Conditions: Patient Adherence
Keywords: PrEP Pre exposure Prophylaxis Truvada CCTG 595 Vitamin D Bone mineral density
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 48
Healthy volunteers: yes

Brief summary:
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week 48. In CCTG 595, plasma from participants are being collected and stored at entry and every 12 weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels in both cases and controls at entry, week 24, and week 48.

Detailed description:
A total of 50 HIV-uninfected men who have sex with men (MSM) and male to female (M to F) transgender individuals already enrolled in CCTG 595 will be offered participation in the sub-study at Week 24 of the main study. All subjects enrolled into the sub-study will be provided Vitamin D 4000 IU/day supplements in addition to their PrEP at Weeks 24 and 36; clinic visits will proceed normally per main study protocol. Upon completion of the sub-study subjects will continue on the main study.

The primary endpoint, bone turnover markers, will be measured from Week 24 to Week 48 via plasma samples collected through the main study. Concurrent controls who are not enrolled in the vitamin D substudy who are reporting supplementation with \< 400 IU of vitamin D/day will be matched 1:1 by randomization arm in the CCTG 595 main study (text messaging arm vs. standard of care), age (± 5 years), race/ethnicity, season of study entry, and BMI (± 3 kg/m2).

Arms:
arm 1: Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks in addition to their PrEP provided through the main study. arm 2: Subjects not enrolled into this sub-study will continue receiving PrEP through the main study. Subjects taking unsupplemented PrEP may still be used as matched controls to sub-study subjects.

Interventions: intervention 1: Vitamin D Supplement
Intervention descriptions: intervention 1: Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks.

Protocol document:
Prot_SAP_000.pdf: 
 
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CCTG 595 
 
 
A Multicenter, Randomized Study of Text messaging to improve Adherence to PrEP In Risky 
MSM (TAPIR) 
 
 
 
A Multicenter Trial of the California Collaborative Treatment Group (CCTG) 
 
Sponsored by: 
 
The California HIV/AIDS Research Program (CHRP) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Co-chairs: 
Sheldon Morris, MD, MPH 
 
David J. Moore, PhD 
 
 
Protocol Version 5.0  
Original: November 1st, 2012 
Amended: August 10th, 2015 
 
 


 
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TABLE OF CONTENTS  
 
PROTOCOL TEAM ROSTER  
 
 
 
 
 
 
 
 pg 4 
 
Study Co-Chairs  
 
 
 
 
 
 
 
 pg 4 
 
 
 
Study Vice-Chairs  
 
 
 
 
 
 
 
 pg 4 
 
Co-Investigators  
 
 
 
 
 
 
 
 pg 4 
 
Clinical Trials Specialist  
 
 
 
 
 
 
 pg 6 
 
Statistician  
 
 
 
 
 
 
 
 
 pg 6 
 
Study Monitor and Data Unit  
 
 
 
 
 
 pg 6 
 
Lab Technician  
 
 
 
 
 
 
 
 pg 7 
LIST OF ABBREVIATIONS  
 
 
 
 
 
 
 
 pg 8 
SCHEMA  
 
 
 
 
 
 
 
 
 
 pg 9 
 
Design  
 
 
 
 
 
 
 
 
 pg 9 
 
Duration  
 
 
 
 
 
 
 
 
 pg 9 
 
Sample Size   
 
 
 
 
 
 
 
 pg 9 
 
Study Population   
 
 
 
 
 
 
 
 pg 9  
 
Stratification   
 
 
 
 
 
 
 
 pg 9 
 
Intervention   
 
 
 
 
 
 
 
 pg 10  
 
Regimen  
 
 
 
 
 
 
 
 
 pg 10 
 
Outcomes  
 
 
 
 
 
 
 
 
 pg 10 
1.0 STUDY OBJECTIVES AND HYPOTHESES   
 
 
 
 
 pg 11 
 
1.1 Study Primary Objectives  
 
 
 
 
 
 pg 11 
 
1.2 Study Secondary Objectives  
 
 
 
 
 
 pg 11 
 
1.3 Exploratory Objectives  
 
 
 
 
 
 
 pg 12 
2.0 INTRODUCTION   
 
 
 
 
 
 
 
 pg 12 
 
2.1 Study Background  
 
 
 
 
 
 
 pg 11 
 
2.2 Study Rationale   
 
 
 
 
 
 
 pg 14 
3.0 STUDY DESIGN  
 
 
 
 
 
 
 
 
 pg 15 
 
3.1 Study Design  
 
 
 
 
 
 
 
 pg 15 
 
3.2 iTAB Adherence Intervention  
 
 
 
 
 
 pg 14 
 
3.3 Qualitative Plasma Concentrations as an Adherence Marker  
 
 pg 16 
4.0 SELECTION AND ENROLLMENT OF SUBJECTS  
 
 
 
 
 pg 17 
 
4.1 Study Inclusion Criteria   
 
 
 
 
 
 pg 17 
 
4.2 Study Exclusion Criteria   
 
 
 
 
 
 pg 17 
 
4.3 Enrollment Procedures   
 
 
 
 
 
 pg 19 
5.0 STUDY TREATMENT  
 
 
 
 
 
 
 
 pg 19 
 
5.1 Regimens, Administration, and Duration  
 
 
 
 pg 18 
 
5.2 Study Product Formulation  
 
 
 
 
 
 pg 20 
 
5.3 Pharmacy: Product Supply, Distribution, and Accountability  
 
 pg 20 
 
5.4 Concomitant Medications  
 
 
 
 
 
 pg 20 
 
5.5 Adherence Assessment   
 
 
 
 
 
 pg 20 
6.0 CLINICAL AND LABORATORY EVALUATION  
 
 
 
 
 pg 22 
 
6.1 Table of Schedule of Events  
 
 
 
 
 
 pg 22 


 
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6.2 Definitions for Schedule of Events and Timing of Evaluations   
 pg 23 
 
6.3 Special Instructions and Definitions of Evaluations  
 
 
 pg 26 
7.0 TOXICITY MANAGEMENT  
 
 
 
 
 
 
 pg 30 
 
7.1 General Management for Grade 1-4 Events  
 
 
 
 pg 30 
 
7.2 Management for Specific Adverse Events  
 
 
 
 pg 31 
8.0 CRITERIA FOR EARLY DISCONTINUATION  
 
 
 
 
 pg 33 
 
8.1 Criteria for Discontinuation from Study   
 
 
 
 pg 33 
9.0 STATISTICAL CONSIDERATIONS   
 
 
 
 
 
 pg 34 
 
9.1 Primary Endpoints  
 
 
 
 
 
 
 pg 34 
 
9.2 Secondary Endpoints  
 
 
 
 
 
 
 pg 34 
 
9.3 Randomization and Stratification  
 
 
 
 
 pg 35 
 
9.4 Study Power and Sample Size Justification  
 
 
 
 pg 35 
 
9.5 Monitoring  
 
 
 
 
 
 
 
 pg 35 
 
9.6 Analyses   
 
 
 
 
 
 
 
 pg 36 
10.0 PHARMACOLOGY PLAN  
 
 
 
 
 
 
 pg 38 
 
10.1 Sample Assay Methods   
 
 
 
 
 
 pg 38 
11.0 DATA COLLECTION AND MONITORING AND ADVERSE EVENT REPORTING   pg 38 
 
11.1 Records to be Kept  
 
 
 
 
 
 
 pg 38 
 
11.2 Role of Data Management  
 
 
 
 
 
 pg 38 
 
11.3 Clinical Site Monitoring and Record Availability  
 
 
 pg 38 
 
11.4 Serious Adverse Experiences (SAE) Reporting   
 
 
 pg 39 
12.0 HUMAN SUBJECTS  
 
 
 
 
 
 
 
 pg 39 
 
12.1 Institutional Review Board (IRB) and Informed Consent  
 
 pg 39 
 
12.2 Subject Confidentiality   
 
 
 
 
 
 pg 39 
 
12.3 Study Discontinuation   
 
 
 
 
 
 pg 39 
13.0 PUBLICATION AND RESEARCH FINDINGS  
 
 
 
 
 pg 40 
14.0 BIOHAZARD CONTAINMENT  
 
 
 
 
 
 
 pg 40 
15.0 REFERENCES  
 
 
 
 
 
 
 
 
 pg 40 
16.0 APPENDICES 
 
 
 
 
 
 
 
 
 pg 42 
APPENDIX I: SAMPLE OF INFORMED CONSENT  
 
 
 
 
 pg 42 
APPENDIX II: QUESTIONNAIRES  
 
 
 
 
 
 
 pg 50 
APPENDIX III: VITAMIN D SUB-STUDY PROTOCOL   
 
 
 
 pg 86 
APPENDIX IV: VITAMIN D SUB-STUDY SAMPLE OF INFORMED CONSENT   
 pg 99 
APPENDIX V: MULTIVITAMIN SUPPLEMENT COMPARISONS 
 
 
 pg 104 
APPENDIX VI: DIETARY CALCIUM AND VITAMIN D INTAKE CALCULATOR   
 pg 106 
 
 
 


 
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PROTOCOL TEAM ROSTER 
 
Study Co-Chairs 
 
 
 
 
 
Sheldon Morris, MD, MPH 
Associate Professor of Medicine 
University of California, San Diego 
Antiviral Research Center 
220 Dickinson St., Suite A 
San Diego, CA 92103 
Phone 
619.543.8080 
Fax           619.543.5066 
E-mail 
shmorris@ucsd.edu 
 
David J. Moore, PhD 
Associate Professor of Psychiatry 
University of California, San Diego 
HIV Neurobehavioral Research Programs 
220 Dickinson St., Suite B 
San Diego, CA 92103 
Phone 
619.543.5093 
Fax 
 619.543.1235 
E-mail 
djmoore@ucsd.edu 
 
 
Co-Investigators 
 
 
 
 
 
Michael Dubé, M.D. 
Professor of Medicine 
Keck School of Medicine 
University of Southern California 
1300 N. Mission Road, Room 349 
Los Angeles, CA 90033 
Phone 
323.343.8288 
Fax 
323.226.2083 
E-mail 
mdube@usc.edu 
 
Eric Daar, M.D. 
Chief, Division of HIV Medicine 
Harbor-UCLA Medical Center 
Professor of Medicine 
David Geffen School of Medicine 
University of California, Los Angeles 
1124 W. Carson St., N-24 
Torrance, CA 90502 
Phone 
310.222.2467 
Fax 
310.533.0447 
E-mail 
edaar@labiomed.org 
 
 
 
 
 
Jill Blumenthal, MD 
HIV Research Fellow 
University of California, San Diego 
Antiviral Research Center 
220 Dickinson St., Suite A 
San Diego, CA 92103 
Phone 
619.543.8080 
Fax           619.543.5094 
E-mail 
jblumenthal@ad.ucsd.edu 
 
Katya Calvo, MD 
Health Sciences Assistant Professor 
David Geffen School of Medicine at UCLA 
Harbor-UCLA Medical Center 
1124 West Carson Street 
N-24 
Torrance, CA 90502 
Phone:  310.222.2159 
Fax:  
310.533.0447 
E-mail 
krcalvo@labiomed.org 
 
 
 
Martin Sattah, MD 
Clinical Assistant Professor 
LAC/USC Medical Center 
Dept. of Internal Medicine/ Division of 
Infectious Diseases 
1300 North Mission Road 
Los Angeles, CA 90033 
 
Deborah Collins, PA-C 
Preventative Health Clinical Services Director 
Long Beach Department of Health and Human 
Services 
2525 Grand Avenue, Suite 106 
Long Beach, CA 90815 
Phone:  562.570.4379 


 
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Phone: 323.343.8255  
Fax:  
323.226.3571 
E-mail  sattah@usc.edu 
Fax: 
E-mail  deborah.collins@longbeach.gov 
 
 
 
 
 
Clinical Trials Specialist 
Eric E. Ellorin 
Staff Research Associate 
University of California, San Diego 
Antiviral Research Center 
220 Dickinson St., Suite A 
San Diego, CA 92103 
Phone 
619.543.8080 
Fax 
619.543.5072 
E-mail 
eellorin@ucsd.edu 
 
Statistician 
 
Sonia Jain, PhD 
Associate Professor, Division of Biostatistics and Bioinformatics 
Director, CCTG Biostatistics Core 
Co-Director, Biostatistics Research Center (BRC) 
University of California, San Diego 
9500 Gilman Dr., MC 0717 
La Jolla, CA 92093-0717 
Phone 
858.822.2388 
E-mail 
sojain@ucsd.edu 
 
Study Monitor and Data Unit 
Edward Seefried, RN 
Medical Monitor, Study Coordinator, CCTG Data Unit 
University of California, San Diego 
Antiviral Research Center 
220 Dickinson St., Suite A 
San Diego, CA 92103 
Phone 
619.543.8080 
Fax 
619.543.5072 
E-mail 
eseefried@ucsd.edu 
 
Lab Technician 
 
DeeDee Pacheco 
Phlebotomist and Lab Manager 
University of California, San Diego 
Antiviral Research Center 


 
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220 Dickinson St., Suite A 
San Diego, CA 92103 
Phone 
619.543.8080 
Fax 
619.543.5067 
E-mail 
dmpacheco@ucsd.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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LIST OF ABBREVIATIONS 
 
AE 
Adverse Event 
ALERT 
Active Linkage, Engagement, and Retention to Treatment 
ARV 
Antiretroviral Therapy 
CCTG 
California Collaborative Treatment Group 
CD4 
CD4 Lymphocytes 
CRF 
Case Report Form 
CT 
Chlamydia 
DSMB 
Data Safety and Monitoring Board 
GC 
Gonorrhea 
HAART 
Highly Active Antiretroviral Therapy 
HIV-1 
Human Immunodeficiency Virus – 1 
iTAB 
Individualized Texting for Adherence Building 
mITT 
Modified Intention to Treat 
MSM 
Men who have Sex with Men 
NAAT 
Nucleic Acid Amplification Test 
PLWH 
Persons Living With HIV/AIDS 
PrEP 
Pre-Exposure Prophylaxis 
RPR  
Rapid Plasmin Reagin 
SAP 
Statistical Analysis Plan 
SAE 
Serious Adverse Event 
SoC 
Standard of Care 
STI 
Sexually Transmitted Infection 
TPPA 
Treponema Pallidum Particle Agglutination Assay 
VAS 
Visual Analog Scale 
VDRL  
Venereal Disease Research Laboratory 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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SCHEMA 
 
Design: 
CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical 
demonstration project to determine if the use of a text-message based 
adherence intervention (iTAB) improves retention and adherence to PrEP 
compared to standard of care (SoC) PrEP delivery.  
 
Duration: 
Each subject will be followed for up to 48 weeks after enrollment of the 
last subject to a maximum of 96 weeks. The primary endpoint will be 
measured at 48 weeks. 
 
Sample Size: 
A total of 400 subjects will be randomized, 200 per arm. 
 
Study Population: 
Eligible subjects will include HIV-uninfected men who have sex with men 
(MSM) and male to female (M to F) transgender individuals who have sex 
with men at least 18 years of age and who have a recent history of high-
risk transmission behavior. 
 
 
 
Stratification: 
The randomization will be stratified based on clinic site. 
 
 
 
CCTG 595 Study Schema 
 
400 MSM at high risk for HIV acquisition 
Standard of Care 
TDF/TFC daily 
HIV/STI Screening 
Adherence Counseling 
Risk Behavior Counseling 
Safety Monitoring 
Follow-up assessments week 4, 12, 24, 36, 48 
Then q12 weeks 
Randomize 1:1 
iTAB Intervention 
iTAB text reminders for adherence 
TDF/TFC daily 
HIV/STI Screening 
Adherence Counseling 
Risk Behavior Counseling 
Safety Monitoring 
 
 


 
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Intervention: 
All subjects will start PrEP with TDF + FTC fixed dose combination given 
once daily.  Subjects will be randomized (1:1) to either the iTAB text 
messaging adherence reminder intervention with SoC or the SoC alone 
arm. Subjects placed into the iTAB intervention arm will receive a 
personalized, automated texting system to maintain adherence and 
retention. Both groups will receive access to PrEP in accordance with 
standardized comprehensive methods of prescribing, risk reduction 
counseling, adherence counseling, and clinical assessments that include 
safety monitoring, as well as HIV and STD screening. 
 
Regimen: 
TDF 300 mg + FTC 200 mg fixed dose combination will be given orally 
once daily starting at the baseline visit (month 0) and continued 
throughout the study.   
 
Outcomes: 
The CCTG 595 primary outcome is defined as a composite endpoint of 
remaining on PrEP and having adherence > 90% over 48 weeks of follow-
up. The adherence endpoint will be derived from the 4 day ACTG 
adherence assessment from each of the visits from week 4, 12, 24, 36, 
and 48. ‘Adherent’ will be defined as self-reported TDF/ FTC adherence of 
90% or greater (at least 18 of 20 days). If a subject misses an adherence 
assessment within the window of a scheduled visit or discontinues study 
prior to week 48, then the missed visits will be counted no adherence for 
the time of that visit. All randomized subjects that were dispensed PrEP 
at baseline will be included in the modified intent-to-treat analysis.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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1.0 
STUDY OBJECTIVES AND HYPOTHESES 
 
1.1 Study Primary Objective:  
 
CCTG 595 will compare adherence to fixed dose TDF/FTC, between 
subjects randomized to receive SoC plus text message reminders versus 
SoC, when used for pre-exposure prophylaxis among MSM at high risk for 
HIV acquisition. 
 
1.1.1 
 
Hypothesis I 
 
 
MSM and transgender M to F having sex with men with high risk of HIV 
acquisition randomized to the iTAB intervention will have higher self-
reported adherence to TDF/FTC for PrEP over 48 weeks (‘adherent’ 
defined with a composite endpoint of continued retention on PrEP and > 
90% adherence to TDF/FTC at 48 weeks) compared to MSM that have 
comprehensive SoC alone. 
 
1.1.2  
Hypothesis II 
 
 
MSM and transgender M to F having sex with men with high risk of HIV 
acquisition randomized to the iTAB intervention will have higher 
adherence to TDF/FTC for PrEP over 48 weeks, as measured by having 
five of five detectable qualitative FTC plasma concentrations at scheduled 
visits compared to MSM that have comprehensive standard of care 
alone. 
 
1.2 Study Secondary Objectives: 
 
 
1.2.1 
To compare adherence to TDF/FTC in the iTAB versus SoC in the subjects 
that remain on PrEP (at 48 weeks and up to 96 weeks of follow up) by the 
continuous measure of percent days adherent by the cumulative 4 day 
ACTG and the visual analog scale (VAS) recall in an ‘as treated’ analysis. 
 
 
1.2.2 
To compare adherence to TDF/FTC in the iTab versus SoC groups for the 
duration of the study (up to 96 weeks). Adherence will be compared 
using the same outcomes as hypothesis I (self-reported to be on drug and 
90% adherent) and II (100% detectable FTC at each scheduled visit) as 
modified intent to treat analysis. 
 
 
1.2.3 
To determine factors associated with poor adherence/lost to PrEP in 
study participants (outcomes of < 90% adherent on drug at 48 weeks by 
ACTG 4 day recall or discontinuation of drug). Factors associated with 
poor adherence to TDF/FTC will include demographics, ongoing 


 
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substance use, untreated mental illness, socioeconomic status, low 
health/HIV and system literacy, fear of disclosure and non-English 
language.  
 
 
1.2.4 
To determine the factors associated with discontinuation of TDF/FTC at 
any time point including change in perceived and actual risk of HIV 
acquisition, demographics, ongoing substance use, untreated mental 
illness, socioeconomic status, low health/HIV and system literacy, fear of 
disclosure and non-English language.  
 
 
1.2.5 
To determine the rate of HIV seroconversion in PrEP users and compare 
the iTAB to SOC arms for number of new infections as a proportion at 48 
weeks and end of study. 
 
 
 
 
 
1.2.6 
To measure acquisition of other sexually transmitted infections (STIs); the 
proportion of subjects with any new STI at any site will be compared 
between the iTAB to SOC arms at 48 weeks and through the end of the 
study. 
. 
 
1.2.7 
To evaluate changes in risk behavior after initiation of PrEP (risk 
compensation) comparing baseline to subsequent visits for number of 
HIV positive/unknown status partners and any unprotected anal 
intercourse with an HIV positive/ unknown status partner. 
 
 
1.2.8 
To evaluate the safety and tolerability of daily TDF/FTC given for PrEP 
including discontinuation for any adverse event, serious adverse events 
and  adverse events (grade 2 or higher). 
 
1.3 Exploratory Objectives:  
 
 
1.3.1 
To describe changes over time of self-reported adherence in real time by 
texting. 
 
 
 
 
 
 
 
 
 
 
 


 
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2.0 
INTRODUCTION 
 
2.1 Study Background 
 
Widespread deployment of PrEP will require operational research to study how best to 
integrate services into clinical care settings and to target them to various at-risk populations [1-
3]. Randomized controlled trials of PrEP have shown a statistically significant reduction in 
acquisition of HIV among at-risk individuals in a research setting but provide little insight into 
how it could be practically applied. Implementing PrEP strategies will necessitate: 1) creation of 
an organizational framework to deliver services; 2) delineation of patient populations where 
PrEP should be targeted and would be most effective; 3) identification and removal of 
structural barriers to PrEP delivery (such as co-ordination of services between organizations, 
and establishing infrastructure to deliver services) and 4) establishing related services such as 
patient education, drug adherence counseling and reminder systems for medication adherence.   
 
Sustainable programs for PrEP delivery may utilize either new clinical care systems or 
existing care providers such as treatment clinics, community care clinics, public health facilities 
or HIV testing sites. Adding PrEP to clinical HIV care may be the most efficient method 
considering the requirements for PrEP: 1) prescription of antiretroviral agents;  2) monitoring 
for adverse events and HIV acquisition; 3) interventions for risk reduction and drug adherence 
and 4) provision of comprehensive care for sexually transmitted infections, mental health and 
substance use [4].  
 
This study will evaluate the integration of PrEP into clinical practice by identifying at-risk 
individuals at HIV testing sites, linking them to treatment clinics, and initiating and maintaining 
PrEP. This model for PrEP utilizes providers that are experienced with ARV drugs, adherence 
counseling, and care of high-risk patients. The CCTG clinical sites have successfully integrated 
other prevention interventions into their care delivery for previous studies and serve 
populations for which PrEP will be most needed [5].  
 
HIV care clinics in California are familiar with the target population for PREP because the 
patient population is largely MSM who continue HIV transmission-associated behaviors.  
Epidemiological studies have found that MSM at the highest risk for acquiring HIV are those 
who have HIV positive partners, a sexually transmitted disease, multiple sexual partners, use 
methamphetamine, and attend specific venues such as bath houses and internet “hook-up” 
sites [6-8]. In the iPREX study, HIV acquisition among a diverse population of high-risk MSM was 
reduced by 44%, leading to current CDC guidance on PrEP which targets MSM who have 
“sustained” risk of HIV acquisition, normal renal function and negative HIV by EIA and no 
symptoms of acute HIV infection [9, 10].  
 
Implementing PrEP for MSM will require education of the high risk groups since initial 
studies found only 47% had some knowledge of PrEP and only 4% were using PrEP [11]. Uptake 


 
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of PrEP is anticipated to be good in some high risk groups. Partners of HIV-infected individuals 
may be most motivated. In one study 80% of discordant heterosexual couples accepted PrEP 
during reproductive planning [12]. A similar study found that 74%  of MSM, who received PrEP 
education, would consider taking it if available [13]. Therefore, increasing the community 
awareness and education of PrEP should increase interest, especially if barriers to referral for 
PrEP are minimized, and counseling and education are provided.  
 
Once linked and engaged in PrEP, candidates will require a systematic approach to 
maintain follow-up and adherence to medication. The literature generally shows that 
adherence levels of 95–100% are needed to ensure optimal treatment effectiveness for the 
treatment of HIV [14]. Similarly, PrEP efficacy in iPREX was shown to be diminished with 
reductions in adherence [9]. In a nested case-control study, TDF and FTC drug levels were 
detectable in only 9% of individuals that seroconverted to HIV compared to 51% of the controls 
that did not acquire HIV [9]. Adherence is commonly defined as ≥ 90% of prescribed doses 
taken, but no single definition has achieved consensus across the literature and various 
definitions have be associated with worsened HIV disease outcome[15]. In iPREX, 90% 
adherence by self-report at 49% of visits was found to increase efficacy from 44% to 75% in HIV 
acquisition reduction. Barriers to adherence have been widely studied in HIV-infected 
individuals and summarized by Mills et al. [16]. From studies in developed countries the factors 
associated with adherence can be summarized as: 1) individual psycho-social factors (sense of 
stigma, feeling hopeless, having addiction diagnosis, mistrust of medical system and 
medications, problems with memory, poor understanding, low self-worth, finances, 
homelessness); 2) beliefs on medication (real or perceived adverse events, complicated 
regimens, uncertainly of effect); 3) daily schedules (irregular routines, coordinating adherence 
with social supports); and 4) issues of social cohesion (lack of trust in providers, social isolation, 
negative publicity in community, negative feedback from social network) [16]. Facilitators of 
adherence relevant to PrEP include 1) increasing self-worth and prioritizing health over 
addiction; 2) having ‘faith’ in the treatment and understanding adherence importance; 3) 
having daily routines and  using reminder systems and 4) trusting providers, disclosing to social 
supports and feeling supported by social network. Maximizing adherence for PrEP will therefore 
require developing good relationships and providing ongoing heath education, counseling and 
reinforcement on HIV and PrEP. A promising method of reinforcing ART adherence is text 
messaging.  In one study in a group of poorly adherent HIV-infected individuals, an increase in 
adherence from 42% to over 70% was observed in those receiving texting [17]. In this proposal, 
a comprehensive approach to routine clinical care will be expanded to provide the necessary 
elements for safely implementing PrEP. HIV prevention and PrEP education will figure 
prominently in the interactions with community and participants including reinforcement of the 
adherence message coupled with risk reduction counseling at each clinic visit. In the 
randomized component of the study, the ALERT worker will use text reminders as a strategy for 
enhancing PrEP adherence. 
 
2.2 Study Rationale 
 


 
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TDF/FTC has been approved by the FDA as an agent for PrEP. As noted previously, there 
is no research on how PrEP will be delivered in the community setting.  CCTG 595, will 
implement PrEP at three sites (UCSD, UCLA/Long Beach Health Department, USC) to explore the 
operationalization of PrEP by the community providers of HIV testing and HIV care. Critical to 
the implementation of PrEP will be to maintain adherence to drug. CCTG 595 will perform a 
randomized controlled study of the iTAB texting intervention for TDF/FTC adherence for PrEP. 
This intervention is meant to be a simple automated method to reinforce adherence.   
 
 
3.0 
STUDY DESIGN 
 
3.1 Study Design  
 
CCTG 595 is a comparative, interventional study that uses text messaging to improve 
adherence of PrEP in MSM and transgender that are at high risk of acquiring HIV.  We will 
conduct an open-label, randomized, controlled clinical trial to evaluate an intervention strategy 
that uses a developed texting adherence method, the iTAB system, to improve adherence and 
retention compared to standard of care which will not have iTAB (see study schema). The RCT 
will occur in the context of implementation of PrEP at three large, diverse, urban HIV care 
clinics in the CCTG network at UCLA-Harbor, USC and UCSD and a fourth site at the Long Beach 
Public Health Department. These sites are collaborating with local testing sites to provide an 
integrated program that identifies individuals at highest risk for HIV acquisition and link them 
into preventive care that will provide the assessment, dispensing and monitoring of PrEP. A 
uniform system of HIV testing, risk assessment, health education and behavioral/adherence 
counseling will be developed for use at consortium sites.  
 
Study enrollment criteria is based on the CDC guidance for PrEP use among MSM and 
transgender with ongoing risk for HIV infection. All subjects will be confirmed to be uninfected 
with no contraindication to TDF/FTC. Subjects will be randomized at baseline to iTAB versus 
SoC. Randomization will be stratified by CCTG site. Study visits will include screening, baseline, 
week 4 and 12 initial visits and then visits every 12 weeks. Visits for iTAB and SoC arms will both 
include routine HIV testing and counseling, STI testing, adherence counseling, and medical 
monitoring. Each visit will include a computer-assisted survey for self-reported adherence 
assessment and risk behaviors. Drug level monitoring will be performed for FTC qualitative 
levels in retrospect on banked samples and additional banked specimens will be available for 
future use and TDF measurement. Adherence by self-reported measures and FTC levels will be 
used for the main and secondary analyses of the study. Additional outcomes for the study will 
include changes in risk behavior and determinants of PrEP adherence. Outcomes will be 
assessed at 48 weeks and for the cumulative follow up of all participants. The study will 
continue for 48 weeks after randomization of the last participant (up to 96 weeks for any 
subject).  
 
 
In order to have adequate representation of African Americans in the study population, 


 
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enrollment of non-African Americans will be capped at 85% of 400 subjects (340) to achieve at 
least 15% African Americans.  If 340 non-African American subjects are enrolled, then 
enrollment for this subgroup will stop and the study will remain open only for African 
Americans.  
 
 
3.2 iTAB Adherence Intervention 
 
This proposal will perform a study of potential methods to improve adherence and 
retention by evaluating standard procedures versus the use of the iTAB platform. All subjects 
will receive SoC that will include health education, clinical assessments, laboratory safety 
monitoring, STI and HIV screening, HIV risk reduction counseling, assessment of psycho-social 
barriers, adherence counseling, and completion of a computer based survey.   
 
Subjects will be randomized to 1) SoC clinic visits as outlined in section 6.0 and 2) SoC 
visits plus support  using text messaging through the iTAB system. Subjects assigned to the iTAB 
intervention will have visits with the study coordinator to introduce the iTAB texting system, 
discuss contact information to assist in recovering the subject if they miss appointments and 
provide training on iTAB framework for texting supportive reminder messages and tracking 
adherence. The study will provide subject reimbursement to pay for unlimited text message use 
and in cases where a subject does not have a phone, the appropriate cell phone will be 
provided.  
 
Daily dosing reminders will be sent for the first 6 weeks and then continue with 
reminders for the duration of the study. Both reminder timing and message content can be 
individualized. The study coordinator will work with the participant to select and refine 10 
personal reminders from a list of pre-determined reminders that cover various themes shown 
to be effective in improving adherence (e.g., social support, loss frame, health gain, etc.) as 
developed through focus groups and targeted group feedback. These messages can be modified 
and the patient can choose to create their own reminders if they prefer. The coordinator will 
work with each participant individually to assure that adherence reminders are sent at times 
consistent with when the patient typically takes his medication.  These reminder times can vary 
for different days of the week to accommodate for changes in schedule (e.g., 8 M-F, and 10 AM 
on Sat/Sun). Once the time is identified, the text reminder system is automated. Patients will 
confirm medication taking via text responses to the personalized reminders. If a participant 
does not respond on three consecutive occasions, a high alert message (chosen by the 
participant) will be sent. If the subject does not respond to this message, the study coordinator 
would initiate phone calls to contact the subject and explore barriers. The coordinator will 
continue to call the participant every 4 days until the participant re-engages with the iTAB 
system.  
 
3.3 FTC Qualitative Plasma Concentration as an Adherence Marker  
 


 
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Adherence to prescribed treatment can be difficult to assess. One objective way to 
measure recent adherence is to measure plasma drug concentrations. FTC concentrations in 
plasma remain detectable throughout the dosing interval. Specifically, trough concentrations of 
FTC are approximately 60 – 70 ng/mL, and range from 10 – 300 ng/mL between subjects [23, 
24]. Peak concentrations are approximately 1300 – 1800 ng/mL, and range from 600 to 2500 
ng/mL. While many factors contribute to variability in plasma concentrations, such as drug-drug 
interactions and genetic differences in absorption and excretion, completely undetectable 
plasma concentrations of FTC are physiologically implausible for patients who are adherent 
with their regimen. Even with the sources of variability noted above, undetectable 
concentrations (< 1 ng/mL) would be 60 to over 1000 times less than the expected 
concentration depending on the time post-dose, and can be justifiably assumed to represent 
missed doses rather than pharmacokinetic variability. We plan for 400 subjects and in total will 
have 3467 levels (an average of 8.6 per person). Samples will be stored at each study visit 
(weeks 4, 12 and every 12 weeks thereafter). 
 
 
4.0 
SELECTION AND ENROLLMENT OF SUBJECTS 
 
4.1 Main Study Inclusion Criteria 
 
 
 
4.1.1 
Man or transgender M to F who has sex with men. 
  
 
 
4.1.2 
Age 18 years or older. 
 
 
 
4.1.3 
Subjects must have substantial ongoing risk of acquisition of HIV as 
evident by one or more of the following: 
 Has at least one HIV infected sexual partner for ≥4 weeks. 
 No condom use during anal intercourse with ≥3 male sex partners 
who are HIV-positive or of unknown HIV status during the last 3 
months   
 No condom use during anal sex with ≥1 male partner and STI 
diagnosis during the last 3 months 
 
 
 
4.1.4 
Negative for HIV infection by rapid HIV test and confirmed negative by 
NAT or other sensitive method such as antibody- antigen test.  
 
 
 
4.1.5 
Acceptable laboratory values in the past 30 days: 
 Calculated creatinine clearance of at least 60 mL/min by the 
Cockcroft-Gault formula (eCcr (male) in mL/min = [(140 – age in 
years) x (lean body weight in kg)] / (72 x serum creatinine in 
mg/dL) 
 Alanine aminotransferase (ALT) and/ or aspartate 
aminotransferase (AST) < 3 x upper limit of normal (ULN)  


 
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 Hemoglobin > 9 g/dL  
 Absolute neutrophil count > 750/ mm3 
 Platelets > 75,000/ mm3 
 
4.2 Main Study Exclusion Criteria 
 
 
 
4.2.1 
Unable to give informed consent. 
 
 
 
4.2.2 
Active hepatitis B (positive hepatitis B surface antigen (HBSAg) or HBSAg 
negative/ HB core antibody positive/ HBV PCR positive) 
 
 
 
4.2.3 
Has substantial medical condition, that in the opinion of the investigator 
would preclude participation, as defined by 
 cardiovascular condition that may lead to an increased risk of 
complication if placed on study drugs. 
 gastrointestinal condition that would impair absorption of study 
drugs. 
 neurological or psychiatric condition that would significantly 
impair the ability to adhere to PrEP. 
 calculated GFR < 60 mL/min 
 alcohol or drug abuse or dependence that would significantly 
impair the ability to adhere to PrEP (only for those with severe 
impairment). 
 Other medical condition that would unacceptably increase the risk 
of harm from study drug or significantly impair the ability to 
adhere to PrEP. 
 
 
 
4.2.4 
Suspected sensitivity or allergy to the study drug or any of its 
components. 
 
4.2.5  
 Currently using an essential product or medication that interacts with the 
study drug such as the following: 
 ART (including nucleoside analogs, non-nucleoside reverse 
transcriptase inhibitors, protease inhibitors or investigational 
antiretroviral agents)  
 Agents with known nephrotoxic potential: 
o aminoglycoside antibiotics (including gentamicin) 
o IV amphotericin B 
o cidofovir 
o cisplatin 
o foscarnet 
o IV pentamidine 
o IV vancomycin 


 
18 of 126 
 
o oral or IV gancyclovir 
o other agents with significant nephrotoxic potential 
 Drugs that slow renal excretion 
o Probenecid 
 Immune system modulators 
o Systemic chemotherapeutic agents (i.e. cancer treatment 
medications) 
o Ongoing systemic corticosteroids (with the exception of short 
courses of tapering steroid doses for asthma or other self- 
limited condition). 
o Interleukin-2 (IL-2) 
o Interferon (alpha, beta, or gamma) 
 Other agent known to have a significant interaction with TDF or 
FTC 
 
4.2.6  
Proteinuria 2+ or greater by urine dipstick 
 
  
4.2.7  
Signs or symptoms suggestive of acute HIV infection 
 
  
4.2.8 
Any other reason or condition that in the opinion of the investigator 
would interfere with participation, complicate interpretation of study 
outcome data, or otherwise interfere with achieving the study objectives. 
 
4.3 Enrollment Procedures 
 
 
4.3.1 
Prior to implementation of this protocol, sites must have the protocol 
and consent form approved by their local institution review board (IRB). 
Sites must be registered with and approved by the CCTG Data Center. Site 
registration must occur before any subjects can be enrolled in this study. 
 
 
4.3.2 
Once a candidate for study entry has been identified, details will be 
carefully discussed with the subject. The subject will be asked to read and 
sign the consent form that was approved by both the local IRB and the 
CCTG Data Center. 
 
 
4.3.3 
A patient identification number (PID) will be assigned to each patient 
screened for the study. PIDs will include site code and be formatted to be 
compatible with the BIT data core. PIDs will not be reassigned even if the 
subject fails to enter the study. The PID must be included on every CRF 
and subject specimen during the study. Each site must maintain a master 
list of PIDs in a central location. The patient registration and 
inclusion/exclusion CRF must be completed on the online system.  
 


 
19 of 126 
 
 
5.0 
STUDY TREATMENT 
 
5.1 Regimens, Administration, and Duration 
 
 
5.1.1 
Regimens 
 
 
 
 
Subjects will be randomized 1:1 to one of the two treatment arms:  
 
 
 
 
 
ARM A: FTC/TDF 200/300 mg fixed dose combination once daily + iTAB 
 
 
ARM B: FTC/TDF 200/300 mg fixed dose combination once daily 
 
 Use of the FTC/TDF fixed dose combination is not allowed if the CrCl 
is <50 mL/min, which should be confirmed within 7 days. TDF/ FTC 
should be discontinued if confirmed. 
 
 
 
5.1.2 
Administering and Dispensing 
 
 
 
Emtricitabine/tenofovir disoproxil fumarate fixed-dose combination 
containing 200 mg of emtricitabine and 300 mg tenofovir disoproxil 
fumarate will be administered orally as one tablet once daily with or 
without food.  
 
 
 
Enough study product should be dispensed to last until the subject’s next 
scheduled visit. 
 
 
5.1.3 
Duration 
 
 
 
Subjects will participate in this study until 48 weeks beyond the 
enrollment of the last subject with a maximum duration of 96 weeks for 
any subject.  Subjects may receive study treatment until their last study 
visit.   
 
Subjects will receive study treatment for the duration of the study unless 
they meet criteria for discontinuation.  
 
5.2 Study Product Formulation  
 
 
 
 
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, Truvada®): 200 
mg/300 mg coformulated tablet. Store at 25°C (77°F); excursions 
permitted to 15°-30°C (59°-86°F) [see USP Controlled Room 
Temperature]. 
 


 
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5.3 Pharmacy: Product Supply, Distribution, and Accountability 
 
 
5.3.1 
Study Product Supply/Distribution 
 
 
 
Emtricitabine/tenofovir disoproxil fumarate will be supplied by Gilead 
Sciences through the UCSD/AVRC Research Pharmacy and distributed to 
all sites.  
 
The site pharmacist can obtain study product for this protocol by 
following the instructions in the CCTG-595 Pharmacy Manual.  
 
 
5.3.2  
Study Product Accountability  
 
The site pharmacist is required to maintain complete records of all study 
product received from the UCSD /AVRC Research Pharmacy. All unused 
study product must be returned to the sponsor (or as otherwise directed 
by the sponsor) after the study is completed or terminated. The 
procedures to be followed are provided in the CCTG-595 Pharmacy 
Manual. 
 
5.4 Concomitant Medications 
 
 
Whenever a concomitant medication or study agent is initiated or a dose changed, site 
investigators must review the concomitant medications and study agent’s most recent package 
inserts, Investigator’s Brochures to obtain the most current information on drug interactions, 
contraindications, and precautions.  
 
 
5.4.1 
Prohibited Medications (Refer to Section 4.2 for addition information on 
prohibited medications). 
 
 
 
5.4.1.1  
All investigational drugs 
 
 
 
 
5.4.1.2  
All HIV vaccines 
 
 
 
5.4.1.3  
Any immunomodulators 
 
 
 
5.4.1.4  
Systemic cytotoxic chemotherapy 
 
 
 
5.4.1.5 
All other antiretroviral medications (excluding FTC/TDF 
given as PEP or PrEP) 
 
 
 
5.4.1.6  
Drugs with known nephrotoxicity 
 
 
 


 
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Subjects must have discontinued prohibited medications at least 30 days prior to entry.  
 
5.5 Adherence Assessment 
 
 
Throughout the study, the documentation of adherence to study drug is essential. The 
adherence questionnaire will be completed during each study visit. This will include the ACTG 4-
day adherence questionnaire as well as the VAS over the previous 4 week period, except for the 
week 4 visit where adherence will be assessed since starting medication.  
 
 
6.0 CLINICAL AND LABORATORY EVALUATION 
 
6.1 Schedule of Evaluation 
 
Schedule of Evaluations 
 
Screen 
Study Weeks of Follow-up 
 
 
Within 
30 
days 
0 
4 
12 
24 
or 
72 
36 
or 
60 
or 
84 
48 
or  
96 
End of 
Study or 
premature 
D/C 
Post-
study, 
3-
month  
Suspected 
HIV/STI 
infection4  
Interim 
for 
Missed 
Visit5 
Visit Window 
 
 
± 14 days 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
Medical/Medication 
History 
X 
 
 
 
 
 
 
 
 
 
 
Documentation of HIV 
status by rapid HIV test 
plus NAT or Ag/Ab 
combo assay 
X 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
Pre/Post Assessments1 
 
X 
 
 
 
 
 
X 
 
 
 
iPAD self–administered 
survey2 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Risk reduction 
Counseling 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Review PrEP adherence 
(ACTG 4 day and VAS) 
 
 
X 
X 
X 
X 
X 
X 
 
X 
X 
Clinical Hx of STI and 
PREP use 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Assessment of adverse 
events 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Targeted exam (as 
clinically indicated) 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Concomitant medications 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Dispense TDF/FTC (if 
HIV rapid test negative) 
 
X 
X 
X 
X 
X 
X 
 
 
 
X 
Calcium and vitamin D 
intake 
 
 
 
 
 
X6 
 
 
 
 
 
Phone call follow-up 
 
 
 
 
 
 
 
 
X 
 
 


 
22 of 126 
 
Schedule of Evaluations 
 
Screen 
Study Weeks of Follow-up 
 
 
Within 
30 
days 
0 
4 
12 
24 
or 
72 
36 
or 
60 
or 
84 
48 
or  
96 
End of 
Study or 
premature 
D/C 
Post-
study, 
3-
month  
Suspected 
HIV/STI 
infection4  
Interim 
for 
Missed 
Visit5 
Laboratory 
 
 
 
 
 
 
 
 
 
 
 
CBC/Chemistry 
X 
 
 
 
 
 
 
 
 
 
 
Calculated GFR (serum 
Cr) 
X 
 
X 
X 
X 
X 
X 
X 
 
 
X 
Urine Dipstick 
X 
 
X 
X 
X 
X 
X 
X 
 
 
X 
Rapid HIV Test 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
STI testing- throat, 
rectum, urine; blood 
RPR 
 
X 
 
 
X 
 
X 
X 
 
X 
X 
Rectal swab (x2) 
 
X 
 
 
X7 
 
X7 
 
 
 
 
HBsAg,/HBsAB/HBcAB 
X 
 
 
 
 
 
 
 
 
 
 
If HBsAg-/HBsAB-
/HBcAb+, 
Hepatitis B DNA PCR 
X 
 
 
 
 
 
 
 
 
 
 
HIV RNA, CD4, HIV 
genotype, banked PBMC 
 
X3 
X3 
X3 
X3 
X3 
X3 
X3 
 
X3 
X3 
Plasma banked specimen 
 
X 
X 
X 
X 
X 
X 
X 
 
X3 
X 
Banked clotted blood 
 
X 
 
 
 
 
 
 
 
 
 
Dried blood spot 
 
 
 
X 
X 
X 
X 
X 
 
X3 
X 
Urine for storage 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
1 Pre: attitudes toward safe sex, disclosure, access to care, social support, texting ability, Kalichman sexual 
compulsivity; Post: satisfaction with iTAB; Pre/Post: HIV literacy, stigma and disclosure, AUDIT, DAST-10 
2includes: risk behavior, adherence assessments, intention to adhere, PHQ9, SCID substance use screen 
3 Perform if HIV+ 
4 Any time history or symptoms suggest potential HIV or STI, check with study MD for appropriate test 
5 Subjects may have an interim visit if past window of scheduled visit, next visit should be back to regular schedule 
6 To be performed at week 36 only 
7 Performed only once on or after Week 48 coinciding with STI screening (Week 48, 72, or 96) 
 
6.2 Definitions for Schedule of Events and Timing of Evaluations 
 
 
6.2.1 
Screening Assessments 
 
Occur prior to the subject taking any study medications, treatments, or 
interventions  
 
 
 
Patient Registration: A patient identification number (PID) will be 
assigned to each patient screened for the study. PIDs should not be 
reassigned even if the patient fails to enter the study. The PID must be 
included on every CRF and patient blood sample. Each site must maintain 
a master list of PIDs in a central location. The patient registration and 
inclusion/exclusion CRF must be completed on the online system. 


 
23 of 126 
 
 
 
All subjects interested in screening for the PrEP project will sign an 
informed consent document that had been approved by local IRB at the 
site. Screening procedures (see schedule of evaluations) will include: 
determination of inclusion and exclusion criteria; confirmation of HIV 
status and screen for acute HIV symptoms. HIV serology will be 
performed as part of screening, including rapid HIV test and NAT or 
equivalent (antigen antibody test). Laboratory screening will include CBC, 
chemistry values, GFR (Cockroft-Galt) LFT and HBsAg. If a subject qualifies 
and signs consent the window to complete the baseline assessment and 
start PrEP will be two weeks. 
 
 
6.2.2 
Entry Evaluations (day 0) 
 
Randomization: subjects that meet all the inclusion and exclusion criteria 
will be randomized at their day 0 entry visit.  Subjects will be randomized 
to receive standard of care or the iTAB adherence intervention, stratified 
by site.  Subjects randomized to the iTAB intervention will set up the 
customized text message stems and enter the timing of the text message 
reminders; the information will be entered in the online iTAB system by 
the study coordinator.   
 
At baseline all subjects will receive HIV transmission risk reduction 
counseling by a health educator and detailed information about the use 
of PrEP, including the risks, potential adverse events and the critical 
importance of drug adherence.  
 
 
6.2.3 
On-Study Evaluations 
 
After counseling, laboratory testing and randomization, participants will 
receive sufficient TDF/FTC study medication to last until the next 
scheduled visit (either 4 or 12 weeks) through the investigational 
pharmacy. Medication renewals will not be available if a subject misses a 
scheduled appointment. An informational pamphlet on TDF/FTC will be 
provided that will summarize the label package insert information for 
patients (in English or Spanish) with changes made to tailor the 
information for someone that is not HIV infected. Participants will be 
directed to take one pill once a day at a convenient routine time. If there 
are missed doses, participants will be told to take the next scheduled 
dose on time and not to take any additional pills to catch up. Bottles with 
any remaining missed doses will be returned to the pharmacy at the time 
of medication renewal and the number of untaken doses will be 
recorded. At each clinic visit, TDF/FTC medication adherence will be 


 
24 of 126 
 
reviewed by the clinician, adverse events will be queried and adherence 
and barriers to adherence will be discussed. All subjects will receive 
episodic adherence counseling within the confines of routine clinic visit. 
Each clinic visit will also include blood draw for calculated GFR (serum 
creatinine) and plasma FTC drug levels, and HIV testing. STI testing 
including NAT screening for GC and chlamydia from throat and rectal 
swabs and from urine and RPR from blood will be done at week 0 and 
every 24 weeks thereafter. 
 
 
 
 
Adherence and Behavioral Assessments 
 
We will measure adherence using the ACTG medication adherence 
questionnaire [25]. At each follow-up visit, the ACTG four-day 
questionnaire will be administered using the web-based data capture 
system. The instrument tracks the number of doses skipped over the past 
four days and reasons why medications may have been skipped. In 
addition, we will ask their ability to adhere by Likert scale and use the 
Visual Analog Scale (VAS), which appears as an ordinal scale representing 
the percent of medication taken relative to that which has been 
prescribed over the past 4 weeks. Subjects are presented with a line 
anchored at 0% and 100% and are asked to mark a line on the scale 
indicating their own PrEP adherence [26]. 
 
In the standard study visit, the coordinator will perform HIV testing and 
blood work, review test results, provide TDF/FTC prescriptions, discuss 
medication use, adherence, risk reduction and troubleshoot any barriers. 
The standard behavioral survey will include assessment of TDF/FTC 
adherence, HIV transmission risk behaviors, substance use, depression 
scores and other risk behavior details (e.g. sexual partnerships, sexual 
acts, condom use). 
 
Laboratory Safety Assessments 
 
At follow-up clinic visits, all participants will have a blood drawn for 
creatinine clearance estimates. A rapid test for HIV will be performed. 
HIV test results will be provided during the clinic visit. If there are grade 
3-4 adverse events (thought to be related to study medication- see 
toxicity section) or HIV seroconversion is detected, the participant will be 
called to discontinue TDF/FTC and to come to the clinic as soon as 
feasible. Any positive rapid test will be confirmed by Western Blot and 
HIV RNA; CD4 cell count and an HIV genotype for drug resistance will be 
done. Newly diagnosed HIV subjects will be counseled and be linked to 
HIV clinical care within the existing clinic or to another provider 


 
25 of 126 
 
designated by the participant. All PrEP-related clinic visits, laboratory 
testing and TDF/FTC medication will be provided by the study without 
charge to the subject. 
 
 
 
 
FTC Qualitative Plasma Concentration as an Adherence Marker:  
 
Plasma will be drawn at every visit starting at week 4 for FTC 
concentrations.  Samples will not be run in real time and will not be 
available for clinical use.  
 
 
Chlamydia, gonorrhea and syphilis testing 
 
Subjects will have day 0 and every 24-week assessment to include urine 
and swabs from the rectum and throat for NAT testing for Chlamydia and 
gonorrhea. Blood will be drawn for RPR. In between visits, subjects will 
be told to come to the study nurse if they experience symptoms of an STI. 
They will also be asked if they were tested elsewhere between visits. All 
new STI cases will be referred to their provider or the Department of 
Health for treatment. They will be given a card to have filled out 
documenting treatment given, which they will be asked to bring back to 
their next study visit. All new STI cases will also be counseled on the need 
for partner therapy and will suggest that they receive assessment and 
treatment or partner delivered therapy. STI testing can also occur as an 
interim visit for high-risk exposure or symptoms suggestive of new STI. 
 
 
 
 
Sexual Risk Counseling 
 
Standard of care HIV risk reduction counseling will be providing to all 
participants consistent with pre- and post-test counseling for persons 
receiving community HIV testing. The study will provide streamlined in-
person risk reduction counseling at each visit that will use the RESPECT 
paradigm of focusing on a single risk behavior as identified by the subject. 
The goal of brief and targeted counseling is to help the individual to 
identify his most significant risky behavior and to implement concrete 
actions to decrease the specific risk behavior until the next study visit. 
Participants will undergo this process at each visit. 
 
6.3 Special Instructions and Definitions of Evaluations 
 
 
6.3.1 
Documentation of HIV infected status at screening 
 
The lack of HIV-1 infection will be documented by any licensed screening 
antibody (rapid test plus NAT or Ab/Ag) test. A positive HIV test will be 
confirmed by a second EIA , Western Blot, or HIV RNA viral load.  


 
26 of 126 
 
 
 
6.3.2 
Medical and Laboratory History 
 
At screening, a medical history will be obtained and will be recorded in 
the source documents. The medical history should include any previous 
illnesses that might be consistent with acute HIV infection, history of STI 
and other routine medical conditions. 
 
 
6.3.3 
Medication History 
 
At screening, a medication history (only of those taken within the last 30 
days prior to entry) with actual or estimated start and stop dates will be 
obtained and recorded in the source documents and the concomitant 
medication CRF, including: 
 
 All prescription medications. 
 Non-prescription medications. 
 Alternative therapies and/or dietary supplements. 
 Allergies to any medications and their formulations must be 
documented. 
 
 
6.3.4 
Concomitant Medications 
 
During study visits all antibiotics and other concomitant medications 
taken since the last visit will be recorded in the source documentation 
and entered into the concomitant medication log CRF. 
 
 
6.3.5 
Study Drug Modifications 
 
No modifications of PrEP regimen will be allowed on this study. TDF/FTC 
may be temporarily held for adverse events as per section 7.  TDF/FTC 
should be discontinued if any criteria for stopping are met (see 
discontinuation section). Discontinuation will be documented on the 
TDF/FTC discontinuation CRF. 
 
 
 
6.3.6 
Clinical Assessments  
 
 
 
Targeted Physical Exam 
 
A targeted physical examination will be based on any signs or symptoms 
previously identified that the subject has experienced within 30 days of 
entry or since the last visit. This examination will be performed at all visits 
when indicated. Documentation must include any symptoms consistent 


 
27 of 126 
 
with acute HIV infection.  
 
 
 
Height and Weight 
 
 
 
Height and weight will be measured at study entry. 
 
 
 
 
 
Signs and Symptoms  
 
All signs, symptoms, toxicities and deaths will be documented in the 
subject’s record. At entry, all signs/symptoms experienced within 30 days 
of entry will be recorded on the CRFs. For all other visits including a 
suspected HIV infection visit, all Grade > 1 signs and symptoms will be 
recorded on the CRFs that have occurred since the last visit. Any signs or 
symptoms that lead to a change in treatment, regardless of Grade, will be 
recorded on the CRF. The source document will include date of onset and 
date of resolution, but the CRF will only record prevalence of a given 
adverse event since the previous study visit. 
 
Refer to the ACTG Table for Grading Adult Adverse Experiences. 
 
 
 
Diagnoses 
 
 
 
The following should be recorded on the CRFs: HIV and STI diagnoses, 
malignancies, new medical conditions and death. The source document 
must include date of diagnosis and date of resolution. 
 
 
6.3.7 
Clinical Assessments for Detected STI 
 
 
 
At all visits ask if the participants if they have had an STI in the interim, 
current symptoms. 
 
 
 
6.3.8 
Laboratory Evaluations 
 
 
 
Record all designated laboratory values on the CRFs throughout the 
course of the study. All baseline values, regardless of toxicity, for specific 
laboratories will also be recorded on the laboratory CRF including: WBC, 
neutrophil count, hemoglobin, platelets, creatinine with estimated GFR 
(Cockcroft-Galt formula), glucose, AST/ALT, alkaline phosphotase and 
total bilirubin. All values of creatinine with estimated GFR (Cockcroft-Galt 
Formula) will be recorded in the CRF and performed as per the SOE.  
 
 
 
Any laboratory toxicities that lead to a change in treatment, regardless of 
Grade, will be recorded on the adverse event CRF. 


 
28 of 126 
 
 
 
 
Refer to the Division of AIDS Table for Grading Adult Adverse 
Experiences. 
 
 
6.3.9 
Urinalysis 
 
 
A dipstick urine test will be done at screening and every visit after day 0.  
Protein, glucose and leukocyte esterase will be recorded in the CRF.  
 
 
6.3.10 
T-cell counts and Virology tests  
 
 
 
 
 
Plasma HIV-1 RNA 
 
 
An HIV-1 RNA viral load will be performed at the site’s local laboratory 
within 7 days of a new positive antibody test or NAT. 
 
 
 
An HIV drug resistance test should be performed with detectable viral 
load of greater than 500 copies/mL.  
 
 
 
 
 
CD4 T-cell enumeration will be performed to obtain absolute CD4+/CD8+ 
count and percentages within 7 days of new HIV diagnosis. 
 
 
6.3.11 
Stored Plasma and other specimens 
 
 
 
Stored plasma will be collected at day 0, at all visits and with any new HIV 
diagnosis.  
  
 
 
*Specimens will be stored at the site’s local laboratory and 
batched shipped to the central laboratory (UCSD) after 
completion of the study. 
 
 
6.3.12 
Pharmacokinetic Studies 
 
 
 
 
 
At each visit, record the time and date of the last 3 doses of TDF/FTC 
medication in the CRF. Dried blood spots will be stored at -80 at each visit 
beginning at Week 12 for possible future use for plasma and intracellular 
TFV and FTC pharmacology. 
 
 
6.3.13 
Questionnaires 
 
 
 
 
 
 
At each visit, the subject should complete the self-reported 
questionnaires. 
 
 
6.3.14 
Rectal swabs 
 


 
29 of 126 
 
 
 
At day 0 and at one additional time point on or after Week 48, all 
subjects will have a rectal swab stored for possible future studies of the 
gut microbiome.  These tests will be done in retrospect and not available 
for the subjects. 
 
 
6.3.15 
At day 0, all subjects will have blood stored for future use to examine 
host DNA.  Subjects will sign a consent that informs them of the storage 
of material for possible host genomic testing. 
 
 
6.3.16 
Participants will be asked to recall food items eaten over the last 3 days 
at the week 36 visit. The calculator used in the ACTG 5280 study, which is 
adopted from the USDA database, will be used to quantify vitamin D and 
calcium intake (see Appendix VI). 
 
6.4 Schedule of Evaluations for Subjects On-Study, Off-Medications 
 
 
6.4.1 
At any point, subjects may elect to stop study medications but remain on 
study. Subjects that stay on study but stop medications will not be 
allowed to resume again.  
 
 
 
Subjects will follow the same schedule as defined in Section 6.1 until the 
end of study. Study medications will not be dispensed at clinic visits, and 
evaluations related to counseling or monitoring of medications (including 
urine dipstick and serum creatinine) will not be performed. These include 
Adherence and Risk-reduction counseling and collection of dried blood 
spots. If the subject was randomized to the iTab arm, their account will 
be switched to “inactive.” 
 
STI and HIV rapid test screenings and questionnaires will still be 
administered as the schedule dictates. 
 
6.5 End of Study Visit and Post-study 3-month Follow-up 
 
 
6.5.1 
At the End of Study (EOS) visit, subjects will be asked to complete 
additional questionnaires in addition to completing regular procedures. 
These surveys will assess subjects’ experiences over the course of the 
study including changes in their medical insurance status, access to other 
health services, changes in their perceptions of PrEP and of their own 
health, and their opinions on the intervention.  
 
 
 
Upon completion, subjects will not be dispensed PrEP and will be 
discontinued from the study.  
 


 
30 of 126 
 
 
 
Subjects that express the desire to continue PrEP after completing the 
study will be provided information regarding access and payment 
strategies.  
 
 
6.5.2 
Subjects that complete CCTG 595 will be approached EOS and asked to 
join a supplement-funded extension, consisting of a one-time phone call 
follow-up scheduled for 3 months post-study. The purpose of this 
extension is to examine sexual risk compensation and the impact of 
transition after cessation of study-provided PrEP.  
 
 
 
Written consent will be obtained at EOS; subjects that have already 
completed their EOS visit will be contacted and verbal consent will be 
obtained over the phone.   
 
 
 
At 3 months post-study, subjects will be contacted over the phone and 
asked questions regarding their current HIV status, their ability to access 
and maintain their PrEP regimen after EOS, and their ability to obtain 
health insurance coverage. If subject is off PrEP and/or has no health 
insurance, the subject will be asked for their reasons and possible 
barriers. Subjects will also be asked an abbreviated number of questions 
from surveys similar to those done during the main study, including 
measures assessing risk compensation, perceptions of PrEP efficacy, and 
adherence (if on PrEP).  
 
 
7.0 TOXICITY MANAGEMENT 
 
 
The management of medication related toxicities should be undertaken by the local 
investigators, with guidance available from the protocol team, protocol pharmacist and 
pharmaceutical sponsor, to ensure the optimal safety and efficacy for the individual subject.  
 
7.1 General Management for Grade 1-4 Events 
 
7.1.1  
Grade 1 or 2 
 
Subjects who develop a Grade 1 or 2 adverse event or toxicity may 
continue TDF/FTC without alteration of the dosage, except as noted 
below. Persistent grade 1 or 2 toxicity should be discussed with the 
protocol team. Those subjects experiencing Grades 1 or 2 adverse events 
which results in discontinuation of the TDF/FTC should continue to be 
followed on study, but off study medication.  
 


 
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7.1.2  
Grade 3 
 
 
Management of Grade 3 toxicities should be discussed with the protocol 
team via email. Please refer to the subsequent sections for management 
of specific events.  
 
In the event that a subject develops a symptomatic Grade 3 reaction 
considered to be TDF/FTC-related, the study drug should be discontinued 
and the subject should be followed weekly until resolution of the adverse 
event. Once Grade 3 is resolved the subject should be followed on-study, 
but off study medication. For subjects with asymptomatic Grade 3 toxicity 
or laboratory abnormalities, the protocol team should be consulted for 
possible re-introduction of TDF/ FTC. 
 
7.1.3  
Grade 4 
 
Subjects who develop a Grade 4 adverse event or toxicity judged to be 
TDF/ FTC-related will have the study drug permanently discontinued. For 
other Grade 4 events, if the toxicity or laboratory elevation is thought not 
to be due to TDF/FTC, TDF/FTC may be continued and laboratories 
repeated within 2 weeks (for example for asymptomatic elevation of CPK 
or triglycerides). If it is not possible for the investigator to discern another  
causative agent/ condition or if TDF/FTC could be the causative agent, 
then TDF/FTC must be discontinued. Subjects experiencing Grade 4 
adverse events requiring permanent discontinuation of TDF/FTC therapy 
should be followed weekly until resolution of the adverse event. Once 
Grade 4 is resolved the subject should be followed on-study, but off study 
medication. 
 
7.2 Management for Specific Adverse Events 
 
7.2.1  
Rash 
 
Grade 1 or 2 


 
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TDF/FTC may be continued without interruption. Subjects with a Grade 1 
or 2 rash may be treated symptomatically with permitted antipyretic, 
antihistamine and/or non-steroidal anti-inflammatory medications, but 
should be monitored closely by the local investigator.  
 
Grade 3 or 4 
 
Grade 3 or 4 rash necessitates that TDF/FTC be held unless the rash is 
determined to be unrelated to TDF/FTC. The rash should be followed 
closely for resolution and the subject followed on-study, off study 
medication.  
 
7.2.2              Nausea and Vomiting  
 
Grade 1 or 2 
 
TDF/FTC may be continued without interruption. Subjects with Grade 1 
and 2 nausea or vomiting may be treated symptomatically with permitted 
oral antiemetic therapies or antiemetic suppositories. Subjects will be 
instructed to take medications with food.   
 
Grade 3 or 4 
 
Subjects with Grade 3 TDF/FTC-related nausea and vomiting should 
interrupt TDF/FTC until the toxicity grade returns to Grade < 2 or to 
baseline and be treated symptomatically. After discussion with the 
protocol team and if the subject is willing, the TDF/FTC may be resumed 
when symptoms have resolved.  If Grade 3 nausea and vomiting recurs 
upon the resumption of TDF/FTC despite symptomatic treatment, 
TDF/FTC should be discontinued.  Grade 4 nausea or vomiting will lead to 
permanent discontinuation of drug. Once resolved, the subject should be 
followed on-study, but off study drug.  
 
7.2.3              Diarrhea 
 
Grade 1 or 2 
 
TDF/FTC may be continued without interruption. Subjects with diarrhea 
of any toxicity grade may be treated symptomatically with permitted 
antimotility agents. 
 
Grade 3 or 4 


 
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For grade 3 diarrhea that is unresponsive to antimotility agents and for 
which an alternative etiology (e.g., infectious diarrhea) is not established, 
TDF/FTC should be interrupted until resolution of diarrhea to Grade ≤ 2 
or baseline.  If Grade ≥ 3 diarrhea recurs upon the resumption of study 
medications, TDF/FTC should be permanently discontinued.  Grade 4 will 
lead to permanent discontinuation of study medication.   
  
7.2.4              Hyperglycemia 
 
Fasting hyperglycemia of > 110 to 125 mg/dL is considered evidence of 
impaired glucose tolerance. A fasting blood glucose level above 126 
mg/dL is highly suggestive of diabetes mellitus. Subjects with fasting 
hyperglycemia may continue TDF/FTC at the discretion of the investigator 
but should be discussed with the protocol team via email. A confirmatory 
fasting glucose will be obtained within 4 weeks and prior to the 
institution of medical therapy. Hyperglycemia may be treated with oral 
hypoglycemic agents or insulin according to standard guidelines. 
Abnormal glucose levels will be monitored closely, and further laboratory 
repeats will be at the discretion of the site PI.  
 
7.2.5              AST/ALT Elevations 
 
Grade 1 or 2 
 
TDF/FTC may be continued. Tests should be repeated and reassessed 
within 2 weeks if AST/ALT results are > grade 2  
 
Grade 3  
 
All grade 3 or 4 elevations of AST/ALT should be discussed immediately 
with the protocol team via email. TDF/FTC may be continued for Grade 3 
AST/ALT elevations at the discretion of the site investigator after 
discussion with the protocol team. Careful assessments should be done 
to rule out the use of alcohol, non-study medication-related drug toxicity, 
or viral hepatitis as the cause of the Grade 3 elevation.  
 
             Grade 4 
 
TDF/FTC will be permanently discontinued for AST or ALT Grade 4 
elevations, and the protocol team will be notified. The subject should 
have repeated  AST or ALT evaluations until the levels have returned to < 
grade 2 or baseline.  Once the AE is resolved, the subject should be 


 
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followed on-study, but off study medication. 
 
7.2.6              Creatinine Elevations 
 
TDF/FTC will be discontinued if the creatinine clearance is confirmed to be 
< 50 mL/min. Subjects should be followed as medically indicated until the 
creatinine returns to baseline. The protocol team will be notified within 48 
hours of any permanent therapy discontinuations due to change in 
creatinine clearance.  
 
If the serum creatinine increases more than 0.3 from baseline, the level 
should be repeated in 2 weeks. Elevations in creatinine will be monitored 
closely, and further laboratory repeats will be at the discretion of the site 
PI. 
 
7.2.7              Anemia/Neutropenia 
 
Subjects with Grade 3 anemia or neutropenia attributed to TDF/FTC 
should have all study treatment interrupted until the abnormality returns 
to Grade ≤ 2. Therapy may be resumed after the anemia or neutropenia 
has returned to Grade ≤ 2. If Grade 3 anemia or neutropenia recurs, 
TDF/FTC will be discontinued, and the protocol team will be notified.  
 
Grade 4 anemia or neutropenia will result in permanent discontinuation 
of study medication if it is due to TDF/ FTC.   
 
 
8.0 CRITERIA FOR TREATMENT DISCONTINUATION 
 
8.1 Criteria for Discontinuation from Study 
 
 
8.1.1 
Diagnosis of HIV infection. 
 
 
8.1.2 
Request by the subject to withdraw. 
 
 
8.1.3 
Request of the primary care provider if s/he thinks the study is no longer 
in the best interest of the subject. 
 
 
8.1.4 
Clinical reasons believed life threatening by the study physician, even if 
not addressed in the toxicity management of the protocol, and can no 
longer continue in follow up. 
 
 
8.1.5 
Subject judged by the investigator to be at significant risk of failing to 


 
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comply with the provisions of the protocol as to cause harm to self or 
seriously interfere with the validity of the study results.  
 
 
8.1.6 
At the discretion of the CCTG, FDA, CHRP or pharmaceutical sponsors. 
 
 
8.1.7 
Misses two consecutive scheduled visits prior to 48 weeks. 
 
 
8.1.8 
Misses one scheduled visit after 48 weeks. 
 
 
9.0 STATISTICAL CONSIDERATIONS 
 
 
A formal Statistical Analysis Plan (SAP) will be drafted and finalized prior to database 
lock. The SAP will contain a more detailed and/or comprehensive presentation of statistical 
methods, attention to any changes of substance to planned analysis procedures relative to 
those indicated in the protocol, and is the final authority for all statistical analyses.  The 
following section briefly describes the planned statistical analyses. In case the language in this 
section differs from the language in the SAP, the SAP takes precedence. 
 
9.1 Primary Endpoints 
 
 
Adherent to PrEP through 48 weeks is defined as a composite endpoint of continuing on 
study (made all scheduled visits within window in the 48 week period) and on study medication 
and greater than or equal to 90% adherent to medication defined by self-report of > 18 of 20 
doses of medication on the 5 ACTG adherence questionnaires at weeks 4, 12, 24, 36 and 48.  
Missing adherence forms will be imputed as no doses taken.  
 
9.2 Secondary Endpoints 
 
 
9.2.1 
Adherent to PrEP by FTC measurement at 48 weeks and at the end of 
study follow-up is defined by attending all scheduled visits and having 
detectable FTC.  
 
 
9.2.2 
Adherent to PrEP in continuous follow up is aggregate percentage of self- 
reported ACTG days of adherence where missed schedule visits are 
counted as 0/4 days.  
 
 
 
9.2.3 
Poor adherence is considered those with <90% self-reported adherence 
by ACTG 4 day survey or if discontinued drug. Subgroup analysis should 
explore the endpoint for discontinuation for reasons other than quit drug 
for lack of risk or confirmed adverse event. 
 
 
9.2.4 
Safety and tolerability defined as: i) discontinuation of TDF/ FTC for any 


 
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toxicity; ii) grade 2 or higher adverse event or laboratory toxicity; iii) 
serious adverse event; iv) death 
 
9.3 Randomization and Stratification 
 
 
 
We will conduct an open-label, randomized, controlled, two-arm, clinical strategy trial 
for PrEP adherence. Subjects will be randomized (1:1) to one of two arms: the Standard of Care 
(SoC) or the iTAB enhanced adherence arm. Randomization will be stratified by clinic site.  A 
total of 400 subjects (200 per arm) will be randomized and followed in the study for 48 weeks 
after enrollment of the last subject. 
 
 
Once eligibility and consent are confirmed, randomization will occur using the web-
based CFAR BIT data management system. 
 
9.4 Study Power and Sample Size Justification 
 
 
The primary objective for this study is to compare the proportion of subjects that reach 
the composite endpoint, defined as: continued retention and adherence to PrEP.  Sample size 
calculations were based on a two-sided, two- sample binomial test to compare the differences 
in composite endpoint proportions between the intervention arm and the standard of care 
arm.  Since attrition is a component of the composite endpoint, attrition rates are not used as 
an adjustment in the power calculations. Assuming 200 subjects per group in each of the two 
groups (for a total of 400 subjects) and alpha set to 0.05, we have 94% power to detect a 
difference of 15%, assuming that 30% with a composite endpoint rate in standard of care and 
that 15% with endpoint in the intervention arm. We have 84% power to detect as small a 
difference of 13% between the two groups (i.e., 30% versus 17%).  
 
9.5 Monitoring 
 
 
The study team will review all adverse events during PrEP therapy by cumulative 
reports, both arms combined in aggregate, on a monthly basis.  Adverse events will be graded 
using the ACTG toxicity grading scale and recorded using standard CCTG AE electronic data 
capture. The study investigators will monitor safety events in aggregate on monthly team calls.  
An independent Data Safety and Monitoring Board (DSMB) will not be used for this study.    
 
9.6 Analyses 
 
 
9.6.1  
Statistical Analysis Plan 
 
In general, analyses will incorporate the modified intent-to-treat (mITT) 
principle, namely, all randomized participants dispensed study 
medication will be included in the analysis. The primary analysis 
compares the iTAB enhanced proportion of adherence to the SOC arm. 


 
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For all secondary analyses of interest, no adjustments for multiple 
comparisons will be made and a p-value of 0.05 will be considered 
statistically significant. Demographic and baseline measurement variables 
will be summarized via standard descriptive statistics.  There will be no 
interim analyses for futility or efficacy conducted. 
 
 
9.6.2  
Analysis of Primary Outcome 
 
The primary analysis will use a two-sample binomial test for proportions 
to determine if the intervention arm will produce an improved composite 
endpoint rate compared to the standard of care arm.  Fisher’s exact test 
will be used along with a 95% confidence interval. As a sensitivity 
analysis, the two components of the composite primary endpoint will be 
analyzed separately (retained on PrEP and Adherence > 90%).  A Fisher’s 
exact test will be used to compare rates of study discontinuation 
between the active intervention arm versus standard of care arm. 
 
 
9.6.3  
Analysis of FTC Plasma Concentrations 
 
With repeated qualitative FTC assays in each subject over time, 
adherence will be defined using a continuous and categorical metric.  The 
percent adherence, calculated as number of detectable samples divided 
by total number of samples measured, will be compared between 
intervention and control using a two- sample t-test (or an appropriate 
non-parametric alternative if parametric assumptions fail).  For strict 
mITT analyses, subjects that are missing a FTC concentration at any time 
point (whether due to missed visit or TDF/ FTC discontinuation) will be 
defined as having an undetectable FTC concentration while per protocol 
analyses will consider only available data (i.e., no imputation for missing 
values).  A categorical metric of good adherence (> 90% of concentrations 
detectable) will be compared between intervention and control with the 
Fisher’s exact test.  
 
 
9.6.4  
Analysis of additional Secondary outcomes 
 
The incidence rate of STI will be compared between SOC and ALERT- iTAB 
intervention arms using Fisher’s exact test as will the rate of HIV 
seroconversion between groups (the rate of new HIV is expected to be 
low). In order to evaluate hypothesis 3c (factors associated with the 
composite primary endpoint of on therapy and adherence > 90%), 
multivariable logistic regression models will also be used.  A subgroup 
analysis by treatment arm will be conducted, looking at each arm 
separately.  Descriptive analysis will be performed within each subgroup 


 
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to compare adherent versus non-adherent subjects.  The models will 
include the following potential covariates:  demographics, ongoing 
substance use, untreated mental illness, socioeconomic status, HIV risk 
transmission behaviors, low health/ HIV and system literacy, fear of 
disclosure and non-English.  Further, any covariates (including 
stratification factors) that are simultaneously unbalanced at baseline 
(univariate p <0.10) and associated with the outcome (univariate p<0.15) 
will be included in the model as observed confounders. Sub-group 
analyses based on race/ ethnicity, gender, primary language, 
socioeconomic status by randomization arm will also be conducted.  
Secondary endpoints for adherence will be analyzed analogously to the 
primary endpoint.  
 
 
 
9.6.5 
Safety and tolerability of daily TDF/FTC given for PrEP including 
discontinuation for any adverse event, serious adverse events and 
adverse events (grade 2 or higher) will be compared between study arms.  
Descriptive statistics will be used to characterize safety events.  Fisher’s 
exact test will be used to compare discontinuation rates due to safety 
and incidence rates of adverse events and serious adverse events.  The 
time to TDF/ FTC discontinuation for adverse events will be compared 
between groups using the log-rank test and plotted using Kaplan-Meier 
curves.  Similar analysis will be done for the time to discontinuation for 
any reason (including drop-out or subject electing to stop PrEP due to 
lack of perceived risk for HIV). 
 
 
10.0  PHARMACOLOGY PLAN 
 
10.1 Sample Assay Methods 
 
FTC concentrations will be measured in the Pediatric Clinical Pharmacology Laboratory of 
the University of California, San Diego by a validated, Liquid Chromatography-Mass 
Spectrometry (LC-MS) method. The laboratory is registered with the ACTG Quality 
Assurance/Quality Control proficiency testing program [27] and successfully completes 
proficiency testing for the accuracy and precision of the FTC assay every 6 months. Inter-assay 
variability is less than 6% for low, middle and high controls. The lower limit of detection of FTC 
is approximately 1 ng/mL (the lower limit of quantitation is 11.8 ng/mL). For qualitative assays, 
unknown samples will be measured in the presence of internal standard to determine if the FTC 
ion peak is present (≥ 1 ng/mL) or absent (< 1 ng/mL). Stored plasma samples will be bulk 
testing of qualitative presence of FTC at the end of follow-up.  Additional pharmacology 
analyses will be done in retrospect and the specific analysis will be included in the SAP prior to 
data log and sample testing. 
 


 
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11.0 DATA COLLECTION AND MONITORING AND ADVERSE EVENT REPORTING 
 
11.1 Records to be Kept 
 
 
Case report forms (CRFs) will be provided for each subject. Subjects must not be 
identified by name on any CRFs. Subjects will be identified by the PID provided by the CCTG 
Data Unit upon registration and the linkage to the PID will be kept in paper copy only in a 
locked cabinet in a secure office at the study sites available only to the site investigators.  
 
 
Subject self-reported surveys that are performed electronically will be automatically 
stored in the electronic database secured by the CFAR BIT group for the CCTG. 
  
11.2 Role of Data Management 
 
 
11.2.1 
Instructions concerning the recording of study data on CRFs will be 
provided by the CCTG Data Unit. 
 
 
11.2.2 
It is the responsibility of the CCTG Data Unit to assure the quality of 
computerized data for this study. 
 
11.3 Clinical Site Monitoring and Record Availability 
 
 
11.3.1 
Site monitors provided by the CCTG will visit participating clinical 
research sites to review the individual subject records including consent 
forms, CRFs, supporting data, laboratory specimen records, and medical 
records (e.g., physician progress notes, nursing notes, individual hospital 
charts), to ensure protection of study subjects, compliance with the 
protocol and accuracy and completeness of records. The monitors also 
will inspect sites’s regulatory files to ensure that regulatory requirements 
are being followed. 
 
 
11.3.2 
The investigator will make study documents (e.g., consent forms and 
CRFs) and pertinent hospital or clinic records readily available for 
inspection by the local IRB or the site monitors. 
 
11.4 Serious Adverse Experience (SAE) Reporting 
 
 
Serious adverse events are not expected in this study. All SAEs must be documented on 
the SAE Reporting Form within 5 working days of site awareness of the event and submitted to 
the CCTG Data Unit. 
 
 


 
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12.0 HUMAN SUBJECTS  
 
12.1 Institutional Review Board (IRB) Review and Informed Consent 
 
 
 
This protocol and the informed consent document and any subsequent modifications 
will be reviewed and approved by the IRB or ethics committee responsible for the oversight of 
the study. A signed consent form will be obtained from the subject. The consent form will 
describe the purpose of the study, the procedures to be followed and the risks and benefits of 
participation. A copy of the consent form will be given to the subject. 
 
12.2 Subject Confidentiality 
 
 
All laboratory specimens, evaluation forms, reports, and other records that leave the 
site will be stripped of any patient identifiers (name, birthdate, medical record number) and 
only identified by the coded PID in order to maintain subject confidentiality. All records will be 
kept locked. All computer entry and networking programs will be done with coded numbers 
only and analyzed centrally without any possibility of linking subject identity with subject data. 
Clinical information will not be released without written permission of the subject, except as 
necessary for monitoring by IRB and governmental agencies. 
 
 
12.3 Study Discontinuation 
 
 
The study may be discontinued at any time by the IRB or other government agencies as 
part of their duties to ensure that research subjects are protected. 
 
13.0 PUBLICATION OF RESEARCH FINDINGS 
 
 
Publication of the results of this trial will be governed by CCTG policies. Any 
presentation, abstract or manuscript will be made available for review by pharmaceutical 
supporters prior to submission. 
 
14.0 BIOHAZARD CONTAINMENT 
 
 
As the transmission of HIV and other blood-borne pathogens can occur through contact 
with contaminated needles, blood and blood products; appropriate blood and secretion 
precautions will be employed by all personnel in the drawing of blood and shipping and 
handling of all specimens for this study, as currently recommended by the Centers for Disease 
Control and Prevention and the National Institutes of Health. 
 
 
All infectious specimens will be transported using packaging mandated in the Federal 
Code of Regulations, CDC 42 CFR Part 72. Please also refer to individual carrier guidelines, e.g., 
FedEx, Airborne, for specific instructions. 
 


 
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15.0 REFERENCES 
 
1.     K. HSeal, et al.; A randomized controlled trial of monetary incentives vs. outreach to 
enhance adherence to the hepatitis B vaccine series among injection drug users;  Drug 
Alcohol Depend; 2003 
2.     J. M. FitzGerald, et al.; Use of incentives to increase compliance for TB screening in a 
population of intravenous drug users. Vancouver Injection Drug Use Study Group;  Int J 
Tuberc Lung Dis; 1999 
3.     D. B. Marlowe, et al.; Day treatment for cocaine dependence: incremental utility over 
outpatient counseling and voucher incentives;  Addict Behav; 2003 
4.     L. W. Kimbrough, et al.; Accessing social networks with high rates of undiagnosed HIV 
infection: The social networks demonstration project;  Am J Public Health; 2009 
5.     J. L. Richardson, et al.; Using patient risk indicators to plan prevention strategies in the 
clinical care setting;  Journal of acquired immune deficiency syndromes; 2004 
6.     M. R. Golden, et al.; Peer referral for HIV case-finding among men who have sex with men;  
AIDS; 2006 
7.     S. R. Morris, et al.; Evaluation of an HIV nucleic acid testing program with automated 
Internet and voicemail systems to deliver results;  Ann Intern Med; 2010 
8.     A. S. Klovdahl, et al.; Social networks and infectious disease: the Colorado Springs Study;  
Soc Sci Med; 1994 
9.     R. M. Grant, et al.; Preexposure chemoprophylaxis for HIV prevention in men who have sex 
with men;  N Engl J Med; 2010 
10.     Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men 
who have sex with men;  MMWR Morb Mortal Wkly Rep; 2011 
11.     N. A. Christakis, et al.; Social network sensors for early detection of contagious outbreaks;  
PLoS One; 2010 
12.     S. F. University of California; http://clinicaltrials.gov/ct2/show/NCT01377857;  
13.     M. J. Mimiaga, et al.; Preexposure antiretroviral prophylaxis attitudes in high-risk Boston 
area men who report having sex with men: limited knowledge and experience but 
potential for increased utilization after education;  Journal of acquired immune 
deficiency syndromes; 2009 
14.     D. R. Bangsberg; Preventing HIV antiretroviral resistance through better monitoring of 
treatment adherence;  The Journal of infectious diseases; 2008 
15.     B. Singh, et al.; Alterations in head and neck cancer occurring in HIV-infected patients--
results of a pilot, longitudinal, prospective study;  Acta Oncol; 1999 
16.     E. J. Mills, et al.; Adherence to HAART: a systematic review of developed and developing 
nation patient-reported barriers and facilitators;  PLoS Med; 2006 
17.     A. Ammassari, et al.; Timed Short Messaging Service Improves Adherence and Virological 
Outcomes in HIV-1-Infected Patients With Suboptimal Adherence to Antiretroviral 
Therapy;  Journal of acquired immune deficiency syndromes; 2011 
18.     K. Voigt; Incentives, health promotion and equality;  Health Econ Policy Law; 2010 
19.     N. M. Petry; Contingency management treatments: controversies and challenges;  
Addiction; 2010 


 
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20.     J. Lorvick, et al.; Incentives and accessibility: a pilot study to promote adherence to TB 
prophylaxis in a high-risk community;  J Urban Health; 1999 
21.     D. C. Perlman, et al.; Impact of monetary incentives on adherence to referral for 
screening chest x-rays after syringe exchange-based tuberculin skin testing;  J Urban 
Health; 2003 
22.     Hepatitis B vaccination for injection drug users--Pierce County, Washington, 2000;  
MMWR Morb Mortal Wkly Rep; 2001 
23.     F. Huang, et al.; Concomitant administration of BILR 355/r with emtricitabine/tenofovir 
disoproxil fumarate increases exposure to emtricitabine and tenofovir: a randomized, 
open-label, prospective study;  Basic Clin Pharmacol Toxicol; 2011 
24.     D. A. Parks, et al.; Steady-state amprenavir, tenofovir, and emtricitabine 
pharmacokinetics before and after reducing ritonavir boosting of a 
fosamprenavir/tenofovir/emtricitabine regimen from 200 mg to 100 mg once daily 
(TELEX II);  HIV Clin Trials; 2009 
25.     M. A. Chesney, et al.; Self-reported adherence to antiretroviral medications among 
participants in HIV clinical trials: the AACTG adherence instruments. Patient Care 
Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS 
Clinical Trials Group (AACTG);  AIDS Care; 2000 
26.     K. R. Amico, et al.; Visual analog scale of ART adherence: association with 3-day self-
report and adherence barriers;  J Acquir Immune Defic Syndr; 2006 
27.     D. T. Holland, et al.; Quality assurance program for clinical measurement of 
antiretrovirals: AIDS clinical trials group proficiency testing program for pediatric and 
adult pharmacology laboratories;  Antimicrob Agents Chemother; 2004 
 
 
 
 
 
 
 
 
 
16.0 APPENDICES 
 
 APPENDIX I: SAMPLE OF INFORMED CONSENT 
 
UNIVERSITY OF CALIFORNIA - SAN DIEGO 
CONSENT TO ACT AS A RESEARCH SUBJECT 
 
TITLE: 
CCTG 595: A Multicenter, Randomized Study of Text messaging to improve 
Adherence to PrEP during In Risky MSM (TAPIR)  
 
Drs. Sheldon Morris, Constance Benson, Maile Karris, Scott Letendre, Susan Little,,Jill 
Blumenthal, Richard Haubrich, David Moore, and their associates are conducting a research 


 
43 of 126 
 
study sponsored by the California Collaborative Treatment Group (CCTG) to determine if using 
text-message based adherence interventions can improve retention and adherence to Pre-
exposure Prophylaxis (PrEP) in HIV-negative men who have sex with men (MSM) and male to 
female transgenders who are at high-risk for HIV acquisition.  
Before you can decide whether or not to volunteer for this study, we would like to let you know 
about the study’s purpose, how it may or may not help you, any risks to you, and what is 
expected of you. This process is called informed consent. 
The FDA recently approved a fixed dose combination of tenofovir disoproxil fumarate/ 
emtricitabine (TDF/FTC) to reduce the risk of HIV infection in uninfected individuals who are at 
high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. 
From other studies, we know that the use of PrEP in HIV negative individuals has been shown to 
reduce acquisition of HIV among at-risk individuals. We also know that the more a person takes 
the PrEP medication (called adherence), the more effective it is. 
The purpose of this study is to evaluate a promising method of reinforcing PrEP adherence using 
text message. In this study, we will hope to learn if text message reminders increase PrEP 
adherence. 
You have been asked to participate in this study because you are HIV-negative and are sexually 
active with men and are at ongoing risk for acquiring HIV.  
 
DURATION OF THE STUDY 
The study will enroll about 400 people at all participating sites. We plan to enroll about 250 
subjects at UCSD. If you participate in the study, you have up to 11 visits at the UCSD Antiviral 
Research Center (AVRC) for at least 1 year and up to a maximum of 2 years.  
PROCEDURES 
If you agree to participate in this study, the following will happen: 
To see if it is okay for you to participate in this study, you will first come to the clinic for a study 
visit known as a “screening” visit. At your first visit, this consent form will be reviewed with you 
and you will be asked to sign it.  
Once you sign this form and agree to participate, we will confirm your HIV status, screen for 
symptoms of recent HIV infection and perform a medical/medication history. You will also be 
asked to complete a survey on a computer. Because you will be asked questions about your 
sexual, and drug using history and practices, the computer you will use to complete this survey 
will be in a private location in the clinic. 
Approximately 2-3 tablespoons of blood will be drawn for laboratory tests including blood 
count, chemistry values, liver function and kidney tests, HIV test and Hepatitis B will be 
obtained. 
Your Screening visit will take about 1 to 2 hours. 
Entry Visit: 


 
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The information gathered at your screening study visit will determine if you are able to take part 
in this study. If you qualify for the study, you will return to the clinic for your “entry visit”. At 
your entry visit, you will have the following procedures done: 
 A medical and medication history will be taken. This will include any recent or previous drug 
history and anti-HIV drugs you have taken. 
 Sample will be obtained for the following tests: 
 Screening for sexually transmitted infections (STIs). In addition to the urine and blood 
sample, a throat and rectal swab will need to be done in order to screen for STIs. These 
collected samples and swabs will be tested to see if you have gonorrhea, Chlamydia, or 
syphilis. These samples will be taken at entry and every 24 weeks after your entry visit. . 
 
The test in your throat will be done by inserting a cotton swab (Q-Tip) into your mouth 
and gently turning it to collect the sample.   
 
The test in your rectum will be done by carefully inserting a cotton swab and gently 
turning it to collect the sample.   
 
If your tests show that you have an STI, our study staff will refer you to your medical 
provider for treatment. If you do not have a provider, you will be referred to the public 
health clinic where treatment will be provided at a small fee or free to those who cannot 
afford this fee. According to California state law, study staff are required to give the 
public health department the names, contact information and treatment records of people 
who have a positive test result for chlamydia, gonorrhea or syphilis.  
 Blood to be stored for future study-related tests including the amount of PrEP medicine in 
your blood. 
 An additional sample from your throat and rectum may be taken for future study related 
tests. 
 Approximately 2-3 tablespoons of blood will be drawn at the entry visit. 
At this entry visit, you will be randomized (assigned by chance, like flipping a coin) into one of 
the following two groups. You have an equal chance of being assigned to either group. 
Group 1: PrEP daily, HIV/STI screening, adherence and risk behavior counseling, and safety 
monitoring 
Group 2: PrEP daily, HIV/STI screening, adherence and risk behavior counseling, and safety 
monitoring as well as iTAB text adherence reminders  
The PrEP medicine is TDF/FTC combination pill. At this study, visit Groups 1 and 2 will 
complete a survey that is done on a computer in a location that is private so no one can see the 
answers to any questions you type into the computer. The survey will ask specific question about 
your sex life and recreational drug use. Groups 1 and 2 will receive detailed information about 
the use of PrEP, including the risks, potential adverse events and the importance of drug 
adherence. You will be provided with enough TDF/FTC to last until your next visit. You will be 
instructed to take one pill once a day at a convenient routine time.  


 
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Group 2 will be introduced to the iTAB (Individualized Texting for Adherence Building) system 
by a study worker who will help you select and refine 10 personal reminders from a list of pre-
determined reminders. The study worker will help you to set adherence reminders that are sent at 
times consistent with when you typically take medications. You will be provided with 
information about how the iTAB texting system works. If you are in Group 2 and do not have a 
cell phone, you will be provided with one at this time.  
This study visit will take about 1 - 2 hours. 
 
Clinic Study Visits (Month 1, 3, 6, 9, 12 and every 3 months thereafter) 
You will come to the clinic at 1 month and then every 3 months (3, 6, 9, 12 and every 3 months) 
for a study visit. At these study visits, you will have the following procedures done: 
 A urine sample and approximately 2-3 tablespoons of blood will be drawn for the following 
tests: 
 Laboratory tests including kidney tests and HIV testing. You will find out the results of 
the HIV test during each visit.  
 Screening for sexually transmitted infections (STIs). In addition to the urine and blood 
sample a throat and rectal swabs will need to be done in order to screen for STIs. These 
collected samples and swabs will be tested to see if you have gonorrhea, Chlamydia, or 
syphilis. Samples will be collected as described above. Screening for STI will be done 
every 6 months after your entry visit. 
 Blood to be stored for future study related tests including blood levels of PrEP 
medications.  
 An additional sample from your throat and rectum may be taken for future study related 
tests. 
At your study visits, you will complete a survey done on a computer that is in a location that is 
private so no one can see the answers to any questions you type into the computer.  The survey 
will ask specific question about your sex life, recreational drug use, how well you took your 
PrEP medication and questions about your mood. You will receive risk assessment and 
adherence counseling. Study medication use and adverse events will be reviewed by study 
personnel. 
 
Each study visit will take about 1 hour. 
 
Additional Study Visits 
If at anytime during the study you think you might have gotten an STI because someone you had 
sex with tells you they were diagnosed with one or you are having symptoms that you think are 
those of a STI or acute HIV infection you need to tell your study staff immediately so you can 
get an appointment to be checked. If you come for an additional visit because you think you have 
an STI, tests for STI will be done (blood and urine sample and rectal or throat swabs).  An HIV 
test will be done if you think you were exposed to HIV or if you have symptoms of HIV.   
 


 
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If you have a positive test for HIV during the study, additional blood tests will be done to find 
out the amount of HIV virus in your blood, to check the HIV strain for drug resistance and to 
look at your immune system (T-cell count).  You will be referred for HIV care. 
 
Contact for Future Studies: 
There may be other studies that are being conducted at the AVRC for which you may qualify. 
You may be asked to participate in one or more of these additional studies. Are you willing to be 
contacted for future research studies by our staff?  
 
________YES  
_______NO 
 
Post-study Follow-up 
We would like to follow-up with you after you complete the study. This is a one-time phone call 
3 months after your end of study visit. We will ask about your HIV status, health insurance 
status, and if you were able to obtain PrEP outside of study. We will also ask you questions 
similar to those that you completed over the course of the study on the iPads. Are you willing to 
be contacted for this follow-up visit and provide additional data? 
 
________YES  
_______NO 
 
Subject has been contacted via telephone and verbally agrees to provide additional data after 
completing the study: 
 
________YES  
_______NO 
 
RISKS/DISCOMFORTS: 
Participation in this study may involve some added risks or discomforts. These include: 
Study drug side effects 
You may experience side effects from the study medication which include but are not limited to 
nausea, vomiting, diarrhea, abdominal pain, rash, dizziness, body weakness, fever, weight loss, 
allergic reaction, elevations in liver tests and impairment in kidney function. Any side effect will 
be carefully evaluated and managed according to standard guidelines and may require 
discontinuation of the study drug.  
A small number of people in this study may have these side effects or other side effects that we 
do not know about. However, we will screen your kidney function and overall health before you 
join the study. This will reduce the chances of having any side effects. 
 
Text messaging adherence reminders 
You may feel increased stigma or intrusions of privacy or confidentiality when receiving text 
message reminders to take your medication.  
Drug Resistance 


 
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In previous studies, it was found that a few people became HIV infected despite taking the study 
drug. Should you become HIV infected during the course of the study, there is a very small 
chance that you may develop resistance to the study drug while participating in the study.  
 
Risks of drawing blood 
 
You may experience temporary discomfort from the blood draws. The needlesticks may cause 
local pain, bleeding, bruising and swelling, as well as lightheadedness, dizziness and rarely, 
blockage of the vein, fainting and/or a local infection. 
 
Sexually Transmitted Infections (STIs) 
 
You may experience some anxiety or embarrassment when being tested for sexually transmitted 
infections.  If you are found to have a sexually transmitted disease, an appropriate referral for 
treatment will be made to one of several free public health clinics in your area. 
 
Since this is an investigational study, there may be other unknown risks that are unforeseen or at 
this time cannot be predicted. You will be told of any significant new risks. If you have questions 
concerning the study, ask the study staff. 
Sample Storage 
 
As a result of your participation in this study, you are now being asked to take part in an optional 
part of the study involving the collection of blood and swabs for genetics testing and storage. It is 
up to you to decide whether to participate. 
 
We would like your permission to store some of your blood and swab samples for future DNA 
research. As scientific discoveries are made, valuable research can be done in the future on 
samples collected today. Therefore, we ask your permission to store your DNA sample to allow 
for research to be done in the future. 
If you agree, some of your blood, swabs, and oral specimens that are left over after all required 
study testing is done may be stored for future use for approved research. Your left over blood 
may be stored for an indefinite length of time. Because research using your left over blood will 
be done in the future, you will not be told the results of the research done on these samples. You 
may cancel your permission to store and use your left over blood at any time and still remain in 
this study. 
 
Please indicate below whether or not you agree to have your blood and swabs stored, which was 
obtained as part of this study. All samples will be identified by a number only (your name will 
not be listed on the sample) 
 ________You agree that your left over samples can be used for future HIV/AIDS-related 
(Initials) 
research. 
 
________You do not agree that your left over samples can be used for future HIV/AIDS-related 
(Initials)   
research. 


 
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________You agree that your left over samples can be used for future DNA-related research. 
(Initials) 
 
________You do not agree that your left over samples can be used for future DNA-related 
(Initials)  
 research. 
 
 
STORED SAMPLES 
Some of your blood, swabs, and oral specimens obtained as part of this study will be stored 
indefinitely and may be used for approved HIV/AIDS-related research in the future. You will not 
be identified by name in any testing and your confidentiality will be maintained. Specimens will 
be identified only by an identification number (your name will not be listed on the sample). All 
of the individuals receiving these specimens will be scientific partners in this study. Your blood, 
swabs, and oral specimens and the DNA that it contains may also be used in additional research 
to be conducted by the University of California personnel collaborating in the research. This 
blood, swabs, and/or oral specimens and its derivatives may have significant therapeutic or 
commercial value. You consent to such uses. 
 
The University has policies and procedures to ensure your confidentiality. We will use our best 
efforts to ensure that your identity and test results will not become known outside the research 
program, which if released, could affect your employment and ability to obtain insurance. 
If you decide later that you do not want the specimens collected from you to be used for future 
research, you may tell this to Dr. Morris, who will use his best efforts to stop any additional 
studies. However, in some cases, such as if the material within your samples are found to be 
generally useful, it may be difficult or impossible, to stop such future research once the materials 
have been widely shared with other researchers. Dr. Morris, his associates, or his successors in 
these studies will keep your DNA specimen or the information derived from it indefinitely. 
BENEFITS 
There may or may not be a direct benefit to you from the procedures done as part of this study. 
However, information learned from this study may help the study doctor/staff learn more about 
different ways to help high-risk HIV negative reduce their risk of acquiring HIV.  
 
NEW FINDINGS 
You will be told of any new information learned during the course of the study that might cause 
you to change your mind about staying in the study. At the end of the study, you will be told 
when study results may be available and how to learn about them. 
 
REASONS FOR WITHDRAWAL FROM THE STUDY DRUGS AND/OR STUDY 
WITHOUT YOUR CONSENT: 


 
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You may be removed from the study without your consent for the following reasons: 
 The study is canceled by the California Collaborative Treatment Group (CCTG) the 
sponsors, the UCSD AVRC study doctor, or the UCSD Institutional Review Board (IRB).  
An IRB is a committee that watches over the safety and rights of research subjects; 
 You are unable to keep appointments as required by the study, including missing 2 
consecutive visits before 48 weeks, 1 visit after 48 weeks or discontinuing study drug at 48 
weeks or more 
 You do not start the study treatment. 
 You experience a high level drug toxicity  
 You acquire HIV or viral hepatitis.  
 
ALTERNATIVES TO PARTICIPATION 
You may decide not to take part in this study. The alternatives to participating in this study is to 
receive counseling on HIV prevention and testing for sexually transmitted infections and HIV 
infection from your current primary care doctor.  The study medication TDF/FTC could be 
obtained from your doctor. 
 
COSTS TO YOU 
There is no cost to you for the study-related medications, clinic visits, procedures, examinations, 
or laboratory tests in this study.  The cost of any drugs you may need to treat other medical 
conditions, and any other medical costs for your treatment outside this study, will be the 
responsibility of you or your insurance company. 
As compensation for your time and any inconvenience you may experience as a result of your 
participation in this study, you will receive $10 after you complete your entry and your month 1, 
3, 6, 9, 12 and every 3 months study visits. You will not receive compensation for visits that are 
not completed. If you consent to the phone call follow-up, you will receive $10 for completing 
the interview. 
CONFIDENTIALITY 
Your research records will be confidential to the extent permitted by law. You will be identified 
by a code, and personal information from your records will not be released without your written 
permission. You will not be personally identified in any publication about this study. However, 
your records may be reviewed, under guidelines of the Federal Privacy Act, by Office for Human 
Research Protection (OHRP), study monitors, drug companies supplying the study drugs and 
their designees and the UCSD Institutional Review Board (IRB). 
The University has policies and procedures to ensure your confidentiality. We will use our best 
efforts to ensure that your identity and test results will not become known outside the research 
program. Please talk with your study staff if you have any concern in this issue. 
Because the University of California complies with the requirements of the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA) and its privacy regulations, and all other 
applicable laws that protect your privacy, in addition to this informed consent form, you will be 


 
50 of 126 
 
asked to read and sign the attached HIPAA Authorization Form prior to your participation in this 
research study. 
The U.S. Department of Health and Human Services (DHHS) has issued a Confidentiality 
Certificate to this research project to help protect your identity. This certificate means that 
researchers cannot be forced to release any research data in which you are identified, even under 
court order or subpoena, without your written consent. If we learn something that would 
immediately endanger you or others, we may discuss it with you, if possible, or seek help from 
others to protect you or others. Having a Certificate of Confidentiality does not prevent you from 
releasing information about yourself and your participation in the study. 
Even with the Certificate of Confidentiality, if the study staff learns of possible child abuse 
and/or neglect or a risk of harm to yourself or others, we will be required to tell the proper 
authorities. 
 
A Certificate of Confidentiality does not represent an endorsement of the research study by the 
Department of Health and Human Services or the National Institutes of Health. 
 
RESEARCH-RELATED INJURY 
If you are injured as a direct result of participation in this study, the University of California will 
provide any medical care you need to treat those injuries. Neither the sponsor of the study 
California Collaborative Treatment Group (CCTG), nor the University of California will provide 
any compensation to you if you are injured. You may call the UCSD Human Research Protection 
Program Office at (858) 455-5050 for more information about this, to inquire about your rights 
as a research subject, or to report research-related problems. 
 
PROBLEMS OR QUESTIONS 
Dr. [[Morris]] and/or _____________________________ has explained this study to you and 
answered your questions. If you ever have questions about this research study, or in case of 
research-related problems, you may reach [[Dr. Sheldon Morris at (619) 543-8080]] or an 
AVRC doctor on call at (619) 543-6737 after working hours or in an emergency. 
Participation in this study is entirely voluntary. You may refuse to participate or withdraw at any 
time without jeopardy to the medical care you will receive from this institution or loss of benefits 
to which you are entitled. 
The study purpose, procedures, possible risks and benefits as outlined in this consent have been 
explained to you. You have been invited to ask any questions about the study that you may have, 
and all your inquiries have been answered. You do not give up any of your legal rights by 
signing this form. 
You have received a copy of this document and a copy of the “Experimental Subject’s Bill of 
Rights” to keep. 
 
You agree to participate. 
 
__________________________________________________________ 
Printed Subjects Name  


 
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__________________________________________________________ __________________ 
Subjects Signature 
 
 
 
 
 
 
 
Date 
 
__________________________________________________________ __________________ 
Printed Name of Person Obtaining Consent  
 
 
Date 
 
__________________________________________________________ __________________ 
Signature of Person Obtaining Consent 
 
 
 
 
Date 
 
 
Subject contacted over the phone on ______________ 
 
 
 
 
 
(Date) 
 
 
________________________________________________ 
Printed Name of Person Obtaining Consent Over the Phone 
 
 
________________________________________________ 
Signature of Person Obtaining Consent Over the Phone 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16.0 APPENDICES 
 
APPENDIX II: QUESTIONNAIRES 


 
52 of 126 
 
 
Domain 
Assay 
Header in Survey 
Page 
# of Q’s 
Schedule 
HIV Literacy 
HIVKQ18 
HIV Knowledge 
2 
20 
B, 48, EOS 
Stigma and 
Disclosure 
USC Survey 
Stigma and disclosure 
4 
20 
B, 48, EOS 
Risk Behavior 
Sexual Risk Scale 
Attitude to safe sex 
9 
24 
B 
Partner 
Disclosure 
Provider 
Education 
Milam Survey 
Provider Education 
11 
4 
B 
 
Anatomic Risk 
 
12 
3 
B 
  
Modified State Form 
Sexual risk survey 
12 
13 
All 
Adherence 
ACTG Adherence, 
modified 
PrEP Adherence 
15 
13 
All except 
baseline 
  
Ira Wilson Adherence 
Questions 
4 week medication recall 
19 
5 
All except 
baseline 
  
Visual Analog Scale 
Adherence scale 
20 
4 
All except 
baseline 
Intention to 
Adhere 
VAS Intention 
  
 
 
All visits 
Depression 
PHQ9 
Mood scale 
22 
10 
All 
Substance Use 
AUDIT 
Alcohol use 
23 
10 
B, 48, EOS 
  
DAST-10 
Drug Use 
25 
10 
B, 48, EOS 
  
SCID Screen 
Drug Use 
26 
16 
All 
Access to Care 
Modified USC 
Access to care 
27 
7 
B  
Social Support 
Modified USC 
Social Support 
30 
6 
B 
Technology 
Text Message Ability 
Texting Knowledge 
33 
8 
B 
Sexual 
Compulsivity 
Kalichman; Scale 1 
Sexual Desire 
34 
9 
B, EOS 
  
iTab/PrEP Feedback 
  
35 
15 
48 
 
 
 
 


 
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iPad Header: HIV Knowledge 
Assay: HIVKQ18, BEHKA 
# of Questions: 20 
Time: 
 
Instructions: Please select the most appropriate answer. 
1. Coughing and sneezing DO NOT spread HIV or STD.  
True 
False 
Don’t Know 
 
2. A person can get HIV or STD by sharing a glass of water with someone who has an STD or HIV. 
True 
False 
Don’t Know 
 
3. Pulling out the penis before a man climaxes/cums keeps their partner from getting HIV or STD 
during sex. 
True 
False 
Don’t Know 
 
4. Anyone can get HIV or STD if they have anal sex with a man.  
True 
False 
Don’t Know 
 
5. Showering, or washing one’s genitals/private parts, after sex keeps a person from getting HIV. 
True 
False 
Don’t Know 
 
6. All pregnant women infected with HIV quickly show serious signs of being infected. 
True 
False 
Don’t Know 
 
7. People who have been infected with HIV quickly show serious signs of being infected. 
True 
False 
Don’t Know 
 
8. There is a vaccine that can stop adults from getting HIV.  
True 
False 
Don’t Know 
 
9. People are likely to get HIV by deep kissing, putting their tongue in their partner’s mouth, if 
their partner has HIV. 
True 
False 
Don’t Know 
 
10. A woman cannot get HIV if she has sex during her period.  
True 
False 
Don’t Know 


 
54 of 126 
 
 
11. A condom that can help decrease a chance of getting HIV.  
True 
False 
Don’t Know 
 
12. A natural skin condom works better against HIV than does a latex condom. 
True 
False 
Don’t Know 
 
13. A person will NOT get HIV if she or he is taking antibiotics. 
True 
False 
Don’t Know 
 
 
14. Having sex with more than one partner can increase a person’s chance of being infected with 
an STD or HIV.  
True 
False 
Don’t Know 
 
15. Taking a test for HIV less than one week after having sex will tell a person if he or she has HIV.  
True 
False 
Don’t Know 
 
16. A person can get HIV or STD by sitting in a hot tub or swimming pool with someone who has 
HIV.  
True 
False 
Don’t Know 
 
17. A person can get HIV from oral sex.  
True 
False 
Don’t Know 
 
18. Using Vaseline or baby oil with condoms lowers the chance of getting HIV or STDs. 
True 
False 
Don’t Know 
 
19. Is the goal of treatment to make the ‘CD4 count” go up or down? 
Up 
Down 
 
20. Is the goal of treatment to make the “viral load” go up or down? 
Up 
Down 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
55 of 126 
 
 
 
 
 
 
 
 
 
iPad Header: Stigma and Disclosure 
Assay: Bluthenthal 
# of Questions: 20 
Time: 
 
Instructions: The next set of questions asks about some of your feelings and opinions about HIV/AIDS. 
Please indicate how much you agree or disagree with the following statements: 
 
1. People who have HIV or AIDS should be isolated from the rest of society. 
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
2. People who have HIV or AIDS should only date other HIV positive people.  
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
3. People who have HIV or AIDS are not sexually desirable.  
 
 
 
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
4. People who have HIV or AIDS are more sexually promiscuous than most people.  
 
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 


 
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4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
 
 
5. The promiscuity of people who are gay is the reason why HIV/AIDS exists. 
 
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
 
In the next questions, we will ask you personal beliefs about privacy. For each of the following 
statements, mark the response that best indicates your experience. On the scale, 1 is Disagree Strongly 
and 7 is Agree Strongly. Please be as honest as possible in your responses. 
 
15. I prefer to keep my sexual relationships rather private.  
 
 
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
16. I keep careful controls over who knows about my sexual relationships with men.  
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
17. My sexual behavior is nobody’s business. 
 
 
 
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 


 
57 of 126 
 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
18. If you are not careful who you ask about their HIV status, you can get very hurt.  
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
 
19. I think very carefully before asking about someone’s HIV status.  
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
20. My sexual orientation is a very personal and private matter.  
1 
Strongly disagree 
2 
Disagree 
3 
Neither agree or disagree 
4 
Agree 
5 
Strongly agree 
 
8 
Do not know 
9 
Prefer not to answer 
 
 
 
 
 
 
 
 
 
 


 
58 of 126 
 
 
 
 
 
iPad Header: Attitude to safe sex 
Assay: Sexual Risk Scale 
# of Questions: 24 
Time: 
 
Instructions: Safer sex means sexual activity which reduces the risk of AIDS virus transmission. Using 
condoms is an example of safer sex. Unsafe, risky, or unprotected sex refers to sex without a condom, or 
to other sexual activity which might increase the risk of AIDS virus transmission. For each of the 
following items, please choose the response which best characterizes your opinion. 
 
 
Strongly 
Disagree 
Disagree 
Undecided 
/neutral 
Agree 
Strongly  
Agree 
1. 
If my partner wanted me to have unprotected sex, I would 
probably “give in”. 
1 
2 
3 
4 
5 
2. 
I may have had sex with someone who was at risk for 
HIV/AIDS. 
1 
2 
3 
4 
5 
3. 
If I were to have sex, I would take precautions to reduce my 
risk for HIV/AIDS. 
1 
2 
3 
4 
5 
4. 
I am at risk for HIV/AIDS. 
1 
2 
3 
4 
5 
5. 
I would try and use a condom when I had sex. 
1 
2 
3 
4 
5 
6. 
Condoms interfere with romance. 
1 
2 
3 
4 
5 
7. 
My friends talk a lot about “safer” sex. 
1 
2 
3 
4 
5 
8. 
If my partner wanted me to participate in “risky” sex and I 
said that we needed to be safer, we would probably end up 
having “unsafe” sex.  
 
1 
 
2 
 
3 
 
4 
 
5 
9. 
Generally, I am in favor of using condoms.  
1 
2 
3 
4 
5 
10. 
If a friend knew I might have sex on a date, he/she would ask 
if I were carrying a condom. 
1 
2 
3 
4 
5 
 
 
Strongly 
Disagree 
Disagree 
Undecided 
/neutral 
Agree 
Strongly  
Agree 
11. 
If I had a date, I would probably not drink alcohol or use 
drugs. 
1 
2 
3 
4 
5 
12. 
“Safer sex” reduces the mental pleasure of sex.  
1 
2 
3 
4 
5 


 
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13. 
If I thought that one of my friends had sex on a date, I would 
ask them if they used a condom.  
1 
2 
3 
4 
5 
14. 
The idea of using a condom doesn’t appeal to me. 
1 
2 
3 
4 
5 
15. 
“Safer” sex is a habit for me.  
1 
2 
3 
4 
5 
16. 
If my partner wanted me to participate in “risky” sex and I 
suggested a lower risk alternative, we would have the 
“safer” sex instead.  
1 
2 
3 
4 
5 
17. 
The sensory aspects (smell, touch, etc.) of condoms make 
them unpleasant. 
1 
2 
3 
4 
5 
18. 
I am determined to practice “safer” sex.  
1 
2 
3 
4 
5 
19. 
My sexual experiences do not put me at risk for HIV/AIDS. 
1 
2 
3 
4 
5 
20. 
Condoms are irritating. 
1 
2 
3 
4 
5 
 
 
Strongly 
Disagree 
Disagree 
Undecided 
/Neutral 
Agree 
Strongly 
Agree 
21. 
When I socialize, I usually drink alcohol or use drugs. 
1 
2 
3 
4 
5 
22. 
If a sexual partner didn’t want to use condoms, we would 
have sex without using condoms. 
1 
2 
3 
4 
5 
23. 
People can’t get the same pleasure from “safer” sex as from 
unprotected sex.  
1 
2 
3 
4 
5 
24. 
Using condoms interrupts sex play.  
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
60 of 126 
 
iPad Header: Provider Education 
Assay: Milam 
# of Questions: 4 
Time: 
 
1. Thinking about all the visits you made to your health care provider(s) during the past 3 months, 
how often did you receive any information (got a brochure, saw a poster, spoke with someone) 
about preventing transmission of HIV infection (choose only one answer)? 
 
0 = every visit 
 
1 = most visits 
 
2 = some visits 
 
3 = none of my visits 
 
7 = Don't Know 
 
8 = Refuse to Answer 
 
2. In the last 6 months, how many times have you been to your health care provider for regular, 
scheduled visits for care that addressed HIV prevention  
 
0 = 0 times 
 
1 = 1 time 
 
2 = 2 times 
 
3 = 3 times 
 
4 = 4 or more times 
 
7 = Don't Know 
 
8 = Refuse to Answer 
 
3. Think about these visits.  At how many of these visits did your care provider talk with you about 
you using safer sex, such as condoms? 
 
0 = 0 visits 
 
1 = 1 visit 
 
2 = 2 visits 
 
3 = 3 visits 
 
4 = 4 or more visits 
 
7 = Don't Know 
 
8 = Refuse to Answer 
 
4. Still thinking about these visits.  At how many of these visits did your care provider talk with 
you about asking your sexual partners about their HIV status? 
 
0 = 0 visits 
 
1 = 1 visit 
 
2 = 2 visits 
 
3 = 3 visits 
 
4 = 4 or more visits 
 
7 = Don't Know 
 
8 = Refuse to Answer 
 
 
 
 
iPad Header: Anatomic Baseline RIsks 
Assay: Morris 
# of Questions: 3 
Time: 


 
61 of 126 
 
 
1. Is your penis circumcised? 
0 
No 
1 
Yes 
 
8 
Do not know 
9 
Prefer not to answer 
2. In the past month how frequently have you performed rectal douching or enema (cleaning out your 
rectum or colon)? 
0 
Never 
1 
Rarely (once or twice) 
2 
A few times (less than weekly) 
3 
Fairly regular (about weekly) 
4 
Many times (more than once a week) 
 
8 
Do not know 
9 
Prefer not to answer 
 
3. For rectal douching or enemas in the past month what do you use? (check all that are apply) 
0 
Nothing in past month 
1 
Soapy water enema 
2 
Plain water enema 
3 
Saline (‘Fleet’) enema 
4 
Mineral oil enema 
5 
Polyethylene glycol oral (e.g. Go-Lytely) 
6 
Other enema type 
7 
Other oral colonic cleanser 
 
8 
Do not know 
9 
Prefer not to answer 
 
 
 
 
 
 
 
 
iPad Header: Sexual Risk Survey 
Assay: Modified State form 
# of Questions:13 
Time: 
 


 
62 of 126 
 
Instructions: The following questions ask more questions about the specific sexual activities that you 
have been participated in recently. 
 
1. In the past 3 months, did you talk about safer sex with any of your sexual partners ? 
5 
Never 
6 
Rarely 
7 
Some of the time 
8 
Most of the time 
9 
All of the time 
 
10 
Do not know 
11 
Prefer not to answer 
2. How many of the sexual partners that you had in the past 1 month knew that you were taking 
medicine to prevent HIV transmission? 
0 
None knew 
1 
Some knew 
2 
All knew 
 
8 
Do not know 
9 
Prefer not to answer 
 
3. In the past three month who did you have sex with? (check all that are apply) 
0 
No sex partners 
1 
Men 
2 
Women 
3 
Male to female transgender 
4 
Female to male transgender 
 
 
8 
Prefer not to answer 
 
4. How many male sexual partners have you had in past 3 months: _____ (if  0, skip) 
 
With your male partners  in the past 3 months, did you 
 
4a. Have Anal insertive (your penis in them) sex? (Y/N) (if N, skip) 
How frequently did you use condoms during anal insertive (your penis in them) sex with men in the 
past 3 months? 
 
 
0 
50  
100 
 
Never 
Half of the time 
All the Time 
 
4b. Anal receptive (their penis in you) condom use 
 
 


 
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0  
50  
100 
 
Never 
Half of the time 
All the Time 
 
5. How many transgender sexual partners have you had in past 3 months: _____ 
 
How frequently did you condoms with men in the past 3 months? 
 
5a. Anal insertive (your penis in them) condom use 
 
 
 
0 
50  
100 
 
Never 
Half of the time 
All the Time 
 
5b. Anal receptive (their penis in you) condom use 
 
 
 
 
 
0 
50  
100 
 
Never 
Half of the time 
All the Time 
 
 
 
5. How many female sexual partners have you had in past 3 months: _____ 
 
How frequently did you condoms with females in the past 3 months? 
 
5a. Anal condom use 
 
 
 
 
0  
50  
100 
 
Never 
Half of the time 
All the Time 
 
 
5b. Vaginal condom use 
 
 
 
 
0 
50  
100 
 
Never 
Half of the time 
All the Time 
 
 
 
6. In the last 3 months have you  
 
Given someone money, drugs, or items in exchange for sex? 
 
(yes) (no) 
 
Yourself received money, drugs, or items in exchange for sex? 
 
(yes) (no) 
 
Had sex with someone who injects drugs? 
 
 
 
(yes) (no) 


 
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Had sex with someone who is HIV positive status? 
 
 
(yes) (no) 
 
Had sex with someone who you did not know their HIV status?  
(yes) (no) 
 
7. How frequently did you know the HIV status with partners before having sex in the past three 
months? 
 
 
 
 
 
 
 
 
(never)  
 
 
 
 
 
 
 
 
 
 
(sometimes)  
 
 
 
 
 
 
 
 
 
 
(usually)  
 
 
 
 
 
 
 
 
 
 
(always) 
 
8. We are interested in your condom use if you had anal sex with someone where you did not know 
their HIV status or that you knew their status was HIV positive. 
How frequently did you condoms  (these) partners in the past 3 months when  
8a. having Anal insertive (your penis in them) sex 
 
 
 
0 
50  
100 
 
Never 
Half of the time 
All the Time 
 
8b. when having anal receptive (their penis in you) sex 
 
 
 
 
0 
50  
100 
 
Never 
Half of the time 
All the Time 
 
 
9. Other 
 
10. Did you inject drugs? 
 
 
(yes) (no) 
 
10a. If you inject, did you share needles?  
 
 
 
 
 
 
(not applicable)  
 
 
 
 
 
(never)  
 
 
 
 
 
(sometimes)  
 
 
 
 
 
(usually)  
 
 
 
 
 
(always) 
 
11. In the past three months did you meet a sex partner through any of the following ways (check 
none or all that apply) 
- 
None 
- 
Internet 
- 
Mobile applications 
- 
Bath house 
- 
Bar 
- 
Sex Party 
- 
Other 


 
65 of 126 
 
 
12. Now we want you to think about just the last month. How many male or transgender sex partners 
did you have in the past one month by status: 
 
# of HIV negative (you know status because you discussed) 
_____ 
 
# of HIV positive (you know status because you discussed) 
_____ 
 
# of HIV unknown (you did not discuss HIV status) 
 
_____ 
 
 
13. Please estimate the number of sex acts you have with those partners that were HIV positive or 
unknown status: 
 
# of unprotected anal receptive (their penis in you) acts  
_____ 
 
# of unprotected anal insertive  (your penis in them) acts 
_____ 
 
# of unprotected oral sex acts 
 
 
 
 
_____ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
iPad Header: PrEP Adherence 
Assay: ACTG 4-day recall 
# of Questions:  
Time: 
 
Instructions: Most people with HIV have many pills to take at different times during the day. Many 
people find it hard to always remember pills: 
• 
Some people get busy and forget to take their pills with 
them. 


 
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• 
Some people find it hard to take their pills according to all 
the instructions, such as “with food”, “on an empty stomach”, “every 8 hours”, or 
“with plenty of fluids”. 
• 
Some people choose to skip pills to avoid side effects or to 
just not be taking pills that day. 
We need to understand how people on PrEP are really doing with their pills. Please tell us what you are 
actually doing. Don’t worry about telling us that you don’t take all your pills. We need to know what is 
really happening, not what you think we “want to hear.” 
Complete frequency of drug  
1. How many times a day are supposed to take your PrEP medication? _____ 
 
2. How many pills you supposed to take when you take this drug? ______ 
 
3. Are you currently taking any of your PrEP medication? 
No…………………………………………………………………………………………………..…………………………………………0 
Yes………………SKIP TO QUESTION 6.……………………..………………………………..………………………………….1 
 
4. Why are you not taking your PrEP medication? (CIRCLE ALL THAT APPLY) 
I wanted to avoid the side effects……..………………………………………………………………………………………1 
Not having sex……..……………………………………………………………………………………………..2 
Having sex but do not think you are at risk..……………………..………..…………………………………………….3 
Don’t believe in these medications….………………………………………………………………………………..………4 
 
5. Over the last 4 days, have you not been able to take any of your PrEP medication? 
No……………SKIP TO QUESTION 7………………….…………....................................................................0 
Yes…………………….………………………………………………………..……………………………………………………………..1 
 
6. The next section of the questionnaire asks about the PrEP medication that you have not been 
able take taking over the last four days. When were not able to take your medication (check 
all that apply) 
Yesterday……..…………………………………………………………………………..………………………………………………1 
Day before yesterday ((2 days ago)……..……………………………….…………………………………………………..2 
3 days ago………………………………………………....……………………..………..…………………………………………….3 
4 days ago……………………………………….………………………………………………………………………………..………4 
7. PrEP medication would best be taken at the same time every day. How closely did you take 
the medication at about the same time  over the last four days? 
Never…………………………………………………………………………………………………………………………………………0 
Some of the Time.……………..………………………………………………………………………………………………………1 
About Half of the Time………………………………….……………………………………………………………………………2 
Most of the Time……………………………………………………………………………………………………………………….3 
All of the Time……………………………………………………………………………………………………………………………4 
 


 
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8. Some people find that they forget to take their pills on the weekend days. Were you not able 
to take any of your PrEP medication last weekend—last Saturday and Sunday? 
No………………………………………………………………………………………………………………………………………………0 
Yes……………………………………………………………………………………………………………………………………………..1 
 
9. Including the four days you just described, when was the last time you were not able to take  
your PrEP medication? 
Never missed PrEP medication……………………………………….……………………………….………………………..0 
More than 3 Months Ago…………………………………………………………………………………………………………..1 
1—3 Months Ago…………………………………………….…………………………………………………………………………2 
2—4 Months Ago……………………………………………………………………….………………………………………………3 
1—2 Weeks Ago…………………………………………………………………………………….…………………………………..4 
Within the Past Week………………………………………………………………………………………………………………..5 
 
Instructions: For participant to complete questions 12 and 13. 
10. People may miss taking their medications for various reasons. Here is a list of possible reasons 
why you may miss taking your medications. How often have you missed taking your 
medications because you: 
 
 
Never 
Rarely 
Sometimes 
Often 
A. 
Were away from home? 
1 
2 
3 
4 
B. 
Were busy with other things? 
1 
2 
3 
4 
C. 
Simply forgot? 
1 
2 
3 
4 
D. 
Had too many pills to take? 
1 
2 
3 
4 
E. 
Wanted to avoid side effects? 
1 
2 
3 
4 
F. 
Did not want others to notice 
you taking medication? 
1 
2 
3 
4 
G. 
Had a change in daily routine? 1 
2 
3 
4 
H. 
Felt like the drug was 
toxic/harmful? 
1 
2 
3 
4 
I. 
Fell asleep/slept through dose 
time? 
1 
2 
3 
4 
J. 
Felt sick/ill from side effects? 
1 
2 
3 
4 
K. 
Felt 
depressed/overwhelmed? 
1 
2 
3 
4 
L. 
Had problem taking pills at 
specified time (with meals, on 
empty stomach, etc.?) 
1 
2 
3 
4 
M. Lost medications? 
1 
2 
3 
4 
N. 
Could not obtain 
medications? 
1 
2 
3 
4 
O.  Did not have sex with a HIV 
positive person 
1 
2 
3 
4 


 
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P.  
Did not have sex with anyone 
unknown status 
1 
2 
3 
4 
Q.  Did not have sex with anyone  1 
2 
3 
4 
 
 
 
 
 
 
 
11. In the last 30 days, how good a job did you do at taking Truvada for PrEP in the way you were 
supposed to? 
            o  Very poor 
            o  Poor 
            o  Fair 
            o  Good 
            o  Very good 
            o  Excellent 
  
12. In the last 30 days, how often did you take Truvada for PrEP in the way you were supposed to? 
            o  Never 
            o  Rarely 
            o  Sometimes 
            o  Usually 
            o  Almost always 
            o  Always 
 
13. In the last 30 days, how hard was it for you to take Truvada for PrEP in the way you are 
supposed to? 
            
            o  Extremely hard 
            o  Very hard 
            o  Somewhat hard 
            o  Not very hard 
            o  Not hard at all 
 
 
 
 
 
 
 
 
 
iPad Header: 4 week medication recall 
Assay: Ira Wilson 
# of Questions:  
Time: 
 
Instructions: Please select the most appropriate answer. 
 
1. Thinking about the past 4 weeks, on average, how would you rate your ability to take all of your 
PrEP medication as your doctor prescribed them? 


 
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o  Very poor 
o  Poor 
o  Fair 
o  Good 
o  Very good 
o  Excellent 
 
2. Thinking about the past 4 weeks, how often did you take all of your PrEP medication as your doctor 
prescribed them? 
o  None of the time 
o  A little of the time 
o  A good bit of the time 
o  Most of the time 
o  All of the time 
 
3. Thinking about the past 4 weeks, what percent of the time were you able to take all your PrEP 
medications as your doctor prescribed them? 
0 / 10 / 20 / 30 / 40 / 50 / 60 / 70 / 80 / 90 / 100 
 
4. Place your finger on the bar and slide to the right to indicate your level of adherence over the past 4 
weeks. Zero percent means you have taken no antiretroviral medications, 50% means you have taken 
half of your antiretroviral medications, 100% means you have taken every single dose of your 
antiretroviral medications during the past 4 weeks. 
 
 
 
0 
50  
100 
 
Never 
Half of the time 
All the Time 
 
5. Thinking about the past 7 days, how many Truvada pills did you take? 
o  All of my pills every day 
o  Most of my pills  
o  About one-half of my pills 
o  Very few of my pills 
o  None of my pills 
 
iPad Header: Adherence Scale 
Assay: VAS; Intention 
# of Questions:  
Time: 
 
Instructions: Please put a mark on the line below indicating what percentage of the time over the past 4 
weeks you took your PrEP medication exactly as prescribed on the pill bottle.  
 
1.  
 


 
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0                                                                                                                                  100 
Never                                                                                                                       All the time 
 
Instructions: Score 
 
2. Adherence Aids. Which of the following devices have you used to help you remember to take 
your PrEP medication: 
Not used; No devices   
 
 
 
 
 
 
 
0 
Alarm/watch   
 
 
 
 
 
 
 
 
1 
Calendar  
 
 
 
 
 
 
 
 
 
2 
“Post-it” reminder pad   
 
 
 
 
 
 
 
3 
Pill box   
 
 
 
 
 
 
 
 
 
4 
iTAB texting reminders   
 
 
 
 
 
 
 
5 
Other mobile phone reminder (e.g. phone app.)  
 
 
 
 
6 
Other—explain: 
 
 
 
 
 
 
 
 
7 
Other—explain: 
 
 
 
 
 
 
 
 
8 
 
Instructions: Please put a mark on the line below indicating what percentage of the time over the next 4 
weeks you INTEND to take your PrEP medication exactly as prescribed on the pill bottle.  
 
1.  
 
0                                                                                                                                  100 
Never                                                                                                                       All the time 
 
 
INSTRUCTIONS TO CLINICIAN: Score:  
 
 
 
 
 
Instructions: Please put a mark on the line below indicating what percentage of the time over the next 4 
weeks you think you will actually take your PrEP medication exactly as prescribed on the pill bottle.  
 
1.  
 
0                                                                                                                                  100 
Never                                                                                                                       All the time 
 
 
 
 
 
 


 
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TOTAL 
 
 
INSTRUCTIONS TO CLINICIAN: Score:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
iPad Header: Mood Scale 
Assay: PHQ9 
# of Questions:  
Time: 
 
                                                   
 
 
 
 
Instructions: Over the last 2 weeks how often have you been bothered by any of the following 
problems? 
 
 
 
 


 
72 of 126 
 
 
 
NOT 
AT ALL 
SEVERAL 
DAYS 
MORE 
THAN HALF 
THE DAYS 
NEARLY 
EVERY DAY 
1. Little interest or pleasure in doing things 
0 
1 
2 
3 
2. Feeling down, depressed, or hopeless 
0 
1 
2 
3 
3. Trouble falling or staying asleep, or sleeping too much 
0 
1 
2 
3 
4. Feeling tired or having little energy 
0 
1 
2 
3 
5. Poor appetite or overeating 
0 
1 
2 
3 
6. Feeling bad about yourself — or that you are a failure or 
have let yourself or your family down 
0 
1 
2 
3 
7. Trouble concentrating on things, such as reading the 
newspaper or watching television 
0 
1 
2 
3 
8. Moving or speaking so slowly that other people could have 
noticed? Or the opposite — being so fidgety or restless that 
you have been moving around a lot more than usual 
0 
1 
2 
3 
9. Thoughts that you would be better off dead or of hurting 
yourself in some way 
0 
1 
2 
3 
 
 
 
NOT 
DIFFICULT 
AT ALL 
SOMEWH
AT 
DIFFICULT 
VERY 
DIFFICULT 
EXTREMELY 
DIFFICULT 
10. 
If you checked off any problems, how difficult have 
these problems made it for you to do your work, take 
care of things at home, or get along with other people 
0 
1 
2 
3 
 
 
 
 
 
 
 
 
 
iPad Header: Alcohol Use 
Assay: AUDIT 
# of Questions:  
Time: 
 
Instructions: These are some questions about your use of alcoholic beverages during the past year. By 
alcoholic beverages we mean beer, wine, or liquor (vodka, whiskey, brandy, etc.). 
 
1. How often do you have a drink containing alcohol? 
Never………………………………………………………………………………….………………………………………………………0 
Monthly or less…………………………………………………………………………………………………………………………..1 
2 to 4 times a month…………………………………………………………………………………………….…………………….2 
2 to 3 times a week…………………………………………………………………………………………………………………….3 


 
73 of 126 
 
4 or more times a week………………………………………………………………………………………………………………4 
2. How many drinks of alcohol do you have in a typical day when you are drinking? 
1 or 2…………………………………………………….……………………………………………………………………………………0 
3 or 4……………………………………………………………………….………………………………………………………………….1 
5 or 6…………………………………………………………………………………………………………………………………………..2 
7, 8 or 9………………………………………………………………………………………………………………………………………3 
10 or more………………………………………………………………………………………………………………………………….4 
3. How often do you have six or more drinks on one occasion? 
Never…………………………………………………………………………………………………………………………………………0 
Less than monthly………………………………………………………………………………………………………………………1 
Monthly……………………………………………………………………………………………………………………………………..2 
Weekly……………………………………………………………………………………………………………………………………….3 
Daily or almost daily……………………………………………………………………………………………………………………4 
4. How often during the last year have you found that you were unable to stop drinking once you 
had started? 
Never………………………………………………………………………………………………………………………………………….0 
Less than monthly……………………………………………………………………………………………………………………….1 
Monthly………………………………………………………………………………………………………………………………………2 
Weekly………………………………………………………………………………………………………………………………………..3 
Daily or almost daily……………………………………………………………………………………………………………………4 
5. How often during the last year have you failed to do what was normally expected from you 
because of drinking? 
Never…………………………………………………………………………………………………………………….……………………0 
Less than monthly………………………………………………………………………………………….…………………………..1 
Monthly………………………………………………………………………………………………………………………………………2 
Weekly………………………………………………………………………………………………………………………………………..3 
Daily or almost daily……………………………………………………………………………………………………………………4 
6. How often during the last year have you needed a first drink in the morning to get yourself going 
after a heavy drinking session? 
Never……………………………………………………………………………………………………………………………….…………0 
Less than monthly…………………………………………………………………………………………………….………………..1 
Monthly………………………………………………………………………………………………………………………………………2 
Weekly………………………………………………………………………………………………………………………………………..3 
Daily or almost daily…………………………………………………………………………………………………………………...4 
7. How often during the last year have you had a feeling of guilt or remorse after drinking? 
Never………………………………………………………………………………………………………………………………………….0 
Less than monthly……………………………………………………………………………………………………………………….1 
Monthly………………………………………………………………………………………………………………………………………2 
Weekly………………………………………………………………………………………………………………………………………..3 
Daily or almost daily……………………………………………………………………………………………………………………4 
8. How often during the past year have you been unable to remember what happened the night 
before because you had been drinking? 
Never ..............................................................................................................................................0 
Less than 
monthly............................................................................................................................................1 
Monthly ...........................................................................................................................................2 


 
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Weekly ............................................................................................................................................3 
Daily or almost 
daily................................................................................................................................................4 
9.  Have you or someone else been injured as a result of your drinking? 
No ....................................................................................................................................................0 
Yes, but not in the last year ............................................................................................................2 
Yes, during the last year ..................................................................................................................4 
10. 10. Has a relative, friend, doctor, or other health worker been concerned about your drinking or 
suggested you cut down? 
No ....................................................................................................................................................0 
Yes, but not in the last year ………………………….................................................................................2 
Yes, during the last year…………………...............................................................................................4 
 
 
 
 
 
 
 
 
 
 
 
 
 
iPad Header: Drug Use 
Assay: DAST-10 
# of Questions:  
Time: 
 
Instructions: The following questions concern your use of any illicit drug (e.g. methamphetamine, 
marijuana, non-prescription opiate, cocaine) during the past 12 months. Carefully read each statement 
and decide if your answer is "Yes" or "No". Then, circle the appropriate response “0” for “No” or “1” for 
“Yes”. 
 
Please answer every question. If you have difficulty with a statement, then choose the response that is 
mostly right. 
 
 
THESE QUESTIONS REFER TO THE PAST 12 MONTHS 
NO 
YES 
1. 
Have you used drugs other than required for medical reasons? 
0 
1 


 
75 of 126 
 
2. 
Do you abuse more than one drug at a time? 
0 
1 
3. 
Are you always able to stop using drugs when you want to? 
0 
1 
4. 
Have you had “blackouts” or “flashbacks” as a result of drug use? 
0 
1 
5. 
Do you ever feel bad or guilty about your drug use? 
0 
1 
6. 
Does your spouse/partner (or parents) ever complain about your involvement 
with drugs? 
0 
1 
7. 
Have you neglected your family because of your use of  drugs? 
0 
1 
8. 
Have you engaged in illegal activities in order to obtain drugs? 
0 
1 
9. 
Have you ever experienced withdrawal symptoms (felt sick) when you stopped 
taking drugs? 
0 
1 
10. Have you had medical problems as a result of your drug use (e.g., memory loss, 
hepatitis, convulsions, bleeding, HIV, etc.)? 
0 
1 
 


 
 
76 of 126 
 
 
 
iPad Header: Drug Use 
Assay: SCID Screen 
# of Questions:  
Time: 
 
Instructions: Please select the most appropriate answer. 
 
1. Alcohol 
 
 
 
 
 
 
No 
 
Yes > 5x 
Yes < 4x 
2. Tobacco (e.g., cigarettes, cigars, chew, snuff)  
 
No 
 
Yes > 5x 
Yes < 4x 
3. Marijuana 
 
 
 
 
 
 
No 
 
Yes > 5x 
Yes < 4x 
4. Cocaine / Crack 
 
 
 
 
 
No 
 
Yes > 5x 
Yes < 4x 
5. Methamphetamine (i.e., crystal meth, ice glass) 
 
No 
 
Yes > 5x 
Yes < 4x 
6. Other Stimulants (e.g., amphetamines, ritalin) 
 
No 
 
Yes > 5x 
Yes < 4x 
7. Heroin 
 
 
 
 
 
 
No 
 
Yes > 5x 
Yes < 4x 
8. Other opioids (e.g., vicodin, oxycontin) 
 
 
No 
 
Yes > 5x 
Yes < 4x 
9. Sedatives (e.g., rohypnol, GHB, Quaaludes, etc.) 
 
No 
 
Yes > 5x 
Yes < 4x 
10. Antianxiety drugs (e.g., valium, Xanax, ativan) 
 
No 
 
Yes > 5x 
Yes < 4x 
11. Hallucinogens (e.g., LSD, mushrooms, acid, etc.) 
 
No 
 
Yes > 5x 
Yes < 4x 
12. Dissociative drugs (e.g., PCP, angel dust, ketamine)  
No 
 
Yes > 5x 
Yes < 4x 
13. Inhalants (e.g., nitrous oxide, gasoline, glue, whippits, etc.) No 
 
Yes > 5x 
Yes < 4x 
14. Poppers (e.g., amyl nitrate, butyl nitrate) 
 
 
No 
 
Yes > 5x 
Yes < 4x 
15. Ecstasy (i.e., MDMA, E, X) 
 
 
 
 
No 
 
Yes > 5x 
Yes < 4x 
16. Other: 
 
 
 
 
 
 
No 
 
Yes > 5x 
Yes < 4x 
 
 
 
 
 
 
 
 
iPad Header: Access to care 
Assay: Modified USC 
# of Questions:  
Time: 


 
 
77 of 126 
 
 
 
Instructions: Please select the most appropriate answer. 
 
1. When was the last time you went to a doctor?  
 
___ 
Less than 3 months ago 
 
___ 
3—6 months ago 
 
___ 
6—12 months ago 
 
___ 
More than a year ago 
2. Has anyone helped you get into medical care? (check all that apply)  
 
1 
Nobody 
 
 
2 
Counselor, social worker, case manager, or other lay professional 
 
3 
Doctor, nurse, or other health care professional 
 
4 
Partner (boyfriend/husband, girlfriend/wife) 
 
5 
Family member 
 
6 
Friend 
 
0 
Don’t want to answer 
 
Barriers to Medical Care 
3. Which of the following are barriers that make it difficult for you to make an appointment and see a 
doctor? (check all that apply) 
 
a. 
Don’t know how 
 
b. 
My other health problems interfere 
 
c. 
I don’t have transportation 
 
d. 
Takes too much time 
 
e. 
I forget 
 
f. 
Other things are more important 
 
g. 
I don’t think it will improve my health 
 
h. 
Costs too much 
 
i. 
I am worried about what other people will think or that they will judge me 
 
j. 
I had a bad experience at an HIV clinic 
 
k. 
I don’t trust the medical system 
 
l. 
I prefer alternative treatments 
 
m. 
The clinic is too busy (no appointments available) 
 
n.  
Worries about immigration status or deportation 
 
4. If you have any prescription medication which of the following are barriers that make it difficult for 
you to take any of your MEDICATIONS? (check all that apply) 
 
a.  
Don’t take any medications  


 
 
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b. 
My other health problems interfere 
 
c. 
I don’t have transportation 
 
d. 
Takes too much time 
 
e. 
I forget 
 
f. 
Other things are more important 
 
g. 
I don’t think it will improve my health 
 
h. 
Costs too much 
 
i. 
I am worried about what other people will think or that they will judge me. 
 
j. 
I had a bad experience at an HIV clinic 
 
k. 
I don’t trust the medical system 
 
l. 
I prefer alternative treatments 
 
m. 
The pharmacy is too busy 
 
n. 
Worries about immigration status or deportation 
 
o.  
Don’t know how  
 
5. Have you experienced any of the following fears or concerns when trying to receive health care? 
(check all that apply) 
 
a. 
Fears that people would find out about HIV risk behavior 
 
b. 
Worries that people would find out about your sexual orientation. 
 
c.  
Worries that family members or partners would be upset 
 
d.  
Worries that family members or partners would be upset 
 
e.  
Fears that children would be taken away 
 
f. 
Concerns that health care providers would ask uncomfortable questions 
 
g. 
Worries that providers would ask about drug abuse 
 
h. 
Worries that providers would ask about sexual practices 
 
i. 
Worries about being judged by hospital staff 
 
Potential Facilitators to Care 
6. Which of the following would help you make and keep an appointment with a doctor? (check all 
that  apply). 
a. Money, e.g. $20 at each visit 
b. Food, e.g. a bag of groceries at each visit 
c. Long term housing 
d. Free cell phone service 
e. Transportation to medical care 
f. I don’t need any incentives 
g. TEXT message reminders 
h. Phone call reminders 
i. 
Other: _______________________ 


 
 
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7. Which of the following would help you get and take your medications? (check all that apply)  
a. Don’t take medications 
b. Money, e.g. $20 at each visit 
c. Food, e.g. a bag of groceries at each visit 
d. Long term housing 
e. Free cell phone service 
f. Transportation to medical care 
g. I don’t need any incentives 
h. TEXT message reminders 
i. 
Phone call reminders 
j. 
Other: _______________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
iPad Header: Social Support 
Assay:  
# of Questions:  
Time: 
 
Instructions: For the next set of questions, please think about the different types of support you may 
receive. Please indicate how much you agree or disagree with the following statements. 
 
1.  There is no one I can talk to about the important decisions in my life. (Choose one) 


 
 
80 of 126 
 
 
1 
 Strongly agree 
2 
 Agree somewhat 
3  
Disagree somewhat 
4 
 Strongly disagree 
8 
Prefer Not to Answer 
 
2.  I feel no one respects who I am. (Choose one) 
1 
 Strongly agree 
2 
 Agree somewhat 
3 
 Disagree somewhat 
4 
 Strongly disagree 
8 
 Prefer Not to Answer 
 
3. No one really understands my most private worries and fears. (Choose one) 
1 
 Strongly agree 
2 
 Agree somewhat 
3 
 Disagree somewhat 
4 
 Strongly disagree 
8 
 Prefer Not to Answer 
 
4. There is no one I can depend on to lend me $50 if I needed it for an emergency. (Choose one) 
1 
 Strongly agree 
2 
 Agree somewhat 
3 
 Disagree somewhat 
4 
 Strongly disagree 
8 
 Prefer Not to Answer 
 
5. I often feel isolated and alone. (Choose one) 
1 
 Strongly agree 
2 
 Agree somewhat 
3 
 Disagree somewhat 
4 
 Strongly disagree 
8 
 Prefer Not to Answer 
 
Cell Phone Questions at baseline 
1. Do you have a cell phone? 
a. Yes 
b. No 
2. Does your cell phone have the ability to send/receive text message? 
a. Yes 
b. No 
c. Not sure 
 
2a. If yes, do you send text messages? 
a. Yes 
b. No 
ii. About how often? 


 
 
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a. Hourly 
b. Daily 
c. Weekly 
d. Monthly 
e. Less than monthly 
 
2b. If yes, do you receive text messages? 
a. Yes 
 
b. No 
ii. About how often? 
a. Hourly 
b. Daily 
c. Weekly 
d. Monthly 
e. Less than monthly 
 
3. Does your cell phone have the ability to send/receive instant messages? (ex. Yahoo messenger, 
MSN messenger, or Google chat) 
a. Yes 
b. No 
c. Not sure 
 
3a. If yes, do you send instant messages? 
a. Yes 
b. No 
ii. About how often? 
a. Hourly 
b. Daily 
c. Weekly 
d. Monthly 
e. Less than monthly 
3b. If yes, do you receive instant messages? 
a. Yes 
b. No 
ii. About how often? 
a. Hourly 
b. Daily 
c. Weekly 
d. Monthly 
e. Less than monthly 
4. Can your cell phone run applications (apps)? 
a. Yes 
b. No 
c. Not sure 
 
4a. If yes, do you use them? 
a. Yes 


 
 
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b. No 
 
5. Can your cell phone access the internet? 
a. Yes 
b. No 
c. Not sure 
 
5a. If yes, do you ever browse the internet or use search engines on your phone? 
a. Yes 
b. No 
 
6. Does your cell phone have the ability to send/receive email? 
a. Yes 
b. No 
c. Not sure 
 
 
6a. If yes, do you send emails on your phone? 
a. Yes 
b. No 
 
6b. If yes, do you receive emails on your phone? 
a. Yes 
b. No 
 
7. How long have you had the same cell phone number? 
a. 0-3 months 
b. 3-6 months 
c. 6 months – 1 year 
d. 1-5 years 
e. More than 5 years 
 
8. Has your cell phone service been disconnected in the last 6 months? 
a. Yes 
b. No 
 
 
 
 
iPad Header: Sexual Desire 
Assay: Kalichman 
# of Questions:  
Time: 
 
 
 
NOT AT ALL 
LIKE ME 
SOMEWHAT 
LIKE ME 
OFTEN LIKE 
ME 
VERY MUCH 
LIKE ME 
1. 
I like wild “uninhibited” sexual encounters. 
1 
2 
3 
4 


 
 
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2. 
The physical sensations are the most important thing about 
having sex. 
1 
2 
3 
4 
3. 
I enjoy the sensations of intercourse without a condom. 
1 
2 
3 
4 
4. 
My sexual partners probably think I am a “risk taker”. 
1 
2 
3 
4 
5. 
When it comes to sex, physical attraction is more important to me 
than how well I know the person. 
1 
2 
3 
4 
6. 
I enjoy the company of “sensual” people. 
1 
2 
3 
4 
7. 
I enjoy watching “X-rated” videos. 
1 
2 
3 
4 
8. 
I have said things that were not exactly true to get a person to 
have sex with me. 
1 
2 
3 
4 
9. 
I am interested in trying out new sexual experiences and 
sensations. 
1 
2 
3 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
iPad Header:  
Assay: iTAB PrEP Feedback 
# of Questions:  
Time: 
 
Scale #1-3 
(1) Extremely unsatisfied 
(2) Somewhat unsatisfied 
(3) Neither unsatisfied nor satisfied 
(4) Somewhat satisfied 


 
 
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(5) Extremely satisfied 
1. How would you rate your overall satisfaction of participating in this study? 
2. How satisfied were you with the medication education that you received at your first study visit? 
3. Overall, how satisfied were you with the text messaging intervention? 
 
Scale #4-11 
(1) Not helpful 
(2) A little helpful 
(3) Somewhat helpful 
(4) Very helpful 
(5) Extremely helpful 
4. How helpful was participating in this study?  
5. How helpful was the medication education that you received at your first study visit? 
6. How helpful was the overall text messaging intervention for your medication adherence? 
7. How helpful were the text messages that reminded you to take your medications? 
8. How helpful were the text messages that praised you for taking your medications? 
9. How helpful were the text messages that asked you why you missed a medication dose? 
10. How helpful were the text messages that told you how adherent you were in the past week? 
11. How helpful were the text messages that told you how adherent you would be when you took 
your next dose? 
 
Scale #12-13 
(1) Not at all 
(2) A little bit 
(3) Moderately  
(4) Quite a bit 
(5) Very much 
12. Overall, this experience was pleasant. 
 
13. A text messaging intervention could be helpful to me in the future. 
 
Scale #14-15 
(1) Strongly disagree 


 
 
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(2) Disagree 
(3) Neither disagree nor agree 
(4) Agree 
(5) Strongly agree 
14. I would use a test messaging intervention like this again. 
15. I would opt to continue receiving the text message intervention if offered. 
 
16. Place your finger on the bar and slide to the right to indicate how effective you think PrEP is in 
preventing HIV. Zero percent means PrEP will not prevent HIV infection and 100% means PrEP will 
always prevent HIV infection. 
 
 
 
 
0 
50  
100 
 
Never 
Half of the time 
All the Time 
 
 
 
 
 
 
 
 
 
 
 
 
 
16.0 APPENDICES 
 
APPENDIX III: VITAMIN D SUB-STUDY PROTOCOL 
 
Effect of Vitamin D Supplementation on Bone Turnover Markers during Tenofovir-
Emtricitibine Pre-Exposure Prophylaxis in Men Who Have Sex with Men 
 
A Sub-study of CCTG 595 
 
 
California Collaborative Treatment Group (CCTG) 
 


 
 
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Protocol Chair: 
Michael P. Dube, MD 
 
USC Keck School of Medicine 
 
 
 
 
Investigators: 
Turner Overton, MD  
 
University of Alabama, Birmingham 
 
 
Kathleen Mulligan, PhD  
 
UC San Francisco 
 
Deepa D. Nanayakkara, MD, MS 
USC Keck School of Medicine 
 
Sheldon Morris, MD 
UC San Diego 
 
 
 
Katya Calvo Corado, MD 
Harbor-UCLA Medical Center 
 
Biostatistician: 
Sonia Jain, PhD 
UC San Diego 
 
 
 
 
 
 
 
 
 
Substudy Version 1.0 
3 September 2014 


 
 
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CONTENTS 
 
 
Page 
 
GLOSSARY OF TERMS  
 
 
 
 
 
 
 
 
 pg 3 
SCHEMA 
 
  
 
 
 
 
 
 
 
 
 pg 5 
1.0 STUDY OBJECTIVES AND HYPOTHESES   
 
 
 
 
 
 pg 11 
2.0 INTRODUCTION   
 
 
 
 
 
 
 
 
 pg 12 
3.0 STUDY DESIGN  
 
 
 
 
 
 
 
 
  
 pg 15 
4.0 SELECTION AND ENROLLMENT OF SUBJECTS  
 
 
 
 
 
 pg 17 
5.0 STUDY TREATMENT  
 
 
 
 
 
 
 
 
 pg 19 
6.0 CLINICAL AND LABORATORY EVALUATION  
 
 
 
 
 
 pg 22 
7.0 CLINICAL MANAGEMENT  
 
 
 
 
 
 
 
 pg 30 
8.0 CRITERIA FOR DISCONTINUATION  
 
 
 
 
 
 
 pg 33 
9.0 STATISTICAL CONSIDERATIONS   
 
 
 
 
 
 
 pg 34 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SITES PARTICIPATING IN THE STUDY 
 
University of California at San Diego (UCSD) 
University of Southern California (USC) 
Harbor-University of California at Los Angeles (UCLA) Medical Center   
 
GLOSSARY OF TERMS 


 
 
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AE 
adverse event 
 
AIDS 
acquired immune deficiency syndrome 
 
ART 
antiretroviral therapy or treatment 
 
ARV 
antiretroviral or antiretroviral drug 
 
BMD 
bone mineral density 
 
BTM 
bone turnover marker 
 
CCTG 
California Collaborative Treatment Group 
 
CDC 
Centers for Disease Control and Prevention 
 
CrCl 
creatinine clearance 
 
CRF 
case report form 
 
CTX 
C-terminal telopeptide or carboxy-terminal collagen crosslinks 
(a marker of bone resorption) 
 
CVD 
cardiovascular disease 
 
DAERS 
DAIDS Adverse Event Reporting System 
 
DHHS 
Department of Health and Human Services (US) 
 
EAE  
expedited adverse event 
 
EC 
ethics committee  
 
FDA 
Food and Drug Administration (US) 
 
FTC 
emtricitabine  
 
HAART 
highly active antiretroviral therapy 
 
HIV 
human immunodeficiency virus 
 
IRB 
institutional review board 
 
ITT 
intent to treat 
 
IU 
international unit 
 
LFT 
liver function tests 
 


 
 
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MI 
myocardial infarction 
 
MVI 
multivitamin 
 
NHANES 
National Health and Nutrition Examination Survey 
 
NIH 
National Institutes of Health 
 
P1NP 
total procollagen type 1 N-terminal propeptide (a marker of 
bone formation) 
 
PEP 
post-exposure prophylaxis 
 
PrEP 
pre-exposure prophylaxis  
 
PTH 
parathyroid hormone 
 
QD 
once daily 
 
SAE 
serious adverse event 
 
SID 
study identification number 
 
SOE 
schedule of events 
 
SOP 
standard operating procedure 
 
TDF  
tenofovir disoproxil fumarate (Viread) 
 
ULN 
upper limit of normal 
 
WBC 
white blood cell count 
 
WHO 
World Health Organization 
 


 
 
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SCHEMA 
 
CCTG 595 Vitamin D Sub-study 
 
Effect of Vitamin D Supplementation on Bone Turnover Markers during Tenofovir-
Emtricitibine Pre-Exposure Prophylaxis in Men Who have Sex with Men 
 
 
DESIGN 
CCTG 595 is an open-label clinical trial of the effect of text messaging 
intervention vs. standard of care on adherence to Truvada (tenofovir-
emtricitibine) as PrEP in MSM at increased risk of HIV infection. 
 
 
This sub-study is a matched case-control study, in which cases 
prospectively take vitamin D3 4000 IU/day beginning at week 24 of PrEP.  
 
 
DURATION 
Subjects will be followed for 6 months (24 weeks) 
 
 
SAMPLE SIZE 
50 eligible subjects will receive vitamin D and will be compared to 50 
matched control subjects from CCTG 595 who are not participating in this 
sub-study. 
 
 
POPULATION 
HIV-negative men aged ≥18 years initiating CCTG 595, who are not taking 
bisphosphonates and do not have a history of osteoporosis, fragility 
fracture, or kidney stones, or use of tenofovir prior to entry into CCTG 595 
 
 
REGIMEN  
Vitamin D3 4000 IU/day from week 24 through 48 of PrEP with Truvada 
 
 
ENDPOINTS 
Primary endpoint will be changes in bone turnover markers from week 24 
through week 48 in the vitamin D intervention group as compared to age- 
and BMI-matched controls 
 
 
ANALYSIS 
A sample size of 44 subjects per group will provide 80% power to detect a 
20% change in P1NP means from week 24 through week 48 between 
matched cases and controls using a paired t-test with a two-sided α = 0.05. 
To account for attrition, a sample size of 100 is proposed, including 50 
vitamin D treated cases and 50 matched controls from CCTG 595. 


 
 
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1.0 
HYPOTHESIS AND STUDY OBJECTIVES 
 
1.1 Hypothesis 
 
Supplementation with vitamin D 4000 IU/day will significantly blunt the increases in 
BTMs that occur after initiation of PrEP with Truvada. 
 
1.2 Primary Objective 
 
To compare the change in P1NP levels from week 24 through week 48 among subjects 
(cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched 
unsupplemented controls. 
 
1.3 Secondary Objectives 
 
1.3.1 To compare the change in CTX levels from week 24 through week 48 among 
subjects who receive vitamin D 4000 IU/day to the change in levels seen in 
matched unsupplemented controls. 
 
1.3.2 To compare the change in PTH level from week 24 through week 48 among 
subjects who receive vitamin D 4000 IU/day to the change in levels seen in 
matched unsupplemented controls. 
 
1.3.3 To compare vitamin D levels at week 48 among subjects who receive vitamin D 
4000 IU/day and matched unsupplemented controls. 
 
1.3.4 To demonstrate the change in P1NP, CTX, PTH, and vitamin D levels from 
baseline to week 24 in both cases and controls. 
 
 
2.0       INTRODUCTION 
 
2.1 Background and Rationale 
 
Current HIV treatment guidelines recommend combination antiretroviral therapy with 
three active ARVs and 7 of the 9 currently recommended initial combination regimens for 
ART-naïve patients include tenofovir disoproxil fumarate (TDF) 1. While treatment with 
TDF-containing antiretroviral treatment (ART) regimens have proven durable, tolerable, 
and effective, TDF has well described toxicities,  including greater loss of bone mineral 
density (BMD) in the first 48 weeks after ART initiation and an increased risk for fragility 
fracture 2-4. The FDA recently approved TDF given with emtricitabine (FTC) as a single 
daily fixed dose combination (FDC) pill (Truvada (TDF/FTC)) for Pre-Exposure 
Prophylaxis (PrEP) to prevent HIV acquisition for persons with increased risk for HIV 
infection. In studies evaluating the efficacy of TDF/FTC for PrEP, daily use has been 
shown to significantly reduce BMD 5,6 albeit to a lesser extent than that seen during initial 
treatment for HIV. Although TDF-containing PrEP has not yet been associated with 
increased fracture risk, reduced BMD is nonetheless a concern for patients and 
providers of PrEP. Thus, strategies are needed to attenuate or prevent BMD loss, 
particularly when TDF-containing PrEP will be given for prolonged periods of time. The 
mechanism by which TDF induces BMD loss is unclear but appears to be mediated 


 
 
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through a reduction in PTH levels and PTH-controlled calcium and phosphate 
metabolism 7. Additional data from ATN 063 suggest that TDF induces a state of 
functional vitamin D deficiency 8  
 
Recently, Overton and colleagues reported a dramatic reduction in the magnitude of 
BMD loss during initial therapy of HIV infection with vitamin D (4000 IU/day) and calcium 
supplementation 9 when co-administered with efavirenz/TDF/FTC ART. The amount of 
BMD loss at the hip measured by DXA over 48 weeks with vitamin D-calcium was 
approximately half that seen with placebo (-1.5% vs. -3.2%, respectively, p< 0.001), and 
was reduced to levels that would be expected with ART that does not contain TDF. 
Notably, the median daily vitamin D intake was low for the cohort (120 IU/day) while 
calcium intake approached recommended daily intake (810mg). Thus, these data 
provide a strong rationale to study prophylactic administration of daily oral supplemental 
vitamin D in subjects receiving PrEP with Truvada. 
 
In ACTG 5280, vitamin D-calcium supplementation prevented the increase in parathyroid 
hormone (PTH) and blunted the increase in bone turnover markers (BTMs), including 
P1NP (a marker of bone formation) and CTX (a marker of bone resorption). Importantly, 
there was a good correlation between changes in DXA-measured BMD over time and 
changes in BTMs, particularly with P1NP. The percentage change of P1NP at week 48 
correlated with the percentage change in total hip BMD (r=-0.32, p=0.01) as well as the 
change in lumbar spine BMD (r=-0.37, p=0.002) [Overton ET, unpublished data]. Due to 
the difficulties and expense of performing DXA scans in a clinical trial, P1NP levels are 
proposed as the primary outcome measure for this pilot trial. 
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. 
standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV 
infection (ClinicalTrials.gov Identifier: NCT01761643). Approximately 1/3 of the planned 
400 subjects have been enrolled as of April 2014. Study sites include University of 
California at San Diego, University of Southern California, and Harbor-UCLA Medical 
Center.  
 
Rationale for use of vitamin D dose:  The dose of vitamin D (4000 IU/day) in this protocol 
carries little risk for the study subjects. This dose was without adverse effects in a more 
ill population, namely the HIV-infected subjects in ACTG 5280 (see above). Generally, 
vitamin D supplementation is well tolerated and safe. Dosages up to 10,000 IU daily in 
healthy adults is considered safe and the current upper U.S. Dietary Reference Intake of 
2,000 IU daily is considered to be well below the actual physiologic requirements 10,11. 
The Institutes of Medicine guideline considers 4000 IU/day to be the safe upper limits for 
daily intake for adults http://www.iom.edu/Reports/2010/dietary-reference-intakes-for-
calcium-and-vitamin-D/DRI-values.aspx. Several studies have focused specifically on 
the safety of chronic daily administration of 4000 IU 12-14. In these studies, 228 adult 
subjects received 4000 IU/day vitamin D with excellent tolerability, no toxicity, and a 
concomitant increase in 25 (OH) vitamin D levels ranging from 39-51 ng/mL. No 
abnormalities in serum calcium or urinary calcium excretion were noted.  
 
In this study supplemental calcium will not be used because: a) in ACTG 5280, calcium 
intake among untreated HIV-infected subjects was generally adequate 9. It can be 
anticipated that the largely healthy HIV-uninfected subjects in CCTG 595 will have levels 
of intake that are higher than the diseased population in ACTG 5280. This suggests 
supplemental calcium will not be required for 4000 IU/d vitamin D’s beneficial effects, 


 
 
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particularly in the CCTG 595 subjects; b) there is concern that multiple additional pills a 
day may influence adherence with the primary intervention used in CCTG 595. 
 
 
3.0       STUDY DESIGN 
 
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. 
standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV 
infection (ClinicalTrials.gov Identifier: NCT01761643).  Eligible subjects for this matched 
case control substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 
through week 48.  In CCTG 595, plasma from participants are being collected and stored 
at entry and every 12 weeks.  These plasma samples will be used to measure P1NP, 
CTX, PTH, and vitamin D levels in both cases and controls at entry, week 24, and week 
48. 
 
 
4.0       SELECTION AND ENROLLMENT OF SUBJECTS 
 
4.1 Inclusion Criteria 
 
4.1.1 All subjects must meet CCTG 595 inclusion criteria. 
 
4.2 Exclusion Criteria 
 
4.2.1 All subjects must meet CCTG 595 exclusion criteria. 
 
4.2.2 Current or prior use of bisphosphonate therapy. 
 
4.2.3 Current use of vitamin D supplements greater than 400 IU/day. 
 
4.2.4 Current use of androgenic hormones or growth hormones. 
 
4.2.5 History of nephrolithiasis (kidney stones). 
 
4.2.6   History of fragility fracture.  
 
4.2.7 No use of tenofovir prior to entry into CCTG 595 
 
4.3 Study Enrollment Procedures 
 
Once a candidate for study entry has been identified, details will be carefully discussed 
with the subject. The subject will be asked to read and sign the approved protocol 
consent form. Participation in this substudy is not required for continued participation in 
CCTG 595. 
 
 
5.0 
STUDY TREATMENT  
 
5.1 
Study Product Formulation and Preparation 
 


 
 
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Vitamin D capsules will be supplied as 2000 IU capsules and will be taken as two 
capsules once daily.  Store at 15°-30°C (59°-86°F).  Do not expose to excessive heat or 
moisture. 
 
5.2 Concomitant Medications 
 
All concomitant medications will be recorded on existing CRFs for CCTG 595, with 
particular attention to vitamin D content of dietary supplements. Use of >400 IU of 
vitamin D3 in any dietary supplement (such as a multivitamin) will be prohibited. 
 
 
6.0       CLINICAL AND LABORATORY EVALUATIONS 
 
These will be performed as per the main study.  All assays on subjects and controls will 
be performed on stored samples already being collected by the main study.   
 
The only additional evaluation that will be performed will be calculating the average daily 
dietary intake of vitamin D and calcium from food.  The participants will be asked to 
recall food items eaten over the last 3 days at the week 36 visit, and the calculator used 
in the ACTG 5280 study, which is adopted from the USDA database, will be used to 
quantify vitamin D and calcium intake. 
 
 
7.0 
CLINICAL MANAGEMENT  
 
Instructions are provided only for toxicities related to study therapy (vitamin D).  The 
grading system for drug toxicities is located in the Division of AIDS Table for Grading the 
Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004 
(Clarification dated August 2009), located at the Division of AIDS Regulatory Support 
Center Web Site: http://RSC.tech-res.com/safetyandpharmacovigilance. 
 
For toxicities attributed to vitamin D, investigators may discontinue therapy.  
 
7.1       Toxicity 
 
The general guidelines presented below apply to toxicities that are not specifically 
addressed in section 7.2. 
 
Grade 1 or 2 
Subjects who develop a Grade 1 or 2 AE or toxicity may continue vitamin D without 
alteration of the dosage.  For subjects experiencing Grade 1 or 2 AEs who choose to 
discontinue vitamin D, the site investigator should contact the protocol chair, and 
encourage the subject to complete other aspects of CCTG 595. 
 
NOTE:  If subjects discontinue study therapies due to experiencing Grade 1 or 2 AEs, 
this should be noted in the CRF as the reason for discontinuation.   
 


 
 
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Grade 3 
If the investigator has evidence that the AE was NOT caused by vitamin D, dosing may 
continue. Subjects who develop a Grade 3 AE or toxicity thought to be related to vitamin 
D, should have vitamin D withheld. The subject should be reevaluated weekly until the 
AE returns to Grade ≤2 or baseline, at which time the study therapies may be 
reintroduced, at the discretion of the site investigator or according to standard practice.  
 
If the same Grade 3 AE recurs within 4 weeks of restarting treatment, vitamin D must be 
permanently discontinued. However, if the same Grade 3 AE recurs after 4 weeks, the 
management scheme outlined above may be repeated. 
 
Subjects experiencing a Grade 3 AE requiring permanent discontinuation of vitamin D 
should be followed weekly until resolution of the AE and should be encouraged to 
complete the follow-up protocol study evaluations.  
 
Grade 4 
Subjects who develop a Grade 4 symptomatic AE or toxicity will have vitamin D 
permanently discontinued. Subjects experiencing a Grade 4 AE requiring permanent 
discontinuation of vitamin D should be followed weekly until resolution of the AE and 
encouraged to complete the follow-up protocol study evaluations.   
 
7.2 Specific Management  
 
7.2.1 Kidney Stones 
 
Subjects who develop signs and symptoms consistent with urinary tract 
obstruction should have further evaluation. Subjects with evidence of a new 
kidney stone on study will be taken off vitamin D but continue to be followed on 
study.  
 
 
8.0 
CRITERIA FOR DISCONTINUATION 
 
8.1 Permanent Treatment Discontinuation 
 
• 
Drug-related toxicity 
• 
Requirement for prohibited concomitant medications 
• 
Subject develops a kidney stone (see section 7.3.1). 
• 
Completion of treatment as defined in the protocol. 
• 
Request by subject to discontinue treatment. 
• 
Discontinuation of PrEP for any reason 
• 
Clinical reasons believed serious by the physician, even if not addressed in the 
toxicity section of the protocol. 
 
 
9.0 
STATISTICAL CONSIDERATIONS  
 
9.1       Sample size justification 
 
In ACTG 5280, administration of vitamin D-calcium resulted in a significant reduction in 


 
 
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the magnitude of the rise in BTMs P1NP and CTX 9. Because of more consistent 
association with changes in BMD with P1NP, this will be used as the primary surrogate 
marker to reflect bone health. Data on TDF effects on P1NP levels in the absence of HIV 
infection (e.g. during PrEP) are not available. In A5280, at week 24 P1NP increased by 
60% with placebo and 36% with vitamin D-calcium (p<0.001). If we anticipate that 
supplementation with vitamin D results in a decrease of similar magnitude from week 24 
to week 48, then the expected intervention effect size is in the range of 24%. The SD of 
the change in P1NP at month 6 for the vitamin D-calcium group was 63%, but it is 
anticipated that the variability of P1NP levels in this study will be much less than that in 
HIV infected subjects undergoing a variety of pro- and anti-inflammatory changes after 
initiation of ART as in A5280. If we anticipate that in the absence of vitamin D 
supplementation that P1NP will increase by 20% and those receiving vitamin D will 
experience a reduction of this amount at week 48, then with an SD of the change in 
P1NP of 40%, a sample size of 44 cases and 44 controls will provide 80% power to 
detect a significant difference in the change in P1NP from week 24 to week 48 between 
cases and controls using a paired t-test with a two-sided α=0.05. In order to account for 
attrition, a sample size of 100 is proposed, consisting of 50 vitamin D treated cases and 
50 matched controls. 
 
9.2 Analyses 
 
All analyses are ITT, unless specified otherwise. Evaluable subjects will be individuals 
who agree to participate in the vitamin D substudy. The primary endpoint analysis will 
use a paired t-test to compare the changes in P1NP levels from week 24 to 48 weeks 
between cases and matched controls. Secondary endpoint analyses will include 
comparison of changes in 25-OH vitamin D levels, PTH, and CTX and will be analyzed 
analogously to the primary endpoint.  If parametric assumptions fail, the corresponding 
non-parametric test will be applied, in this case, the Wilcoxon signed rank test.  
Sensitivity analyses will include linear regression models that adjust for possible 
confounding covariates, such as dietary intake. 
 
Matching: Concurrent controls who are not enrolled in the vitamin D substudy who are 
reporting supplementation with < 400 IU of vitamin D/day will be matched 1:1 by 
randomization arm in the CCTG 595 main study (text messaging arm vs. standard of 
care), age (± 5 years), race/ethnicity, season of study entry, and BMI (± 3 kg/m2).   
 
 
 


 
 
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REFERENCES 
 
1. 
DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines 
for the use of antiretroviral agents in HIV-1-infected adults and adolescents. 2014; 
http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 
May 1, 2014. 
2. 
Bedimo R, Maalouf NM, Zhang S, Drechsler H, Tebas P. Osteoporotic fracture risk 
associated with cumulative exposure to tenofovir and other antiretroviral agents. 
AIDS. Apr 24 2012;26(7):825-831. 
3. 
Gallant JE, DeJesus E, Arribas JR, et al. Tenofovir DF, emtricitabine, and efavirenz 
vs. zidovudine, lamivudine, and efavirenz for HIV. New England Journal of 
Medicine. Jan 19 2006;354(3):251-260. 
4. 
McComsey GA, Kitch D, Daar ES, et al. Bone mineral density and fractures in 
antiretroviral-naive persons randomized to receive abacavir-lamivudine or 
tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-
ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect 
Dis. Jun 15 2011;203(12):1791-1801. 
5. 
Liu AY, Vittinghoff E, Sellmeyer DE, et al. Bone mineral density in HIV-negative 
men participating in a tenofovir pre-exposure prophylaxis randomized clinical trial 
in San Francisco. PLoS ONE [Electronic Resource]. 2011;6(8):e23688. 
6. 
Mulligan K, Glidden DV, Gonzales P, et al. Effects of emtricitabine/tenofovir on 
bone mineral density in seronegative men from 4 continents: DEXA results of the 
global iPrex study. 18th CROI. Boston, MA2011:Abstract 94LB. 
7. 
Havens PL, Stephensen CB, Hazra R, et al. Vitamin D3 decreases parathyroid 
hormone in HIV-infected youth being treated with tenofovir: a randomized, 
placebo-controlled trial. Clinical Infectious Diseases. Apr 2012;54(7):1013-1025. 
8. 
Havens PL, Kiser JJ, Stephensen CB, et al. Association of higher plasma vitamin d 
binding protein and lower free calcitriol levels with tenofovir disoproxil fumarate 
use and plasma and intracellular tenofovir pharmacokinetics: cause of a functional 
vitamin D deficiency? Antimicrobial Agents & Chemotherapy. Nov 2013;57(11):5619-
5628. 
9. 
Overton ET, Chan ES, Brown TT, et al. High-Dose Vitamin D and Calcium 
Attenuates Bone Loss With ART Initiation: Results From ACTG A5280. Paper 
presented at: Conference on Retroviruses and Opportunistic Infections; March 
2014, 2014; Boston, MA. 
10. 
Vieth R, Bischoff-Ferrari H, Boucher BJ, et al. The urgent need to recommend an 
intake of vitamin D that is effective. American Journal of Clinical Nutrition. Mar 
2007;85(3):649-650. 
11. 
Mitka M. More evidence on low vitamin D levels fuels push to revise recommended 
intake. JAMA. Dec 16 2009;302(23):2527-2528. 
12. 
Vieth R, Chan PC, MacFarlane GD. Efficacy and safety of vitamin D3 intake 
exceeding the lowest observed adverse effect level. American Journal of Clinical 
Nutrition. Feb 2001;73(2):288-294. 
13. 
Vieth R, Kimball S, Hu A, Walfish PG. Randomized comparison of the effects of the 
vitamin D3 adequate intake versus 100 mcg (4000 IU) per day on biochemical 
responses and the wellbeing of patients. Nutr J. 2004;3:8-18. 


 
 
98 of 126 
 
 
14. 
Hollis BW, Wagner CL. Vitamin D requirements during lactation: high-dose 
maternal supplementation as therapy to prevent hypovitaminosis D for both the 
mother and the nursing infant. American Journal of Clinical Nutrition. Dec 
2004;80(6 Suppl):1752S-1758S. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16.0 APPENDICES 
 


 
 
99 of 126 
 
 
APPENDIX IV: VITAMIN D SUB-STUDY SAMPLE OF INFORMED CONSENT 
 
 
CALIFORNIA COLLABORATIVE TREATMENT GROUP (CCTG) 
 
SAMPLE INFORMED CONSENT 
 
Study Title 
CCTG 595 Substudy: Effect of Vitamin D Supplementation on Bone Turnover 
Markers during Tenofovir-Emtricitibine Pre-Exposure Prophylaxis in Men Who 
Have Sex with Men 
 
 
INTRODUCTION 
 
You are being asked to take part in this research study because you are HIV-negative 
and are sexually active with men and are at ongoing risk for acquiring HIV.  You are 
taking a medication (tenofovir-emtricitibine, also known as Truvada), to reduce risk of 
HIV infection but which may affect your bone health.   
 
This study is sponsored by the California HIV Research Program and receives 
additional funding from Gilead Sciences, the makers of Truvada.  The doctor in charge 
of this study at this site is: (insert name of Principal Investigator).  Before you decide if 
you want to be a part of this study, we want you to know about the study.  
 
This is a consent form. It gives you information about this study.  The study staff will talk 
with you about this information.  You are free to ask questions about this study at any 
time. If you agree to take part in this study, you will be asked to sign this consent form.  
You will get a copy to keep. 
 
 
WHY IS THIS STUDY BEING DONE? 
 
The purpose of this study is to see if taking vitamin D will help prevent the bone loss 
that sometimes happens when people are taking PrEP with Truvada.  The risks seen 
with this vitamin D treatment are the same that you would encounter when taking this 
dose of this vitamin outside of the study.   
 
Vitamin D, which is a nutritional supplement important for bone health, will be provided 
by the study.  
 
 
WHAT DO I HAVE TO DO IF I AM IN THIS STUDY? 
 
Screening and Entry 
If you would like to be in this sub-study, you will already be participating in CCTG 595 


 
 
100 of 126 
 
 
when you are asked to participate in this substudy after you have been taking Truvada 
for 24 weeks. Specifically for this study: 
• You will be asked questions about your medical history and any medications and 
vitamin/mineral supplements you are taking or have taken within the last 30 days. 
• You will be asked questions about your dietary intake. 
• Blood already being drawn as part of the main study will be used to measure the 
amount of vitamin D as well markers of bone formation and breakdown (P1NP, CTX, 
and PTH) in your blood. The results of these tests will not be available until after the 
end of the study. 
 
If you do not enroll into the study: 
If you decide not to take part in this study or if you do not meet the eligibility 
requirements, this will not affect your participation in the main CCTG 595 study.  
 
Study Visits 
No additional study visits are required by this sub-study.  Bottles of vitamin D at a dose 
of 4000 units per day (supplied as two 2000 unit capsules) will be dispensed to you at 
your regular week 24 visit and your week 36 visit. You will be asked to bring your bottles 
of study medications with you to each of your regular visits.  
 
If You Have to Stop Taking Vitamin D Early or You Have to Stop the Study Early 
If you stop taking vitamin D or leave the vitamin D sub-study early due to side effects, 
you may be asked to come to the clinic for an additional study visit. 
• You will have a brief physical exam. 
• You will be asked about your health and any changes in your medicines since your 
last visit. 
 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? 
About 50 people will take part in this study. 
 
HOW LONG WILL I BE IN THIS STUDY? 
 
You will be in this sub-study for about 24 weeks (about 6 months). This will be from your 
regular week 24 visit until your regular week 48 visit. After completion of this sub-study, 
you will continue with the main study. 
 
 


 
 
101 of 126 
 
 
WHY WOULD THE DOCTOR TAKE ME OFF THIS STUDY EARLY? 
The study doctor may need to take you off the study early without your permission if: 
• 
You are not able to attend the study visits as required by the study. 
• 
The study is stopped or canceled. 
• 
You are not able to take vitamin D as required by the study. 
• 
Your primary care physician no longer thinks that participating in the study is in your 
best interest. 
 
The study doctor may also need to take you off vitamin D without your permission if: 
• Continuing vitamin D may be harmful to you. 
• You need a treatment that you may not take while on the study. 
• You develop a fragility fracture. (A fragility fracture is a fracture that occurs after any 
fall from a standing height or less. Our bodies should be able to sustain a fall from 
this height, without a fracture, unless there is some underlying cause like 
osteoporosis. The spine, wrist, and hip are the most common sites for fragility 
fractures.) 
• You develop a kidney stone. 
 
If you must stop taking vitamin D before the study is over, the study doctor may ask you 
to continue to be part of the study and return for some study visits and procedures.  
 
IF I HAVE TO PERMANENTLY STOP TAKING STUDY-PROVIDED VITAMIN D, OR 
ONCE I LEAVE THE STUDY, HOW WOULD DRUGS BE PROVIDED? 
 
During the study: 
If you must permanently stop taking study-provided vitamin D before your study 
participation is over, the study staff will discuss other options that may be of benefit to 
you. 
After the study: 
After you have completed your study participation, the study will not be able to continue 
to provide you with vitamin D that you received on the study. If continuing to take 
vitamin D or similar drugs/agents would be of benefit to you, the study staff will discuss 
how you may be able to obtain them. 
 
WHAT ARE THE RISKS OF THE STUDY? 
Risks of PrEP 
The drug used in this study, Tenofovir-Emtricitibine, also known as Truvada, may have 
side effects, as listed in the CCTG 595 consent form.   
 


 
 
102 of 126 
 
 
Risks of Vitamin D 
• High calcium levels in the blood (muscle weakness, headache, indifference, loss of 
appetite, nausea/vomiting, bone pain, calcium deposits in the tissues of the body, 
kidney disease, high blood pressure, and irregular heartbeats) 
• High calcium levels in urine (kidney stone disease and kidney failure) 
 
NOTE: With the doses of vitamin D provided in the study, the risk of having high calcium 
in blood or urine is low. 
If you have questions concerning side effects of vitamin D, please ask the medical staff 
at your site. 
 
There is a risk of serious and/or life-threatening side effects when non-study 
medications are taken with any of the study drugs.  For your safety, you must tell the 
study doctor or nurse about all medications you are taking before you start the study 
and also before starting any new medications while on the study.  Also, you must tell the 
study doctor or nurse before enrolling in any other clinical trials while on this study. 
 
 
SIGNATURE PAGE 
If you have read this consent form (or had it explained to you), all your questions have 
been answered and you agree to take part in this study, please sign your name below. 
 
 
 
____________________________ 
__________________________________ 
Participant’s Name (print) 
Participant’s Signature and Date 
 
 
_______________________________ ___________________________________ 
Participant’s Legally Authorized  
Participant’s Legally Authorized 
Representative (print)  
Representative’s Signature and Date 
(As appropriate) 
 
 
 
_______________________________ ___________________________________ 
Study Staff Conducting 
Study Staff’s Signature and Date 
Consent Discussion (print)  
 
 
_______________________________ ___________________________________ 
Witness’s Name (print) 
Witness’s Signature and Date 
(As appropriate) 


 
 
103 of 126 
 
 
Appendix V:  Multivitamin Supplement Comparisons 
  
  
  
  
  
  
  
  
Multivitamin Supplement 
  
  
  
  
  
  
Calcium and Vitamin D content 
  
  
  
  
  
  
  
  
  
  
  
  
References 
Drug Facts and Comparisons 
  
  
  
  
  
  
Dietary Supplements Database 
(http://dietarysupplements.nlm.nih.gov) 
  
  
  
  
  
  
  
  
  
  
  
  
Manufacturer/
Brand 
Product 
servings 
Calcium/
serving 
(mg) 
VitD/serving 
(IU) 
  
  
  
  
  
  
  
  
  
21st Century 
Multi Vitamin and Multi Mineral 
Diabetes formula 
3 tablets 
1500 
400.00 
  
  
  
  
  
  
  
  
  
4Life 
CM Super Calcium & Magnesium 
Superiority 
3 tablets 
2000 
400.00 
  
  
  
Multiplex Vitamin & Mineral Formula 
2 tablets 
100 
400.00 
  
  
  
RiteStart Men 
2 tablets 
225 
400.00 
  
  
  
RiteStart Women 
2 tablets 
1100 
400.00 
  
  
  
Transfer Factor 
2 tablets 
200 
400.00 
  
  
  
  
  
  
  
  
  
Alacer 
Emergen C Immune Defense Drink 
Mix 
1 packet 
50 
100.00 
  
  
  
EmerGen-C Kids Multi (various 
flavors) 
1 packet 
63 
400.00 
  
  
  
  
  
  
  
  
  
Albertsons 
Calcium + D 
2 tablets 
1200 
400.00 
  
  
  
  
  
  
  
  
  
Alcon 
I Caps MV Major 
4 tablets 
330 
400.00 
  
  
  
  
  
  
  
  
  
American 
Health 
Chewy Bears Multi Vitamin with 
Calcium 250mg 
2 bars 
250 
400.00 
  
  
  
More Than a Multiple (with or without 
iron) 
3 tablets 
500 
400.00 
  
  
  
Nutri-Mega 
2 
capsules 
400 
400.00 
  
  
  
  
  
  
  
  
  
Amerifit 
Estoven Plus Multi-Vitamin 
1 capsule 
200 
1000.00 
  
  
  
Estroven PM 
1 capsule 
60 
800.00 
  
  
  
Estroven Maximum Strength 
1 capsule 
100 
400.00 
  
  
  
  
  
  
  
  
  
AmeriScience
s 
Childrens Chewable 
1 tablet 
20 
400.00 
  
  
  
Mens Master-Multi 
2 packets 
540 
400.00 
  
  
  
Osteo 
1 tablet 
175 
300.00 
  
  
  
Sleep 
4 tablets 
250 
150.00 
  
  
  
Womens Master-Multi 
1 packet 
585 
400.00 
  
  
  
  
  
  
  
  
  


 
 
104 of 126 
 
 
AN 
Active Womans Formula 
3 tablets 
400 
400.00 
  
  
  
Prenatal Plus 
4 tablets 
800 
400.00 
  
  
  
  
  
  
  
  
  
Anselmo 
Super Multis 
3 tablets 
105 
800.00 
  
  
  
  
  
  
  
  
  
Atkins 
Basic 3 
3 tablets 
50 
200.00 
  
  
  
  
  
  
  
  
  
  
Barefoot Coral Calcium Plus 
3 tablets 
250 
400.00 
  
  
  
  
  
  
  
  
  
Azur Pharm 
Natalle-ez 
1 tablet 
100 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
Bayer 
Citracal Plus Bone Density Builder 
2 tablets 
600 
400.00 
  
  
  
Citracal Plus Heart Health 
1 tablet 
315 
250.00 
  
  
  
Citracal UltraDense Calcium Citrate 
Petites 
2 caplets 
630 
400.00 
  
  
  
Citracal UltraDense Calcium Citrate 
Tablets 
2 tablets 
400 
400.00 
  
  
  
Citracal UltraDense Calcium Citrate 
Plus with Magnesium 
2 tablets 
500 
250.00 
  
  
  
  
  
  
  
  
  
Belvedere 
Healthy Day Multi 
1 tablet  
100 
400.00 
  
  
  
One a Day 
1 tablet  
20 
200.00 
  
  
  
  
  
  
  
  
  
Bionatures 
Advanced Mega Multi 
6 
capsules 
400 
400.00 
  
  
  
Bone Support 
3 
capsules 
500 
200.00 
  
  
  
Coral Calcium Plus - 1000mg 
1 tablet 
715 
200.00 
  
  
  
  
  
  
  
  
  
Biotics 
Aqueous Multi-Plus 
1 tablet 
25 
400.00 
  
  
  
Bio-Multi Plus (all types) 
3 tablets 
200 
400.00 
  
  
  
  
  
  
  
  
  
BodyTech 
Tech X Lite 
1 packet 
300 
240.00 
  
  
  
Tech X Mass Gainer  
1 packet 
500 
200.00 
  
  
  
  
  
  
  
  
  
Breckenridge 
Multifol Tablets 
1 tablet 
125 
400.00 
  
  
  
Vinate GT 
1 tablet 
200 
400.00 
  
RX 
only 
  
Vinate II 
1 tablet 
200 
400.00 
  
RX 
only 
  
Vinate-M 
1 tablet 
200 
400.00 
  
RX 
only 
  
Vinate Calcium 
1 tablet 
125 
400.00 
  
RX 
only 
  
Multifol Plus 
1 tablet 
100 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
Bronson 
Laboratories 
Calcium 600mg with Vitamin D 
4 tablets 
125 
500.00 
  
  
  
Therapeutic Vitamin & Mineral 
Formula 
1 tablet 
100 
400.00 
  
  


 
 
105 of 126 
 
 
  
  
  
  
  
  
  
Brookstone 
BP Prenate 
1 tablet 
100 
425.00 
  
RX 
only 
  
  
  
  
  
  
  
Canopy 
Roads 
Pharmaceutic
als 
CRNatal 
1 tablet 
100 
425.00 
  
RX 
only 
  
  
  
  
  
  
  
Carlson 
Cardi-Rite 
4 tablets 
400 
400.00 
  
  
  
Kids Chewable Vitamins with Minerals 
1 tablet 
50 
400.00 
  
  
  
Liquid Cal Mag 
1 gelcap 
200 
500.00 
  
  
  
Mini-Gel Vitamins & Minerals 
6 gelcaps 
1000 
1200.00 
  
  
  
Mini-Multi Vitamins & Minerals 
1 tablet 
20 
400.00 
  
  
  
Super-1-Daily Vitamins & Minerals 
1 tablet 
50 
400.00 
  
  
  
Super-2-Daily Vitamins & Minerals 
2 tablets 
50 
600.00 
  
  
  
  
  
  
  
  
  
Centrum 
Regular 
1 tablet 
200 
400.00 
  
  
  
Performance 
1 tablet 
100 
400.00 
  
  
  
Silver 
1 tablet 
200 
400.00 
  
  
  
Women's Silver 
1 tablet 
500 
800.00 
  
  
  
Men's Silver 
1 tablet 
250 
600.00 
  
  
  
Chewable 
1 tablet 
108 
400.00 
  
  
  
Cardio 
1 tablet 
54 
200.00 
  
  
  
Advanced 
1 tablet 
162 
400.00 
  
  
  
Ultra Men's Formula 
1 tablet 
210 
600.00 
  
  
  
Ultra Women's Formula 
1 tablet 
500 
800.00 
  
  
  
Kids Complete Chewable (various) 
1 tablet 
108 
400.00 
  
  
  
  
  
  
  
  
  
Country Life 
Chewable Adult Multi 
8 wafers 
480 
400.00 
  
  
  
Daily Total One 
2 wafers 
40 
400.00 
  
  
  
Life Essential Lfe Caps 
8 caps 
320 
400.00 
  
  
  
Max for Men 
4 tablets 
200 
400.00 
  
  
  
Daily Multi Sorb 
2 tablets 
50 
400.00 
  
  
  
Liquid Multi 
30ml 
50 
400.00 
  
  
  
Life Superior Multiple 
3 wafers 
200 
100.00 
  
  
  
  
  
  
  
  
  
Cyclin 
VITa-PMS Plus 
1 tablet 
167 
17.00 
  
  
  
  
  
  
  
  
  
Cypress 
Calcium 600 with D 
1 tablet 
600 
200.00 
  
  
  
Calvite P & D 
1 tablet 
  
120.00 
  
  
  
Prenatal AD 
1 tablet 
200 
400.00 
  
RX 
only 
  
Prenatabs CBF 
1 tablet 
200 
400.00 
  
RX 
only 
  
Prenatab FA 
1 tablet 
200 
400.00 
  
RX 
only 
  
Prenatal 19 (Regular & Chewable) 
1 tablet 
200 
400.00 
  
RX 
only 
  
Prenatabs OBN 
1 tablet 
200 
400.00 
  
RX 
only 
  
Trinate 
1 tablet 
200 
400.00 
  
RX 


 
 
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only 
  
PrenaFirst 
1 tablet 
200 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
Cytosport 
Cytogainer (all flaviors) 
6 scoops 
500 
200.00 
  
  
  
Muscle Milk (all flavors) 
240ml 
1000 
600.00 
  
  
  
  
  
  
  
  
  
Douglas Labs 
FM Support Pack 
1 packet 
250 
50.00 
  
  
  
Pro-PCA Fuel 
4 scoops 
250 
200.00 
  
  
  
Ulta-Ostivone 
4 
capsules 
600 
200.00 
  
  
  
  
  
  
  
  
  
ETHEX 
NutriSpire Tablets 
1 tablet 
200 
400.00 
  
  
  
Prenatal MR 90 FE 
1 tablet 
250 
400.00 
  
RX 
only 
  
NatalCare PIC Forte 
1 tablet 
250 
400.00 
  
RX 
only 
  
Advanced NatalCare 
1 tablet 
200 
400.00 
  
RX 
only 
  
Ultra NatalCare 
1 tablet 
200 
400.00 
  
RX 
only 
  
NatalCare GlossTabs 
1 tablet  
200 
400.00 
  
RX 
only 
  
Advanced-RF NatalCare 
1 tablet 
200 
400.00 
  
RX 
only 
  
Prenatal Z Advance formula 
1 tablet 
200 
400.00 
  
RX 
only 
  
Prenatal RX 1 
1 tablet 
200 
400.00 
  
RX 
only 
  
NataTab CFe 
1 tablet 
200 
400.00 
  
RX 
only 
  
NataTab FA 
1 tablet 
200 
400.00 
  
RX 
only 
  
CareNatal DHA 
1 tablet 
200 
400.00 
  
RX 
only 
  
NatalCare Three 
1 tablet 
200 
400.00 
  
RX 
only 
  
Prenatal MTR with Selenium 
1 tablet 
200 
400.00 
  
RX 
only 
  
NatalCare Plus 
1 tablet 
200 
400.00 
  
RX 
only 
  
NatalCare PIC  
1 tablet 
125 
400.00 
  
RX 
only 
  
Cal-Nate 
1 tablet 
125 
400.00 
  
RX 
only 
  
NatalCare RX 
1 tablet 
100 
200.00 
  
RX 
only 
  
  
  
  
  
  
  
Everett 
Vitafol Caplets 
1 caplet 
125 
400.00 
  
  
  
Vitafol-PN Caplets 
1 caplet 
125 
400.00 
  
  
  
Vitafol-OB Caplets 
1 caplet 
125 
400.00 
  
  
  
Calcifolic-D Wafers 
1 wafer 
125 
300.00 
  
  
  
Vitafol-OB+DHA 
1 tablet 
100 
400.00 
  
Rx 


 
 
107 of 126 
 
 
  
  
  
  
  
  
  
Freeda 
Yelets Teenage Formula 
1 tablet 
60 
400.00 
  
  
  
Monocaps 
1 tablet 
50 
400.00 
  
  
  
Vitalets Chewables 
1 tablet 
80 
200.00 
  
  
  
Quintabs-M 
1 tablet 
30 
400.00 
  
  
  
Ultra-Freeda with Iron 
1 tablet 
83 
133.00 
  
  
  
Ultra-Freeda 
1 tablet 
83 
133.00 
  
  
  
Fem-Cal 
1 tablet 
80 
100.00 
  
  
  
Fem-Cal Citrate 
1 tablet 
60 
80.00 
  
  
  
KPN Prenatal with Extra Calcium 
1 tablet 
333 
133.00 
  
  
  
A-Free Prenatal 
1 tablet 
333 
133.00 
  
  
  
  
  
  
  
  
  
Future 
Biotics 
Calcium Essentials 
6 caps 
900 
100.00 
  
  
  
Hair Skin and Nails 
6 tablets 
1200 
400.00 
  
  
  
MV Teen 
3 
capsules 
100 
400.00 
  
  
  
PMSharmony 
8 tablets 
600 
200.00 
  
  
  
Pressure Lo 
4 tablets 
1000 
300.00 
  
  
  
Vegetarian Super Multi 
6 tablets 
400 
400.00 
  
  
  
Vitomegamen 
3 tablets 
100 
400.00 
  
  
  
Vitomegawomen 
3 tablets 
100 
400.00 
  
  
  
  
  
  
  
  
  
GNC 
ActiveCal 
2 tablets 
1000 
200.00 
  
  
  
Calcimate Plus 800mg 
4 caps 
800 
800.00 
  
  
  
Calcium Citrate Plus 800 
2 caps 
400 
400.00 
  
  
  
Chewable Calcium 600 
1 tablet 
600 
200.00 
  
  
  
Coral Calcium 
4 
capsules 
800 
400.00 
  
  
  
Kids Multibite Plus minerals Chewable 
2 tablets 
30 
400.00 
  
  
  
Kids Vitamin Chews 
1 tablet 
150 
400.00 
  
  
  
Mega Men Sport 
4 
capsules 
400 
400.00 
  
  
  
Mega Teen 
3 tablets 
100 
400.00 
  
  
  
Mens Mega Men 
4 tablets 
400 
400.00 
  
  
  
Mens Mega Men 50 PLUS 
2 
capsules 
200 
400.00 
  
  
  
Men's Mega Multi Time Release 
2 tablets 
200 
1600.00 
  
  
  
Multi Mega Minerals 
2 tablets  
1000 
400.00 
  
  
  
Multi-Gel 
2 gelcaps 
200 
400.00 
  
  
  
Natural Brand Fantastic Fiber 
10gm 
250 
400.00 
  
  
  
Preventron 
4 tablets 
60 
400.00 
  
  
  
Solotron (with or without) 
1 tablet 
60 
400.00 
  
  
  
Solotron Platinum 
2 tablets 
200 
400.00 
  
  
  
Teen Chewable Mega Teen 
2 tablets 
100 
400.00 
  
  
  
Ultra Mega Gold (with or without iron) 
2 tablets 
100 
400.00 
  
  
  
Ultra Mega Green 
2 
capsules 
50 
400.00 
  
  
  
Ultra Mega Timed Release 
2 tablets 
100 
400.00 
  
  
  
Ultra Mega Two Timed Release (with 
or without iron) 
2 tablets 
50 
400.00 
  
  
  
Women's Mega Multi Time Release 
2 tablets 
200 
1600.00 
  
  


 
 
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Women's Prenatal without Iron 
2 tablets 
500 
400.00 
  
  
  
Womens Ultra Mega 
2 
capsules 
500 
400.00 
  
  
  
  
  
  
  
  
  
Garden of 
Life 
Living Calcium Advanced 
3 
capsules 
500 
300.00 
  
  
  
Living Multi Optimal Womens formula 
6 
capsules 
400 
200.00 
  
  
  
Vitamin Code 50 & Wiser Women 
4 
capsules 
50 
1000.00 
  
  
  
Vitamin Code Men 
4 
capsules 
20 
400.00 
  
  
  
  
  
  
  
  
  
GlaxoSmithKl
ine 
Geritol Complete 
1 tablet 
148 
400.00 
  
  
  
Fiber Choice Chewable 
1 tablet 
100 
50.00 
  
  
  
Os-Cal Ultra 
1 caplet 
600 
500.00 
  
  
  
Os-Cal Chewable 
1 caplet 
500 
600.00 
  
  
  
Oscal-D 
1 caplet 
500 
200.00 
  
  
  
Oscal Extra D 
1 caplet 
500 
600.00 
  
  
  
Oscal 500 + D 
1 tablet or 
1 
chewable 
500 
400.00 
  
  
  
  
  
  
  
  
  
Goldline 
Therapeutic Tablets 
1 tablet 
400 
400.00 
  
  
  
Calcarb 600 with Vitmain D 
1 tablet 
600 
200.00 
  
  
  
Oyst-Cal-D 
1 tablet 
200 
125.00 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Health HNS Fat Cutter 
4 tabs 
600 
400.00 
  
  
  
  
  
  
  
  
  
  
Healthy N Fit Nutri Pack 
1 tablet 
1000 
400.00 
  
  
  
  
  
  
  
  
  
Hawthorne 
ICAR Prenatal Therapy 
1 tablet 
600 
200.00 
  
RX 
only 
  
  
  
  
  
  
  
Health Sense 
Once Daily 
1 tablet 
400 
400.00 
  
  
  
Complete Senior 
1 tablet 
200 
400.00 
  
  
  
  
  
  
  
  
  
Hero 
Nutritionals 
Vegetarian Calcium with Vitamin D 
1 gummie 
125 
100.00 
  
  
  
  
  
  
  
  
  
Integrative 
Therapeutics 
Vitaline Total Formula 3 
1 tablet 
500 
400.00 
  
  
  
  
  
  
  
  
  
Integrity 
Stuart Prenatal 
1 tablet 
200 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
Irwin Naturals 
Kids Supervitamin 
1 
softchew 
150 
400.00 
  
  
  
Super Calcium 
3 
capsules 
1000 
400.00 
  
  


 
 
109 of 126 
 
 
  
Mens Living Green Lig-Gel Multi 
3 gelcaps 
50 
400.00 
  
  
  
Liqui-Gel Multi 
4 
capsules 
100 
200.00 
  
  
  
  
  
  
  
  
  
Ivax 
Certagen Tablets 
1 tablet 
162 
400.00 
  
  
  
One-Tablet-Daily with Minerals 
1 tablet 
162 
400.00 
  
  
  
Generix-T 
1 tablet 
58 
400.00 
  
  
  
Prenatal S 
1 tablet 
200 
400.00 
  
  
  
  
  
  
  
  
  
Jarrow 
Formulas 
All Capsule Health Pak 
1 packet 
500 
200.00 
  
  
  
Bone-Up 
6 
capsules 
1000 
400.00 
  
  
  
  
  
  
  
  
  
KAL 
Enhanced energy 
3 tablets 
300 
400.00 
  
  
  
Amino-Max 
2 tablets 
1000 
200.00 
  
  
  
Beyond Calcium Ipriflavone 
5 tablets 
1000 
400.00 
  
  
  
Bone Meal 
4 tablets 
1000 
400.00 
  
  
  
Cal Citrate Plus 
4 tablets 
1000 
400.00 
  
  
  
Enhanced Energy Teen Complete 
1 tablet 
100 
400.00 
  
  
  
High Potency Soft Multiple 
2 
capsules 
200 
400.00 
  
  
  
Mega Vita-Min 
1 tablet 
50 
400.00 
  
  
  
Multi-Four Plus 
4 tablets 
500 
400.00 
  
  
  
Multi-Max 1 
1 tablet 
50 
400.00 
  
  
  
Multiple Energy 
4 tablets 
500 
400.00 
  
  
  
MultiSaurus DinoSours 
1 packet 
50 
200.00 
  
  
  
Vita Mom Advanced 
3 tablets 
600 
200.00 
  
  
  
  
  
  
  
  
  
Kenwood/Bra
dley 
Kenwood Therapeutic Liquid 
5ml 
250 
133.00 
  
  
  
  
  
  
  
  
  
Kirkland 
Signature 
Calcium 500mg + D 
2 tablets 
1000 
400.00 
  
  
  
Calcium Chews 500mg + D + K 
2 chews 
1000 
400.00 
  
  
  
Calcium Citrate, vitamin D, 
Magnesium & Zinc 
2 tablets 
500 
250.00 
  
  
  
Childrens Chewable Multivitamin 
1 tablet 
200 
400.00 
  
  
  
Daily Multivitamin Pack with Energy 
Boosting Nutrients 
1 pack 
1200 
400.00 
  
  
  
Daily Multivitamin with Lutein 
1 tablet 
162 
400.00 
  
  
  
Mature Multi Vitamins & Minerals 
1 tablet  
200 
400.00 
  
  
  
Premium Performance Multivitamin 
with Lycopene & Lutein 
1 tablet 
165 
400.00 
  
  
  
  
  
  
  
  
  
Laser 
Lactocal-F 
1 tablet 
200 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
Leiner 
One Daily Mens Health Formula 
1 tablet 
210 
400.00 
  
  
  
  
  
  
  
  
  


 
 
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Life 
Enhancement
s 
3-way Calcium complex (Womens 
Health) 
2 
capsules 
500 
400.00 
  
  
  
BioEnhance with DNAble 
4 
capsules 
1000 
50.00 
  
  
  
  
  
  
  
  
  
Life 
Extension 
Childrens Formula Life Extension Mix 
2 tablets 
100 
400.00 
  
  
  
Mix with Extra Niacin Without Copper 
4 tablets 
100 
400.00 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
LifePlus Daily Biobasics 
1 scoop 
500 
300.00 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Liquimins Ca; Mag Zinc 
1.25ml 
1200 
400.00 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Longs Womnes 
Multivitamin/Multimineral.Herbs 
2 tablets 
500 
400.00 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
MD Select Advanced Breast support 
2 
capsules 
225 
400.00 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Major 
Certavite with Lutein 
1 tablet 
162 
400.00 
  
  
  
Certavite with Lutein 
1 tablet 
160 
400.00 
  
  
  
High Potency 
1 tablet 
60 
400.00 
  
  
  
Thera 
1 tablet 
400 
400.00 
  
  
  
Calcium 600-D 
1 tablet 
600 
200.00 
  
  
  
Oyster Shell Calcium 500 + D 
1 tablet 
500 
200.00 
  
  
  
Oyster Shell Calcium with D 
1 tablet 
400 
125.00 
  
  
  
Prenatal Plus 
1 tablet 
200 
400.00 
  
  
  
  
  
  
  
  
  
Marmel 
Marnatal-F Plus 
1 tablet 
250 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
McNeil 
Viactiv 
1 caplet 
200 
400.00 
  
  
  
Viactiv for Teens 
1 tablet 
500 
200.00 
  
  
  
Viactiv Calcium plus Vitamin D and K 
1 chew 
500 
100.00 
  
  
  
Viactiv Flavor Glides 
1 glide 
500 
100.00 
  
  
  
Viactiv Multi Vitamin Flavor Glides 
1 glide 
200 
400.00 
  
  
  
Viactiv Multivitamin Chocolate Milk 
8oz 
200 
400.00 
  
  
  
  
  
  
  
  
  
Michaels 
Neuropathic 
Childrens Chewables 
4 wafers 
200 
400.00 
  
  
  
JUST ONE Multivitamin 
1 tablet 
50 
400.00 
  
  
  
Vision Factors 
6 tablets 
150 
100.00 
  
  
  
  
  
  
  
  
  
Miller 
Ragus 
1 tablet 
193 
133.00 
  
  
  
Complere 
1 tablet 
150 
133.00 
  
  
  
Sclerex 
1 tablet 
8 
67.00 
  
  


 
 
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Theramill Plus 
1 tablet 
67 
33.00 
  
  
  
Theramill Forte 
1 capsule 
67 
33.00 
  
  
  
  
  
  
  
  
  
Mission 
Calcet Plus 
1 tablet 
160 
400.00 
  
  
  
Fosfree 
1 tablet 
175 
150.00 
  
  
  
Citracal 
1 caplet 
315 
200.00 
  
  
  
Citracal Plus 
1 caplet 
300 
125.00 
  
  
  
Calcet 
1 tablet 
200 
100.00 
  
  
  
Citracal Prenatal 90 + DHA 
1 tablet 
200 
400.00 
  
RX 
only 
  
CitraNatal 90 DHA 
1 tablet 
200 
400.00 
  
RX 
only 
  
Citracal Prenatal + DHA 
1 tablet 
125 
400.00 
  
RX 
only 
  
CitraNatal DHA 
1 tablet 
125 
400.00 
  
RX 
only 
  
CitraNatal Rx 
1 tablet 
125 
400.00 
  
RX 
only 
  
Prenatal F.A 
1 tablet 
50 
400.00 
  
  
  
Prenatal HP 
1 tablet 
50 
400.00 
  
  
  
Prenatal 
1 tablet 
50 
400.00 
  
  
  
  
  
  
  
  
  
Natrol 
My Favorite Multiple 
4 tablets 
200 
400.00 
  
  
  
My Favorite Multiple with Coral 
Calcium and Zeanthin 
2 
capsules 
250 
400.00 
  
  
  
  
  
  
  
  
  
Naturade 
Head Start Nutritional Breakfast drink 
240ml 
200 
100.00 
  
  
  
Power Shake 
1 scoop 
280 
400.00 
  
  
  
Ribo-tein Vital 
1 scoop 
280 
400.00 
  
  
  
Super Weight Gain 
4 scoops 
30 
200.00 
  
  
  
  
  
  
  
  
  
Natural 
Factors 
Big Friends Childrens Chewable 
(various flavors) 
1 tablet 
65 
400.00 
  
  
  
Calcium & Magnesiuim Citrate with D 
4 tablets 
1000 
400.00 
  
  
  
Mens 50 Plus MultiStart 
4 tablets 
400 
200.00 
  
  
  
Mens MultiStart 
4 tablets 
400 
100.00 
  
  
  
MulitFactors Womens 50 Plus 
3 
Capsules 
200 
1000.00 
  
  
  
MultiStart prenatal 
3 
capsules 
500 
50.00 
  
  
  
Super Multi Iron Free 
1 tablet 
125 
400.00 
  
  
  
Ultra Multi Plus 
1 tablet 
125 
400.00 
  
  
  
Womens MultiStart 
3 tablets 
500 
200.00 
  
  
  
Womens Plus MultiStart 
3 tablets 
500 
200.00 
  
  
  
  
  
  
  
  
  
Nature Made 
Women's Multi for Her 
1 tablet 
250 
1000.00 
  
  
  
Men's Multi for Him 
1 tablet 
162 
1000.00 
  
  
  
Women's Multi for Her 50+ 
1 tablet 
250 
1000.00 
  
  
  
Men's Multi for Him 50+ 
1 tablet 
162 
1000.00 
  
  
  
Advanced High Absorption Calcium 
with 100mg Phytonutrients 
2 tablets 
500 
200.00 
  
  


 
 
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Calcium Magnesium Zinc with Vitamin 
D 
1 tablet 
333 
200.00 
  
  
  
Calcium Plus soy 
1 tablet 
500 
200.00 
  
  
  
Calcium with Vitamin D 
1 tablet 
600 
200.00 
  
  
  
Diabetes Health Pack 
1 packet 
200 
400.00 
  
  
  
Essential 50+ 
1 tablet 
200 
400.00 
  
  
  
Essential Balance Compete Multi 
Vitamin/Mineral 
1 tablet 
100 
400.00 
  
  
  
Essentail Daily 
1 tablet 
450 
400.00 
  
  
  
Essential Man 50+ 
1 tablet 
450 
400.00 
  
  
  
Essential multi Plus Energy 
1 tablet 
50 
200.00 
  
  
  
Essential Woman 50+ 
1 tablet 
250 
400.00 
  
  
  
Man with Lycopene 
1 tablet 
100 
400.00 
  
  
  
Maximin Pack 
1 packet 
850 
800.00 
  
  
  
Mens Pack 
1 packet  
350 
400.00 
  
  
  
Multi Complete with Iron & Calcium 
1 softgel 
100 
1000.00 
  
  
  
Multi for Her with Iron & Calcium 
1 softgel 
100 
1000.00 
  
  
  
Multi Prenatal Premium 
1 tablet 
200 
400.00 
  
  
  
  
  
  
  
  
  
NatureSmart 
Disney Princess Complete 
Multivitamin Chewable Tablet 
1 tablet 
100 
400.00 
  
  
  
Winnie the Pooh Chewables 
1 tablet 
100 
400.00 
  
  
  
Gummies (Finding Nemo, Winnie the 
Pooh, etc) 
1 
gummies 
100 
400.00 
  
  
  
  
  
  
  
  
  
Natures Best 
Hardcore Pack 
1 packet 
1100 
400.00 
  
  
  
Zero Carb Isopure 
1 scoop 
300 
100.00 
  
  
  
  
  
  
  
  
  
Nature's 
Bounty 
Theravim-M 
1 tablet 
40 
400.00 
  
  
  
Multi-Day plus Minerals 
1 tablet 
162 
400.00 
  
  
  
Mega VM-80 
1 tablet 
19 
400.00 
  
  
  
Absorbable Calcium 1220 + D 
2 softgels 
1200 
200.00 
  
  
  
Calcium 500mg with Vitamin D 
4 tablets 
120 
500.00 
  
  
  
Calcium 600 + Vitamin D with Soy 
Isoflavones 
2 tablets  
100 
400.00 
  
  
  
Chewable Calcium Wafers Plus 
Vitamin D 
2 wafers 
200 
200.00 
  
  
  
Coral Calcium 1000mg Plus Vitamin D 
and Magnesium 
2 tablets  
370 
400.00 
  
  
  
Green Source 
3 tablets 
250 
400.00 
  
  
  
Hair Skin and Nails Formula 
3 tablets 
830 
100.00 
  
  
  
High Potency Vitamin D 1000IU 
1 tablet 
120 
1000.00 
  
  
  
Multi-Day Weight Trim with Green Tea 
EGCG 
1 tablet 
300 
400.00 
  
  
  
Oystercal-D Calcium 500mg with 
Vitamin D3 
1 tablet 
500 
400.00 
  
  
  
Pre-Natal Formula 
1 tablet 
200 
400.00 
  
  
  
Prescriptive Formulas Optimal Mens 
1 packet 
712 
200.00 
  
  
  
Prescriptive Formulas Optimal 
Womens 
1 packet 
975 
525.00 
  
  


 
 
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Soy Protein shake Powder 
30gm 
900 
40.00 
  
  
  
Ultra Man Time Release 
2 tablets  
200 
200.00 
  
  
  
Ultra Vita-Min 
1 tablet 
60 
400.00 
  
  
  
Ultra Woman 
2 tablets  
500 
400.00 
  
  
  
Vitmain D 2000IU 
1 tablet 
1500 
2000.00 
  
  
  
  
  
  
  
  
  
Natures Life 
Antioxidant Soft Multi 
2 sofgels 
200 
400.00 
  
  
  
Great Greens 
3 tablets 
250 
800.00 
  
  
  
Green Pro-96 Multi 
1 tablet 
50 
200.00 
  
  
  
One Daily Vegetarian Multiple 
1 capsule 
20 
400.00 
  
  
  
Prenatal Multiple 
6 
capsules 
1000 
200.00 
  
  
  
Soft Gelatin Multiple 
2 softgels 
200 
400.00 
  
  
  
Stress Soft Multi 
2 softgels 
200 
400.00 
  
  
  
Ultra Mega Vite Multi 
1 tablet 
100 
400.00 
  
  
  
  
  
  
  
  
  
Natures Plus 
Adults Chewable MultiVitamin and 
Minerals 
1 tablet 
10 
400.00 
  
  
  
Adults Chewable Vitamin D3 1000IU 
1 tablet  
80 
1000.00 
  
  
  
Adults Dental Care Probiotic Lozenges 
1 
lozenges 
150 
400.00 
  
  
  
Adults Multi-Vitamin Chewable 
1 tablet 
10 
400.00 
  
  
  
Childrens Chewable Dental Probiotic 
(various flavors) 
2 tablets 
300 
400.00 
  
  
  
Bone Power - Calcium with Boron 
4 softgels 
1000 
200.00 
  
  
  
Dyno Vites Sustained Release 
2 tablets 
50 
1000.00 
  
  
  
Golden Years 
6 tablets 
300 
400.00 
  
  
  
Especially Yours Women's Multiple 
3 tablets 
150 
400.00 
  
  
  
Liquid Bone Power 
15ml 
1000 
200.00 
  
  
  
Liquid Calcium 
15ml 
1000 
40.00 
  
  
  
Love Bites Childrens Chewable 
1 tablet 
20 
400.00 
  
  
  
Mega Force Tablets for Men Only 
3 tablets 
25 
400.00 
  
  
  
Nutri-Genic Softgels for Sensitive 
People 
2 softgels 
50 
400.00 
  
  
  
Nutri-Genic Tablets for Sensitive 
People 
2 tablets 
50 
400.00 
  
  
  
Power Teen for Her Chewable 
2 tablets 
100 
500.00 
  
  
  
Power Teen for Him Chewable 
2 tablets 
50 
500.00 
  
  
  
Power-Plex sustained release 
MultiVitamin and Mineral 
1 tablet 
26 
400.00 
  
  
  
Regeneration Liquid Sunshine 
60ml 
200 
400.00 
  
  
  
Regeneration Multivitamin and mineral 
Softgels 
3 softgels 
100 
400.00 
  
  
  
Source of Life Adults Chewable Multi 
2 wafers 
100 
400.00 
  
  
  
Source of Life Animal Parade Liquid 
30ml 
20 
200.00 
  
  
  
Source of Life GOLD Mini-Tablets 
3 tablets 
250 
400.00 
  
  
  
Source of Life Gold tablets 
3 tablets 
250 
400.00 
  
  
  
Source of Life Gold Vcaps (Vegan) 
9 caps 
250 
1000.00 
  
  
  
  
  
  
  
  
  
Natures 
Secret 
womens Whole Body Daily 
Multivitamin 
2 softgels 
100 
400.00 
  
  


 
 
114 of 126 
 
 
  
  
  
  
  
  
  
Natures 
Sunshine 
Super Supplemental Vitamins and 
Minerals without Iron 
4 tablets 
400 
600.00 
  
  
  
  
  
  
  
  
  
Natures Way 
Alice Iron-Free Multivitamin 
3 tablets 
250 
400.00 
  
  
  
Alive Mens Multivitamin & Mineral 
3 tablets 
250 
800.00 
  
  
  
Alive Womens Multivitamin & Mineral 
3 tablets 
500 
1000.00 
  
  
  
BoneSoy 
2 tablets 
400 
133.00 
  
  
  
Coral Calcium 
3 
capsules 
600 
200.00 
  
  
  
Natures Way Alive 
3 tablets 
250 
400.00 
  
  
  
Once Daily Women's 50 +Ultra 
Potency 
1 tablet 
500 
1000.00 
  
  
  
Once Daily Men's 50 +Ultra Potency 
1 tablet 
100 
1000.00 
  
  
  
Alive Once Daily Energy 50 + 
1 tablet 
100 
1000.00 
  
  
  
  
  
  
  
  
  
New Chapter 
Every Womans Daily 
1 tablet 
10 
400.00 
  
  
  
Bone Strength Take Care 
3 tablets 
680 
800.00 
  
  
  
Every Man 
3 tablets 
8 
400.00 
  
  
  
Every Woman 
3 tablets 
25 
400.00 
  
  
  
Every Woman II 
6 tablets 
75 
400.00 
  
  
  
Only One 
1 tablet 
2 
400.00 
  
  
  
Perfect Prenatal 
3 tablets 
30 
400.00 
  
  
  
Unbound Energy 
3 tablets 
5 
1000.00 
  
  
  
  
  
  
  
  
  
New Phase 
Complete Menopause Support 
4 
capslets 
800 
400.00 
  
  
  
  
  
  
  
  
  
Nnodum 
Pharmaceutic
als 
Inatal Advance  
1 tablet 
200 
400.00 
  
RX 
only 
  
Inatal Ultra  
1 tablet 
200 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
North Star 
Daily Defense Plus 
3 
capsules 
200 
200.00 
  
  
  
Ultimate Bionic Plus 
1 packet 
500 
400.00 
  
  
  
  
  
  
  
  
  
Novato 
Multivitamin Plus 
1 tablet  
200 
400.00 
  
  
  
Super Multivitamins 
2 
capsules 
50 
400.00 
  
  
  
  
  
  
  
  
  
Now Foods 
Full Spectrum Minerals 
2 tablets 
1000 
200.00 
  
  
  
ADAM Superior 
3 
capsules 
350 
400.00 
  
  
  
Bone Calcium 
4 tablets 
1000 
200.00 
  
  
  
Daily Vits Vitamin 
1 tablet 
150 
100.00 
  
  
  
Calcium Citrate 
2 tablets  
600 
100.00 
  
  
  
Eco-Green Multi Vitamin 
2 
capsules 
50 
100.00 
  
  
  
Full Spectrum Minerals 
2 tablets 
1000 
200.00 
  
  
  
Kids Vit Chewable (various flavors) 
2 tablets 
40 
200.00 
  
  


 
 
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Liquid Cal Mag 
15ml 
500 
400.00 
  
  
  
Liquid Multi Gels 
2 gelcaps 
100 
400.00 
  
  
  
Magnesium & Calcium 
3 tablets 
400 
200.00 
  
  
  
  
  
  
  
  
  
NSI 
Prenatal Plus 
6 
capsules 
1300 
400.00 
  
  
  
Synergy Basic Multi Vitamin Version 2 
2 
capsules 
20 
700.00 
  
  
  
Synergy Mens Multi Vitamin Version 2 
8 
capsules 
50 
700.00 
  
  
  
Synergy Multi Vitamin Version 10 
6 
capsules 
500 
1000.00 
  
  
  
  
  
  
  
  
  
Nutrilite 
Cal Mag D 
4 tablets 
1000 
400.00 
  
  
  
Daily Multivitamin and Multimineral 
1 tablet 
200 
400.00 
  
  
  
  
  
  
  
  
  
Nutrition Now 
Calcium Soft Chews 
1 
softchew 
500 
100.00 
  
  
  
Rhino Beanie Vites 
2 tablets 
4 
100.00 
  
  
  
Rhino Calcium 
1 tablet 
250 
100.00 
  
  
  
Rhino Wigglers 
1 wiggler 
2 
400.00 
  
  
  
  
  
  
  
  
  
One A Day 
Essential Multi 
1 tablet 
45 
400.00 
  
  
  
Men's Health 
1 tablet 
210 
400.00 
  
  
  
Men's 50+ 
1 tablet 
120 
400.00 
  
  
  
Women's 
1 tablet 
450 
800.00 
  
  
  
Maximum 
1 tablet 
162 
400.00 
  
  
  
Complete Chewable (Flintstones, 
Bugs Bunny, Scooby Doo, etc 
1 tablet 
100 
400.00 
  
  
  
Gummies (Flintstones, Bugs Bunnies, 
etc 
1 gummie 
100 
400.00 
  
  
  
Energy 
1 tablet 
250 
400.00 
  
  
  
Active 
1 tablet 
110 
400.00 
  
  
  
Cholesterol Plus 
1 tablet 
200 
400.00 
  
  
  
Daily Multivitamin Vital Body and Cells 
Formula 
1 tablet 
200 
400.00 
  
  
  
Joint and Bone Vitality 
1 tablet 
250 
67.00 
  
  
  
Men's Pro Edge 
1 tablet 
200 
800.00 
  
  
  
Menopause Formula 
1 tablet 
300 
800.00 
  
  
  
Women's Prenatal 
1 tablet 
300 
400.00 
  
  
  
Women's Active Mind & Body 
1 tablet 
300 
800.00 
  
  
  
Women's Active Metabolism 
1 tablet 
300 
800.00 
  
  
  
Weight Smart 
1 tablet 
300 
400.00 
  
  
  
Carb Smart 
1 tablet 
200 
400.00 
  
  
  
Today 
1 tablet 
240 
400.00 
  
  
  
Science Daily 
1 tablet 
250 
400.00 
  
  
  
Nutrilite 
1 tablet 
200 
400.00 
  
  
  
Teen Advantage for Her 
1 tablet 
300 
800.00 
  
  
  
Teen Advantage for Him 
1 tablet 
200 
400.00 
  
  
  
  
  
  
  
  
  
Optimox 
Gynovite Plus 
1 tablet 
83 
67.00 
  
  
  
  
  
  
  
  
  


 
 
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Optimum 
Nutrition 
OptiMen 
3 tablets 
200 
300.00 
  
  
  
OptiWomen 
2 
capsules 
150 
600.00 
  
  
  
Nutrition Serious Mass 
2 scoops 
590 
200.00 
  
  
  
  
  
  
  
  
  
Perque 
Life Guard 
2 tablets 
50 
400.00 
  
  
  
Bone Guard Forte 20 
4 
capsules 
500 
400.00 
  
  
  
Life Guard Chewables 
1 
chewable 
50 
200.00 
  
  
  
Mito Guard 100 Plus 
1 tablet 
50 
200.00 
  
  
  
  
  
  
  
  
  
Pfizer 
Myadec 
1 tablet 
162 
400.00 
  
  
  
Caltrate 600-D 
2 tablets 
or 
softchews 
1200 
800.00 
  
  
  
Caltrate 600-D Plus minerals 
2 tablets 
or 
softchews 
1200 
800.00 
  
  
  
  
  
  
  
  
  
Pharmanex 
Bone Formula 
2 tablets 
250 
50.00 
  
  
  
Life Essentials 
1 tablet 
100 
200.00 
  
  
  
LifePak Kosher 
1 packet 
250 
200.00 
  
  
  
LifePak Prenatal 
1 packet 
325 
200.00 
  
  
  
LifePak Prime Anti Aging Formula 
1 packet 
500 
300.00 
  
  
  
LifePak Teen 
1 capsule 
250 
200.00 
  
  
  
LifePak Women 
1 packet 
500 
200.00 
  
  
  
Nutrimmune chews 
1 
chewtab 
250 
50.00 
  
  
  
Vitox 
2 
capsules 
250 
200.00 
  
  
  
  
  
  
  
  
  
Pharmaton 
Ginsana Gold Formula 
2 softgels 
200 
400.00 
  
  
  
  
  
  
  
  
  
Pharmics 
O-Cal FA 
1 tablet 
200 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
PhysioLogics 
MultiLogics Iron-Free Once Daily 
1 capsule 
92 
400.00 
  
  
  
OsteoLogic Pro 
2 tablets 
400 
150.00 
  
  
  
Phytotality Daily Multivitamin + 
Minerals 
3 tablets 
252 
400.00 
  
  
  
Ultra MultiLogics for Men High 
Potency 
2 tablets  
200 
400.00 
  
  
  
Ultra Multillogics for Women High 
Potency 
2 tablets 
500 
600.00 
  
  
  
  
  
  
  
  
  
Precision 
Engineered 
Milk and Egg Protein Powder 
1 scoop 
600 
140.00 
  
  
  
Muscle Weight Gainer 
5 tbs 
1100 
200.00 
  
  
  
ProtoPlex Deluxe 
3 scoops 
600 
200.00 
  
  
  
  
  
  
  
  
  


 
 
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Prevention 
Age-Defying Multivitamin & Mineral for 
Men 50 Plus 
2 tablets 
250 
400.00 
  
  
  
Diabetic Support MultiNutrient  
2 tablets 
240 
400.00 
  
  
  
High Potency Multivitamin & Mineral 
for Women 
1 tablet 
250 
400.00 
  
  
  
  
  
  
  
  
  
Prime 
Marketing 
Thera-M with Minerals 
1 tablet 
40 
400.00 
  
  
  
Complete Tablets 
1 tablet 
162 
400.00 
  
  
  
Prenatal 
1 tablet 
200 
400.00 
  
  
  
  
  
  
  
  
  
Pure 
Encapsulatio
ns 
Nutrient 950 (various formulations) 
6 
capsules 
300 
800.00 
  
  
  
PureBears 
2 tablets 
100 
400.00 
  
  
  
Daily Multi 
3 
capsules 
200 
200.00 
  
  
  
  
  
  
  
  
  
Puritans 
Pride 
ABC PLUS SENIOR with Lutein & 
Lycopene 
1 tablet 
200 
400.00 
  
  
  
Absorbable Calcium with Vitamin D 
2 
capsules 
1000 
100.00 
  
  
  
Adult Chewable Multi-Vitamin 
1 
chewtab 
10 
400.00 
  
  
  
Calcium Magnesium with D 
3 tablets 
1000 
400.00 
  
  
  
Childrens Chewable Animal Chews 
(various formaltions) 
1 
chewtab 
125 
200.00 
  
  
  
Childrens Chewable Multivitamin 
1 
chewtab 
50 
400.00 
  
  
  
Complete One 
1 tablet 
54 
400.00 
  
  
  
Daily 3 Multiple with Cholesterol 
Regulators 
3 
capsules 
106 
800.00 
  
  
  
Formula 100 with Beta Carotene 
1 tableet 
100 
400.00 
  
  
  
Green Source 
3 tablets 
750 
400.00 
  
  
  
High Potency Calcium 600 + Vitamin 
D 
2 tablets 
1200 
400.00 
  
  
  
Iron Free green Source 
3 tablets 
252 
400.00 
  
  
  
Mega Vita Gel 
2 softgels 
200 
400.00 
  
  
  
Mega Vita Min for Seniors 
2 tablets 
200 
400.00 
  
  
  
Mega Vita Min for Women 
2 tablets 
500 
400.00 
  
  
  
Mega Vita min for Women Timed 
Release 
2 tablets 
510 
400.00 
  
  
  
Mega Vita Min 
1 capsule 
15 
400.00 
  
  
  
Multi-Day Plus Minerals 
1 tablet 
162 
400.00 
  
  
  
Multi-Day Take One Green Tea 
Formula 
1 tablet 
300 
400.00 
  
  
  
Potent 75 Super VM  
1 tablet 
50 
400.00 
  
  
  
Prenatal Complex 
4 
capsules 
1300 
400.00 
  
  
  
Puritron 
6 tablets 
800 
400.00 
  
  
  
Super All Day Nutricom Powder 
15gm 
500 
400.00 
  
  
  
Ultra Vita-Mam Time Release for Men 
2 tablets 
200 
200.00 
  
  


 
 
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Ultra Vita-Min VM-33 
1 tablet 
60 
400.00 
  
  
  
Vita-min Complete Formula 1 
6 tablets 
800 
200.00 
  
  
  
Whole Food Concentrate 
3 
capsules 
500 
400.00 
  
  
  
  
  
  
  
  
  
Quantum 
Mega 1 Daily Iron Free 
1 capsule 
25 
200.00 
  
  
  
Natures Daily Multi Vitamin 
1 tablet 
50 
400.00 
  
  
  
Complete Super Vitamin Multi 
1 tablet 
50 
400.00 
  
  
  
  
  
  
  
  
  
Radiance 
Absorbable Calcium with Vitamin D 
2 softgels 
1000 
100.00 
  
  
  
Calcium 600 + Vitamin D 
2 tablets 
1200 
250.00 
  
  
  
Coral Calcium 500 Plus 
2 
capsules 
370 
400.00 
  
  
  
Green Source Multivitamins and 
minerals 
3 tablets 
250 
400.00 
  
  
  
Mega Vita Gel 
2 softgels 
200 
400.00 
  
  
  
Mega Vita Min for women 
2 tablets 
500 
400.00 
  
  
  
Mega Vita Min High Potency 9 time 
Release 
2 tablets 
500 
400.00 
  
  
  
Prenatal Vitamin 
1 tablet 
200 
400.00 
  
  
  
Skin, Hair & Nails Formula 
3 tablets 
834 
100.00 
  
  
  
Ultra Vita Man High Potency Timed 
Release 
2 tablets 
200 
200.00 
  
  
  
Vanilla Soy Protein shake 
30gm 
200 
200.00 
  
  
  
  
  
  
  
  
  
Rainbow 
Light 
Active Health Teen Multi 
3 tablets 
200 
100.00 
  
  
  
Active Senior Multivitamin 
1 tablet 
200 
400.00 
  
  
  
Advanced Nutritional System 
6 tablets 
240 
400.00 
  
  
  
Complete Menopause Support 
4 tablets 
1000 
400.00 
  
  
  
Everyday Calcium with Enzymes 
4 tablets 
1200 
200.00 
  
  
  
Just Once Iron Free Safe Guard 
multivitamin 
1 tablet 
30 
400.00 
  
  
  
Just Once Food Based Calcium 
1 tablet 
500 
200.00 
  
  
  
Mens One Multivitamin 
1 tablet 
50 
400.00 
  
  
  
Nutritional Systems NutriStars 
2 tablets 
40 
50.00 
  
  
  
Prenatal One Multivitamin 
1 tablet 
200 
400.00 
  
  
  
Womens Nutritional System 
6 tablets 
1000 
400.00 
  
  
  
Womens One Multivitamin 
1 tablet 
200 
400.00 
  
  
  
Womens Whole Nutrition Liquid Multi 
2 softgels 
100 
400.00 
  
  
  
Mens Whole Nutrition Liqiud Multi 
2 softgels 
100 
400.00 
  
  
  
  
  
  
  
  
  
Reliv 
RelivClassic 
2 scoops 
1000 
400.00 
  
  
  
RelivNow for kids 
2 scoops 
1000 
400.00 
  
  
  
Simplicity 
1 scoop 
500 
200.00 
  
  
  
  
  
  
  
  
  
Rexall-
Sundown 
Complete Daily with Lutein 
1 tablet 
162 
400.00 
  
  
  
SunVite 
1 tablet 
162 
400.00 
  
  
  
Daily Multi Caplets 
1 caplet 
162 
400.00 
  
  
  
Complete Energy 
1 caplet 
100 
400.00 
  
  


 
 
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Vitamins to Go Maximum 
1 tablet 
777 
525.00 
  
  
  
Daily Multi 50+ 
1 tablet 
162 
400.00 
  
  
  
Osteo Bi-Flex Plus Calcium With 
Vitamins C and D 
3 caplets 
500 
400.00 
  
  
  
  
  
  
  
  
  
Rite Aid 
Whole Source Mature Adult 
Multivitamin/Mineral 
1 tablet 
165 
400.00 
  
  
  
Calcium Soft Chews 
1 
softchew 
500 
100.00 
  
  
  
600mg Calcium Plus Vitamin D 
1 tablet 
600 
200.00 
  
  
  
Central Vite 
1 tablet 
162 
30.00 
  
  
  
  
  
  
  
  
  
River's Edge 
VitaPhil 
1 tablet 
100 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
Rugby 
Advance Formula Cerovite  
1 tablet 
162 
400.00 
  
  
  
Cerovite Jr. Chewables 
1 tablet 
108 
400.00 
  
  
  
VITa-PMS 
1 tablet 
21 
17.00 
  
  
  
Calcium 600-D 
1 tablet 
600 
200.00 
  
  
  
Oysco 500 + D 
1 tablet 
500 
200.00 
  
  
  
Oysco D 
1 tablet 
400 
125.00 
  
  
  
Prenavite 
1 tablet 
200 
400.00 
  
  
  
  
  
  
  
  
  
Schiff 
Childrens chewables 
1 
chewtab 
20 
200.00 
  
  
  
Guided Minerals Multi Minerals 
Complex 
3 tablets 
1200 
400.00 
  
  
  
Hair, Skin and Nails with MSM 
2 tablets 
170 
800.00 
  
  
  
Prime Years Multi Vitamin 
1 softgel 
100 
400.00 
  
  
  
Prostrate Health 
2 
capsules 
29 
400.00 
  
  
  
Single Day Antioxidant Rich 
1 tablet 
10 
400.00 
  
  
  
Super Calcium 1200 with Vitamin D 
2 softgels 
1200 
400.00 
  
  
  
Sustained Release Single Day Multi 
Vitamin 
1 tablet 
25 
400.00 
  
  
  
Vegetarian Multiple with Beta 
Carotene 
2 
capsules 
200 
400.00 
  
  
  
  
  
  
  
  
  
Shaklee 
Vita-Lea Iron Formula High Potency 
Multivitamin & Mineral 
2 tablets 
450 
200.00 
  
  
  
OsteoMatrix 
4 
capsules 
1000 
400.00 
  
  
  
Vita-Lea Gold Vitamin K Formula high 
Potency Multivitamin & Mineral 
2 tablets 
450 
400.00 
  
  
  
Chewable Cal Mag Plus 
4 
chewtabs 
1000 
200.00 
  
  
  
Cinch 3-in-1 Inch Loss Plan Boost 
3 tablets 
300 
260.00 
  
  
  
  
  
  
  
  
  
Sciele 
Pharma 
OptiNate 
1 tablet 
200 
400.00 
  
RX 
only 
  
  
  
  
  
  
  
Solaray 
Iron Free Spectro Multi-Vita-Min 
6 
500 
400.00 
  
  


 
 
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capsules 
  
Mens Golden Multi-Vita-Min 
3 
capsules 
75 
400.00 
  
  
  
Multi-Vita Mega-Mineral Multi-Vita-Min 
4 
capsules 
420 
400.00 
  
  
  
Once Daily High Energy Multi-Vita-Min 
1 capsule 
10 
400.00 
  
  
  
Once Daily Softgel with Lutein Multi-
Vita-Min 
1 softgel 
25 
400.00 
  
  
  
Provide Multi-Vita-Min 
2 softgels 
200 
400.00 
  
  
  
Spectro 50 Plus Multi-Vita-Min 
4 
capsules 
200 
800.00 
  
  
  
Spectro Energy Multi-Vita-Min 
4 
capsules 
250 
800.00 
  
  
  
Spectro Kid Multi-Vitamin 
2 tablets 
200 
400.00 
  
  
  
Spectro Man Multi-Vita-Min 
4 
capsules 
200 
400.00 
  
  
  
Spectro Woman Multi-Vita-Min 
4 
capsules 
400 
800.00 
  
  
  
Twice Daily Multi-Vita-Min 
2 
capsules 
200 
400.00 
  
  
  
Vegetarian Spectro Multi-Vita-Min 
6 
capsules 
500 
400.00 
  
  
  
VitaPrime for Men Multi-Vita_min 
4 
capsules 
400 
400.00 
  
  
  
VitaPrime for Women Multivitamin and 
Multimneral 
4 
capsules 
400 
400.00 
  
  
  
Womens Golden Multi-Vita-min 
3 
capsules 
75 
400.00 
  
  
  
YumAid Multi-Vita-Min Punch 
1tsp 
50 
400.00 
  
  
  
  
  
  
  
  
  
Solgar 
Adv Proanthocyanidin Complex 
2 
capsules 
170 
800.00 
  
  
  
Calcium Magnesium with Vitamin D 
5 tablets 
1000 
400.00 
  
  
  
Earth Source Multi-Nutrient 
3 tablets 
250 
400.00 
  
  
  
Female Multiple  
3 tablets 
400 
400.00 
  
  
  
Formula V VM-75 Multivitamin with 
Chelated Minerals 
2 
capsules 
20 
400.00 
  
  
  
Formula VM-2000 
2 tablets 
50 
400.00 
  
  
  
Formula VM-Prime for Adults 50 Plus 
Iron Free 
1 tablet 
20 
400.00 
  
  
  
Iron Free Formula VM-75 
1 tablet 
20 
400.00 
  
  
  
Kangavites Complete Childrens 
Formula 
2 tablets 
128 
200.00 
  
  
  
Male Multiple 
3 tablets 
400 
400.00 
  
  
  
Omnium Multiple Vintamin and Mineral 
Formula Iron Free 
2 
tabletws 
25 
200.00 
  
  
  
Prenatal Nutrients 
4 tablets 
1300 
400.00 
  
  
  
  
  
  
  
  
  
Source 
Naturals 
Advanced One Multiple (witn and 
without Iron) 
1 tablet  
50 
400.00 
  
  
  
Advanced Triple Boron with Calcium 
1000mg 
2 
capsules 
500 
400.00 
  
  
  
Calcium & Magnesium 300mg 
1 tablet  
200 
500.00 
  
  


 
 
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Calcium Hydroxyapatite 
2 tablets 
600 
500.00 
  
  
  
Calcium Night 150mg 
2 tablets 
300 
100.00 
  
  
  
Calcium 200mg 
1 tablet  
200 
500.00 
  
  
  
Elan Vital Multiple 
6 tablets 
200 
400.00 
  
  
  
Life Defense 
4 tablets  
95 
200.00 
  
  
  
Life Force 
4 
capsules 
100 
1000.00 
  
  
  
Mega Kid 
1 wafer 
20 
200.00 
  
  
  
Mens Life Force 
3 tablets 
100 
400.00 
  
  
  
Mothers Choice 
4 tablets  
615 
400.00 
  
  
  
Spirulina  
2 tablets 
106 
400.00 
  
  
  
Ultra 
6 tablets 
125 
400.00 
  
  
  
Womens Life Force 
3 tablets 
200 
400.00 
  
  
  
  
  
  
  
  
  
Sundown 
Advanced SunVite 
1 tablet 
162 
400.00 
  
  
  
Calcium 600 + D 
1 capsule 
600 
200.00 
  
  
  
Calcium Oyster Shell 1000mg 
3 tablets 
1000 
400.00 
  
  
  
Complete Daily with Lutein 
1 caplet 
162 
400.00 
  
  
  
Daily Multi & Min 
1 caplet 
162 
400.00 
  
  
  
Daily Multiple 50+ Iron Free with 
Lutein & Lycopene 
1 caplet 
200 
400.00 
  
  
  
Multiple Complete Womens 
1 caplet 
250 
400.00 
  
  
  
Naturals Prenatal Formula 
1 tablet 
200 
400.00 
  
  
  
One Daily Multiple for Women 
1 caplet 
400 
400.00 
  
  
  
Prenatal Vitamin and Mineral Formula 
1 tablet 
200 
400.00 
  
  
  
Vitamins to Go Womens 
1 packet 
660 
125.00 
  
  
  
  
  
  
  
  
  
Super 
Nutrition 
Calcium Blend 
3 tablets 
1000 
1000.00 
  
  
  
Longevity 
1 tablet 
68 
400.00 
  
  
  
Menopause Multiple Blend 
8 tablets 
750 
500.00 
  
  
  
Mens Blend 
3 tablets 
300 
500.00 
  
  
  
Simply One Prenatal 
1 tablet 
210 
500.00 
  
  
  
Simply One - One Per Day 
1 tablet 
33 
400.00 
  
  
  
Simply Perfect Kids 
4 tablets 
120 
400.00 
  
  
  
Super Blend 
4 tablets 
500 
500.00 
  
  
  
  
  
  
  
  
  
Ther-RX 
PrimaCare Softgel 
1 softgel 
400 
400.00 
  
RX 
only 
  
PrimaCare Advantage 
1 softgel 
250 
230.00 
  
RX 
only 
  
PrimaCare ONE 
1 
capsules 
150 
170.00 
  
RX 
only 
  
  
  
  
  
  
  
Thompson 
Adult Plex 
3 tablets 
300 
400.00 
  
  
  
All in One Multivitamin Iron Free 
1 capsule 
100 
400.00 
  
  
  
Coachs Formula with Enzymes 
2 tablets 
333 
133.00 
  
  
  
Mega 80 
1 tablet 
45 
600.00 
  
  
  
Multi Formula for Women 
2 
capsules 
300 
200.00 
  
  
  
Multi Vitamins with Minerals 
2 tablets 
170 
200.00 
  
  
  
Nuplex with Iron 
1 tablet 
120 
400.00 
  
  


 
 
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Prenatal Formula 
2 tablets 
68 
610.00 
  
  
  
Teenplex Multivitamin 
2 tablets 
200 
400.00 
  
  
  
  
  
  
  
  
  
TwinLab 
Daily One Caps (with or without Iron) 
1 capsule 
25 
400.00 
  
  
  
Dr. Greene Childrens (various flavors) 
1 tablet 
100 
400.00 
  
  
  
Dr. Greene Healthy Bone Formula 
1 tablet 
500 
200.00 
  
  
  
Dr. Greene Pre-Natal formula 
2 
capsules 
500 
400.00 
  
  
  
Dualtabs Mega Vitamin and Mineral 
formula 
2 tablets 
500 
200.00 
  
  
  
Allergy Multi Caps 
2 
capsules 
333 
133.00 
  
  
  
Animal Friends Kids Chewable 
(various flavors) 
1 
chewable 
100 
400.00 
  
  
  
Bone Support with Ostivone 
4 tablets 
1500 
800.00 
  
  
  
Cal Quick Liquid 
5ml 
500 
100.00 
  
  
  
Calcium 500 with Magnesium & 
Vitamin D 
1 tablet 
500 
200.00 
  
  
  
Calcium Citrate Chewable 
4 wafers 
1000 
400.00 
  
  
  
Pre-Natal Care 
2 
capsules 
400 
400.00 
  
  
  
Womens Ultra Daily 
4 
capsules 
510 
400.00 
  
  
  
  
  
  
  
  
  
Usana 
Active Calcium 
4 tablets 
800 
400.00 
  
  
  
Body Rox Active Calcium Chewable 
4 
chewtabs 
800 
400.00 
  
  
  
Essentials Usanimals 
1 tablet 
75 
100.00 
  
  
  
HealthPak 
1 packet 
335 
1000.00 
  
  
  
  
  
  
  
  
  
VegLife 
MultiVeg Energy 
4 tablets 
34 
400.00 
  
  
  
MultiVeg Energy with Lutein and Iron 
3 
capsules 
50 
800.00 
  
  
  
SpectroVeg High Energy 
6 tablets 
500 
400.00 
  
  
  
Vegan Cal-Mag Citrate Plus Vitamin D 
3 tablets 
500 
200.00 
  
  
  
Vegan Kids 
2 tablets 
30 
400.00 
  
  
  
Vegan One Multi with Iron 
1 tablet 
50 
400.00 
  
  
  
Vital Teen Boys 
2 
capsules 
150 
800.00 
  
  
  
Vital Teen Girls 
2 
capsules 
150 
1000.00 
  
  
  
  
  
  
  
  
  
Vitabase 
Active Mans Formula 
1 tablet 
50 
400.00 
  
  
  
Childrens Multiple Liquid 
30ml 
200 
220.00 
  
  
  
Coral Calcium 1000mg 
1 capsule 
250 
200.00 
  
  
  
Hair, Skin & Nails Liquid 
3 
liquicaps 
300 
200.00 
  
  
  
Kids Chewable Calcium 
2 
chewtabs 
200 
200.00 
  
  
  
PreNatal Plus 
4 tablets 
800 
400.00 
  
  
  
Super Calcium & Magnesium 
3 tablets 
1000 
200.00 
  
  
  
Super Softgel Formula 
2 softgels 
200 
400.00 
  
  


 
 
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Vitaline 
Total Formula 
1 tablet 
100 
400.00 
  
  
  
Total Formula 2 
1 tablet 
100 
400.00 
  
  
  
Maximum Red 
1 tablet 
83 
67.00 
  
  
  
  
  
  
  
  
  
Vitamin 
Shoppe 
1 Daily  
1 tablet 
100 
400.00 
  
  
  
Ultimate Man 
2 tablets 
200 
1000.00 
  
  
  
Ultimate Woman 
2 tablets 
500 
1000.00 
  
  
  
Calcium Citrate 
2 tablets 
333 
204.00 
  
  
  
  
  
  
  
  
  
Vitamin 
World 
Bone Reinforcer with Hydroxyapatite 
4 tablets 
1200 
400.00 
  
  
  
Calcium Magnesiun with D 
3 tablets 
1000 
400.00 
  
  
  
Coral Calcium 500mg Plus Vitamin D 
2 
capsules 
370 
400.00 
  
  
  
Daily 3 Multiple with Chloesterol 
Regulators 
3 
capsules 
106 
800.00 
  
  
  
Green Source 
3 tablets 
250 
400.00 
  
  
  
Spirulina Soy protein Drink 
1 scoop 
300 
400.00 
  
  
  
Thervim M 
1 tablet 
40 
400.00 
  
  
  
Ultra Vita Man timed release 
2 tablets 
200 
200.00 
  
  
  
  
  
  
  
  
  
Whole Health 
Cal-Mag Calcium & Magnesium 
Citrates 1400mg 
4 tablets 
1000 
400.00 
  
  
  
Childrens Chewable Multivitamin 
2 
chewtabs 
55 
400.00 
  
  
  
GreenHealth Natural Multi 
2 
capsules 
50 
100.00 
  
  
  
HerHealth 
4 
capsules 
780 
600.00 
  
  
  
HisHealth 
3 
capsules 
272 
400.00 
  
  
  
Prenatal Health 
4 tablets 
1000 
220.00 
  
  
  
Super Multi Plus 
3 tablets 
400 
400.00 
  
  
  
  
  
  
  
  
  
Whole 
Source 
Mature Adults Multi Mineral with Herbs 
1 tablet 
165 
400.00 
  
  
  
  
  
  
  
  
  
Windmill 
Ezcal 2000 + D (regular tablets & 
chewables) 
1 tablet 
1000 
400.00 
  
  
  
  
  
  
  
  
  
Women's 
Health 
America 
ProCycle Gold 
1 tablet 
  
100.00 
  
  
  
  
  
  
  
  
  
Wonder Labs 
Mulitvitamin/Multimineral with Beta 
Carotene & Lycopene 
1 tablet 
162 
400.00 
  
  
  
Pure coral Calcium 2500mg 
3 
capsules 
2500 
200.00 
  
  
  
  
  
  
  
  
  
Xanodyne 
Duet DHA 
1 tablet 
200 
400.00 
  
RX 


 
 
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only 
  
Duet Chewable 
1 tablet 
100 
400.00 
  
RX 
only 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
125 of 126 
 
 
Appendix VI:  Dietary calcium and vitamin D intake calculator 
 


 
 
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