Vaginal Practices and Associations with Barrier Methods
and Gel Use Among Sub-Saharan African Women Enrolled
in an HIV Prevention Trial
Ariane van der Straten•Helen Cheng•
Agnes Chidanyika•Guy De Bruyn•
Nancy Padian•the MIRA Team
Published online: 30 March 2010
? The Author(s) 2010. This article is published with open access at Springerlink.com
and/or the effectiveness of female-initiated prevention
methods. We investigated whether vaginal practices dif-
fered by randomization group in a phase III trial of the
diaphragm with lubricant gel (MIRA) in Sub-Saharan
Africa (n = 4925), and if they were associated with con-
sistent use of study methods. At baseline, vaginal practices
were commonly reported: vaginal washing (82.77%),
wiping (56.47%) and insertion of dry or absorbent mate-
rials (20.58%). All three practices decreased during the
trial. However, women in the intervention group were
significantly more likely to report washing or wiping dur-
ing follow-up compared to those in the control group.
Additionally, washing, wiping, and insertion, were all
independently and inversely associated with consistent
diaphragm and gel use and with condom use as well,
Vaginal practices may interfere with the use
regardless of study arm. A better understanding of the
socio-cultural context in which these practices are
embedded could improve educational strategies to address
these potentially modifiable behaviors, and may benefit
future HIV prevention interventions of vaginal methods.
Female-initiated methods ? Condoms ? Africa
Vaginal practices ? HIV prevention trials ?
In Sub-Saharan Africa, vaginal practices are widespread
with prevalence reportedly ranging from 6 to 98% .
They are conducted for a variety of reasons including, but
not limited to, genital hygiene, sexuality (sex preparation
or sexual enhancement), and vaginal health/treatment of
genital symptoms [2–4]. Women’s genital hygiene is
highly valued and there are clear norms regarding lubri-
cation during sex, vaginal cleanliness and related vaginal
practices. Specifically, the natural state of the vagina is
expected to be dry and tight, with the interrelated positive
sensations of cleanliness and warmth/heat generated by
friction during sex. Consequently, women in this area are
concerned with excessive wetness or lubrication, which
may indicate disease, ‘‘dirt’’ in the vagina or a ‘‘loose’’
sexuality [4–7]. To maintain the desired vaginal state, a
range of practices are used, including intravaginal cleans-
ing and insertion of substances . The most common
substances used during vaginal practices are water, soap,
commercial detergents, lemon or vinegar as well as tradi-
tional preparations with herbs or other dry materials such
as cloth, paper or cotton wool [8, 9].
Given the high prevalence of vaginal practices in Sub-
Saharan Africa, it is essential to understand whether these
A. van der Straten (&) ? H. Cheng
Women’s Global Health Imperative, RTI International,
114 Sansome Street, Suite 500, San Francisco, CA 94104, USA
A. van der Straten
Department of Medicine, Center for AIDS Prevention Studies,
University of California San Francisco, San Francisco, CA, USA
UZ-UCSF Collaborative Research Programme,
University of Zimbabwe, Harare, Zimbabwe
A. Chidanyika ? N. Padian
School of Public Health, University of California, Berkeley,
Berkeley, CA, USA
G. De Bruyn
Perinatal HIV Research Unit, University of the Witwatersrand,
Johannesburg, South Africa
AIDS Behav (2010) 14:590–599
practices are associated and possibly interfere with the use
of chemical or physical barrier methods that are currently
being evaluated for their effectiveness in preventing HIV
infection . Female-initiated methods, such as microbi-
cides and diaphragms, require vaginal insertion of a device
or application of gel through a delivery system (single dose
or reusable applicator, ring, diaphragm or other cervical
barriers) [10–12]. While experience with vaginal practices
may facilitate ease and comfort with inserting or removing
these investigational vaginal methods, such habits, partic-
ularly if they occur for sex preparation and around the time
of sex, could interfere with willingness to use and correct
use of these methods (especially if such methods are coi-
tally dependent), as well as their biological efficacy. The
protocols for HIV prevention trials of female-initiated
methods have often requested that participants abstain from
vaginal practices, but it is not clear whether these guide-
lines have been followed [7, 13, 14].
To examine the relationship between vaginal practices
and provision and use of female-initiated methods, we
analyzed data from the MIRA study, an open-label multi-
site randomized controlled trial to assess the effectiveness
of the diaphragm used with lubricant gel for the prevention
of HIV/STI acquisition in HIV-negative women recruited
from the general population in Southern Africa . We
previously reported that the diaphragm and gel had high
acceptability among participants . However, diaphragm
adherence was sub-optimal and condom use was differen-
tial between study arms. [17, 18]. Continuing our exam-
inations of factors influencing study methods use in MIRA,
here, we investigated whether vaginal practices influenced
use, whether practices changed during the trial, and if they
differed between women randomized to the intervention
(who received a diaphragm, vaginal gel and condoms), as
compared to those in the control arm (who received male
The MIRA trial was conducted in Harare, Zimbabwe,
Durban and Johannesburg, South Africa, between 2003 and
2006 and included a total of 5,039 participants. Retention
rate was high (93%) and was similar between study ran-
domization groups . Women were followed quarterly
for 12–24 months, depending on their calendar date of
enrolment, with a median of 21 months follow-up or 7
quarterly visits (range 0–8 quarterly visits). The study
protocol was reviewed and approved by all participating
institutions’ ethical review boards (www.ClinicalTrials.gov,
NCT00121459); detailed trial procedures and primary
results have been published elsewhere .
MIRA Trial Participants
Women were recruited from the general community and
health facilities that provided services to women. Key
eligibility criteria included being: sexually active; between
18 and 49 years; HIV negative; STI negative for cervical
and vaginal STIs (or treatment thereof); with a healthy
cervix, able to demonstrate the ability to correctly insert the
diaphragm prior to randomization, and able to provide
informed consent for participation.
At the enrolment visit, all women received diaphragm
education and demonstration using a pelvic model, and
were fitted with a diaphragm by a trained clinician and
practiced diaphragm insertion at the clinic as described
previously . Women completed a baseline Audio
Computer Assisted Self-interviewing (ACASI) question-
naire (in local language) on: demographics, sexual behav-
ior, vaginal practices, as well as current and previous use of
the diaphragm, gel, and condoms. Eligible consenting
women were then randomly assigned to intervention or
control groups . Because the intervention was not
blinded, treatment assignment was known to the participant
and clinical team (but not to the investigators and analysis
team). At each quarterly follow-up visit, women completed
an ACASI, and received: a clinical exam if indicated,
product adherence and risk reduction counseling and a
resupply of male condoms, as well as study gel (in the
intervention group only). Use of effective contraception
was encouraged and hormonal contraceptives were pro-
vided at no cost to all participants.
Intervention and Product Counseling
In the intervention group, women received a latex dia-
phragm (All_Flex Arcing Spring diaphragm: Ortho-
McNeil Pharmaceutical, Raritan, NJ), a supply of non-
contraceptive lubricant gel (Replens?, Lil Drug Store
Products, Cedar Rapids, IA) and male condoms. Women
randomized to the control group received male condoms
only. Participants in both groups received a comprehensive
HIV prevention package including HIV/STI pre-and post-
test counseling, treatment of curable laboratory-diagnosed
STIs, condom promotion, and intensive risk reduction
Women in the intervention group were counseled to
insert the diaphragm into the vagina any time convenient to
them prior sexual intercourse, and to leave it in for 6 h post
coitus. We counseled women to use the diaphragm with the
lubricant gel by emptying an applicator of gel (2.5 g) into
the dome of the diaphragm and spreading it onto the rim
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