Hindawi Publishing Corporation
Infectious Diseases in Obstetrics and Gynecology
Volume 2011, Article ID 107140, 5 pages
Do WomenUsingLong-Acting Reversible
MariaF.Gallo,1Lee Warner,1DeniseJ. Jamieson,1andMarkusJ. Steiner2
1Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion,
Centers for Disease Control and Prevention, Atlanta, GA 30341-3724, USA
2Clinical Sciences Division, FHI 360, Durham, NC 27713, USA
Correspondence should be addressed to Maria F. Gallo, firstname.lastname@example.org
Received 26 April 2011; Revised 2 June 2011; Accepted 17 June 2011
Academic Editor: Jessica M. Sales
Copyright © 2011 Maria F. Gallo 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.
Long-acting reversible contraceptive (LARC) methods are highly effective against pregnancy. A barrier to their widespread
promotion can include the concern they will lead reduced condom use and, thus, will put couples at higher risk for sexually
transmitted infections (STIs). We review evidence from previous studies of condom “migration” associated with the use of LARC
and propose a novel study design to address the two main methodological issues that have limited these earlier studies. Namely,
we propose to use a randomized controlled trial design and to use a biological marker of semen exposure for measuring changes
in condom use.
Because long-acting reversible contraception (LARC) meth-
ods have very high efficacy and low burden to users after
their initiation, the American College of Obstetricians and
Gynecologists recommends that women be offered LARC as
first-line contraceptive methods . These methods, which
include intrauterine devices (IUD) or systems (IUS) and
contraceptive implants, avoid the need for frequent visits
for resupply, are highly cost effective, and allow a rapid
return to fertility after their removal. However, while LARC
methods are extremely effective against pregnancy, they
offer no protection against the transmission of HIV and
other sexually transmitted infections (STIs). Thus, policy
promote the use of LARC, in part, because of concerns that
women who initiate their use (or their male partners) could
be less motivated to use condoms [2, 3]. Because women
using LARC essentially are no longer at risk of pregnancy,
they may choose not to use condoms or may no longer be
able to convince their partner to use condoms solely for
disease prevention. Because condoms, used consistently and
correctly, remain the most effective method of protection
against HIV/STIs for sexually active individuals [4, 5],
changes in condom use patterns from the introduction of
LARC could put women and their partners at increased risk
of infection. Similar concerns about condom “migration”
related to the introduction of other interventions, such as
microbicides, circumcision, and preexposure prophylaxis for
HIV prevention, also have been raised [6, 7].
1.1. Literature on Condom “Migration”. The available evi-
dence—albeit limited—supports the possibility that LARC
use could lead to reduced condom use. A multivariable
analysis of a nationally representative survey of women
in the US found that condom use was lower for women
using injectables, intrauterine devices or implants compared
to women using oral contraception , and a survey of
reproductive-aged women in Baltimore revealed a signifi-
cantly lower prevalence of condom use among implant users
than nonusers . Similarly, a study among Hispanic and
African-American female adolescents in Manhattan found
condom use in the prior month was lower among women
relying on the injectable or implant compared to those using
2Infectious Diseases in Obstetrics and Gynecology
Recruit women willing
to initiate use of the
Randomize women in
“Delayed” LARC arm:
• Collect vaginal swab
“Immediate” LARC arm:
• Start LARC method
• Collect vaginal swab
• Collect vaginal swab
Last follow-up visit
• Collect vaginal swab
• Start LARC method for
those in “delayed”
Figure 1: Proposed study schema.
condoms only . A case-control study of adolescents in
than among oral contraceptive users .
Three prospective cohort studies also have evaluated
the association between LARC and condom use. A study
of adolescents in San Francisco found that women who
chose to use implants reported less condom use after
two years of followup than at baseline . Condom use
among implant users was also lower than among those
who chose to use oral contraception or condoms alone. In
a study conducted in three large urban hospitals of 1,073
women initiating use of implant or injectable contraception,
after one year of followup . Only one study, conducted
among 98 postpartum adolescents in Pennsylvania who
chose to use either implants or oral contraception, failed to
find differences between groups in the levels of condom use
Prior studies on condom migration suffer from two
main methodological weaknesses: reliance on self-reports of
condom use and lack of randomization. Participant reports
of condom use could be inaccurate for many reasons,
including recall bias or—especially in intervention studies
in which condoms are heavily promoted or distributed—
social desirability bias [15–18]. Studies that have detected
biological markers of semen (e.g., prostate-specific antigen
[PSA] or y-chromosome DNA) in vaginal fluid specimens
collected from women who reported no recent exposure
suggest substantial underreporting of unprotected sex [19–
24]. Furthermore, misreporting of unprotected sex might
not be distributed randomly across a study population,
as suggested by a recent study that assessed predictors
of discordance between spermatozoa detection and self-
reported lack of unprotected sex . For example, if the
misreporting of condom use were to differ with respect
to the use of other contraceptive methods, the conclusions
reached by previous studies on condom migration could be
The second—and perhaps more serious—limitation of
past studies involves the lack of randomization for assigning
women to method use. Women who choose different
contraceptive methods often vary by their characteristics
. Confounding by indication could occur if the women
who choose to use LARC methods (or the women whose
providers promote LARC methods to) are predominantly
those at low risk of HIV/STIs and, thus, infrequent users of
condoms. Those who opt to initiate a LARC method may
have inherently different patterns of condom use than those
who choose not to use the method; thus, earlier studies
could be biased as a result of systematic differences between
and condoms have attempted to control for these differences
and thus are subject to confounding; moreover, controlling
for these factors would likely be difficult as not all factors
influencing condom use (e.g., perceived HIV/STI risk, ability
to negotiate condom use with partner) are known or easily
2.Randomized Controlled TrialUsing
We propose a randomized design for studying the effect of
introducing a specific type of LARC method (i.e., IUD, IUS,
major methodological weaknesses inherent in the previous
studies. Under this design, women at risk of pregnancy
without contraindications to the method [27, 28] would be
randomized to one of two groups: (1) “immediate” start
of the LARC method or (2) “delayed” start of the LARC
method (i.e., at completion of their last study follow-up
visit) (Figure 1). Participants would be asked to complete
an enrollment visit and follow-up visits scheduled at regular
intervals during the period (e.g., 6–12 months) following
swabbing by the participant herself or by a study provider—
at all study visits for testing for PSA, and participants would
be counseled on correct and consistent use of condoms. The
study would assess whether use of the LARC method affects
the number of unprotected sex acts (i.e., without a condom)
as measured by the detection of an objective biomarker of
unprotected intercourse, such as PSA, in the vaginal swab.
Infectious Diseases in Obstetrics and Gynecology3
PSA, a glycoprotein produced by the prostate gland and
secreted into the seminal plasma, was first identified by
forensic scientists who were trying to find a substance in
seminal fluid to facilitate the investigation of rape cases
. More recently, PSA has been used in contraception
and HIV/STI research to assess recent (i.e., within the
laboratory assays can be employed to quantify PSA levels or
other biomarkers of semen exposure (e.g., Y-chromosome
DNA), they require specialized laboratory equipment and
by laboratory technicians without specialized training has
been showed to provide reliable and valid semiquantitative
measures of PSA and, thus, makes the use of PSA as a semen
biomarker feasible in a wide range of research settings .
3.Challenges to Study Design
Ideally, such a study would be conducted in a site in which
the women normally do not have access or are na¨ ıve to
use of the specific LARC method. Participants would be
randomized to receive the LARC method at enrollment or
after the end of followup. Precedent for this type of design
in which the introduction of the intervention is delayed in
the control arm until the end of study participation can
be found, for example, in the recent trials on the effect
of circumcision on HIV acquisition in which men were
randomized to immediate or delayed circumcision .
Ethically, investigators cannot withhold a LARC method
(even for a limited interval) from women in settings where
the normal standard of care allowed for its provision.
Consequently, depending on the availability of the LARC
Another limitation is the potential for the request for
swab collection to influence participant behavior. Women
could either be asked for their consent to test their col-
lected vaginal specimens for PSA at time of enrollment or,
retroactively, at their last study visit. Although a randomized
controlled trial did not find evidence that the advance
knowledge of testing for PSA caused women to report
more unprotected sex , such knowledge still could
cause women to modify their behavior (e.g., abstain from
unprotected sex before study visits). Asking for consent
for PSA testing retroactively circumvents the possibility
of behavioral change from swab collection; however this
approach requires another reason to justify swab collection
during the study (e.g., as an opportunity for STI testing)
and would risk losing data from women who do not return
for their last visit or who decline to consent to the testing.
Regardless of the timing of the consenting process for PSA
testing, women simply might tend to change behavior in
general before attending study visits; for example, women
may abstain from sex before a scheduled pelvic examination
due to hygienic concerns.
Any study of risk compensation will have problems with
generalizability. Even if the proposed study does not demon-
strate evidence of condom migration from the initiation
of the contraceptive implant, this would not preclude its
occurrence in other settings or with other populations. The
effect of adopting a LARC method on participant levels
of condom use could vary by numerous factors, including
participant characteristics, participant perceived risk of STIs,
quality of provider counseling and patient-provider rapport,
and social norms surrounding condom use. Study findings
from one setting cannot be assumed to be generalizable to
The proposed study design addresses two methodical
weaknesses (i.e., reliance on self-reported data and lack of
randomized design) that have limited the interpretation
of findings from previous studies on this topic. More
broadly, the detection of semen biomarkers could be
applied to research on condom migration associated with
other contraceptive methods and with HIV-prevention
interventions, including male circumcision and oral or
topical microbicides. Given that the occurrence of condom
migration from the introduction of LARC methods or HIV-
prevention interventions could vary by study populations,
the utility of testing for PSA might be even more useful
for on-going, population-level surveillance of changes
in condom use patterns. This surveillance could provide
accurate information with which to identify subgroups in
a setting that might benefit from more intensive condom
counseling. Also, by monitoring the frequency of PSA
detection in a population, providers could evaluate and
compare the effectiveness of different methods of counseling
on condom use. Researchers should consider incorporating
testing for semen biomarkers routinely into studies as well
as surveillance requiring measures of unprotected sex.
The findings and conclusions in this report are those of the
authors and do not necessarily represent the official position
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