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Misunderstanding of questions regarding anal sex in microbicide HIV prevention trial
Lesley Odendal, 2014-11-10 15:20:00
There was widespread misunderstanding and misinterpretation of questions
about anal sex being asked of participants in the Vaginal
and Oral Interventions to Control the Epidemic (VOICE) trial, according to findings of a qualitative
ancillary study to the VOICE trial qualitative
analysis study (called MTN-003D or VOICE-D) presented at the HIV Research for Prevention conference (R4P) in Cape Town, South Africa last month.
“It is very important for us to know if women are having penile-anal
intercourse (anal sex) in prevention trials due to the increased risk of HIV
acquisition through anal sex, especially if they are using vaginal prevention
products, such as microbicides,” said Zoe Duby, lead author and presenter of
VOICE-D was conducted at a third of the 15 VOICE sites in South
Africa, Uganda and Zimbabwe and was designed to explore the contextual and
trial-specific issues affecting actual and reported product use and sexual
behaviors during women's participation in VOICE. VOICE was a phase 2B, randomised, double-blind study which was designed to test the
safety and efficacy to prevent HIV of daily Truvada
(tenofovir 300mg plus emtricitabine 200mg) as pre-exposure prophylaxis (PrEP),
daily tenofovir (300mg) as PrEP and a 1% tenofovir-containing gel to be used as
a vaginal microbicide. The results of the VOICE trial found that less than a
third of women were regularly using the microbicide as prescribed.
Participants in the original VOICE study were asked, using Audio
Computer-Assisted Self Interviewing (ACASI), how many times they had had anal
sex in the past three months. It was further explained to participants that by
anal sex, the question was asking about “when a man puts his penis inside your
anus”. Although the use of ACASI elicits higher reporting of stigmatised
behaviours, there is no opportunity to identify miscomprehension.
High reporting of anal sex at the initial VOICE study’s baseline raised
concerns regarding the limitations of using ACASI. Terms for anal sex were revised
and re-translated and implemented 18 months after VOICE started. This led to a
decrease in reported anal sex prevalence at South African sites, for example,
where overall prevalence of anal sex in the previous three months decreased
form 21% to 17%.
Stage 1 of VOICE-D involved 88
women (22 women from Uganda, 26 women from Zimbabwe and 40 women from South Africa), who took part in
individual one-time in-depth interviews after exiting VOICE, most of whom were
interviewed before the trial's results were made publicly available. Participants
were pre-selected to ensure more than 10% had reported anal sex during VOICE. Stage 1 was designed in part to better understand women’s
perceptions and understanding of various risk behaviours, including anal sex,
using in-depth interviews (IDI) to cover the topic of anal sex. A body-mapping
activity was used to initiate discussion on sex and was used as a visual aid to
provide clarity on anatomical knowledge and understanding of terms used in the
Inconsistencies were found between the self-reporting of anal sex in
VOICE ACASI and VOICE-D’s in-depth interviews among the 88 women. Twenty-four of 88
participants who had reported anal sex in ACASI did not disclose ever having
anal sex in the in-depth interviews of VOICE-D and a third of these women needed the
term for anal sex to be clarified during the in-depth interviews. Seven (of 88) reported having had anal sex in the in-depth interviews and
not in ACASI, and 11 reported having had anal sex in both the in-depth
interviews and ACASI.
This inconsistency may be due to a miscomprehension of ACASI questions
or terms relating to anal sex, or social desirability and unwillingness to
disclose anal sex behaviours to interviewers in in-depth interviews.
The widespread interpretation (in both the interview methods) of the
translated terms for anal sex was for it to mean vaginal sex ‘from behind’.
This could be because the widely used (formal and slang) terms for anal sex in
all of the local languages (isiZulu, Shona and Luganda) are euphemistic,
indirect, vague, ambiguous or could refer to both anal sex or vaginal sex, such
as ‘dog-style’, ‘at the back’ or ‘from behind’.
were used by most women to discuss pleasure, however only half of the women
used the tool to identify areas associated with pain. Only six women were
reluctant to discuss their sexual behaviour: two refused due to religious
beliefs, one only labelled biological functions of the body, two avoided
looking at the map and one woman was too uncomfortable to discuss anal sex.
Communication about sex is complex and subject to social and
cultural norms. Due to taboos and social stigmatisation of anal sex,
participants may not disclose openly, regardless of reporting method. It is
also typically ambiguous, indirect and euphemistic. This creates challenges in
sexual behaviour research where unambiguous, precise, yet understandable and
socially acceptable terms, must be selected by researchers for participants to
understand what is being asked of them. These challenges are amplified in
cross-cultural or multi-site research, where equivalent translated terms need
to be used.
It was recommended
that triangulation and multi-methods, such as longitudinal in-depth interviews,
ACASI and visual aids, are needed to improve validity and reliability of
reporting socially stigmatised sexual behaviours. Rigorous pre-testing of terms
and tools with target audience is necessary to ensure comprehensibility an
accuracy of translated terms.
“We need to
pay attention to the language and translation that we use. Sometimes direct and
potentially uncomfortable terms may need to be used in the interest of ensuring
the accuracy of the research”, said Duby.