S27-S30. doi: https://doi.org/10.1111/j.1524-4733.2004.7s107.x 
29. Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of 
questionnaires could not bring out a consensus. J Clin Epidemiol 2015;68(4):435-41. doi: 
https://doi.org/10.1016/j.jclinepi.2014.11.021 

12 
 
30. AARDEX. MEMS® 2010 [Available from: 
http://www.aardexgroup.com/aardex_index.php?group=aardex accessed September 15 
2010. 
31. Katz ML, Young GS, Reiter PL, et al. Barriers reported among patients with breast and 
cervical abnormalities in the patient navigation research program: Impact on timely care. 
Womens Health Issues 2014;24(1):e155-62. doi: 10.1016/j.whi.2013.10.010 
32. Bowen DJ, Kreuter M, Spring B, et al. How we design feasibility studies. Am J Prev Med 
2009;36(5):452-57. doi: 10.1016/j.amepre.2009.02.002. 
33. Sekhon M, Cartwright M, Francis JJ. Acceptability of health care interventions: A theoretical 
framework and proposed research agenda: Wiley Online Library, 2018. 
34. NViVo 10 For Windows [program]: QSR International, 2014. 
35. Knodel J. The design and analysis of focus group studies: A practical approach. Successful 
focus groups: Advancing the state of the art. London: Sage Publications 1993:35-50. 
36. SAS software version 9.4 [program]. Cary, NC: SAS Institute, 2013. 
37. 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):2587-99. doi: 
10.1056/NEJMoa1011205