When researchers returned to Zimbabwe several months after the end of a trial involving condom and diaphragm use, they were disappointed to find that condom use - which had risen to 86 percent during the trial - had reduced significantly.
"What happens after trials has always remained very much a mystery, and today, with biomedical prevention that has proved to be partly efficacious, such as the microbicide gel from the CAPRISA trial [which found that a vaginal gel containing tenofovir, an antiretroviral (ARV) drug, was 39 percent effective at reducing women's risk of contracting HIV during sex], it would be interesting to see what happens after the trial," Ariane van der Straten, lead author of a recent study on the issue, told IRIN/PlusNews.
"We were disappointed to see that all the effort and intense counselling provided to participants didn't seem to have a long-lasting effect - in effect, condom use went back to enrolment levels."
The Methods for Improving Reproductive Health in Africa (MIRA) trial, conducted between 2003 and 2006 in South Africa and Zimbabwe, evaluated the effectiveness of the diaphragm in the prevention of HIV and other sexually transmitted infections (STIs). It involved more than 5,000 women randomized into two arms - one group received a diaphragm, lubricant and male condoms, while the other received only male condoms; participants received intensive HIV counselling as well as STI treatment.
The trial found that the diaphragm and lubricant did not provide extra protection compared to condoms and treatment of STIs.
The follow-up study involved 801 women who were assessed 2-20 months after the end of the MIRA trial. During the MIRA trial, condom use rose to about 86 percent, but dropped to about 67 percent during post-trial visits.
"The trial is an [HIV prevention] intervention in and of itself - it could be that after the trial women did not feel the need to continue using the methods without the support they received from the study," said van der Straten. "The results showed us that it is a challenge to use concurrent HIV prevention methods, particularly barrier methods... If tenofovir gel becomes available, women may ask - if we have the microbicide, why use a condom?"
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She noted that male condoms were generally not favoured by people in long-term relationships; most of the women in the post-MIRA trial were in stable sexual partnerships.
Despite the trial finding no evidence that the diaphragm provided protection against HIV, many women in the diaphragm arm of the MIRA trial continued to use the device. Prior to the trial, only one woman reported ever using one; at the end of the trial, nearly all the women in this arm elected to keep or be fitted for a new diaphragm. During the MIRA trial, diaphragm use was as high as 88 percent, dropping to 50 percent in the post-trial study.
About half of the women in the condom arm also chose to be fitted with diaphragms at the end of the MIRA trial; in the post-MIRA study, about 14 percent of these reported using a diaphragm during their last sexual encounter.
"This speaks to the huge unmet need for female-initiated methods... Hopefully tenofovir gel can fill that gap," van der Straten said.
Unltimately, she noted, the post-MIRA study highlighted the need for increased support for women in their use of prevention methods.
"Any new prevention method will require support and education to be sustainable, such as follow-up counselling to help make sure that the method is used and continues to be used," she said. "Just providing access is not sufficient."
"In the past we have been naive, thinking that female-controlled methods could be used independent of men's involvement, but it's difficult to use any of these methods secretly, so there is a need to involve male partners in female-controlled methods so that they support their partners."