The
trial involved 5 000 women in Soweto , Durban and Harare , but found no
difference in HIV infection between women given both condoms and the diaphragm
and those given just condoms.Unfortunately, the results do not support
the addition of the diaphragm to the use of condoms in current HIV prevention
strategies. To date, condoms remain the only proven barrier method for HIV
prevention, said Dr. Guy de Bruyn of the Perinatal HIV Research Unit of the
University of the Witwatersrand , a principal investigator for the study.
The
diaphragm, a rubber dome-shaped disk that is inserted over the cervix and used
with a lubricant, has been used by women for decades as a contraceptive device.
However, the study has dashed hopes that it could also offer women protection
against HIV. During the study, 76 out of 742 Durban women became HIV infected in
the group that received condoms only, and 72 out of 743 women became HIV
infected in the group that received the diaphragm, lubricant and condoms. At the
Soweto site, 23 out of 505 women became HIV infected in the condom only group,
and 24 out of 503 women became HIV infected in the diaphragm and condom group.
In
Harare , 52 out of 1229 women in the condom only became HIV infected while 62
out of 1226 became HIV infected in the diaphragm and condom group. In the
context of the comprehensive HIV prevention package provided to all
participants, the trial found no additional benefit against HIV infection from
the diaphragm and lubricant in the intervention arm, said the trials lead
investigator, Dr Nancy Padian, director of the Womens Global Health
Imperative at the University of California , San Francisco . Both the trial
(condom and diaphragm) and control (condom only) groups were extensively
counseled on safer sex, how to use male condoms and on the importance of
treating sexually transmitted infections to reduce the risk of HIV.
The
up-side of the failed trial is that the extensive counseling of the 5000 women
led to all of them using condoms more often than they usually would, and more
often than the norm in their communities and thus probably resulted in fewer
of the trial participants getting HIV. The MIRA (Methods for Improving
Reproductive Health in Africa) trial was conducted by the Womens Global
Health Imperative in partnership with the Perinatal HIV Research Unit, the
Medical Research Council of South Africa, the University of Zimbabwe , and Ibis
Reproductive Health.