Vijayakumar G, Mabude Z, Smit J, Beksinska M, Lurie M. A Review of Female-Condom Effectiveness: Patterns of Use and Impact on Protected Sex Acts and STI Incidence. Int J STD AIDS. 2006 Oct;17(10):652-9.
To review the literature related to various aspects of the female condom; to assess the effectiveness of the female condom using results from five randomized controlled trials; and to examine the demographic variables that predict female-condom acceptability and use.
In all, 137 articles were included in this systematic review. Of the 137 articles reviewed, 60 dealt with acceptability, 23 with condom use, nine with cost-effectiveness or use-effectiveness, five with re-use, nine with facilitators/barriers to use, 13 with negotiation, 11 with technical efficacy, and 17 with promotion. Eleven of the reviewed articles were commentary or review papers. Only English-language articles were included and most articles reviewed were published between 1996 and 2004.
Comprehensive searches of both PubMed and POPLINE were conducted using the keywords "female condom" and "female-controlled barriers." To supplement their search, authors also searched the bibliographies of the papers reviewed. The included studies were reviewed and catalogued into nine main categories: "acceptability," "use," "re-use," "negotiation," "effectiveness," "commentary/reviews," "facilitators/barriers to use," "technical efficacy," and "promotion." Studies on female-condom use among men having sex with men were excluded.
The majority of the studies were conducted in North America and Africa, with limited information from Thailand, Cambodia, Brazil, China and the United Kingdom. Participants of the five randomized controlled trials assessed in this review included the following: commercial sex workers from urban Thai sex establishments participating in an STD diagnosis and treatment program; walk-in clients at a large urban public STD clinic in the United States; plantation workers in rural Kenya; and brothel-based commercial sex workers from an urban location in Zimbabwe. The authors did not adequately describe the participants of the ten included longitudinal studies.
The interventions varied among the studies examined. Of the five RCTs included in the review, one randomized participants to receive either female condoms as a secondary option to male condoms or male condoms only; one compared the effects of hierarchical counseling with male-condom-only or female-condom-only counseling; one randomized communities to receive either a female- and male-condom community intervention or a male-condom-only intervention; one randomized participants to receive a female-condom intervention or a male-condom intervention; and one randomized participants to receive either a female-condom-only intervention or a female-condom and male-condom intervention.
Outcomes varied among the included studies. Of the five RCTs, four addressed male and female condom use, four addressed STI incidence and one assessed STI prevalence. The 10 longitudinal studies examined the relationship between demographic variables and positive response to the female condom.
The studies included in this review indicate the female condom's potential for increasing protected sex acts when promoted in a well-informed and effective manner. Of the four RCTs that evaluated male and female condom use, all found consistent or exclusive female-condom use much lower than consistent or exclusive male-condom use, between 5% and 13%. However, inconsistent use was often much higher for female than male condoms, because many women alternated between the male and female condoms. Of the four RCTs that measured STI incidence, two found lower STI incidences in the study arm that included the female condom, although both results were statistically insignificant. The one study that assessed STI prevalence found no reduction in prevalence between the control and interventions group. There was no consensus between the studies as to the demographic predictors of female-condom use.
The authors concluded that considerable evidence exists to suggest that the female condom is effective both in increasing protected sex acts and possibly in reducing STI incidence.
This study was of adequate quality, scoring 11 out of 15 possible points using the QUORUM grading scale for systematic reviews. As there were only five randomized controlled trials included in the analysis and there was significant heterogeneity between the studies, the authors did not conduct a pooled analysis. Furthermore, the authors did not assess the quality of the studies included.
In Context (Reviewer Comment)
The female condom, introduced in 1994, has received attention due to its prevention potential and its potential ability to help reverse the power dynamics in heterosexual relationships. Although a large number of studies have focused on the acceptability of female condoms, a recent study found that acceptability does not necessarily predict consistent and correct use. (1)
Because many women alternate between the male and the female condom, calculating the proportion of unprotected and protected sex acts may provide a more accurate measure of the effectiveness of the female condom. Future interventions should view the female condom within the context of a range of choices. Further research is needed to provide evidence that providing both female and male condoms is at least as effective in increasing the proportion of protected sex acts as is providing the male condom alone.
- Minnis A, Shiboski SC, Padian NS. Barrier contraceptive method acceptability and choice are not reliable indicators of use. Sex Transm Dis 2003 Jul;30(7):556-61.