Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs
Conditions: HIV/AIDS
Sponsor: Drexel University

1. PROTOCOL TITLE: Packaging PrEP to Prevent HIV Transmission among Women who Inject Drugs 
(WWID) 
2. IRB REVIEW HISTORY: Approved 4/25/17; Modification 7 approved 07/06/2018 
3. OBJECTIVES/AIMS: This study will address the following objectives or specific aims:  
Aim 1: To describe WWID’s engagement in the PrEP care continuum. Using data from baseline and exit 
(N=200), we will quantify participant engagement including: (1) attending initial clinical appointment; (2) 
enrolling in health insurance or medication assistance programs for uninsured participants; (3) accepting a 
PrEP prescription; (4) filling the PrEP prescription; (5) adhering to PrEP, and (6) returning for follow-up care. 
These activities represent critical moments when women could disengage or need additional support to 
remain in care.  
 
Aim 2: To assess the impact of predisposing, enabling, and need-related factors on WWID’s 
engagement in the PrEP care continuum. We will test for associations between Behavioral Model for 
Vulnerable Populations (BMVP) factors and stage of engagement.  
 
Aim 3: To explore how and why model factors are associated with WWID’s decisions and ability to 
engage in PrEP care. A subset of WWID representing those who never initiated PrEP (n=15), those who 
initiate but disengage (n=15), and those who adhere/return for 3 months (n=15) will complete an in-depth 
qualitative interview that explores individual and structural facilitators and barriers that support or hinder 
engagement. Interviews will draw on quantitative findings and provide contextual accounts of how factors 
operate, potential modification of service delivery and targets for behavioral interventions to support 
engagement.  
 
Aim 4. To describe sexual behavior and incident STI among WWID. Using data from baseline, follow-
up and exit (N=200), we will describe sexual risk behavior and acquisition of incident infections of syphilis, 
gonorrhea, chlamydia, and trichomoniasis among WWID. We will test for differences in risk/STI between 
those who initiated PrEP and those who did not. 
 
4. BACKGROUND: Pre-exposure prophylaxis (PrEP) is a promising bio-medical HIV prevention strategy that 
involves the use of antiretroviral medications by HIV negative individuals to reduce their risk of acquiring HIV. 
In 2013, the Centers for Disease Control and Prevention (CDC) recommended emtricitabine/tenofovir 
disoproxil fumarate (FTC/TDF) as PrEP for people who inject drugs (PWID).1 However, research and programs 
to bring PrEP to scale have yet to focus on this group. Therefore, little knowledge exists to help address PrEP 
implementation challenges among PWID. Research is necessary to identify strategies that successfully 
promote engagement in PrEP care among at-risk PWID. The proposed study will address these gaps. 
Compared to men, women who inject drugs (WWID) are less likely to control drug preparation practices and 
more likely to share syringes, have a sex partner who also injects drugs, and to be injected by their partners.2-5 
They are also more likely to report risky sexual behavior. In our recent study 1:4 WWID tested positive for 
chlamydia or gonnorhea.6 This is 4-fold the rate for men and likely corresponds to the statistically greater 
proportion of women reporting recent transactional sex, higher numbers of sex partners, and inconsistent 
condom use.6 Research indicates that STI can be considered a biologic marker for imminent HIV infection.7,8 
These data suggest no single intervention strategy will eliminate HIV among WWID because they are at an 
intersection of three types of risks – those associated with drug use, those associated with high-risk sexual 
behavior, and those associated with belonging to high-prevalence networks. It also suggests the WWID should 
be prioritized for initial strategies to implement PrEP for PWID as a complement to existing interventions known 
to reduce HIV risk such as syringe exchange.  
One concern regarding PrEP is that many WWID face a number of challenges to accessing medical care, 
including a lack of engagement in primary care, transiency, and opioid dependence.9 Our research indicates 
they will face similar challenges to accessing PrEP.10 Therefore, alternative care approaches based outside of 
traditional clinical settings are needed to increase the individual and public health benefits of PrEP. Syringe 
exchange programs (SEPs) are well integrated within this community and may be uniquely qualified to “seek, 
test, prevent and retain” WWID in PrEP services. Our rationale for this approach is that (1) SEPs may currently 
provide prescription medications and long-term monitoring for other conditions such as buprenorphine for 
opioid dependence, so PrEP is a natural extension of what is already being done with great success, (2) SEPs 

are a viable access point for many HIV-uninfected WWID who would be considered eligible for PrEP under 
current clinical guidelines, and (3) PrEP interventions, delivered in settings already utilized by WWID, will 
increase uptake, adherence and retention in PrEP (hereafter called engagement in the PrEP care continuum).  
5. INCLUSION AND EXCLUSION CRITERIA 
 
Inclusion criteria are:  
1. Age of 18 years or older;  
2. ability to speak and read in English; 
3. engagement in high-risk behavior within 30 days including non-prescription injection drug use;  
4. engagement in at least one of the following in the last 6 months: sex exchange, inconsistent condom use 
with partners who are HIV+, MSM, or IDU, bacterial STI, syringe sharing, or recent opioid agonist treatment;  
5. HIV seronegative (documented with test results dated within 2 weeks) 
6. not currently taking Truvada/PrEP; 
7. able to understand informed consent documents; and  
8. willing to provide informed consent.  
 
Exclusion criteria are: 
1. HIV seropositivity;  
2. pregnancy, breastfeeding or intention to become pregnant within 3 months; 
3. currently taking PrEP 
4. previous participation in the study. 
 
☐    Adults unable to consent 
☐    Individuals who are not yet adults (infants, children, teenagers) 
☐ Pregnant women 
☐    Prisoners 
☒    Not Applicable 
 
 
6. STUDY-WIDE NUMBER OF PARTICIPANTS 
N = 200 
 
7. STUDY-WIDE RECRUITMENT METHODS 
Recruitment materials that include study purpose, methods, and research team contact information (see study 
flyer) will be placed in public spaces at PPP, their outreach vans and within the harm reduction packets 
distributed via the secondary exchange (in which those accessing the SEP take harm reduction supplies to 
individuals in their social and sexual networks). To screen potential participants for eligibility we will meet with 
them face-to-face in a private space at PPP or speak to them by phone and complete a brief screening 
assessment (see Appendix 1 for Eligibility Screener). These recruitment and screening procedures will be 
similar to those used by Dr. Roth in other studies conducted at PPP.  
 
Based on our pilot data and the characteristics of the target population served by PPP, we anticipate 
approximately 15% of women who are interested in participating will be ineligible based on their risk profile or 
HIV status. Thus, we anticipate screening approximately 250 women to reach our final sample of 200. While 
this may seem like a large N of a WWID, a very hidden population, our community partner Prevention Point 
Philadelphia (PPP) is the largest harm reduction agency in the mid-Atlantic. Through their main building and 
mobile outreach, PPP served approximately 5,700 unduplicated clients in 2015; approximately 20% were 
women and 10% were living with HIV. In 2015, PPP clients reported accessing supplies for an additional 
48,000 PWID via the secondary exchange. Therefore, we anticipate few challenges engaging with 250 WWID 
in order to enroll our final sample. 
 
8. STUDY TIMELINES 

To achieve study objectives/aims, Dr. Roth will hold weekly research meetings with project staff, discuss the 
project on a monthly basis with co-investigators, and on a quarterly basis with consultants/collaborators and 
the CAB. The study timeline is: 0 to 2 months: hire and train staff, assemble CAB and obtain IRB approval. 3 to 
6 months: pilot instruments; revise instruments based on pilot testing, initiate recruitment and data collection. 7 
to 21 months: continue enrollment and follow-up; begin analysis. 22 to 36 months: prepare and clean data; 
continue analysis; present at scientific meetings; publish manuscripts; develop application for an intervention to 
overcome mechanisms for non-initiation or suboptimal adherence based on findings that will be evaluated in a 
R34/R01 controlled trial.  
 
• 
The duration of an individual subject’s participation in the study is approximately 7 months. 
• 
The duration anticipated to enroll all study subjects is 21 months. 
• 
The estimated date for the investigative team to complete preliminary analysis for this study is 24 months. 
• 
The estimated duration for the majority of dissemination activities (publication, presentations, etc) is 36 
months. 
 
9. STUDY ENDPOINTS  
Our novel structural intervention of pairing PrEP and SEP services represents a new approach for the delivery 
of effective biomedical HIV prevention strategies. To our knowledge, this strategy has not been previously 
tested. One endpoint is to determine the acceptability and feasibility of this approach. Further, we will identify 
the populations of WWID who need additional intervention to fully engage in PrEP and the best strategies for 
supporting engagement. Findings will inform a tailored intervention, delivered within the SEP, to increase 
engagement at each stage. While this study will be set in Philadelphia, one metropolitan area, we believe the 
innovative approach of packaging STI/PrEP services in a community-based SEP will be replicable in other 
cities. The reproducibility of this study’s approach significantly increases this work’s potential impact to improve 
outcomes among PWID in other cities and settings. Thus, the long term-impact of this project will be a 
reduction in HIV incidence among WWID which aligns with national HIV prevention priorities. 
10. METHODS INVOLVED 
This will be a mixed-methods observational study. We will recruit 200 PrEP-eligible WWID from SEPs 
operating in Philadelphia and follow them over three months. At baseline (T0), participants will complete a 
survey based on our conceptual framework, undergo STI testing and relevant testing for PrEP medical 
monitoring, receive a brief educational intervention, undergo a clinical consultation, be offered PrEP, and 
scheduled for a STI results appointment. At follow-up approximately 7 days later (T1), we will provide STI 
results/treatment and participants will complete a brief survey. A subset of those declining the PrEP 
prescription will participate in a qualitative interview exploring this decision (n=15). At follow-up (T2) 
approximately 90 days after T1, participants will undergo STI testing complete a semi-structured interview 
based on our conceptual framework to explore individual and structural factors that support or hinder 
engagement in the PrEP continuum and those who initiated PrEP will receive relevant tests for medical 
monitoring. At follow-up approximately 7 days later, we will provide STI results/treatment. A subset those who 
initiate but disengage (n=15) and those who remain engaged for 3 months (n=15) will complete an in-depth 
qualitative interview exploring how and why individual and structural factors hinder or support engagement. At 
exit (T3) approximately 6 months after T1, participants will undergo STI testing and complete a semi-structured 
interview based on our conceptual framework to explore individual and structural factors that support or hinder 
engagement in the PrEP continuum. Those who initiated PrEP will receive relevant tests for medical 
monitoring. At follow-up approximately 7 days later, we will provide STI results/treatment. 
 
10.a Study Setting  
Our study will take place in PPP’s main building located in the Kensington neighborhood of Philadelphia at  
2913 Kensington Ave, Philadelphia, PA 19134. We will embed PrEP services within PPP’s existing clinical 
infrastructure that includes seven private patient rooms. As part of the informed consent and health 
authorization process, participants will agree to allow the study team to access their medical and case 
management records from PPP in order to obtain information relevant to the study, namely HIV and Hepatitis 
C test results and case management records regarding enrollment in health insurance (described in detail in 
10.b Study Procedures). 
10.b Study procedures  

10.b.i Informed Consent 
Prior to beginning the study, eligible participants will be given a consent form and asked to follow along while 
the interviewer reviews it with them. Included in the informed consent document are check boxes wherein the 
participant agrees to the study team accessing their PPP records. Staff will answer questions about the 
consent forms or research process. Before signing the consent, the interviewer will assess whether the 
individual comprehends the consent by asking 3 true/false questions such as “I will have the opportunity to be 
screened for sexually transmitted infections in my vagina, throat and rectum and if I test positive I will have 
access to free treatment at PPP.” “Through this study, I will learn about a new medication to prevent HIV.” “I 
can agree to participate and then change my mind at any time with no penalty.”) If any of the responses to 
these questions are incorrect, the consent form will be re-reviewed with the individual. The individual will be 
given 3 chances to answer the questions correctly. After 3 failures, the individual will be considered to be 
unable to give voluntary, informed consent. Each participant will receive a copy of the consent form to keep for 
their records.  
 
10.b.ii Baseline (T0) & Initial PrEP Visit 
At T0 after providing informed consent, participants will be assigned a unique study ID number, and complete 
participant tracking forms and HIV test release of information (Appendix 6 and Appendix 11). Client names 
linked to ID number will be in a separate locked file cabinet and only the PI (and project manager) will have 
access to this file. Participants will undergo venipuncture to collect blood for syphilis (RPR) and hepatitis B 
serologies and creatinine testing utilizing PPP’s staff and standard practice; participants with evidence of 
syphilis, active hepatitis B infection, or abnormal renal function will be referred for evaluation for treatment, and 
those with who are susceptible to hepatitis B will be referred for hepatitis B vaccination. Next, participants will 
self-obtain specimens (throat, urogenital, and rectal) for gonorrhea (GC), chlamydia (CT), trichomoniasis (TV; 
vaginal test only at baseline) screening as well as a urine sample for pregnancy testing. Self-collection 
instructions can be found in Appendix 10. Trained staff will provide verbal and written instructions regarding the 
self-sampling procedures and answer any questions related to this procedure. This procedure is acceptable 
to participants, is of minimal discomfort, has minimal safety risks (sample collection is considered 
non-invasive from a regulatory perspective), and provides reliable specimens. Women who test positive 
for pregnancy will be withdrawn from the study and referred to their primary care provider (PCP). If women do 
not have a PCP we will work with them to establish care. Participants will then compete a quantitative baseline 
assessment (QBA). The QBA will be scripted using Qualtrics software, pre-tested, and administered face-to-
face on an iPad and will take approximately 60 minutes to administer. The QBA is available in Appendix 9. 
Finally, staff will conduct a brief educational intervention (~10 minutes) about PrEP. We will start the 
educational session with a video https://www.youtube.com/watch?v=ueKrjO6rAyE developed by Dr. Rivet 
Amico (co-investigator). The video includes PrEP-related information such as clinical indications for PrEP, a 
description of the medication and common side effects, need for adherence and ongoing clinical monitoring, 
how to pay for PrEP. We will also provide participants with PrEP educational materials tailored for WWID that 
are adapted from the CDC’s PrEP information sheet (see Appendix 2).11 We will then assess participant’s 
insurance status and will help participants obtain health insurance coverage by working with PPP case 
manager to facilitate enrollment into Medicaid or prescription assistance from Gilead. Participants in need of 
health insurance will be asked to sign of release of information for PPP so that we verify if they were signed up 
for insurance (Appendix 11). Next, the  clinical provider (CP) who will be either currently licensed medical 
doctor, nurse practitioner or physician’s assistant, will meet with participants to discuss any of the patients’ 
remaining questions or concerns about PrEP. She will obtain a medical history, provide counseling on PrEP, 
contraception and HIV risk-reduction as recommended by the CDC, and asses participant interest in PrEP. All 
participants will receive the PrEP Resource Guide (Appendix 12) which has information on the hours of 
operation for neighborhood pharmacies where they can fill their prescription, locations for local STI clinics and 
social service providers offering women-specific services, and some basic information on HIV transmission.  
Participants will receive $40 for this visit. 
 
 
10.b.iii Follow-Up (T1): STI Results  
At this visit, the CP will provide participants with test results. Those screening positive for RPR, CT or GC will 
receive or be referred for no-cost treatment. Finally, we will review participant contact information and schedule 
participants for their second follow-up appointment and participants will receive $20 for this visit.  
 

At this visit, we will recruit a purposive sample of 15 WWID who declined the PrEP prescription. Recruitment 
will be done so that we elicit diverse reasons for refusal. Questions will focus on key domains from the BMVP 
such as how perceived HIV susceptibility and attitudes toward PrEP impacted this decision. A draft of the 
interview questions for those who decline a PrEP prescription is in Appendix 4. This subset of participants will 
receive $20 for completing the qualitative interview.  
10.b.iv Provision of Prescriptions 
Any insured participant who is interested in PrEP or birth control will be given 2 options for obtaining their 
prescriptions (should baseline tests indicate they are clinically eligible for PrEP per the CDC guidelines—
Creatinine clearance >60mL/Min): 1) the study team will fax prescriptions to Philadelphia Pharmacy who will 
deliver the PrEP prescription to Prevention Point Philadelphia (Appendices 17, 18) or 2) a paper prescription 
that the participant will be given so that they may fill it at the pharmacy of their choice. Given the opioid crises 
in Philadelphia and its impact on study participants, we will also offer a prescription for Naloxone, a medication 
that rapidly reverses the effects of an opioid overdose which is safe, recommended for use in this population 
by the CDC, and has been in use in hospitals and ambulances since 1979. Participants will also have the 
option to receive refills for their prescriptions at PPP. Participants preferring the study team fax the prescription 
will complete the prescription authorization and release of information form (Appendix 17). Participants who 
prefer the paper prescription will complete the pharmacy release of information (Appendix 14).   
10.b.v PrEP Check In: For only those who accepted a PrEP prescription If participants choose to take a 
prescription for PrEP, we will schedule them for a check in visit to assess tolerance and adherence for 
approximately two weeks after T1. The “check in” assessment is in Appendix 13. Participants will receive $5 for 
this visit. 
10.b.vi Follow-Up Visit (T2)  
T2 will occur approximately 3 months after T1. Participants will self-obtain specimens (throat, urogenital, and 
rectal) to monitor incident gonorrhea (GC) and chlamydia (CT). Participants will also provide urine and blood 
specimen to monitor PrEP adherence,79-81 creatinine levels, syphilis, pregnancy, and HIV (provided by PPP per 
their standard of care). PrEP adherence, creatinine levels, and pregnancy testing will only be performed for 
women taking PrEP. Participants will complete a semi-structured interview to explore psycho-social factors 
associated with HIV/STI risk, and engagement across key transition points in the PrEP care continuum 
including (1) attending initial clinical appointment; (2) enrolling in health insurance or medication assistance 
programs for uninsured participants; (3) accepting a PrEP prescription; (4) filling the PrEP prescription; (5) 
adhering to PrEP using a validated three-item self-report measure for anti-retroviral therapy adherence in the 
last 30 days, modified for PrEP adherence;12 (6) and returning for follow-up care. These activities represent 
critical moments when women could disengage or need additional support to remain in care. If participants 
disengage in care at any point in the PrEP continuum, we will ask about the factors motivating this decision. 
Then, we will assess the acceptability of receiving PrEP care at the SEP, intention to remain engaged in PrEP 
care, and the factors motivating them to do so (or drop out of care). A draft of the semi-structured interview is 
in Appendix 3. Participants will receive $25 for this visit. Any participant needing clinical follow-up after T2 will 
be scheduled with the CP outside of study hours. Women who test positive for pregnancy will not be eligible for 
follow-up PrEP care at PPP. They will be referred to their primary care provider (PCP). If women do not have a 
PCP we will work with them to establish care.  
We will also recruit a purposive sample of WWID who initiate but disengage (n=15) and WWID who 
adhere/remain engaged in PrEP for 3 months (n=15) to participate in an in-depth qualitative interview. 
Recruitment will be done so that we elicit diversity in opinions, challenges, and successful strategies to 
engagement. Interviews will elicit previously unmeasured but critical factors impacting women’s decisions and 
will also explore individual and structural facilitators and barriers that hinder or support engagement at each 
stage of the care continuum drawing from the BMVP. A preliminary draft of the in-depth interview is in 
Appendix 5. This subset of participants will receive $20 for participating in the qualitative interview. 
10.b.vii T2 Follow Up For STI Results  
At follow-up approximately 7 days later, we will provide STI results/treatment. Participants will receive $5 for 
this visit.  
10.b.viii Follow-Up Visit (T3) 
T3 will occur approximately 3 months after T2. Participants will self-obtain specimens (throat, urogenital, and 
rectal) to monitor incident gonorrhea (GC) and chlamydia (CT). Participants will also provide blood specimen to 

monitor creatinine levels (if someone is taking PrEP only), syphilis and HIV (provided by PPP per their 
standard of care). Urine specimen will be collected to monitor pregnancy for women taking PrEP. They will also 
sign a release of information (Appendix 14) to allow us to contact the pharmacy where they report filling their 
PrEP prescription to verify fill dates. Participants will complete a semi-structured interview to explore psycho-
social factors associated with HIV/STI risk and engagement across key transition points in the PrEP care 
continuum. If participants disengage in care at any point in the PrEP continuum, we will ask about the factors 
motivating this decision. Then, we will assess the acceptability of receiving PrEP care at the SEP, intention to 
remain engaged in PrEP care, and the factors motivating them to do so (or drop out of care). A draft of the 
semi-structured interview is in Appendix 15.  Participants will receive $35 for this visit. Any participant needing 
clinical follow-up after T3 will be scheduled with the CP outside of study hours. Women who test positive for 
pregnancy will not be eligible for follow-up PrEP care at PPP. They will be referred to their primary care 
provider (PCP). If women do not have a PCP we will work with them to establish care. 
We will also recruit a purposive sample of WWID who initiate but disengage (n=15) and WWID who 
adhere/remain engaged in PrEP for 6 months (n=15) to participate in an in-depth qualitative interview. 
Recruitment will be done so that we elicit diversity in opinions, challenges, and successful strategies to 
engagement. Interviews will elicit previously unmeasured but critical factors impacting women’s decisions and 
will also explore individual and structural facilitators and barriers that hinder or support engagement at each 
stage of the care continuum drawing from the BMVP. A preliminary draft of the in-depth interview is in 
Appendix 5. This subset of participants will receive $20 for participating in the qualitative interview. 
10.b.viv T3 Follow Up For STI Results  
At follow-up approximately 7 days later, we will provide STI results/treatment. Participants will receive $5 for 
this visit.  
 
10.d Continuity of Care for those who engage in PrEP 
Following the T3 (last) visit we will offer participants who want to remain in PrEP, standard care using the same 
clinical staff and facilities for the duration of the study. At study conclusion, we will facilitate transfer of clinical 
care to an appropriate medical provider. We have developed a list of local PrEP providers who have expressed 
willingness to work with our population (see Appendix 7). Referral will include provision of the provider list and 
help with scheduling their first clinical appointment for those expressing this need.  
10.e Retention 
To decrease attrition, we will develop a tracking protocol to ensure multiple points of contact with participants. 
Using their preferred mode of contact, we will remind participants of study visits and follow up with those who 
“no show.” For each “no show,” we will follow up twice weekly for 3 weeks. Any participant failing to contact 
staff within 3 weeks will be considered lost to follow up. However, they will not be withdrawn from the study. 
Using these procedures, we anticipate >85% retention.  
10.f Laboratory Tests   
Philadelphia Department of Health will perform STI testing using the AC2 CT/GC assay on the Hologic Tigris 
platform, Hepatitis B testing will be performed on the Abbott Architect and creatinine testing will be performed 
on the Beckman Coulter DXC. Positive test results will be reported to disease control agencies per local 
regulations. This process is outlined in the informed consent. Philadelphia FIGHT will perform drug-level 
monitoring using a semi-quantitative liquid chromatography-tandem mass spectrometry urine assay with high 
sensitivity and specificity to monitor TFV. Specimens will be processed and confidential results returned within 
7 days. Pregnancy tests will be performed by the CP using a rapid urine assay to detect human chorionic 
gonadotropin hormone. 
10.e Procedures to lessen the probability or magnitude of risk 
Free treatment for STI: Participants screening positive for STI will receive no cost treatment at their follow-up  
appointments T1, T2 and T3. Participants screening positive who fail to return for test results and appropriate 
treatment, will be referred to the Philadelphia Department of Health to arrange treatment. Participants will 
consent to PDH follow-up if they fail to obtain treatment from the study team during the informed consent 
process.  
 
Pregnancy: We will provide patients with contraceptive counseling and prescriptions as in the current standard 
of care for women on PrEP per CDC PrEP clinical guidelines. Women who test positive for pregnancy will be 

withdrawn from the study and referred to their primary care provider (PCP). If women do not have a PCP we 
will work with them to establish care. 
Medication adverse effects: There is minimal risk of harms associated with the use of daily FTC/TDF as PrEP 
by HIV-uninfected individuals. Medication intolerance during clinical trials included nausea, vomiting, 
abdominal pain, and diarrhea. These effects occurred in a minority of PWID (<20%) participating in the 
Bangkok Tenofovir Trial and most participants reported symptoms had resolved by the 2nd month. Of these 
side effects, only nausea and vomiting were statistically higher among PWID on Tenofovir than those taking 
the placebo. Tenofovir has been linked to renal impairment when used for HIV treatment, and a meta-analysis 
of 3 PrEP efficacy studies found that use of TDF/FTC was associated with small but statistically significant 
decreases in renal function. However, increased creatinine was observed in only 3% of patients in the Bangkok 
Tenofovir study, and other studies have found that changes in renal function with use of PrEP are reversible 
upon discontinuation of TDF/FTC13,14. To monitor for potential medication-related renal toxicity, we will 
measure creatinine levels at T1 and T2 (which will be scheduled over 3 months) as is recommended in the 
current CDC PrEP clinical guidelines and is considered standard of care. We will also follow-up with 
participants accepting a PrEP prescription approximately 2 weeks after T1. During that check-in we will assess 
for medication intolerances, assess adherence, and provide adherence counseling. Any participant with 
intolerances (i.e. that do not resolve by 2 months after use of PrEP) or any abnormal renal function testing will 
be scheduled with the CP. Those with any persistent intolerances or abnormal renal function will be referred to 
their primary care provider (PCP). If women do not have a PCP we will work with them to establish care.  
10.f Data Sources 
☒Medical Record/Chart Review 
☐Films/X-rays 
☐Computer/Database 
☐Hospital administrative/billing records 
☐Quality Improvement Records 
 
Other types of records please specify: 
Surveys and interview data. All instruments are included as appendices. 
Is data ONLY from the clinical department of the PI and sub-I’s?☐ Yes   ☒ No 
11. DATA AND SPECIMEN BANKING 
Not applicable. 
 
12. DATA MANAGEMENT 
12a. Data analysis plan 
Aim 1. Describe WWID’s engagement in the PrEP care continuum among WWID. We will use summary 
statistics (frequency and percent with associated error terms) to describe participant engagement across key 
transition points in the care continuum including: (1) returning for STI results at T1; (2) enrolling in health 
insurance or medication assistance programs for uninsured participants between T0 and T2; (3) accepting a 
PrEP prescription; (4) filling the PrEP prescription or providing authorization for the PrEP prescription to be 
filled between T0 and T2; (5) adhering to PrEP between T1 and T3;16 (6) and returning for follow-up care at T2 
and T3. Descriptive analyses will also be used to characterize adherence in terms of perfect defined as a dose 
of TFV within 48 hours (>1000 ng/mL), low adherence (>10 to >100 ng/mL), and non-adherence as defined by 
last dose more than one week prior (<10 ng/mL).79-81 We will also compare concordance of self-reported 
adherence to urinalysis. 
 
Aim 2. To assess the impact of predisposing, enabling, and need-related factors on WWID’s 
engagement in the PrEP care continuum. We will test the association between BMVP factors and WWID’s 
engagement at each stage outlined above using procedures that have been used previously to describe gaps 
in the PrEP care continuum for MSM.(9,14) Independent variables will represent each of the model’s domains 
including: predisposing factors, enabling factors, and need (drawn from Table 1). In the case WWID do not 
populate each stage describe above we will collapse engagement into an ordered categorical variable similar 
to how we are approaching qualitative data. In this case, engagement would be treated as a 3-level variable: 
never initiated PrEP vs those who initiate but disengage vs those who remain engaged for 3 months. Inferential 
statistics will be used to identify associations between factors in the model and PrEP engagement. For 

continuous variables, such as age or number of sex partners, we will provide medians with associated 
interquartile ranges and utilize independent samples t-tests or Mann-Whitney U tests to identify differences in 
medians between women who do or do engage at each stage. For categorical and binary variables, such as 
race/ethnicity or insured (yes/no), χ2 tests will be used to detect differences in factors that may be associated 
with PrEP engagement. Assessing the factors impacting engagement is critical for the design of intervention 
strategies, as different populations of WWID may need different cues to action or support in order to engage at 
each stage. These analyses will inform future study designs and sample size. 
 
Aim 3. To explore how and why model factors are associated with WWID’s decisions and ability to 
engage in PrEP care. One of the objectives of this study is to determine the relative importance of factors that 
are facilitators or barriers to PrEP engagement. This will be done using content analysis of qualitative data. To 
do this, we will explore the relative impact of predisposing, enabling, and need-related factors on PrEP 
continuum engagement. Interviews will draw on the quantitative findings and provide contextual accounts for 
how these factors impact decisions about and ability to engage in PrEP care. Data from WWID who never 
initiated PrEP, those who initiate but disengage, and those who adhere/engage for 3 and for 6 months will be 
analyzed separately and then compared/contrasted. To create a coding framework for analyzing interview data 
we will use an iterative process. First, a priori “structured codes” corresponding to the domains in the interview 
guide will be developed. Second, “emergent codes” that reflect unanticipated factors outside of our conceptual 
framework will be developed. Two analysts will code each transcript. Discrepancies in coding will be resolved 
by discussion until inter-rater reliability is >75%. Finally, we will triangulate data with quantitative assessments 
and member check findings with the CAB to increase the validity of the findings. Analyses will answer the 
following research questions (this list is not exhaustive): 1) What predisposing, enabling, and need-related 
factors influence women’s decision to initiate (or decline) PrEP and how do they operate? 2) What contextual 
factors positively (and negatively) impact women’s ability to adhere to PrEP? 3) Are there differences in the 
narratives told within the subpopulations of women (i.e., those with STI, those engaging in transactional sex, or 
by primary vs secondary exchange clients)? 4) What features of a structural or behavioral intervention could 
assuage barriers to care and how would they need to operate? 5) What factors are associated with risk 
compensatory behavior among WWID who initiate PrEP? Our team has experience with similarly structured 
qualitative data to understand barriers/facilitators and patient preferences for sexual health care and is well 
equipped to conduct these analysis.17-19 
 
12b. Power analysis 
Not applicable as this is an exploratory study we are not testing hypotheses because there are few data from 
which we can draw to estimate PrEP initiation among WWID (which highlights the gap in knowledge regarding 
this vulnerable population). However, we selected a target sample of 200 women based on the following data: 
estimating numbers from our pilot data collected from this population in which 86% of WWID expressed a 
willingness to use PrEP. We conservatively estimate that approximately 50% of those expressing willingness to 
initiate PrEP will do so. We also estimate15% attrition at each study visit (based on previous experience with 
this population). Thus, we expect to have a final sample of approximately 122 WWID with 61 WWID in the 
PrEP initiation group and 61 in the declined group.  
12b.  Steps to be taken to secure data 
 
Surveys will be identified solely with a participant study ID number. Surveys will be completed in Qualtrics, an 
electronic survey platform available through Drexel One. In order to log into Qualtrics, users must provide a 
username and password. Further, the participants will complete surveys on a password protected laptop or 
tablet. Thus, these data are electronically secured. Access will be limited to only the study’s PI and study staff. 
Client names linked to ID number will be in a separate locked file cabinet and only the PI and Research 
Coordinator will have access to this file. 
 
Qualitative interviews will be identified using the same unique ID number that was assigned during the 
assessment.  We will not collect participants’ names or other identifying information.  The unique ID that was 
assigned to the QBA survey we will link the qualitative interview information with the quantitative data for 
analyses.   
The Qualitative Interviews will result in three pieces of information: 
1. The digital audio recording file 

2. A typed transcript of the digital recording 
3. Hand- or computer-written notes from the interview 
 
All of the information generated from the Qualitative Interview will be identified solely with the unique study ID 
number. Data generated from the Qualitative interviews will be maintained on password-protected Drexel 
University computer network server with access limited to only the study’s PI and research staff using the 
same procedures for data security and backup outlined above. 
 
Risks to subjects will be also minimized through staff ethics training, layered data security and by restricting 
access of sensitive information to staff members who have a specific need for the information.  
▪ 
Training: All study staff are trained in the ethical treatment of study subjects and subject data with 
special emphasis on maintaining confidentiality. 
▪ 
Data Security: All subjects will be assigned an identification number at the screening interview which 
will be used in place of names. All data files will be encrypted and password protected with passwords 
known only to the Principle Investigator and research staff.  
▪ 
Restricted Access:  Laptop computers will all be secured with password access and available only to 
study staff members. Laptops will be locked in cabinets in the secured study office when not in use.  
 
Identifying information on participants will be on the consent forms and tracking forms.  These forms will be 
kept in a locked filing cabinet in the PI or Research Coordinators office and will be separate from all other 
study-related data. Information from the tracking form and data relating to the management of participants will 
also be entered into and stored on the Drexel University College of Medicine secure, web-based solution 
designed to support data collection strategies for research studies — REDCap. The contact information will be 
stored in one study database separate from all other study-related data ((i.e., acceptance of a PrEP 
prescription, STI dx and related treatment, adherence call follow-up details) which will be identified with only 
the participant’s unique study ID. 
 
12c.  Procedures to control quality of collected data 
 
All staff will undergo extensive training on protocol. We will develop a checklist for each study visit to ensure 
consistency in data collection. The checklists (see Appendix 8) will detail the order of the appointment, forms to 
be completed, and specimen to be collected. Training will also included role-playing and mock interviewing. 
We will perform twice monthly review of subject files to ensure data completeness.  
 
12.d. How data and specimens will be handled study-wide 
• 
What information will be included in that data or associated with the specimens?  
o Urine specimens transported for Philadelphia FIGHT will be labeled only with participant 
unique study identifiers. Blood and swabs transported to the Philadelphia Health 
Department Laboratory will be labeled only with participant names per the requirements 
of health department and state law for reporting notifiable infections. On these 
specimens participant IDs will not be included; thus, linking between ID and name will be 
impossible.  
• 
Where and how data or specimens will be stored?  
o Specimens will be stored in a locked case that only study personnel will have the keys to 
until they are transferred to an accredited laboratory for testing. Specimens going to 
FIGHT and to the Philadelphia public health lab will be transported in separate cases to 
ensure names and study ID numbers are separated.  
• 
How long the data or specimens will be stored?  
o Specimens will be stored overnight in a locakable refrigerator and following testing the 
samples will be retained until the conclusion of the study.  All data regarding subjects will 
be retained until the completion of the study and until manuscripts describing the data 
have been published. 
• 
Who will have access to the data or specimens?  

• 
Only members of the research team will have access to subject data. 
Philadelphia Department of Health will perform STI, Hepatitis B and creatinine 
testing. They are located at 500 S. Broad Street. Philadelphia, PA 19146. 
Philadelphia FIGHT will perform drug-level monitoring. FIGHT is located at: 
located at 1207 Chestnut Street, Philadelphia, PA 19107. Research team 
members will transport specimens to the lab for processing within 72 hours of 
their collection.  
• 
Who is responsible for receipt or transmission of the data or specimens?  
o Principal Investigator (AMR) or co-Investigators (MAF and BLP) are responsible for 
receipt and transmission of the data/specimens. 
• 
Will data be sent outside of the Drexel University system? NO IF YES 
o Where will the data be sent?  
o Why is it necessary to send the data outside of the Drexel University system? 
o How and in what format will the data be sent?  (PHI must be encrypted).  
o How data and specimens will be transported?  
13. Provisions to Monitor the Data to Ensure the Safety of Subjects 
This study is considered minimal risk as there is minimal risk associated with daily FTC/TDF as PrEP by HIV-
uninfected individuals. Side effects during clinical trials included nausea, vomiting, abdominal pain, and 
diarrhea. These effects occurred in a minority of PWID (<20%) participating in the Bangkok Tenofovir Trial and 
most participants reported symptoms had resolved by the 2nd month. Of these side effects, only nausea and 
vomiting were statistically higher among PWID on Tenofovir than those taking the placebo. Tenofovir has been 
linked to renal impairment when used for HIV treatment, however, increased creatinine was observed in only 
3% of patients in the Bangkok Tenofovir study.  
Therefore a DSMB is not needed. 
14. Withdrawal of Subjects 
During the consent processes, potential participants will be informed that the alternative to study participation 
is not to participate.  They will be informed that their decision regarding participation will not affect their 
participation in PPP or Drexel University services. If a participant screens positive for HIV during the baseline 
appointment, the PI will remove the participant from the study. If participants choose to withdraw, all data 
collection will stop. Participants will receive relevant compensation for having attended the study visit if they 
choose to withdrawal.   
 
As stated above, we will follow up with participants twice weekly for 2 weeks when they “no show” for an 
appointment. Any participant failing to contact staff within 2 weeks will be considered lost to follow up. 
However, they will not be withdrawn from the study.   
 
15. Risks to Subjects 
Loss of Confidentiality: There is the possibility that participants’ confidentiality could be compromised through 
the inadvertent loss of confidential information. Participants may experience loss of confidentiality if participant 
information is inadvertently shared with individuals not authorized to view it. To minimize this risk, all data 
collection will occur in a private space. A unique study identification number will be assigned to each 
participant and will be used to link participant quantitative surveys, audio-files, and transcription of the open-
ended sections of semi-structured interviews with clinical records. On these data, the participant’s identification 
number—not their name—will be used in the files to be analyzed. 
Psychological Discomfort: There is the possibility that participants could experience psychological discomfort 
as a result of study questions during quantitative surveys or interviews relating to assessments of sexual 
behavior and drug use or if they were to receive a positive STI result during the study. We minimize the 
potential for psychological discomfort by informing participants that they are not required to participate in the 
study, that they should only share information they feel comfortable sharing, that they can refuse to answer any 
individual questions or withdraw from the study completely, and that there is no penalty for not participating. 

We feel that these procedures will be effective in minimizing risks to the participants.  
STI Testing: There is the minimal risk that participants could injure themselves through over-aggressive 
sample collection. We will minimize this risk by providing all participants instructions on how to collect their 
specimen.  The literature shows that this procedure is acceptable to participants, is of minimal discomfort, has 
minimal safety risks (sample collection is considered non-invasive from a regulatory perspective), and provides 
reliable specimens.  
Pregnancy: We will provide patients with contraceptive counseling and prescriptions as in the current standard 
of care for women per CDC PrEP clinical guidelines. 
Toxicity: There is minimal risk associated with daily FTC/TDF as PrEP by HIV-uninfected individuals. Side 
effects during clinical trials included nausea, vomiting, abdominal pain, and diarrhea. These effects occurred in 
a minority of PWID (<20%) participating in the Bangkok Tenofovir Trial and most participants reported 
symptoms had resolved by the 2nd month. Of these side effects, only nausea and vomiting were statistically 
higher among PWID on Tenofovir than those taking the placebo. Tenofovir has been linked to renal impairment 
when used for HIV treatment, however, increased creatinine was observed in only 3% of patients in the 
Bangkok Tenofovir study. To monitor toxicity, we will measure creatinine levels at T1 and T2 (which will be 
scheduled over 3 months) as is recommended in the current CDC PrEP clinical guidelines and is considered 
standard of care.  
16. Potential Benefits to Subjects 
4.1 Benefits to Subjects 
Study participants might experience direct benefits in several ways. Participants will receive free HIV, Hepatitis 
C, STI, pregnancy and creatinine testing. As many of these women are unlikely to receive regular preventive 
medical care, we detect acute infections and by treating them, prevent sequelae. They will also receive HIV 
risk reduction counseling and be given information about PrEP, a promising biomedical intervention to prevent 
HIV.   
 
4.2 Benefits to Others 
These data will be used for future public health planning in the region. Specifically, information learned from 
WWID about barriers and facilitators to PrEP uptake/utilization will provide insights to design relevant and 
culturally appropriate intervention activities to reduce their risk to HIV infection.   
The proposed observational study does not constitute a clinical trial or involve the use of experimental 
treatments (behavioral or medical) on human subjects; thus, a Data and Safety Monitoring Plan is not 
required. However, we consider the security of data collected in this study to be of the utmost 
importance.  
17. Vulnerable Populations 
Not applicable 
18. Multi-site Research 
Not applicable 
19. Community-Based Participatory Research 
Since the beginning of the HIV epidemic, community engagement has been critical to understanding and 
meeting the needs of those most impacted by HIV.15 We will engage and collaborate with PPP to establish a 
community advisory board (CAB) comprised of clients, staff, and other community advocates.  The CAB will 
meet quarterly throughout the project period to review study instruments, protocols, and contextualize data. 
This will increase the reliability and validity of findings by allowing for member checking, a method for 
confirming the study team’s interpretation and implications of the data.  
 
20. Sharing of Results with Subjects  
The results of the study will be summarized in an easy-to-read document, such as a pamphlet, that can be 
distributed to the CAB, PPP board of directors, PPP clients, and Drexel University School of Public Health. The 
pamphlet will be made available in the PPP office. In addition, a luncheon will be held at PPP detailing the 
results of the study to staff members. 

21. Setting 
Our study will take place in PPP’s main building located in the Kensington neighborhood of Philadelphia where 
both an open air drug market and well-known sex work stroll operate.16,17 We will embed PrEP services within 
PPP’s existing clinical infrastructure that includes seven private patient rooms. PPP is located at 2913 
Kensington Ave, Philadelphia, PA 19134. The study team has been provided with private clinic rooms to 
conduct study visits and a lockable file cabinet for study files. We have also obtained a lockable refrigerator to 
store study specimens. Only study team will have access to the keys of the cabinet and refrigerator. Informed 
consents and participant tracking forms will be stored in research team’s main office in the Dornsife School of 
Public Health at 3215 Market St, 4th floor, 19104. 
22. Resources Available 
Feasibility of recruiting subjects: Prevention Point Philadelphia (PPP) is the largest harm reduction agency in 
the mid-Atlantic. Founded in 1991, PPP serves approximately 5,500 unduplicated clients each year; 
approximately 20% are women. Weekly PPP serves approximately 50 women during a SEP for women. We 
anticipate we can enroll the sample within 12-months which will require successful enrollment of ~16 
women/month which will be feasible even once follow-up visits begin.  
23. Prior Approvals 
Original IRB Approval: 4/25/17 
Approved Modification: 5/9/17 

 
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