World Journal of AIDS, 2013, 3, 179-186
http://dx.doi.org/10.4236/wja.2013.33023 Published Online September 2013 (http://www.scirp.org/journal/wja) 179
The Motivations and Experiences of Young Women in a
Microbicide Trial in the USA and Puerto Rico
Rebecca Giguere1, Gregory D. Zimet2, Jessica A. Kahn3, Curtis Dolezal1, Cheng-Shiun Leu1,
Marina Mabragaña1, Ian McGowan4, Alex Carballo-Diéguez1
1HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, USA;
2Department of Pediatrics, Indiana University School of Medicine, Indianapolis, USA; 3Cincinnati Children’s Hospital Medical Cen-
ter and the University of Cincinnati College of Medicine, Cincinnati, USA; 4Division of Gastroenterology, Hepatology, and Nutrition,
Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, USA.
Received May 23rd, 2013; revised June 23rd, 2013; accepted July 23rd, 2013
Copyright © 2013 Rebecca Giguere et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Young women are an important target group in microbicide research, yet little is known about why they participate and
stay in microbicide trials. Our study examined motivations for participating in a Phase I microbicide trial among 61
women ages 18 - 24 years in the continen tal USA and Puerto Rico. We also examined their perspectives on study parti-
cipation. Participants und erwent a semi-structured in-dep th interview in which th ey were asked about factors that moti-
vated enrollment and their experiences while participating. They also completed a Web-based Computer Assisted Self
Interview in which they were asked to rate study burden (1 = low to 4 = high). Factors that motivated enrollment were
altruism (29%), compensation (17%), a combination of altruism and compensation (37%) and free medical exams
(17%). Factors that encouraged participants to stay in the study were study staff (95%), confirmation of good health
(41%), and the opportunity to learn about their bodies (17%). Mean ratings of study burden ranged from 1.83 (having to
travel to site) to 2.41 (colposcopy), indicating that participants were not highly bothered by visits or procedures. Al-
though Phase I trials require invasive procedures, participants were not highly bothered by them and recognized them as
necessary. Good relationships with staff and clear information about how procedures contribute to study goals may en-
courage participants to remain in trials. Young wo men may be motivated to en ter microbicide trials by stressing the ro le
they will play in discovering better HIV-p rev en tion method s and h igh lightin g th e comprehens ive preven tiv e exams th ey
will receive.
Keywords: USA; Puerto Rico; Microbicides; Motivatio n; Research Participation; Young Women; HIV
1. Introduction
The results of the CAPRISA 004 microbicide trial in 2010
gave hope to HIV-prevention researchers that tenofovir
1% gel might reduce women’s risk of contracting HIV by
39% [1]. Although a subsequent larg e trial [2,3] failed to
confirm the results, new trials are being undertaken by
other ag ents as resea rchers contin ue the quest for an effi-
cacious and acceptable topical microbicide. For these
trials to be successful, researchers must recruit and retain
thousands of women in studies that may last up to three
years. Young women between the ages of 15 and 24 years
are a particularly important target group in microbicides
research given that they account for 26% of new HIV in-
fections globally [4]. In sub-Saharan Africa, they are
eight times more likely than men to be HIV positive [5].
Therefore, learning how to improve recruitment and re-
tention of young women in microbicide trials will allow
researchers to understand better the safety, efficacy, and
acceptability of microbicide candidates among this target
population [6].
Several factors that motivate participants to enter cli-
nical trials for HIV-prevention have been identified in
prior studies: personal health benefit, [7-9] societal health
benefit, [7-11] financial compensation, [7-9,12-14] trust
in health professionals or researchers, [15] and support of
relatives or partners for trial participation [7,1 4,16]. Con-
versely, barriers to recruitment and retention in clinical
trials include dislike of needles, [9,10,17] concerns about
study burden, [8,10] safety con cerns [8-11,17,18], and mis-
trust of re searche rs [9,10].

The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico 180
However, most of this literature has focused on poten-
tial trial participants rather than actual ones. Information
is particularly lacking on why young women enroll in
microbicide studies, especially in a Phase I safety trial
that needs healthy participan ts with no immediate reason
to test a drug whose benefits and risks are unknown. Be-
cause younger age has been associated with loss to fol-
low-up among women in microbicide and HIV vaccine
trials, [19,20] knowledge of how to retain this population
is important.
Our study explored factors that motivated young wo-
men between the ages of 18 and 24 to enroll and remain
in a Phase I microbicide trial. We highlighted important
lessons for recruitment and retention of this key popula-
tion for fu ture tria ls .
2. Methods
2.1. Sample
The data for this study came from a placebo-controlled
Phase I study of the safety and acceptability of VivaGel®
applied vaginally in sexually active young women (MTN-
004) and an ancillary stud y of microbicide-use adherence,
acceptability, and attitudes among women participating
in MTN-004 (ATN-062). The safety and accep tability re-
sults have been reported elsewhere [21-23]. An explora-
tory objective of the ancillary study was to obtain feed-
back on study participation from the participant’s per-
spective, including motivation to participate and experi-
ences as a participant. Trial participants were 61 young
women randomly assigned to use either a microbicide
(VivaGel®) or a placebo gel (HEC placebo or VivaGel®
placebo) and were told that it was not known if the gel
would work to protect women from getting HIV, what
side effects it might cause, and whether it was safe and
tolerated in all women. The research took place between
August 2007 and November 2009 at three sites: Pitts-
burgh, Pennsylvania; San Juan, Pu erto Rico; and Tampa,
Florida. Participants were r ecruited through media adv er-
tisements, flyers, and lists of former research participants
who agreed to be recontacted. Eligible study candidates
were women aged 18 to 24 years who were HIV-negative,
non-pregnant, sexually active, and using hormonal con-
traception or an intrauterine device (IUD). The study was
reviewed and approved by the Institutional Review Boards
at all participating institutions, and participants provided
written informed consent.
2.2. Clinical Procedures
Participants underwent screening for eligibility prior to
enrolling. Upon enro llment, they were instructed to in sert
an applicator with the assigned study gel in the vagina
twice daily for 14 days and to use male condoms during
vaginal sex. Participants returned to the clinics weekly
for follow-up visits while using the study gel and again
one week after completing study gel usage (final study
visit), for a total of five clinic visits, spanning on e month.
At each visit participants gave urine and blood samples
and underwent a pelvic exam (including speculum and
bimanual exams) and a targeted physical exam (including
vital signs and an abdominal exam). They also underwent
a colposcopy at enrollment and again upon completing
the study gel regimen (no biopsies were taken). Partici-
pants received approximately US$400 for completing all
clinic visits.
2.3. Behavioral Procedures
In addition to clinical procedures, participants agreed to
complete several behavioral procedures, including three
Web-based Computer-Assisted Self Interviews (CASI) in
English or Spanish, two semi-structured in-depth inter-
views via video teleconference with a bilingual research
assistant, and twice daily reporting of every occasion of
product use using a telephone diary, also available in
English or Spanish. Participants received up to US$130
for completing the behavioral procedures.
2.4. Quantitative Measures
Demographic information was collected at baseline via
CASI. At the final study visit, participants responded to a
CASI about study burden, including how much they were
bothered by the number and length of study visits, bur-
den of travel to and wait time at the study site, having
pelvic exams and a colposcopy, and adequacy of compen-
sation.
2.5. Qualitative Measures
The qualitative interviews were conducted using a web-
cam for video and a telephone f or the audio portion with
open-ended questions and follow-up probes based on an
interview guide. At the final clinic visit, the interv iew ex-
plored women’s motivations for participating and their
experiences as trial participants. The questions focused
on reasons for enrolling, wheth er they would enroll again
and under what conditions, favorite and least favorite as-
pects of participating, including what they thought about
the type and number of procedures required, and sugges-
tions for improving fut ure stu dies.
The audio portion of the qualitative interviews was re-
corded and transcribed, and the transcripts were verified
for accuracy by comparison with the audio recording.
The final visit teleconference lasted on average 31 min-
utes (range = 12 - 65 minutes). Fifty-nine of the 61 wo-
men agreed to be interviewed.
2.6. Data Analysis
A codebook that incorporated categories and themes

The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico 181
from the interview guide was developed to analyze data
from qualitative interviews [24]. The codebook included
definitions, inclusion and exclusion criteria, and exam-
ples of passages for inclusion. To validate and finalize
the codebook, three researchers coded an initial set of
three transcripts independently and then compared the
codes to assess concordance. Any discrepancies were
discussed until consensus was reached. The codebook
was modified where necessary, and researchers coded the
remaining transcripts independently using QSR NVivo
8.0 software for qualitative data analysis, [25] coding
every fifth transcript in pairs to ensure intercoder agree-
ment. Comparisons yielded over 90% agreement consis-
tently. Coding reports were generated for the following
codes: best and worst aspects of the study, motivation for
participation, and suggestions for future studies. Coding
reports were analyzed using content analysis, [26] then
summarized and discussed by team members. So that
groups could be compared, participants were then cate-
gorized based on their responses to the question: What
motivated you to participate in this study? Finally, the
first author selected quotes that contributed to under-
standing participants’ motivations and experiences and,
when necessary, translated them from Spanish into Eng-
lish.
Descriptive statistics were generated for demographic
variables and study burden ratings. After four motivation
categories were created based on qualitative analysis, Fi-
sher’s exact tests were used to compare the four motiva-
tion groups on categorical demographic variables (race/
ethnicity, study site, employment status, and education
status). ANOVAs were used to compare the four groups
on continuous variables (income and age). Analysis was
performed using SPSS Statistics v.18.0 [27].
3. Results
3.1. Participant Demographics
The mean age of respondents was 21 years, and the ma-
jority of participants were White or Hispanic/Latina with
some college education. Seventy percent of participants
were employed either full or part-time. There were no
statistically significant differences in any of the demogra-
phic characteristics among participants based on motiva-
tion for enrolling (see Table 1).
3.2. Motivation to Enroll
Participants were asked in the qualitative interviews, “What
motivated you to enroll in this stu dy?” Their responses fit
four categories: 1) altruism; 2) the compensation; 3) me-
dical exams; 4) multiple reasons.
Almost a third of the participants (29%) were moti-
vated principally by altruistic reasons. These included
Table 1. Motivations for participating by demographic characteristic (N = 59).
Altruism Compensation Medical Exams Multiple Reasons
N (%) N (%) N (%) N (%)
Total 17 (29%) 10 (17%) 10 (17%) 22 (37%)
Race/Ethnicity N (%) N (%) N (%) N (%)
White 9 (53%) 5 (50%) 3 (30%) 11 (50%)
Hispanic/Latina 6 (35%) 4 (40%) 7 (70%) 7 (32%)
Black/African-American 1 (6%) 1 (10%) 0 (0%) 3 (14%)
Asian/Pacific-Islander 1 (6%) 0 (0%) 0 (0%) 1 (5%)
Study Site
Tampa 9 (53%) 4 (40%) 3 (30%) 13 (59%)
Pittsburgh 3 (17%) 3 (30%) 1 (10%) 3 (14%)
San Juan 5 (29%) 3 (30%) 6 (60%) 6 (27%)
Employment & Education
Employed (Full or Part-Time) 13 (77%) 7 (70%) 6 (60%) 15 ( 68%)
In School (Full or Part- Time) 13 (77%) 8 (80%) 10 (100%) 20 (91%)
M (SD) M (SD) M (SD) M (SD)
Annual Income $8395 (7394) $10,840 (6998) $7791 (4582) $8479 (6429)
Age (in Years) 20.53 (1.70) 21.00 (1.83) 20.60 (1.51) 21.00 (1.69)

The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico 182
“helping other women,” “making a difference,” and “con-
tributing to a product that could be life-changing for
everybody.” For example, one participant felt that being
only 18 years old, “it’s cool to be a part of something as
big as this, that I normally wouldn ’t have the op portunity
to be a part of.” (Participant #06) Others were happy to
participate in a study they saw as “empowering wo-
men… giving us a say in having protection.” (#53) An-
other participant had a more personal reason: “There are
many girls who have multiple partners and don’t protect
themselves, and they don’t realize how horrible it is to
have that disease. My uncle died of AIDS, so I don’t
know, maybe that motivated me, too.” (#60)
Nearly one-fifth of the participants (17%) were moti-
vated to join primarily due to the compensation; up to
approximately US$530 for completing all study proce-
dures. Many stated that the compensation allowed them
to pay off debts or purchase items for their homes and
children. As one participant stated, “Honestly, the finan-
cial incentive motivated me because it helped me a lot
economically. I could pay off some debts because I was
out of work for a while.” (#25)
In addition, 17% of women mentioned the opportunity
to get free medical exams as their main reason for joining
the study. One woman explained, “I had a problem with
my insurance plan… I couldn’t get tests like a Pap smear
or blood tests because the plan wanted to charge me, it
was a mess. [With the study] I could have the results of
the tests, and I like to always be on top of how my body
is, if I am healthy, if not, what I have to do.” (#01)
Over a third of the participants (37%) gave multiple
reasons; most stated that the compensation piqued their
interest initially, and when they learned more about the
study, they felt they would be contributing to something
important. As one participant stated, “I guess the thing
that first drew me to it was the compensation. Th en when
I got more involved, and I learned about what this could
do for other people, I think that definitely drove me to
continue. So the compensation is great, and it definitely
helped in my decision to enroll, but you can’t really help
that other thing where you want to help other people, you
want to be a part of something that can do well for oth-
ers.” (#46)
3.3. What Participants Liked about the Study
The retention rate for the study was 100%. We asked
participants about their experiences in the study to un-
derstand which aspects of participation encouraged them
to remain in the study and which contributed to study
burden. When asked, “What did you like most about par-
ticipating in this trial?” particip ants often named multiple
positive aspects of study participation. Almost all par-
ticipants (95%) mentioned the study staff, including the
coordinators and clinicians, as a positive aspect. Partici-
pants felt comfortable with the staff, some emphasizing
that they were at ease during examinations since many
staff members were also young women. They also appre-
ciated being able to ask the clinicians questions. A few
participants were p articularl y enth usiast ic, st ating th at they
would miss seeing the study staff every week once the
study ended.
Another positive aspect mentioned by 41% of partici-
pants was getting intensive, free, regular medical exams
and the reassurance of finding out th ey were healthy. For
example, one participant (#38) stated that she w as glad to
get tested for sexually transmitted infections since she
knew her boyfriend had had multiple partners before
their relationship started.
Furthermore, 17% of women said that the colposcopy
examination presented an opportunity to learn more
about their bodies. As one you ng woman said, “At first I
felt a little uncomfortable, but then it became something
fascinating.” (#39) Another woman stated, “I felt it was
neat because I was able to see exactly what my cervix
looks like, what it does, and why. And I asked a lot of
questions… so I thought that was very informational.”
(#16)
Thirty-four percent of participants mentioned contrib-
uting to a good cause as the best part of participating in
the study. As one participant (#21) commented: “The
best part was the cause, for sure. The only reason why I
came back and continued to let people poke around and
draw blood and stuff is, you know, I know th at’s a really
good cause, and hopefully it’ll get approved and really
help a lot of people.”
Finally, when asked about the video interviews, about
half of participants (49%) appreciated having the chance
to give their opinions: “I felt like someone cared, like—I
wasn’t just a test subject… my opinion really mattered.”
(#43) Others appreciated that this aspect of the study was
easy (7%) and used novel technology (7%); one said that
it helped her to grow more comfortable with discussing
her sexuality. In addition, several participants (12%) ap-
preciated the extra financial compensation for the quali-
tative interviews.
3.4. What Participants Disliked about the Study
We also asked participants, “What did you like least
about participating in this trial?” Again, often partici-
pants named multiple aspects of study participation that
they disliked. Fifty-eight percent of participants disliked
the pelvic examinations, including the colposcopy. One
woman (#10) said, “And the colpo exams. Those were
hell... It just hurt really bad—the first one especially.” In
addition, 14% of participants disliked the large number
of staff in the room during the colposcopy (typically de-

The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico 183
scribed as four or more), and one was uncomfortable
with a male resident observing the pelvic exam and ask-
ing questions.
Thirty-two percent of participants stated that they dis-
liked weekly blood draws. One commented that the
amount of blood drawn was excessive: “I didn’t feel like
they needed that much blood. They usually have like five
or six vials of blood.” (#53) Conversely, another partici-
pant stated that she was afraid of needles but that having
to get her blood drawn weekly helped her to overcome
that fear and that she was willing to do it “to help oth-
ers.” (#57)
A number of participants disliked the time commit-
ment involved in participating. Thirty-one percent of par-
ticipants stated that study participation often involved a
long wait at the clinic, and some described study visits o f
up to four hours. This was especially hard for women
with childre n or who were working and in school. A few
participants mentioned excessive paperwork for partici-
pants and staff, and one found the consent process to be
too long. Finally, 22% of participants mentioned that the
video in-depth interviews took too long.
Despite these complaints, very few participants d escri-
bed being highly bothered by the procedures, and almost
all mentioned they had been through many of them be-
fore or expected them as part of the study. Some also ex-
plained that knowing why the procedures were necessary
helped them to withstand them. As one woman (#59)
stated, “The thing is, you need to have all the tests and
everything to get things accurate—get things passed and
everything. So it was just expected. Like, I knew why
they needed to take my blood. Obviously I knew why
they were going down in my vagina, because they defi-
nitely need to check that out—it needs to be right.” Oth-
ers qualified their comments by saying that they got used
to the procedures over time or taking a matter-of-fact
attitude; for example, a participant (#40) said “Of course
those are bothersome exams, but I agreed to do this. It
wasn’t like forced upon me type of thing. ”
3.5. Study Burden
Responses to the quantitative assessment on stud y burd en
(1 = Not bothered at all to 4 = Bothered very much) con-
firmed qualitative findings, as the most burdensome fac-
tors included the colposcopy (M = 2.41), the length of
the study visits (2.37), and pelvic exams (2.14). Never-
theless, the mean ratings for stud y burden were all <3 out
of 4, indicating that participants were not highly bothered
by study visits or procedures (see Table 2).
3.6. Suggestions for Improvement
Thirty-six percent of participants did not have any sug-
gestions for improving the study. Of those who did,
many focused on how to decrease the wait-time for par-
ticipants while at the clinic, including reducing the pa-
perwork that study coordinators filled out; having either
two study doctors or one clinician dedicated only to the
study; and streamlining the information collected from
participants.
Other suggestions focused on increasing comfort and
convenience such as allowing participants more flexibil-
ity in scheduling visit times; providing snacks during
long visits; provid ing childcare for women with ch ildren;
reducing the number of people in the exam room; and
conducting the in -depth interview at the beginning of the
visit so that participants are not tired or hungry during
the interview.
A few participants (10%) had suggestions for recruit-
ment, including modifying the recruitment flyer to pro-
vide more information about the study and using online
modes of recruitment including Facebook and MySpace.
Another suggested having recruiters available in person
to answer question s for prospective p articipants (Some of
these techniques were used in this stud y).
Nevertheless, participants often modified their com-
ments by acknowledging that the procedures were clearly
necessary: “I think everything that they’re doing here has
a purpose, and it is the way it is for a reason.” (#49). An-
other (#59) said, “... even though the colposcopy is not
the most comfortable thing in the world, I know it needs
needs to be done, so I wouldn’t change that.”
4. Discussion
This study was the first, to our knowledge, to explore
factors motivating young women to enroll and remain in
Table 2. Study burden (N = 59).
I was bothered by…a
Study Visits M (SD)
Number of Study Visits 1.97 (1.19 )
Length of Study Visits 2.37 (0.89)
Having to Travel to Study Site 1.83 (1.19)
Waiting Time at Visits 1.92 (1.15)
Study Procedures
Pelvic Exams 2.14 (1.14)
Colposcopy 2.41 (1.13)
Study compensation N (%)
Not Enough 2 (3%)
About Right 49 (83%)
More than Enough 8 (14%)
aFour point s cale from 1 = Strongly disagree to 4 = Stro ngly agre e.

The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico 184
a microbicide trial. The majority of participants were
motivated to join the study for altruistic or financial rea-
sons. Our findings confirm that previous research on wil-
lingness to participate in HIV-prevention trials may ap-
ply to participants in a microbicide trial [7,10,11] and
add to the body of literature showing that, although
compensation plays a part in motivation to enroll and
return for follow-up, a combination of factors that also
include altruism and personal convenience is at play
[28,29].
Based on our findings, an effective way to motivate
young women to enter microbicide trials could be to
stress the important role they will play in helping to dis-
cover better HIV-prevention methods for women. This
could be especially relevant for those who, like one of
our participants, know someone who is HIV-infected.
Nonetheless, helping to empower other women motivat-
ed many of the young women, and most emphasized the
importance of doing something for others. Some enjoyed
being part of a project they considered important; hence,
making women feel that they are partners with research
staff to advance science may encourage participation.
Participants also frequently mentioned the free medi-
cal exams and diagnostic tests that they received as an-
other motivating factor. In add ition, young women in ou r
study appreciated forming relationships with clinic staff
and learning about sexual health. Given that you ng adults
within the USA commonly have low rates of health in-
surance, [30] access to preventive care and follow-up
may be an important motivating factor for some young
women to participate in trials.
Our findings confirm the importance of having friend-
ly, informative study staff. Prior research has shown that
the researcher-participant relationship is critical, that
friendliness and helpfulness of staff influence recruit-
ment and retention, and that good communication is high-
ly valued by participants [31]. Good relationships with
staff that can provide clear information about how pro-
cedures contribute to study goals may encourage par-
ticipants to remain in trials and to be adherent to product
use. Ensuring that participants have repeated contact with
the same staff members at every visit can facilitate the
development of these relationships.
Finally, although Phase I trials can require invasive
procedures, our participants are not highly bothered by
them and recognized them as necessary. Given that par-
ticipants are enthusiastic about receiving medical care
and feel comfortable with study staff, these factors may
have mitigated the burden of weekly invasive procedures.
Although a major strength of our study is our diverse
sample of young women and rich qualitative data, our
results are not generalizable given our relatively small
US-based convenience sample and the specific focus of
this trial on an experimental vaginal microbicide. Also,
participants may have self-censored their feedback on
study burden du ring the videoconfer ences out of a desire
not to criticize the interviewer directly. Another limita-
tion is that this was a one-month study and motivations
might be markedly different for longer phase 2 and 3
trials in developing world settings. Finally, we did not
measure barriers to enrollment among those who were
screened but chose not to enroll in th e study.
Our study shows that participants’ motivations can be
multi-faceted and may include financial need, personal
health benefit, and a desire to help others. Motivations
also may change over the course of the study; therefore,
greater attention throughout the study to what motivates
participants to return for visits and their perceived level
of study burden will likely affect reten tion. Finally, deep -
ly engaging participants as partners in research is essen-
tial because their perception of the importance of their
role in reaching the study’s goals may influence their
faithfulness to the protocol and ensure the success of the
study, bringing us closer to developing an efficacious mi-
crobicide.
5. Acknowledgements
The authors would like to thank Ana Ventuneac for her
invaluable support as research project manager, Emily
Maynard for her help with interviewing participants and
coding data for this study, and Timothy Frasca, Mobola-
ji Ibitoye, and Tsitsi Masvawure for their help and guid-
ance during the writing process. In addition, we greatly
appreciate the hard work of the study staff at the sites,
and are indebted to the study participants for volunteer-
ing their time and for their willingness to discuss per-
sonal matters with us. This research was sponsored by
the US National Institutes of Health (NIH), and cospon-
sored by CONRAD and Starpharma Pty Ltd. The studies
were designed and implemented by the Microbicide Tri-
als Network (MTN-004, Ian McGowan, PI) and the Ado-
lescent Trials Network (ATN-062, Alex C arballo-Dié guez,
PI). The MTN (UM1AI068633) has been funded by
NIAID, NICHD, and NIMH. MTN-004 and ATN-062
were also funded through NICHD awards to the Adoles-
cent Trials Network (U01HD040533 and U01 HD040474)
co-funded by NIMH and NIDA. The study products were
provided free of charge by Starpharma Pty Ltd. The Sta-
tistical Center was supported by NIAID (U 01AI068615).
Additional support came from the National Institute of
Mental Health to the HIV Center for Clinical and Be-
havioral Studies at NY State Psychiatric Institute and
Columbia University (P30-MH43520; Principal Investi-
gator: Anke A. Ehrhardt). The content is solely the re-
sponsibility of the authors and does not necessarily rep-
resent the official views of NIH.
REFERENCES
[1] Q. Abdool Karim, S. S. Abdool Karim, J. A. Frohlich, A.

The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico 185
C. Grobler, C. Baxter, L. E. Mansoor, et al., “Effective-
ness and Safety of Tenofovir Gel, an Antiretroviral Mi-
crobicide, for the Prevention of HIV Infection in Wo-
men,” Science, Vol. 329, No. 5996, 2010, pp. 1168-1174.
doi:10.1126/science.1193748
[2] M. E. Quiñones-Mateu and G. Vanham, “HIV Microbi-
cides: Where Are We Now?” Current HIV Research, Vol.
10, No. 1, 2012, pp. 1-2.
[3] A. van der Straten, L. Van Damme, J. E. Haberer and D.
R. Bangsberg, “Unraveling the Divergent Results of Pre-
Exposure Prophylaxis Trials for HIV Prevention,” AIDS,
Vol. 26, No. 7, 2012, pp. F13-F19.
doi:10.1097/QAD.0b013e3283522272
[4] UNAIDS, “AIDS at 30: Nations at the Crossroads,” 2011.
http://www.unaids.org/unaids_resources/aidsat30/aids-at-
30.pdf
[5] UNAIDS, “UNAIDS Report on the Global AIDS Epi-
demic 2010,” 2010.
http://www.unaids.org/globalreport/global_report.htm
[6] R. J. DiClemente, M. S. Ruiz and J. M. Sale s, “Barrie rs to
Adolescents’ Participation in HIV Biomedical Prevention
Research,” Journal of Acquired Immune Deficiency Syn-
dromes, Vol. 54 No. S1, 2010, pp. S12-S17.
doi:10.1097/QAI.0b013e3181e1e2c0
[7] G. Colfax, S. Buchbinder, G. Vamshidar, C. Celum, D.
McKirnan, J. Neidig, et al., “Motivations for Participating
in an HIV Vaccine Efficacy Trial,” Journal of Acquired
Immune Deficiency Syndromes, Vol. 39, No. 3, 2005, pp.
359-364. doi:10.1097/01.qai.0000152039.88422.ec
[8] P. A. Newman, N. Duan, K. J. Roberts, D. Seiden, E. T.
Rudy, D. Swe ndeman, et al., “HIV Vaccine T rial Partici-
pation among Ethnic Minority Communities: Barriers,
Motivators, and Implications for Recruitment,” Journal of
Acquired Immune Deficiency Syndromes, Vol. 41, No. 2,
2006, pp. 210-217.
doi:10.1097/01.qai.0000179454.93443.60
[9] C. D. Voytek, K. T. Jones and D. S. Metzger, “Selec-
tively Willing and Conditionally Able: HIV Vaccine Trial
Participation among Women at ‘High Risk’ of HIV Infec-
tion,” Vaccine, Vol. 29, No. 36, 2011, pp. 6130-6135.
doi:10.1016/j.vaccine.2011.06.064
[10] S. P. Buchbinder, B. Metch, S. E. Holte, S. Scheer, A.
Coletti and E. Vittinghoff, “Determinants of Enrollment
in a Preventive HIV Vaccine Trial: Hypothetical versus
Actual Willingness and Barriers to Participation,” Journal
of Acquired Immune Deficiency Syndromes, Vol. 36, No.
1, 2004, pp. 604-612.
doi:10.1097/00126334-200405010-00009
[11] R. P. Strauss, S. Sengupta, S. Kegeles, E. McLellan, D.
Metzge r, S. Eyre, et al., “Willingness to Volunteer in Fu-
ture Preventive HIV Vaccine Trials: Issues and Perspec-
tives from Three US Communities,” Journal of Acquired
Immune Deficiency Syndromes, Vol. 26, No. 1, 2001, pp.
63-71.
[12] L. Balfour, K. Corace, G. A. Tasca, C. Tremblay, J.-P.
Routy and J. B. Angel, “Altruism Motivates Participation
in a Therapeutic HIV Vaccine Trial (CTN 173),” AIDS
Care, Vol. 22, No. 11, 2010, pp. 1403-1409.
doi:10.1080/09540121003693522
[13] R. A. Jenkins, S. China worapong, P. A. Morgan, C. Ruan-
gyuttikarn, A. Sontirat, J. Chiu, et al., “Motivation, Re-
cruitment, and Screening of Volunteers for a Phase I/II
HIV Preventive Vaccine Trial in Thailand,” Journal of
Acquired Immune Deficiency Syndromes, Vol. 18, No. 2,
1998, pp. 171-177.
doi:10.1097/00042560-199806010-00009
[14] K. Tharawan, C. Manopaiboon, C. Ellertson, K. Limpa-
karnjanarat, S. Chaikummao, P. H. Kilmarx, et al., “Wo-
men’s Willingness to Participate in Microbicide Trials in
Northern Thailand,” Journal of Acquired Immune Defi-
ciency Syndromes, Vol. 28, No. 2, 2001, pp. 180-186.
[15] E. R. Volkmann, D. Claiborne and J. S. Currier, “Deter-
minants of Participation in HIV Clinical Trials: The Im-
portance of Patients’ Trust in Their Provider,” HIV Cli-
nical Trials, Vol. 10, No. 2, 2009, pp. 104-109.
doi:10.1310/hct1002-104
[16] C. Woodsong, P. Alleman, P. Musara, A. Chandipwisa,
M. Chirenje, F. Martinson, et al., “Preventive Misconcep-
tion as a Motivation for Participation and Adherence in
Microbicide Trials: Evidence from Female Participants
and Male Partners in Malawi and Zimbabwe,” AIDS Be-
havior, Vol. 16, No. 3, 2012, pp. 785-790.
doi:10.1007/s10461-011-0027-7
[17] E. Ruzagira, S. Wandiembe, L. Bufumbo, J. Levin, M. A.
Price, H. Grosskurth, et al., “Willingness to Participate in
Preventive HIV Vaccine Trials in a Community-Based
Cohort in South Western Uganda,” Tropical Medicine &
International Health, Vol. 14, No. 2, 2009, pp. 196-203.
doi:10.1111/j.1365-3156.2008.02200.x
[18] J. M. O’Connell, R. S. Hogg, K. Chan, S. A. Strathdee, N.
McLean, S. L. Martindale, et al., “Willingness to Partici-
pate and Enroll in a Phase 3 Preventive HIV-1 Vaccine
Trial,” Journal of Acquired Immune Deficiency Syn-
dromes, Vol. 31, No. 5, 2002, pp. 521-528.
doi:10.1097/00126334-200212150-00010
[19] G. deBruyn, M. G. Hudgens, P. S. Sullivan and A. C. Du-
err, “Participant Retention in Clinical Trials of Candidate
HIV Vaccines,” Journal of Acquired Immune Deficiency
Syndromes, Vol. 39, No. 4, 2005, pp. 499-501.
doi:10.1097/01.qai.0000148532.12329.df
[20] P. J. Feldblum, V. Halpern, C.-C. Lie, O. Ob unge, F. O gun-
sola, W. Ampofo, et al., “What Predicts Non-Retention in
Microbicide Trials?” Contemporary Clinical Trials, Vol.
32, No. 4, 2011, pp. 512-516.
doi:10.1016/j.cct.2011.03.008
[21] A. Carballo-Diéguez, R. Giguere, C. Dolezal, B. A. Chen,
J. Kahn, G. Zimet, et al., “Tell Juliana’: Acceptability of
the Candidate Microbicide VivaGel® and Two Placebo
Gels among Ethnically Diverse, Sexually Active Young
Women Participating in a Phase 1 Microbicide Study,”
AIDS Behavior, Vol. 16, No. 7, 2012, pp. 1761-1774.
doi:10.1007/s10461-011-0028-6
[22] I. McGowan, K. Gomez, K. Bruder, I. Febo, B. A. Chen,
B. A. Richardson, et al., “Phase 1 Randomized Trial of
the Vaginal Safety and Acceptability of SPL7013 Gel
(VivaGel) in Sexually Active Young Women (MTN-
004),” AIDS, Vol. 25, No. 8, 2011, pp. 1057-1064.
doi:10.1097/QAD.0b013e328346bd3e

The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico 186
[23] R. Giguere, A. Carballo-Diéguez, A. Ventuneac, M. Ma-
bragaña, C. Dolezal, B. A. Chen, et al., “Variations in Mi-
crobicide Gel Acceptability among Young Women in the
USA and Puerto Rico,” Cult Health Sexuality, Vol. 14,
No. 2, 2011, pp. 151-166.
doi:10.1080/13691058.2011.630099
[24] K. M. MacQueen, E. McLellan, K. Kay and B. Milstein,
“Codebook Development for Team-Based Qualitative
Analysis,” Cultural Anthropology Methods, Vol. 10, No.
2, 1998, pp. 31-36.
[25] “NVivo Qualitative Data Analysis Software; QSR Inter-
national Pty Ltd. Version 8, 2008,” 2008.
[26] M. Q. Patton, “Qualitative Research and Evaluation Me-
thods,” SAGE, Thousand Oaks, 2002.
[27] “PASW Statistics 18, Relea se Version 18.0.0 (SPSS, Inc.,
2009, Chicago, IL, www.spss.com).”
[28] R. W. Grant and J. Sugarman, “Ethics in Human Subjects
Research: Do Incentives Matter?” Journal of Medicine
and Philosophy, Vol. 29, No. 6, 2004, pp. 717-738.
doi:10.1080/03605310490883046
[29] E. B. D. Ripley, “A Review of Paying Research Partici-
pants: It’s Time to Move beyond the Ethical Debate,”
Journal of Empirical Research on Human Research Eth-
ics: An International Journal, Vol. 1, No. 4, 2006, pp.
9-20. doi:10.1525/jer.2006.1.4.9
[30] S. T. Callahan and W. O. Cooper, “Uninsurance and Health
Care Access among Young Adults in the United States,”
Pediatrics, Vol. 116, No. 1, 2005, pp. 88-95.
doi:10.1542/peds.2004-1449
[31] C. Scott, J. Walker, P. White and G. Lewith, “Forging
Convictions: The Effects of Active Participation in a Cli-
nical Trial,” Social Science & Medicine, Vol. 72, No. 12,
2011, pp. 2041-2048.
doi:10.1016/j.socscimed.2011.04.021