Promoting CSD500 Use Among Women in Established Relationships
Phase: NA
Conditions: PSA, Unprotected Sex
Sponsor: Ohio State University

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 1 
 
Promoting CSD500 Use among Women in Established Relationships 
NCT02934620 
Protocol 
 
The protocol was last revised on August 9, 2018.   The IRB approved the revision on August 
27, 2018. 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 2 
 
 
 
 
 
Promoting CSD500 Use among Women in Established Relationships 
 
 
 
Protocol 
 
 
 
 
 
 
August 8, 2018 
 
 
 
 
 
 
 
 
Collaborating institutions: 
 
The Ohio State University, Columbus, OH, U.S. 
Ministry of Health of Vietnam 
University of North Carolina at Chapel Hill, NC, U.S. 
 
 
 
 
 
 
 
 
 
 
 
 
 
This document may contain confidential information. It is understood that persons to whom this 
information is disclosed will not disclose it further without permission from The Ohio State 
University, the Ministry of Health of Vietnam and the University of North Carolina at Chapel Hill 
unless such information is published or otherwise becomes public knowledge. 
 
 
 
 
 
 
Short study title: “Vietnam CSD500 Study” or “VN CSD500” 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 3 
TABLE OF CONTENTS 
 
 
 
 
ABBREVIATIONS AND ACRONYMS ........................................................................................ 3 
 
1. 
ADMINISTRATIVE INFORMATION ................................................................................... 4 
 
2. 
STUDY SUMMARY ............................................................................................................ 5 
 
3. 
STUDY PRODUCT: CSD500 ............................................................................................. 5 
 
4. 
RATIONALE....................................................................................................................... 6 
 
5. 
PSA OUTCOME................................................................................................................. 8 
 
6. 
STUDY POPULATION ....................................................................................................... 9 
 
7. 
STUDY AIMS ....................................................................................................................10 
 
8. 
STUDY PROCEDURES ....................................................................................................11 
 
9. 
STATISTICAL CONSIDERATIONS...................................................................................13 
 
10.  DATA MANAGEMENT ......................................................................................................16 
 
11.  TRANSLATION .................................................................................................................16 
 
12.  INCIDENTS AND INCIDENT REPORTING.......................................................................16 
 
13.  PROTECTION OF HUMAN SUBJECTS ...........................................................................18 
 
14.  PLANS FOR REPORTING RESULTS...............................................................................19 
 
15.  REFERENCES..................................................................................................................20 
 
16.  ATTACHMENTS ...............................................................................................................24 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 4 
ABBREVIATIONS AND ACRONYMS 
 
AE 
Adverse event 
CCTS 
Center for Clinical and Translational Science 
CI 
Confidence interval 
DCF 
Data collection form 
DSMC 
Data Safety Monitoring Committee 
GEE 
Generalized estimating equation 
IRB 
Institutional review board 
MOH 
Ministry of Health 
OSU 
The Ohio State University 
PBS 
Phosphate buffered saline 
PI 
Principal investigator 
PIN 
Participant identification number 
PSA 
Prostate-specific antigen 
QSE 
Quality of Sexual Experience 
RCT 
Randomized controlled trial 
RR 
Relative risk 
SAE 
Serious adverse event 
SEX-Q 
Sexual Experience Questionnaire 
SRPS 
Sexual Relationship Power Scale 
STD-CRC 
Sexually Transmitted Diseases Cooperative Research Center 
UNC 
University of North Carolina 
UPIRTSO 
Unanticipated problem involving risk to subjects or others 
USD 
United States dollar 
VND 
Vietnamese dong 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 5 
1. 
ADMINISTRATIVE INFORMATION 
 
1.1 
Key staff 
 
Study investigators and primary affiliations are as follows: 
 
Investigator 
Institution 
Study role 
John Casterline, PhD 
OSU 
Co-investigator 
Marcia Hobbs, PhD 
UNC 
Co-investigator 
Maria Gallo, PhD 
OSU 
Principal Investigator 
Nghia Nguyen, MD, PhD 
MOH-Vietnam 
Site Investigator 
Rebecca Andridge, PhD 
OSU 
Statistician 
 
 
1.2 
Study organization 
 
The study will be fielded at the Thanh Hoa Provincial Centre of Reproductive Health in Vietnam. 
Testing for prostate-specific antigen (PSA) will be conducted at the Microbiology and Human 
Challenge Core Laboratories of the UNC Sexually Transmitted Diseases Cooperative Research 
Center (STD-CRC) in Chapel Hill, NC, US. Data management will occur through collaboration 
between the field site and OSU. The Site Investigator will manage the daily trial operation. Key 
staff will employ regular communication by telephone (occurring weekly during study start-up and 
initiation and then decreasing to a monthly basis unless needed more often), and the Principal 
Investigator (PI) or designee will perform on-site monitoring at pre-initiation, during study 
implementation (occurring annually or more often, if needed), and at study close-out. 
 
1.3 
Ethical review 
 
Ethical oversight for the research will be provided by The OSU Biomedical Institutional Review 
Board (IRB), which is registered with the Office of Human Research Protections and covered by 
a Federal Wide Assurance (FWA00006378), and the Hanoi University of Public Health 
Biomedical IRB (FWA00009326). UNC-Chapel Hill will defer their review of the protocol to the 
OSU IRB. 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 6 
2. 
STUDY SUMMARY 
 
This randomized controlled trial will test whether promoting the novel condom CSD500 (Futura 
Medical Developments; Surrey, UK) for improved sexual pleasure results in couples having less 
unprotected vaginal sex – measured with a biological marker of recent semen exposure – 
compared to the promotion of a standard condom for disease and pregnancy prevention. CSD500 
contains an erectogenic drug and was developed to improve sexual pleasure by increasing penile 
firmness, size, and erection duration. 
 
We will recruit eligible, monogamous, heterosexual couples at Thanh Hoa Provincial Centre of 
Reproductive Health in Vietnam to participate in a randomized controlled trial (RCT) of two 
balanced arms of approximately 250 couples each. At enrollment and at three follow-up visits 
scheduled at 2, 4 and 6 months after enrollment, we will provide condom counseling, will collect 
double-headed vaginal swabs to test for the semen biomarker, prostate-specific antigen (PSA), 
and will administer a questionnaire to the female participants on their demographics, sexual and 
condom-related attitudes and practices, including sexual pleasure and perceptions of partner’s 
sexual pleasure. Although the intervention is directed to the women, couples will be enrolled to 
ensure that the male partners consent to CSD500 use. After enrollment, male participants will not 
participate in study visit activities, including data collection, until the time of their female partner’s 
final 6-month visit. Because of the differences in counseling messages, participants and study staff 
at the site cannot be blinded to arm assignment. 
 
Primary aims:   
1. To evaluate whether CSD500 provided to improve sexual pleasure, as 
compared to the standard condom, results in less semen exposure 
among women in an established relationship 
2. To evaluate the effects of CSD500 provision on men and women’s 
reports of sexual pleasure compared to the standard condom 
3. To identify correlates of semen exposure measured by PSA positivity 
Study design: 
RCT with two arms: CSD500 for sexual pleasure or the standard condom 
currently provided for pregnancy and disease prevention 
Study site: 
Thanh Hoa Provincial Centre of Reproductive Health 
Data collection: 
Women: questionnaires and vaginal swabs for PSA testing at enrollment 
and the 2, 4, and 6-month visits 
Men: questionnaires at enrollment and the 6-month visit 
Sample size: 
~500 couples with balanced assignment to the two study arms 
Study population: 
Adult, monogamous, heterosexual couples willing to use the assigned 
condoms and who at enrollment are not using – or intending to start in the 
next 6 months – a modern contraceptive method other than condoms  
Data analysis: 
Intent-to-treat analysis 
 
 
3. 
STUDY PRODUCT: CSD500 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
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CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the 
international standard for male latex condoms. The 53 mm-width, latex condom is transparent 
with a teat at the end containing a pharmacological dose of Zanifil™ (active ingredient glyceryl 
trinitrate 1% w/w). The product works by increasing blood flow, which helps to maximize erection 
hardness. 
 
CSD500 has been approved for over-the-counter use in 27 European nations and is being sold 
under the name “Blue Diamond™” in The Netherlands and Belgium but has not been registered 
in the U.S. or Vietnam. They will be labeled with the brand name “Futura Max” in the present 
trial. We will meet NIH requirements for regulatory oversight (see 
http://www.niaid.nih.gov/researchfunding/sci/human/pages/hshandbook.aspx) by obtaining 
regulatory approval from the Vietnam MOH to use the product solely for research purposes in 
compliance with local laws (see letter from Dr. Hong). Futura Medical Developments has agreed 
to provide CSD500 for the study at no cost without having any other role or influence (see letter 
from David Davies). To maximize sales and improve adherence to condom use, the 
manufacturer recommends that its distribution partners use a target price that is, at most, 50% 
more than current condom prices (David Davies, written communication, August 2014). CSD500 
is expected to be widely available in settings worldwide, and its access is unlikely to be limited 
by price given its modest premium compared to standard male condoms. 
 
Two industry-sponsored trials have assessed the effects of CSD500 on user performance and 
pleasure. The first was a randomized crossover trial conducted among 120 healthy, 
heterosexual couples recruited from a clinic in London, England who reported being in stable 
relationships of ≥6 months and in which the male partner reported ≥1 partial or total loss of 
penile tumescence during condom use in the past six months (David Davies, written 
communication, August 2014). Couples were randomly assigned to use CSD500 or standard 
condoms for five acts followed by five uses of the other condom type. Both the man and woman 
independently completed a diary for each condom use. Females perceived an increase in penile 
firmness (p<0.01), an increase in penis size (p=0.07), and erections of longer duration (p=0.04) 
with CSD500 relative to the standard condom. Men also reported increased penis size (p<0.01) 
and erections of longer duration (p=0.02) with CSD500 compared to the standard condom. The 
second was a single-arm trial of CSD500 among heterosexual men (N=91) and women (N=38) 
in Argentina. Both men (54%) and women (63%) reported that the condom improved sexual 
performance, with participants citing improved sensations, comfort, texture, erection duration 
and confidence (James Barder, written communication, January 2015). 
 
 
 
4. 
RATIONALE 
 
Promoting a novel condom designed to improve sexual pleasure could lead to less 
unprotected sex and, thereby, reduce the risks of both unintended pregnancy and 
HIV/STI. 
 
As the sole method for dual protection against pregnancy and HIV/STI, condoms play an 
important role in public health. Male condoms protect against pregnancy (Trussell 2011) and the 
transmission of HIV, chlamydia, gonorrhea, trichomoniasis, herpes simplex virus type 2, and 
syphilis (Holmes 2004; Weller 2002). Given their effectiveness against both pregnancy and 
disease when used consistently and correctly, condoms alone (rather than with another modern 
method) have been recommended for those needing dual protection (O'Leary 2011). Condoms 
have many positive attributes: low cost, availability without a prescription, minimal side effects, 
few contraindications, and global presence. Sustained use, however, is notoriously difficult to 
achieve. Only 9% of reproductive-age women in the U.S. in 2011-2013 reported current condom 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 8 
use (Daniels 2014). Similarly, a national survey in Vietnam found that only 9% and 7% of 
sexually-active, married, reproductive-age women reported condom use at last sex act and 
consistent condom use, respectively (Do 2011). Substantial unmet need for contraception, partly 
stemming from concerns about safety of hormonal contraception, drives Vietnam’s high 
abortion rate. Married women account for about one-third of HIV cases in Vietnam (MOH 2009), 
and among this group, most were exposed to the virus through sexual activity with their 
husband (UNAIDS 2010; Nguyen 2008). Thus, increasing condom use within established 
partnerships is crucial for preventing HIV/STIs while also protecting women against 
unintended pregnancy. 
 
A range of condom-related factors can diminish sexual pleasure: physical effects, including 
dulled sensation, pain, discomfort, or vaginal dryness (possibly from inadequate condom 
lubrication); unappealing perception of the touch, taste, or smell of condoms; lack of spontaneity 
or interruption to the flow of sex; and social constructs (e.g., decreased emotional closeness or 
inability to express male vitality by ejaculating into the vagina) (Hensel 2012; Sanders 2014). 
Dulled sensation can lead to erection loss: an estimated 9%-37% of condoms users have 
had erection problems during condom application or use (Graham 2006; Sanders 2012; 
Sanders 2014). This experience – especially during initial, formative sexual encounters – has 
been shown to make some men less confident about their ability to maintain an erection during 
condom use, which may then cause a negative feedback loop of erectile dysfunction (Sanders 
2014). Condom-related erection loss also could dissuade men from future attempts to use a 
condom. 
 
A national survey in Vietnam found that despite widespread lack of personal experience with the 
device, about 70% of youth believed that condoms reduce sexual pleasure (MOH 2005). This 
finding is consistent with a 14-country study identifying diminished sexual pleasure as the 
primary objection to condom use (Mehryar 1995) and with a large U.S. study, in which 31% of 
heterosexual male and female users of condoms reported a problem with the feel of the device 
(Crosby 2013). Although the physical properties of condoms directly affect men, women can be 
even more resistant toward condom use possibly, in part, from weighing their male partner’s 
pleasure as an important contributor toward their own pleasure (Higgins 2008). Women also 
might be reluctant to require condom use because of concerns that this will lead to their partner 
seeking unprotected sex elsewhere. Perceptions about condom effects on sexual pleasure and 
arousal are important because they are directly related to frequency of actual use (Crosby 2013; 
Higgins 2009; Randolph 2007). While the effectiveness of structural and community-level 
interventions for increasing condom use remains unclear (Moreno 2014), individual counseling 
has been shown to reduce STI incidence among adolescent and high-risk adult populations (Lin 
2008). Less research has focused on heterosexual couples in purportedly monogamous 
relationships. 
 
Increasingly, the importance of sexual pleasure has been recognized for informing 
interventions on safer sex. Condoms have been modified in terms of their size, taste, 
appearance, texture, smell and thickness to improve the user experience (Cecil 2010; Crosby 
2010). Eroticizing the protection afforded by condoms appears to be a successful strategy 
employed by consistent condom users in Mexico and the Dominican Republic (García 2003; 
García 2004). Other interventions have included selling condoms packaged with water-based 
lubricant sachets as pleasure enhancements in Cambodia and socially-marketing textured male 
condoms in Uganda (Philpott 2006). Increased sales of these products suggest that 
interventions to improve sexual pleasure with condoms can increase frequency of condom use. 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 9 
5. 
PSA OUTCOME 
 
The primary study endpoint, detection of PSA in vaginal fluid, is a feasible marker of 
women’s recent exposure to semen from penile-vaginal sex. Forensic research 
demonstrates that PSA clears from the vagina in a mean of 20-27 hours and is undetectable 
after 47 hours (Graves1985; Kamenev 1989). More recently, the protein has been studied for its 
potential as a semen biomarker for research purposes. Three studies using a controlled design 
in which women were exposed to specific quantities of their partner’s semen in a clinic setting 
showed high proportions of women tested PSA-positive immediately after exposure (Lawson 
1998) followed by a sharp decay curve (Macaluso 1999; Jamshidi 2013). For example, when 
women were exposed to 1 mL of semen (a volume on the same order of magnitude as the 
amount in a typical ejaculate) (Cooper 2010), Macaluso et al. found PSA (>1 ng/mL) in 92%, 
29% and 3% of women immediately, 24 hours, and 48 hours afterwards, respectively (Macaluso 
1999). Given this pattern of clearance from vaginal fluid, observed PSA positivity should be 
interpreted as the lower bounds of exposure in the past 48 hours. PSA is stable in specimens 
stored at −70°C after collection (Gallo 2013a). Because it is expressed independently of 
spermatozoa, PSA is useful for identifying exposure even from men who are vasectomized or 
otherwise without high levels of spermatozoa. False positive PSA tests from women’s 
endogenous sources of PSA (e.g., serum or urine) are improbable given that the resulting PSA 
levels would be several orders of magnitude below the established threshold for defining PSA 
positivity from semen exposure (Gallo 2013b). 
 
To compare condom use between randomization arms, we will sample three short periods of 
exposure during follow-up (at 2, 4 and 6 months). Studies relying on self-reports of sex and 
condom use have a similar limitation in that they rarely attempt comprehensive measurement of 
condom use throughout study follow up. These studies typically ask about condom use at last 
sex act or, less often, over a short recent period to minimize potential for recall bias. The study 
will be powered to detect differences in semen exposure between the groups using this 
sampling. Biomarkers provide an unbiased comparison of the frequency of semen 
exposure between randomized arms. In contrast, studies that rely on participant reports 
of exposure can be biased; the validity of reports vary by numerous study and 
participant factors, including HIV risk (Gallo 2011), which can result in confounding that 
cannot be addressed adequately in the analysis. 
 
We previously demonstrated in an RCT that advance knowledge of testing for PSA did not 
change women’s behavior with respect to semen exposure or reporting of this behavior 
(Thomsen 2007). Thus, the act of consenting to study procedures, including sampling vaginal 
fluid to test for PSA, is not expected to influence participant behavior. 
 
Preliminary data from an in vitro experiment conducted at the UNC laboratory provide 
evidence that the CSD500 condom does not interfere with the detection of PSA (Marcia 
Hobbs, written communication, August 2014). Laboratory technicians spiked condom extracts 
(including material from the inside only, outside only, or a combination of both) and non-condom 
controls consisting of phosphate buffered saline (PBS) only with three concentrations of PSA 
(0.25, 2.00 and 11.50 ng/mL) and no PSA (control). Five independent samples of each condom 
extract condition were prepared for a total of 60 specimens and the PBS controls. Table 1 
shows the mean PSA detected for each condition, which were all within manufacturer ranges. 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 10 
Table 1.  Detection of PSA in PBS alone or material extracted from the inside or outside of 
CSD500 condoms from spiked specimens, by PSA concentrations used for spiking 
Spiked PSA 
concentration 
(ng/mL) 
Architect Total PSA result (mean +/- standard deviation in ng/mL) 
for specimens prepared witha 
PBS 
Condom inside 
Condom outside 
Condom in/out 
0.00 
0.00 +/- 0.00 
0.00 +/- 0.00 
0.00 +/- 0.00 
0.00 +/- 0.00 
0.25 
0.23 +/- 0.01 
0.23 +/- 0.01 
0.22 +/- 0.01 
0.22 +/- 0.01 
2.00 
1.88 +/- 0.03 
1.88 +/- 0.08 
1.89 +/- 0.07 
1.95 +/- 0.12 
11.50 
11.74 +/- 0.29 
11.76 +/- 0.59 
11.71 +/- 0.59 
12.08 +/- 0.31 
aEach of the 16 test conditions (spiked PSA concentration by PBS or condom extract) evaluated for 5 independent specimens 
PBS = phosphate buffered saline; PSA = prostate-specific antigen 
 
 
6. 
STUDY POPULATION 
 
6.1 
Study site 
 
All enrollment and data collection activities will occur at the Thanh Hoa Provincial Centre of 
Reproductive Health. 
 
6.2 
Eligibility criteria 
 
The study will enroll approximately 500 couples with roughly equal distribution to the two study 
arms. Couples must speak Vietnamese to be eligible for study participation. 
 
In addition, women must meet all of the following criteria at enrollment to be eligible: 
•   Be 18-45 years of age; 
•   Not currently using a modern contraceptive method other than condoms or intending to start 
using a modern contraceptive method other than condoms in the next 6 months; 
•   Willing to use the assigned study condoms as the sole method of contraception for the next six 
months; 
•   Not breastfeeding; 
•   Not known to be pregnant; 
•   Want to avoid pregnancy for at least the next six months; and 
•   Be in a monogamous relationship for at least the past six months with her current male partner. 
 
Couples are ineligible for study participation if either person in the couple is known to be HIV- 
positive or has any of the following contraindications to CSD500 use (see Package Insert): 
•   History of low blood pressure or heart condition; 
•   Current use of medication for anemia, blood pressure, erectile dysfunction (man only), 
migraines, headaches or glaucoma; 
•   Inflamed or broken skin that the condom could come into contact with (man only); or 
•   Latex allergy or sensitivity. 
 
Both the woman and her male partner need to be willing and able to consent to the study 
procedures, including the use of the assigned study condoms. 
 
Our justification for excluding women who are known to be pregnant or already using a modern 
method of contraception other than condoms and couples in which either partner has a known HIV-
infection is that these individuals might differ in unknown ways from others with respect to 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 11 
their adherence to the promotion of condoms for avoiding semen exposure. Furthermore, 
individuals who are known to be HIV-positive typically receive more intensive safer sex 
counseling, and the scientific integrity of the study findings require that all participants receive 
standardized condom counseling according to their study arm. 
 
 
 
7. 
STUDY AIMS 
 
The study has three main aims. 
 
7.1 
Aim 1: To evaluate whether CSD500 provided to improve sexual pleasure, as 
compared to the standard condom, results in less semen exposure among women in 
an established relationship 
 
We hypothesize that providing women in an established relationship with CSD500 accompanied 
by counseling focusing on the new condom’s ability to improve male performance will result in less 
unprotected vaginal sex than providing the standard condom with traditional counseling focusing 
on disease and pregnancy prevention only. The primary outcome is the relative risk (RR) 
comparing PSA positivity (per established threshold of >1 ng of PSA per mL vaginal swab eluate) 
at the 2, 4 and 6-month follow-up visits between the two study arms. 
 
7.2 
Aim 2: To evaluate the effects of CSD500 provision on men and women’s reports of 
sexual pleasure compared to the standard condom 
 
We will assess sexual pleasure with the Quality of Sexual Experience (QSE) scale, which is a 
validated measure of the pleasure and satisfaction of event-level sexual experiences (Sanders 
2013). The construct of sexual pleasure can vary dramatically between individuals. For example, 
when interpreting a sexual act as pleasurable, individuals could be focused on different types of 
activity (e.g., foreplay, touch, use of erotica or toys, and oral or anal intercourse) or different 
aspects of the experience (e.g., orgasm or even pain). In order to account for the diversity of 
experiences that might make a sexual act pleasurable for an individual, the QSE scale does not 
capture specific physical or emotional aspects of the experience, but rather measures seven 
broad, event-level, bipolar items. Note that CSD500 could increase erection duration, which could 
(positively or negatively) influence the man’s perception of the sexual pleasure of the act. Thus, 
we will also consider a modified QSE scale that adds an item to assess pleasure related to the 
act’s duration. 
 
The QSE scale was validated for men using three single-item questions that measured the 
individual’s assessment of 1) the overall quality of the sexual act; 2) the act compared to the 
individual’s typical act; and 3) the occurrence and quality of the respondent’s orgasm during the 
act (Sanders 2013). QSE scores predicted much of the variance and were statistically significantly 
correlated (P < 0.001) with each of the measures. The scale also had high internal consistency 
(Cronbach’s alpha of 0.96). 
 
7.3 
Aim 3: To identify correlates of semen exposure measured by PSA positivity 
 
We hypothesize that condom usage will differ by demographic (e.g., age and marital status), 
personal (e.g., sexual relationship power), and study-related factors (e.g., length of follow up). To 
date, most evidence on correlates of condom nonuse is derived from studies where women were 
asked to report on their sex and condom use behavior; consequently, these studies might have 
identified correlates of reporting unprotected sex rather than correlates of 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 12 
actual unprotected sex. No published research has used a semen biomarker to characterize women 
in an established relationship who engage in unprotected sex. 
 
 
 
8. 
STUDY PROCEDURES 
 
For an overview, see “Schedule of study procedures.” 
 
8.1 
Recruitment 
 
Study staff will recruit women attending the Thanh Hoa Provincial Centre of Reproductive 
Health to the study using a standard Recruiting Script and the Study Brochure (see Attachments). 
Also, we will display the Study Poster (see Attachment) throughout the Thanh Hoa Provincial Centre 
of Reproductive Health.  Initially, we will not recruit from outside of the Centre to ensure a slow rate of 
enrollment. Depending on the enrollment pace, we may start to recruit outside of the Centre.  This 
recruitment will involve displaying the Study Poster and distributing the Study Brochures in places of 
employment (e.g., factories and school teachers) in Thanh Hoa city.  This passive recruitment will 
require those interested in participating in the study to attend the Centre to obtain more information.   
 
If their male partner is not present at the Centre, women will be asked to return with him to complete 
the enrollment visit. 
 
Staff will complete the Eligibility Assessment Form to determine the couple’s eligibility. Women who 
are potentially interested in starting a modern contraceptive method other than condoms will be 
referred following standard care and will not undergo any further recruitment to the study. 
 
8.2 
Enrollment visit 
 
If the couple is eligible per the Eligibility Assessment Form, study staff will conduct the consent 
process by reading the Annotated Enrollment Consent Form aloud to the couple in a private location 
and answering any questions. Only couples who demonstrate comprehension of the embedded 
questions during the consent process and who sign the Enrollment Consent Form will be enrolled.  
 
The REDCap software program will provide the arm assignment after each couple is enrolled into the 
trial. Study staff will record the couple’s names, their unique participant identification numbers (PINs), 
and their assigned arm onto the Participant Identification Log. In the presence of the female 
participant only, staff will administer the Female Enrollment Questionnaire, and a study clinician will 
collect a double-headed vaginal swab per established procedures (Gallo 2013a). In the presence of 
the male participant only, staff will administer the Male Enrollment Questionnaire. Staff will provide 
the appropriate condom counseling (see Counseling Checklist: Control Arm and Counseling 
Checklist: Intervention Arm) to the couple together, and distribute the assigned study condoms. 
Participants in the intervention arm will receive the Futura Max Information Sheet. At the end of the 
enrollment visit, staff will administer the Participant Contact Form to the couple and will provide the 
male and female partner each with 110,000 VND (~5 USD) as compensation for their time for 
participation and travel costs to the clinic. 
 
8.3 
Follow-up visits 
 
Female participants will be asked to return for follow up at 2, 4 and 6 months after enrollment. They 
will be instructed to return on the scheduled day regardless of their menstrual cycle. At each woman’s 
follow-up visit, study staff will administer the Female Follow-up Questionnaire and a study clinician 
will collect a double-headed vaginal swab. At 2 and 4-month visits, staff will provide condom 
counseling (per study arm), give 20 (or more if needed based on expected coital frequency) of the 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 13 
assigned study condoms, and confirm the accuracy of the information on the Participant Contact 
Form. At the 6-month visit, all women will receive the standard condom, which is provided for free of 
charge per standard care. 
 
Men will be asked to return at the 6-month visit to complete the Male Follow-up Questionnaire. 
 
Female participants will be compensated at the end of the 2-month (110,000 VND; ~5 USD), 4- 
month (220,000 VND; ~10 USD), and 6-month visits (440,000 USD; ~20 USD) for their time and 
travel costs. Male participants will be compensated at the end of the 6-month visit (330,000 
VND; ~15 USD). 
 
8.4 
Interim visits 
 
We will instruct participants to return to the clinic at any time for any study-related problem. Also, 
study staff may request that participants attend interim visits to follow-up on adverse events (AEs). All 
procedures at interim visits will be documented on the Adverse Event Form. 
 
8.5 
Condom counseling 
 
Staff will provide standardized condom counseling on proper use of the assigned condom type to 
couples at enrollment and to the female participants at the follow-up visits (see Counseling Checklist: 
Control Arm and Counseling Checklist: Intervention Arm). Counseling for the two arms differs in the 
rationale given for condom use. Specifically, the intervention arm will receive counseling that briefly 
addresses condom’s dual protection against pregnancy and HIV/STI but that otherwise emphasizes 
the potential for increased sexual pleasure with CSD500 use. 
 
Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly 
massage the gel inside the condom teat onto the penis head after donning the condom and to 
not use multiple condoms within a 24-hour period. In contrast, the control arm will receive standard 
counseling to use condoms for pregnancy and disease prevention without receiving 
any messages about the use of condoms for sexual pleasure. 
 
Study staff will be trained with a formal curriculum (adapted from Pathfinder 2000) to counsel women 
on condom use. Training will address 1) key condom messages (per the intervention arm as 
described above); 2) mechanism of action and condom effectiveness; 3) factors that influence 
condom effectiveness; 4) indications and rationale for condom use; 5) counseling patients on correct 
condom use; and 6) correct condom storage procedures in service delivery settings. Only staff who 
demonstrate proficiency will provide condom counseling to study participants. 
 
8.6 
Specimen collection and testing 
 
Trained clinicians will collect a vaginal fluid specimen (using a 1-mL, rayon-tipped double-headed 
swab) from each participant at each of the four scheduled study visits. Swabs will be stored onsite at 
−70°C following collection until their shipment in batches on dry ice to the UNC laboratory, where one 
of the double-headed swabs will be processed and tested in batches for total PSA (Architect Total 
PSA; Abbott Diagnostics, Abbott Park, IL) by trained laboratory personnel following established 
procedures (Gallo 2013a). The second of the double-headed swabs may be used for quality 
assurance testing during the study. 
 
8.7 
Referrals 
 
We will follow standard of care (MOH 2002) to refer participants for HIV/STI screening and care at the 
site. This care is not part of the study. 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 14 
 
8.8 
Contact tracing 
Study staff will attempt to trace participants – using contact information provided by the participant for 
this purpose – if participants do not return for their Follow-up Visits in a timely manner. 
 
8.9 
Early study discontinuation 
 
Participants have the right to withdraw their participation from the study at any time for any reason. 
They may also be discontinued if the study staff determines that further participation would be 
detrimental to the participants’ health or well-being. All incidences of study discontinuation will be 
documented on the Study Discontinuation Form. 
 
 
 
9. 
STATISTICAL CONSIDERATIONS 
 
9.1 
Sample size 
 
Sample size calculations are based on 
detecting a clinically relevant RR of PSA 
positivity between the intervention 
and control arms. Our primary outcome 
is PSA positivity at the three follow-up 
points for each participant. Sample size 
calculations are based on formulae for 
correlated binary response variables 
(Fitzmaurice 1995; Jung 2003), using 
specifically GEE to fit a log-binomial 
model (Rochon 1998; Dahmen 2004). 
We show calculations (Figure 1) based 
on significance level of 0.05 (two-sided 
test), power to detect the effect set at 
80% and 90%, and probability of PSA 
positivity in the control arm of 0.15. 
While the frequency of PSA positivity 
observed in past research has ranged 
from 8-38% (Table 2), these studies 
almost uniformly either studied populations with PSA positivity that could be expected to be 
higher (sex workers) or lower (syndromic STI patients or women in serodiscordant relationships) 
than in the proposed trial. Only two trials studied HIV-negative women who were not sex 
workers or syndromic STI patients; PSA positivity in these trials ranged from 0.22 to 0.25 
(Minnis 2009). To be conservative in ensuring an adequate sample size, we reduced our 
expected frequency of positivity roughly by 1/3 to 0.15. We assume an exchangeable correlation 
structure (same correlation, rho, between any two observations on the same subject). Given that 
previous studies produced an estimated rho of approximately 0.23 (Anderson 2013; Hobbs 
2009; Gallo 2007), we display sample sizes required for values of rho ranging from 0.15 to 0.3. 
We considered RRs from 0.5 to 0.6, meaning a reduction of PSA positivity from 15% in the 
control arm to between 7.5% and 9% in the intervention arm. Finally, we adjusted the sample 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 15 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
sizes to account for attrition. Specifically, we assumed that 10% would fail to return after 
enrollment and, among the 90% remaining in the study, the probability of missing a follow-up visit 
would be 25%. 
 
Given these assumptions, 500 subjects split equally in two arms will provide us with adequate 
power (80% for all assumed ranges of values and 90% in many) to detect a clinically meaningful 
reduction in PSA positivity for most values of rho. For example, at the estimated rho of 0.23, this 
sample size yields 80% power to detect a RR of approximately 0.61 at alpha level of 0.05. Thus, a 
total sample of 500 women will ensure adequate power to detect a clinically meaningful change in 
the frequency of PSA positivity between the study arms. 
 
9.2 
Randomization 
 
After having been determined to be eligible and having provided written consent for participation, 
couples will be randomized to one of the two study arms in roughly equal proportions. The 
Statistician will prepare the randomization program in REDCap before study initiation. The 
concealment of allocation process will be accomplished using the relevant function in the REDCap 
electronic data capture system. 
 
9.3 
Data analysis 
 
The success of the study objectives will be judged by results of statistical tests. Each objective will 
be operationalized in three steps: 1) specific endpoints are identified and measured; 2) statistical 
hypotheses relate the objectives to the measured endpoints; and, 3) the statistical 
Table 2.  Frequency of observed PSA positivity, by study 
 
 
 
 
PSA positivity 
 
 
 
 
 
Study 
Location  
Female population 
PSA tests 
No. 
(%) 
Hobbs 2003 
Bangladesh 
Sex workers  
402 
154 
(38.3) 
Evans 2013 
Cambodia  
Sex workers  
183 at month 6 
172 at month 9 
170 at month 12 
42 
42 
33 
(23.0) 
(24.4) 
(19.4) 
Pépin 2006 
Guinea, Togo, 
Ghana & Mali 
Sex worker, syndromic STI patients 
Syndromic STI clinic patients  
508 
658 
94 
58 
(18.5) 
(8.8) 
Aho 2010 
Guinea 
Sex workers  
219 
84 
(38.4) 
Anderson 2013 
Jamaica 
Syndromic STI patients  
285 at day 0 
286 at day 6 
24 
29 
(8.4) 
(10.1) 
Rattray [in 
press]a 
Jamaica 
HIV-negative, seeking 
contraception 
414 at month 0 
401 at month 1 
389 at month 3 
103 
93 
95 
(24.9) 
(23.2) 
(24.4) 
Gallo 2007 
Kenya 
Sex workers 
194 at month 0 
183 at month 12 
30 
21 
(15.5) 
(11.8) 
Mose 2013 
Kenya 
In a HIV-discordant relationship 
124 
3 
(10.5) 
Gallo 2006 
Madagascar 
Sex workers  
332 
126 
(38.0) 
Minnis 2009a 
Zimbabwe 
Sexually-active, HIV-negative 
910 
196 
(21.5) 
aTwo trials of HIV-negative women who were not sex workers or syndromic STI patients 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 16 
hypotheses are tested, using appropriate analytic procedures. Supportive analyses will include 
simple descriptive tables at baseline. The frequency and causes of missing and mistimed data 
values will be examined. 
 
An intent-to-treat analysis will be used for the primary analysis in Aim 1. To that end, every effort 
will be made to obtain complete data on participants, including those who report not using (or 
failing to successfully use for the entire act) the assigned condoms. All variable data values will be 
used whenever possible. 
 
The following sections describe the plans for formal estimation and inference. 
 
9.3.1 
Analysis of Aim 1 
 
We hypothesize that the frequency of PSA detection (defined as <1 ng/mL) during the six months 
of follow up will be lower in the intervention arm compared to the control arm. To test our 
hypothesis, we will calculate a relative risk (RR) with 95% confidence interval (CI) for the 
frequency of PSA positivity between arms, using generalized estimating equation (GEE) 
methods to account for correlation across visits from individual participants. Sensitivity analyses 
will include 1) calculating the RR of PSA positivity at least once during follow up (i.e., using 
women, instead of visits, as the unit of analysis); 2) using a higher threshold (4 ng/mL) to define 
PSA positivity; and 3) considering the effect of study duration on the main comparison. These 
analyses will be based on an intent-to-treat design (Lachin 2000). Although masking participants 
and clinic study staff to arm assignment is not feasible, the Statistician and laboratory staff will 
remain masked until the primary analyses are completed. We will follow CONSORT guidelines for 
reporting the primary results (Moher 2001). 
 
9.3.2 
Analysis of Aim 2 
 
We hypothesize that couples randomized to receive CSD500 will experience greater sexual 
pleasure compared to those receiving the standard condom. To test our hypothesis, we will use 
linear regression to compare QSE scores for the most recent use of a study condom for vaginal 
intercourse between women in the intervention and control arms at the 2, 4 and 6-month visits 
using GEE methods and between men in the two arms at the 6-month visit. We will repeat these 
analyses using an alternative measure of sexual pleasure, the Sexual Experience Questionnaire 
(SEX-Q) (Jones et al. 2008). Other secondary analysis will include 1) evaluating whether PSA 
positivity (defined as <1 ng/mL) is associated with women’s QSE scores, women’s perceptions 
of their partner’s pleasure, men’s QSE scores, and men’s SEX-Q scores (in separate models) and 
2) men’s acceptability of the study condom using descriptive statistics. In the event that the 
intervention is not statistically associated with a reduction in observed PSA positivity (i.e., the 
hypothesis for Aim 1 is not supported), these data could be useful for elucidating relationships 
between sexual pleasure and condom use within specific subgroups of the study population. 
 
9.3.3 
Analysis of Aim 3 
 
We will evaluate the following as potential correlates of semen exposure (PSA positivity defined 
as >1 ng/mL) at enrollment and the three follow-up visits: 1) woman’s sexual relationship power, 
as measured by the sexual relationship power scale (SRPS) (Pulerwitz 2000); 2) her or her 
partner’s regulatory focus (promotion versus prevention-focus) (Gomez 2013); 3) her partner’s 
perceived barriers to condom use, as measured by the Condom Barriers Scale (St. Lawrence 
1999), which has been modified for use in males (Doyle 2009); 4) variables based on the 
Theory of Gender and Power as applied to women’s HIV risk (e.g., age, difference in age with 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 17 
her male partner, prior condom experience, past sexual partners, history of other contraceptive 
method use, alcohol or other drug use, and perceived risk of infection or pregnancy and degree of 
motivation to avoid these) (Wingood 2000). Secondary analyses will include 1) identifying 
correlates of self-reported recent semen exposure (dichotomous variable for any report of vaginal 
sex without condom use with study partner in the past 48 hours) and 2) assessing whether 
correlates of semen exposure differ according to the outcome measure (PSA positivity or self-
report). To conduct the latter exploratory analysis, we will simultaneously fit models for the two 
outcomes using bivariate logistic regression (Fitzmaurice 1995). We will apply GEE with 
alternating logistic regression (Carey 1993), which directly models within-woman associations 
using pairwise odds ratios. This bivariate approach will allow us to directly test whether the two 
models differ rather than assume that a significant finding in one model but not the other would 
imply that the two outcomes differ in their risk factors. 
 
 
 
10. 
DATA MANAGEMENT 
 
Given the potential for low participant literacy, trained study staff will administer all study forms 
and questionnaires and will electronically record responses directly onto a laptop computer using 
REDCap software. REDCap, which is supported by the Center for Clinical and Translational 
Science (CCTS) at OSU, facilitates the transmittal of secure, encrypted and password-protected 
data. CCTS will prepare the data entry screens with built-in quality control checks. Entered data 
will be instantaneously uploaded behind the secure OSU firewall. The PI will monitor the data 
during the study to resolve any potential issues upon detection. 
 
In the case of internet outage or other technical difficulties, study staff will record data onto paper 
forms using a pen. These data will be entered into REDCap when the internet access is restored. 
PSA test results will be sent from the UNC laboratory to the PI in an electronic spreadsheet. The 
Site Investigator and PI will review the data files on an ongoing basis for accuracy. To maintain 
participant confidentiality, only a coded PIN will identify all data collection forms (DCFs), reports, 
and other records. Participants’ names will be stored separately in a locked file in a locked office 
at the study site. No reports will link individual names with person-level data. Unique PINs will be 
used to link participant-specific data. All records will be secured in a locked room, accessible only 
by trained study staff. All computer entry and networking programs will be done with coded 
numbers only. Electronic files will be password-protected, with access only by authorized study 
personnel. Clinical information will not be released without written permission of the participant, 
except as necessary for monitoring by OSU or its designee. 
 
 
 
11. 
TRANSLATION 
 
All study materials will be translated into Vietnamese. After translation into Vietnamese, the DCF, 
Enrollment Consent Form and Futura Max Information Sheet will be back translated into English 
to ensure linguistic equivalence between the two versions. 
 
 
 
12. 
INCIDENTS AND INCIDENT REPORTING 
 
12.1 Adverse events 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 18 
 
Adverse events (AEs) are defined as any untoward health-related reaction, effect, toxicity, or 
abnormal laboratory result that a study participant experiences during the course of a study. Only 
new untoward health-related events or worsening of a baseline condition are considered AEs. 
 
An unexpected AE is one whose specificity or severity is not listed in the CSD500 package insert. 
Expected AEs include headaches, faintness and nausea, loss of sensation, dizziness and skin 
irritation. Information on expected AEs will be recorded on study DCFs, but these events will not 
be reported to the relevant IRBs unless the event is also serious or is an unanticipated problem 
involving risks to subjects or others (UPIRTSO). 
 
Study staff will record information on all AEs that are classified 1) as possibly, probably, or 
definitely related to study participation or 2) as serious. 
 
An AE is considered serious if it is fatal or life-threatening, requires in-patient hospitalization or 
prolongation of an existing hospitalization, results in a persistent or significant disability or 
incapacity, is a congenital anomaly or birth defect, jeopardizes the participant or requires 
intervention to prevent one of the outcomes listed above, or any other event deemed serious by 
the investigator. Study personnel will report any AE to the Site Investigator, who will determine 
1) its relatedness to study participation and 2) its seriousness. 
 
All SAEs will be reported in an expedited manner by completing the Adverse Event Form within 
two working days of when the site identifies the SAE. If it is determined that the SAE is 
unanticipated and anything other than “not related” (i.e., possibly, probably or definitely related), 
then the Site Investigator and PI will coordinate the notification of the relevant IRBs. 
 
Non-serious AEs will be recorded on DCFs but do not require expedited reporting unless they are 
classified as UPIRTSO. All AEs will be managed according to the standard of care for the clinical 
practice and the judgment of the on-site clinicians. 
 
12.2 Reporting other incidents that are unanticipated problems involving risks to subjects 
or others (UPIRTSO) incidents 
 
UPIRTSO are any events or information that were unexpected and indicate that research 
procedures caused harm to participants or others or indicate that participants or others are at 
increased risk of harm. An unanticipated problem may involve any aspect of the research study 
and could involve anyone including participants, research staff, or others not directly related to the 
study. AEs that are unexpected and related and protocol violations are specific examples of 
UPIRTSO. Not all AEs are UPIRTSO, and not all UPIRTSO are AEs. 
 
Examples of other UPIRTSO include 1) a breach of confidentiality; 2) a change to the protocol 
taken without prior IRB review to eliminate an apparent immediate hazard to a research 
participant; 3) halting of the study by a sponsoring agency; and 4) a participant complaint that 
indicates unexpected risks or that cannot be resolved by the study team. Any possible UPIRTSO 
will be recorded on the appropriate log and report form. The Site Investigator or designee will 
decide whether the incident meets the definition of UPIRTSO and, thus, requires prompt reporting 
to the IRBs. 
 
12.3 Sponsor and principal investigator responsibilities 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 19 
The sponsors, PI, Site Investigator, or designees have the authority to stop the study due to 
SAEs, UPIRTSOs, protocol violations, or problems related to inadequate recruitment or follow- up, 
or upon the direction of an IRB. 
 
The Site Investigator or designee has the authority to change the protocol to eliminate an 
apparent immediate hazard to a research participant. 
 
 
13. 
PROTECTION OF HUMAN SUBJECTS 
 
13.1 Informed consent process 
 
Study staff will read the Annotated Enrollment Consent Form aloud to the couple. This Form is 
identical to the Enrollment Consent Form except that the former has questions embedded to ask 
to the potential participants to gauge their comprehension of the study during the consent process. 
Only couples who demonstrate comprehension of the answers to these questions will be enrolled. 
 
Both members of the couple will indicate their agreement to participate in the study by signing the 
Enrollment Consent Form. Individuals who are illiterate will provide an “X” on the form to indicate 
consent; the full discussion of the consent process for these participants will be conducted in the 
presence of a witness, who will sign the Enrollment Consent Form indicating that the witness has 
observed the entire consent process. The female and male participants will be asked for their 
consent for future contact about new research. They will indicate whether they consent to this by 
checking the appropriate box on the Enrollment Consent Form. The couple do not consent to 
future contact, they can still enroll in the study. The couple will be given an unsigned copy of the 
Enrollment Consent Form to keep for future reference, as it provides contact information for staff 
responsible for the conduct of the research study in the event of any questions or concerns. 
 
13.2 Minimizing coercion or undue influence 
 
The reimbursements for participation have been set in line with the local economy and recent 
research studies conducted with this population and will only compensate participants for their 
time in completing the questionnaires. The Enrollment Consent Form specifies the reimbursement 
amounts in the local currency, VND. 
 
13.3 Description of risks 
 
This study poses no more than minimal risk to participants. The active ingredient in CSD500 can 
cause headaches, faintness and nausea, loss of sensation, dizziness and skin irritation (see 
Package Insert). Participants will be instructed to stop using the study condoms if either they or 
their partner experience any of these symptoms and will be referred for standard care, as 
indicated. 
 
Participants may experience psychological risks associated with answering questions about 
sensitive topics or reporting attitudes and behaviors, such as their sexual activity and details of 
their sexual relationships. Several measures have been implemented to minimize these risks. 
First, during the consent process, participants will be advised that they are free to decline study 
participation. Participants also will be informed that they can decline to answer any questions. 
Participants also will be informed of their freedom to terminate the interview or visit at any time. All 
interviews that take place in-person will occur in a private setting by interviewers who have been 
trained thoroughly on the importance of confidentiality, the procedures to protect a participant’s 
confidentiality, and the penalties associated with breaches of confidentiality. 
 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 20 
Participants’ personal information will be kept confidential. Access to the signed consent forms 
and the Participant Identification Log (i.e., the roster linking participant names and PINs) will be 
limited to authorized study personnel and remained locked in a file cabinet when not in use. 
 
We will not perform any genetic testing. 
 
13.4 Description of anticipated benefits to the research participant 
 
There are no study benefits to the research participant. Participants and others may indirectly 
benefit in the future from the trial results. 
 
13.5 Description of potential risk to anticipated benefit ratio 
 
The potential risks involved in trial participation are reasonable in relation to the anticipated 
benefits. 
 
13.6 Provisions for protecting privacy and confidentiality 
 
Participants’ privacy and the confidentiality of data will be protected through training of 
interviewers and other study staff; conducting all interviewing, and physical examinations in 
private; storing study materials in a locked room; and securing computer files that include 
identifiers. Only the study PINs will identify participant research records. Linkages between PINs 
and participants’ identifying information will not be maintained in a computer database; rather, 
they will be maintained in a paper log that is kept locked and only accessible to study staff at the 
study site. These linkages will be destroyed at an agreed upon timeframe after the main study 
articles are published. Data identifying individual study participants will not be published or 
released to persons outside of the project. 
 
13.7 Treatment and compensation for injury 
 
No money has been set aside for compensation for injury from study participation; however, this 
study poses no more than minimal risk to participants. 
 
13.8 Data and Safety Monitoring Committee (DSMC) 
 
The Regulatory and Ethics Core of the CCTS at OSU will assemble a Data Safety Monitoring 
Committee (DSMC) – consisting at minimum of a research ethicist / research subject advocate, 
biostatistician, and gynecologist – to independently monitor the safety of the study. The DSMC will 
review 1) the protocol before the accrual of human subjects; and the accumulated data after 
2) approximately 50-100 women-months of follow up have been completed; 3) after approximately 
half of the expected women-months have been accrued; and 4) after study follow-up has ended. 
The DSMC will evaluate participant safety and study conduct and progress and will make 
recommendations to the sponsor and investigators concerning the trial continuation, modification 
or termination. No specific stopping guidelines will be presented with the data, and 
recommendations for stopping early for safety reasons will be based on the judgment of the 
DSMC. The Committee will approve a detailed DSMC plan before the accrual of human subjects. 
 
 
 
14. 
PLANS FOR REPORTING RESULTS 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 21 
Upon completion of data analyses, the Site Investigator will organize the dissemination of the 
main study findings to the study team in Vietnam as well as to local stakeholders. In addition, the 
primary results will be written up for publication in a peer-reviewed scientific journal. Additional 
papers will also be written and submitted to peer-reviewed scientific journals as appropriate. 
 
A publication policy will be established to govern the publication of the results of the trial. 
Authorship roles will be assigned primarily according to the contributions of individual members as 
well as the likelihood that the authors will be able to complete data analysis and preparation of 
manuscripts in a timely manner. All investigators will be encouraged to participate in the 
discussions regarding authorship. All abstracts and publications resulting from this study must be 
cleared and approved by all participating institutions prior to submission to scientific meetings or 
journals. 
 
 
 
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Sanders SA, Hill BJ, Crosby RA, et al. Correlates of condom-associated erection problems in 
young, heterosexual men: condom fit, self-efficacy, perceptions, and motivations. AIDS Behav 
2014;18:128-34. 
Sanders SA, Yarber WL, Kaufman EL, et al. Condom use errors and problems: a global view. Sex 
Health 2012;9:81-95. 
St Lawrence JS, Chapdelaine AP, Devieux JG, et al. Measuring perceived barriers to condom 
use: psychometric evaluation of the Condom Barriers Scale. Assessment 1999;6:391-404. 
Thomsen SC, Gallo MF, Ombidi W, et al. Randomized controlled trial on whether advance 
knowledge of prostate-specific antigen testing improves participant reporting of unprotected 
sex. Sex Transm Infect 2007;83:419-20. 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 24 
Trussell J. Contraceptive failure in the United States. Contraception 2011;83:397-404.  
UNAIDS. HIV transmission from men to women in intimate partner relationships in Viet Nam: a 
Discussion Paper. UNAIDS, 2010. Accessed on September 23, 2014 at 
http://www.un.org.vn/en/publications/un-widepublications/doc_details/221-hiv-transmission-
from-men-to-women-in-intimate-partner-relationships-invietnam-a-discussion-paper.html 
Weller S, Davis K. Condom effectiveness in reducing heterosexual HIV transmission. Cochrane 
Database Syst Rev 2002;(1):CD003255. 
Wingood GM, DiClemente RJ. Application of the theory of gender and power to examine HIV- 
related exposures, risk factors, and effective interventions for women. Health Educ Behav. 
2000;27:539-65. 

Last revised on August 9, 2018 
 
 
 
 
 
 
 
 
p. 25 
16. 
ATTACHMENTS 
 
1.  Study timeline 
 
2.  Schedule of study procedures 
 
3.  Futura Max package insert 
 
4.  Futura Max packaging design 
 
5.  Recruitment Script 
 
6.  Counseling Checklist 
•   Control Arm 
•   Intervention Arm 
 
7.  Futura Max Information Sheet 
 
8.  Letters of support 
•   Luong Ngoc Truong, MD 
•   Luu Thi Hong, MD, PhD 
•   David Davies 
 
9.  Data Safety and Monitoring Committee Charter 
 
10. Data collection forms 
•   Eligibility Assessment Form 
•   Randomization Assignment Form 
•   Vaginal Swab Collection Form 
•   Female Enrollment Questionnaire 
•   Male Enrollment Questionnaire 
•   Female Follow-up Questionnaire 
•   Male Follow-up Questionnaire 
•   Study Discontinuation Form 
•   Interim Visit Form 
•   Adverse Event Form 
 
11. Enrollment Consent Form 
 
12. Annotated Enrollment Consent Form 

 
 
 Last revised on December 19, 2016  
 
 
 
 
 
 
 
 
p. 26 
Study timeline 
 
 
 
 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Quarter: 
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 
If relevant, obtain IRB approvals on protocol amendment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Form Data Safety Monitoring Committee 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pilot counseling messages and data collection forms 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Create study manual of operation including logs and forms 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Finalize data management plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Test and finalize electronic versions of data collection forms 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hire study staff 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop training curricula 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct site pre-initiation visit, staff training, and “wet” run 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct recruitment, enrollment, and follow up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clean data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disseminate study findings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 Last revised on December 19, 2016  
 
 
 
 
 
 
 
 
p. 27 
Schedule of study procedures 
 
Visit 
Study procedure 
Enroll-
ment 
2-month 4-month 6-month Interim 
Participant identification number (PIN) assigned 
⚤  
 
 
 
 
Eligibility Assessment Form 
⚤  
 
 
 
 
Enrollment Consent Form 
⚤  
 
 
 
 
Randomization Assignment Form 
⚤  
 
 
 
 
Female Enrollment Questionnaire 
♀ 
 
 
 
 
Male Enrollment Questionnaire 
♂ 
 
 
 
 
Condom counseling  
⚤a 
♀a 
♀a 
⚤ 
 
Condom provision 
⚤a 
♀a 
♀a 
♀ 
† 
Provide Futura Max Information Sheet 
⚤a 
♀a 
♀a 
 
 
Vaginal swab collection and Form 
♀ 
♀ 
♀ 
♀ 
 
Female Follow-up Questionnaire 
 
♀ 
♀ 
♀ 
 
Male Follow-up Questionnaire 
 
 
 
♂ 
 
Study Discontinuation Form 
† 
† 
† 
† 
† 
Interim Visit Form 
 
 
 
 
† 
Adverse Event Form 
† 
† 
† 
† 
† 
Obtain contact information 
⚤ 
♀ 
♀ 
 
 
Participant compensation 
⚤ 
♀ 
♀ 
⚤ 
 
Procedure completed by couple (⚤); woman only (♀); man only (♂); only if needed (†) 
aAccording to randomized arm assignment 

 
 
 Last revised on December 19, 2016  
 
 
 
 
 
 
 
 
p. 28 
VN CSD500 Study 
Counseling Checklist: Control Arm 
 
 
1. 
Greets patient respectfully.   
• Assures privacy.   
• Tries to put at ease if shy or embarrassed. 
 
2. 
Asks what patient knows about condoms and about past experience with 
condoms.  
• Corrects any myths or incorrect information. 
 
3. 
Provides basic facts about condoms. 
• Explains that condoms provide a barrier to 1) protect man and woman 
against spread of HIV and other sexually transmitted infections and 2) 
woman against pregnancy. 
• Counsels talking with partner about using condoms. 
• Asks if has any questions and answers them. 
 
4. 
Provides specific instruction on how to correctly use and when to use condoms. 
• Couple should use during every act of intercourse. 
• Couple should not "test" condoms by blowing up or unrolling. 
• Condom should be put on when penis is erect. 
• Condom should be put on before the penis comes near or is put into the 
vagina. 
 
5. 
Demonstrates how to correctly put on condom by using a model, banana, or two 
fingers. 
• 
Cautions not to unroll condom before putting on. 
• 
Shows how to place condom rim on penis and how to unroll up to penis 
base. 
• 
Instructs on how to leave 1/2 inch space for semen at tip of condom, which 
must not be filled with air or it may burst. 
• 
Shows how to expel air by pinching tip of condom as it is put on. 
• 
Cautions about tearing accidentally with fingernails or rings. 
 
6. 
Counsels about what to do if condom breaks or slips off during sex. 
• Woman should return to clinic to be assessed for emergency contraception. 
• Woman should request emergency contraceptive pills within 72 hours (the 
earlier the better) of unprotected sex or breakage of a condom. 
 
7. 
Has patient demonstrate and practice putting on condom using the model, banana 
or fingers. 
• Corrects any technique errors. 
 
8. 
Counsels patient on how to remove penis from vagina with condom intact and 
without spilling semen. 
• Hold on to rim of condom when withdrawing. 
 

 
 
 Last revised on December 19, 2016  
 
 
 
 
 
 
 
 
p. 29 
• Be careful not to let semen spill into vagina when penis is flaccid. 
9. 
Discusses use of lubricants and what not to use. 
• Do not use any of these: petroleum-based products (e.g., Vaseline); mineral, 
vegetable, or cooking oil; baby oil; margarine or butter. 
 
10. Advises to use a spermicide or water-based lubricant if one is needed. 
 
 
11. Advises patient to dispose of condoms by burning, burying, or throwing in the 
latrine. 
 
 
12. Repeats main condom messages to patient. 
• Be sure to have condom on hand before you need it. 
• Use a condom with every act of intercourse. 
• Do not use a single condom more than once. 
• Do not rely on condom if package is damaged, torn, outdated, dry, brittle or 
sticky. 
 
13. Provides patient with condoms for two months. 
• Multiply patient’s expected weekly coital frequency by 9. Give her this 
number of condoms or, if this number is less than 20, give her 20 condoms. 
 
 
14. Instructs patient not to share study condoms with anyone but main partner. 
• Do not share study condoms with family or friends. 
 
15. Reassures patient that should return at any time for advice or more condoms. 
 
 
 

 
 
 Last revised on December 19, 2016  
 
 
 
 
 
 
 
 
p. 30 
 
VN CSD500 Study 
Counseling Checklist: Intervention Arm 
 
 
1. 
Greets patient respectfully.   
• Assures privacy.   
• Tries to put at ease if shy or embarrassed. 
 
2. 
Asks what patient knows about condoms and about past experience with 
condoms.  
• Corrects any myths or incorrect information. 
 
3. 
Provides basic facts about condoms. 
• Briefly mentions that condoms protect against pregnancy and HIV and other 
sexually transmitted infections. 
• Explains that patient is receiving the new Futura Max condom. Futura 
Max condoms have a small amount of a special gel inside of the 
condom. This gel increases blood flow within the man’s penis.  This 
makes the man’s erection harder and last longer. This can make sex an 
intense and more pleasurable experience for the couple.  
• Counsels talking with partner about using Futura Max condoms. 
• Asks if has any questions and answers them. 
 
4. 
Provides specific instruction on how to correctly use and when to use condoms. 
• Couple should use during every act of intercourse. 
• Couple should not "test" condoms by blowing up or unrolling. 
• Condom should be put on when penis is erect. 
• Condom should be put on before the penis comes near or is put into the 
vagina. 
• Couple should not use more than one Futura Max condom within 24 hours. 
If having sex again within 24 hours, use a standard condom. 
 
5. 
Demonstrates how to correctly put on condom by using a model, banana, or two 
fingers. 
• 
Cautions not to unroll condom before putting on. 
• 
Shows how to place condom rim on penis and how to unroll up to penis 
base. 
• 
Instructs on how to leave 1/2 inch space for semen at tip of condom, which 
must not be filled with air or it may burst. 
• 
Shows how to expel air by pinching tip of condom as it is put on. 
• 
Explains that once the condom is on the penis, the man or woman 
should squeeze the teat of the condom and massage the gel, which is 
inside the condom teat, onto the head of the penis for 15 seconds.  
• 
Cautions about tearing accidentally with fingernails or rings. 
• 
If the condom starts to roll back up during sex, it should be rolled back 
down straight away. If the man feels the condom slip or tighten 
excessively, he should stop and check the condom placement to avoid it 
 

 
 
 Last revised on December 19, 2016  
 
 
 
 
 
 
 
 
p. 31 
breaking. If the condom comes off the penis, the man should stop and put 
on a standard (not a Futura Max) condom. 
6. 
Counsels about what to do if condom breaks or slips off during sex. 
• Woman should return to clinic to be assessed for emergency contraception. 
• Woman should request emergency contraceptive pills within 72 hours (the 
earlier the better) of unprotected sex or breakage of a condom. 
 
7. 
Has patient demonstrate and practice putting on condom using the model, banana 
or fingers. 
• Corrects any technique errors. 
 
8. 
Counsels patient on how to remove penis from vagina with condom intact and 
without spilling semen. 
• Hold on to rim of condom when withdrawing. 
• Be careful not to let semen spill into vagina when penis is flaccid. 
 
9. 
Discusses use of lubricants and what not to use. 
• Do not use any of these: petroleum-based products (e.g., Vaseline); mineral, 
vegetable, or cooking oil; baby oil; margarine or butter. 
 
10. Advises to use a spermicide or water-based lubricant if one is needed. 
 
 
11. Advises patient to dispose of condoms by burning, burying, or throwing in the 
latrine. 
 
12. Repeats main condom messages to patient. 
• Be sure to have condom on hand before you need it. 
• Use a condom with every act of intercourse. 
• Do not use a single condom more than once. 
• Do not rely on condom if package is damaged, torn, outdated, dry, brittle or 
sticky. 
• Futura Max condoms are designed to make sex more fun for the 
couple.  Futura Max condoms contain a special gel that makes the 
man’s erection get harder and last longer.  This can make sex more 
pleasurable for the couple. 
 
13. Provides patient with condoms for two months. 
• Multiply patient’s expected weekly coital frequency by 9. Give this number of 
condoms or, if this number is less than 20, give 20 condoms. 
• Give 2 standard condoms to use in case the couple has sex more than once 
within 24 hours. 
 
14. Instructs patient not to share study condoms with anyone but main partner. 
• Do not share study condoms with family or friends. 
 
15. Reassures patient that should return at any time for advice or more condoms. 
 
 
 

 
 
VN CSD500 Study 
Futura Max™ Information Sheet 
 
Futura Max™ condoms are natural rubber latex condoms which contain Zanifil® gel. They have been 
shown to maximize hardness by stimulating blood flow within the penis. This can help prevent loss or partial 
loss of erection, ensuring an intense experience for both you and your partner. 
 
How to use:  Use a condom only once. Condoms used more than once are more likely to slip or break and 
not provide adequate protection. Infections can be passed on in bodily fluids present in the condom after use. 
 
1. Tear open the foil and remove 
the condom. Be careful with 
sharp objects such as nails 
and jewelry. If the carton or foil 
is damaged, discard and use a 
condom from an undamaged 
package. 
 
2. Put the condom on the erect 
penis before any contact 
occurs between the penis and 
the partner’s body. This will 
help prevent sexually 
transmitted infections and 
pregnancy. Squeezing the teat 
at the end of the condom, 
ensuring no air is trapped and 
that the Zanifil® gel is on the 
inside, place the condom on 
the top of the penis and fully 
roll it down the shaft with the 
other hand. 
3. Once the condom is on the penis, 
squeeze the teat of the condom and 
massage the gel, which is inside the 
condom teat, onto the head of the penis 
for 15 seconds. Ensure not to damage 
the condom by sharp objects such as 
jewelry or fingernails. If the condom 
starts to roll back up during sex, roll it back 
down straight away. If you feel the condom 
slipping or tightening excessively stop and 
check – or it may break. If it comes off, 
stop and put on a standard condom. 
 
4. Withdraw soon after ejaculation, while the 
penis is still erect, holding the condom in 
place at the rim. 
 
 
 
5. Dispose of the used condom in a bin. 
Never flush it down the toilet. 
 
 
 
Important warnings: 
The active ingredient, Glyceryl Trinitrate 1%, can cause 
headaches, faintness and nausea, loss of sensation, 
dizziness and skin irritation. If you experience any of 
these symptoms, stop using Futura Max™ condoms. If 
your symptoms continue, contact your doctor. 
 
Don’t use Futura Max™ condoms if: 
•   You or your partner are taking medication to lower 
your blood pressure or for male impotence, migraines, 
headaches, glaucoma or anemia. 
•   The condom is likely to come into contact with 
inflamed or broken skin. 
•   You are pregnant or breast feeding. 
 
Consult your doctor before use if you or your partner: 
•   Have low blood pressure or a pre-existing heart 
condition; 
•   Are using medicines that could come into contact with 
the condom; 
•   Might be sensitive or allergic to latex. 
 
•   Don’t use more than one condom in a 24 hour period. 
•   Don’t use for oral sex. 
•   For anal sex, use additional lubricant on the outside 
of the condom to help reduce the risk of breaking or 
slipping. 
•   No method of contraception can provide 100% 
effectiveness against pregnancy or the transmission 
of HIV or STIs. 
•   If you are concerned that your partner may have 
become pregnant or infected, contact your doctor 
immediately. 
•   Seek medical advice as soon as possible, at least 
within 72 hours, if a condom you are using breaks or 
leaks. 
•   Use only additional lubricants that are compatible with 
latex condoms. 
•   Don’t use with oil-based lubricants such as petroleum 
jelly, baby oil, body lotions, massage oils, butter or 
margarine. 
 
Important information for Futura Max™ condoms: 
Last revised on December 16, 2016 
p. 31