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American Journal of Public Health logoLink to American Journal of Public Health
. 2011 Dec;101(12):2241–2244. doi: 10.2105/AJPH.2011.300260

Off-Label Use of the Female Condom for Anal Intercourse Among Men in New York City

Elizabeth A Kelvin 1,, Joanne E Mantell 1, Norman Candelario 1, Susie Hoffman 1, Theresa M Exner 1, William Stackhouse 1, Zena A Stein 1
PMCID: PMC3222431  NIHMSID: NIHMS334907  PMID: 22021299

Abstract

We surveyed 111 male clients of an HIV/AIDS service organization in New York City in 2008 and 2009. Seventeen percent had used the female condom for anal intercourse; of these, 89.3% had used the female condom with male partners, 21.4% with female partners, and 10.7% with both. Users of the female condom for vaginal intercourse were more likely to use it for anal intercourse (odds ratio = 12.7; 95% confidence interval = 2.5, 64.9; P = .002). The safety and efficacy of the female condom for anal intercourse are unknown and should be evaluated.


The female condom was approved for vaginal use by the Food and Drug Administration in 1993,1 but not for anal use.2 Despite inconclusive safety data,3,4 previous studies found that some men who have sex with men used the female condom for anal intercourse.3,5,6 We conducted a survey among 111 men to describe and examine predictors of anal use of the female condom.

METHODS

We recruited clients of the health care services at Gay Men's Health Crisis in New York City from December 2008 to June 2009. In stage 1, we recruited 100 men regardless of female condom use to get an estimate of the prevalence of anal use of the device. Participants were eligible if they were male, were at least 18 years old, spoke English, and had had anal intercourse in the past 6 months with a man or woman. In stage 2, we restricted recruitment to anal users of the female condom to oversample this group, and we added a fifth eligibility criterion: use of the female condom for anal intercourse at least once. The total sample comprised 111 men (100 from stage 1 and 11 from stage 2).

We approached 268 men for screening. Seventy-three men (27.2%) declined to participate, of whom 89.0% refused even to be screened. Eighty-four screened men (41.4%) were ineligible for the study (26 in stage 1; 58 in stage 2); 97% of the ineligible men in stage 2 did not meet the criterion of having used the female condom for anal intercourse.

We computed the lifetime (ever) and active (past 6 months) prevalence of female condom use for anal intercourse for the 100 stage 1 participants. We used logistic regression to examine predictors of anal use of the female condom in the stage 1 sample of 100 and the total sample of 111.

RESULTS

The lifetime prevalence of female condom use for anal intercourse for the first 100 survey participants (stage 1) was 17.0% (95% confidence interval [CI] = 10.8%, 25.7%). The prevalence of active female condom use (past 6 months) was 14.0% (95% CI = 8.4%, 22.3%). The demographic characteristics of the study sample overall and separately by anal use of the female condom are presented in Table 1.

TABLE 1.

Descriptive Statistics for Men Who Have Anal Intercourse, Overall and Separately by Female Condom Use: New York City, December 2008–June 2009

Total, No. (%)a Men Who Ever Used the Female Condom for Anal Intercourse, No. (%) Men Who Never Used the Female Condom for Anal Intercourse, No. (%) P
Total 111 (100) 28 (25.2) 83 (74.8)
Used female condom for anal intercourse in past 6 mo
    No 88 (79.3) 5 (5.7) 83 (94.3)
    Yes 23 (20.7) 23 (100.0) 0 (0.0)
Age, y .268b
    < 40 55 (50.0) 11 (20.0) 44 (80.0)
    ≥ 40 55 (50.0) 16 (29.1) 39 (70.9)
Race .549b
    Black 46 (41.4) 14 (30.4) 32 (69.6)
    White 35 (31.5) 8 (22.9) 27 (77.1)
    Other 30 (27.1) 6 (20.0) 24 (80.0)
Ethnicity .402b
    Hispanic 40 (36.4) 8 (20.0) 32 (80.0)
    Non-Hispanic 70 (63.6) 19 (27.1) 51 (72.9)
Average annual income, $ .374c
    < 10 000 44 (40.7) 14 (31.8) 30 (68.2)
    10 000-49 000 49 (45.4) 12 (24.5) 37 (75.5)
    ≥ 50 000 15 (13.9) 2 (13.3) 13 (86.7)
Education .832c
    < high school diploma 18 (16.2) 5 (27.8) 13 (72.2)
    High school diploma 60 (54.1) 16 (26.7) 44 (73.3)
    > high school diploma 33 (29.7) 7 (21.2) 26 (78.8)
Sexual orientation .298c
    Homosexual 80 (74.8) 21 (26.3) 59 (73.8)
    Bisexual 21 (19.6) 4 (19.0) 17 (81.0)
    Heterosexual 6 (5.6) 3 (50.0) 3 (50.0)
Had male partners in lifetime .05c
    No 4 (3.6) 3 (75.0) 1 (25.0)
    Yes 106 (96.4) 25 (23.6) 81 (76.4)
Had vaginal intercourse with female partners in lifetime .211b
    No 46 (42.2) 9 (19.6) 37 (80.4)
    Yes 63 (57.8) 19 (30.2) 44 (69.8)
Had anal intercourse with female partner in lifetime .185b
    No 71 (64.0) 15 (21.1) 56 (78.9)
    Yes 40 (36.0) 13 (32.5) 27 (67.5)
Had > 1 male partner in past 6 mo .69b
    No 31 (27.9) 7 (22.6) 24 (77.4)
    Yes 80 (72.1) 21 (26.3) 59 (73.8)
Had > 1 female partner in past 6 mo .226b
    No 102 (91.9) 24 (23.5) 78 (76.5)
    Yes 9 (8.1) 4 (44.4) 5 (55.6)
Used female condom for vaginal intercourse .004c
    No 95 (85.6) 19 (20.0) 76 (80.0)
    Yes 16 (14.4) 9 (56.3) 7 (43.8)
Experienced problems with male condomsd .488b
    No 31 (29.2) 9 (29.0) 22 (71.0)
    Yes 75 (70.8) 17 (22.7) 58 (77.3)
Rated male condoms as excellent for disease protection .232b
    No 73 (66.4) 16 (21.9) 57 (78.1)
    Yes 37 (33.6) 12 (32.4) 25 (67.6)
Rated male condoms as very negatively influencing pleasure of anal intercourse .036c
    No 104 (94.5) 24 (23.1) 80 (76.9)
    Yes 6 (5.5) 4 (66.7) 2 (33.3)
a

Due to missing data the total number in some categories is < 111.

b

χ2 test.

c

Fisher's exact test.

d

Such as slipping, leaking, or breaking.

Of the 28 men who had used the female condom for anal intercourse, 22 (78.6%) had done so only with male partners, 3 (10.7%) only with female partners, and 3 (10.7%) with both. Eighteen men (64.3%) reported removing the inner ring at last use, and 23 (82.1%) used additional lubricant. Five men (17.9%) reported having experienced problems (slipping, leaking, or breaking) with the female condom during anal intercourse (70.8% reported problems with the male condom). Seven men (25%) reported that the female condom had a very or somewhat negative effect on pleasure during anal intercourse (31.4% experienced this with the male condom).

Of the 18 men who reported removing the inner ring the last time they used the female condom for anal intercourse, 5 (27.8%) experienced problems (slippage or breakage), although not necessarily the last time they used the product; none of the 10 men who left the inner ring in at last use reported problems (Fisher's exact P = .128). However, 4 men (40.0%) who had not removed the inner ring at last use said the female condom has a negative impact on pleasure, compared to 3 (16.7%) of the men who had removed the inner ring (Fisher's exact P = .207).

In the multivariate model with only stage 1 participants (n = 87, data missing on at least one variable included in the multivariate model for 13 participants), we found a significant association between female condom use for anal intercourse and female condom use for vaginal intercourse (odds ratio [OR] = 27.5; 95% CI = 2.7, 277.7; P = .005). We also observed an association between female condom use for anal intercourse and rating of the male condom as excellent for prevention of HIV and sexually transmitted infection (OR = 8.3; 95% CI = 1.3, 51.2; P = .023). The association with reporting that the male condom had a very negative impact on pleasure during anal intercourse was of borderline significance (OR = 7.7; 95% CI = 0.7, 83.6; P = .095). After adding the stage 2 participants to the model (n = 96, data missing on at least one variable in the multivariate model for 15 participants), the results were similar except that the association with rating the male condom as excellent for sexually transmitted infection prevention was of only borderline significance (OR = 3.2; 95% CI = 1.0, 10.4; P = .055; Table 2).

TABLE 2.

Logistic Regression Models Examining Predictors of Female Condom Use for Anal Intercourse Among Men: New York City, December 2008–June 2009

Univariate Model
Multivariate Model
No. OR (95% CI) P OR (95% CI) P
Stage 1 participants (multivariate model n = 87)
Rated male condoms as excellent for HIV/STI protection 99 2.0 (0.7, 5.9) .192 8.3 (1.3, 51.2) .023
Experienced problems with male condomsa 97 0.7 (0.2, 2.1) .521 0.6 (0.1, 2.9) .556
Rated male condoms as very negatively influencing pleasure of anal intercourse 99 12.3 (2.0, 74.1) .006 7.7 (0.7, 83.6) .095
Used female condoms for vaginal intercourse 100 5.9 (1.7, 20.9) .006 27.5 (2.7, 277.7) .005
Mean annual income > $10 000 97 0.4 (0.2, 1.2) .111 0.7 (0.1, 4.8) .712
Age > 40 y 99 2.5 (0.8, 7.8) .119 1.7 (0.4, 7.5) .488
Black race 100 1.5 (0.9, 2.6) .129 1.3 (0.6, 3.2) .529
Hispanic ethnicity 99 0.4 (0.1, 1.4) .141 0.2 (0.03, 1.4) .104
Homosexual orientation 96 1.2 (0.4, 3.9) .727 0.3 (0.04, 2.4) .262
Education beyond high school diploma 100 0.5 (0.1, 1.5) .187 0.2 (0.03, 1.7) .157
Stage 1 and 2 participants (multivariate model n = 96)
Rated male condoms as excellent for HIV/STI protection 110 1.7 (0.7, 4.1) .234 3.2 (1.0, 10.4) .055
Experienced problems with male condomsa 106 0.7 (0.3, 1.8) .489 0.6 (0.2, 2.0) .423
Rated male condoms as very negatively influencing pleasure of anal intercourse 110 6.7 (1.2, 38.7) .034 4.2 (0.6, 30.7) .163
Used female condoms for vaginal intercourse 111 5.1 (1.7, 15.6) .004 12.7 (2.5, 64.9) .002
Mean annual income > $10 000 108 0.6 (0.3, 1.4) .249 0.7 (0.2, 3.0) .675
Age > 40 y 110 1.6 (0.7, 4.0) .27 0.9 (0.3, 2.8) .88
Black race 111 1.3 (0.8, 1.9) .29 1.1 (0.6, 2.0) .827
Hispanic ethnicity 110 0.7 (0.3, 1.7) .404 0.6 (0.2, 2.0) .381
Homosexual orientation 107 1.0 (0.4, 2.7) .974 0.3 (0.1, 1.6) .161
Education > high school diploma 111 0.9 (0.3, 2.7) .785 0.7 (0.2, 3.4) .668

Note. CI = confidence interval; OR = odds ratio; STI = sexually transmitted infection.

a

Such as slipping, leaking, or breaking.

DISCUSSION

We found a 17% lifetime prevalence of female condom use for anal intercourse, which is within the range found in previous studies.3,5,6 Our study provides the first documentation that the female condom is also used for heterosexual anal intercourse.

Our study was small, so results should be viewed with caution and may not be generalizable to other groups. However, our findings suggest that some couples are using the female condom for anal intercourse in the absence of reliable information regarding safety, efficacy, and optimal method of use for this purpose. These results highlight the urgent need to evaluate the safety and efficacy of the female condom in anal intercourse to fill this knowledge gap and help people make informed choices about the methods they use to protect themselves during anal intercourse.

Acknowledgments

This study was supported by a pilot grant from the HIV Center for Clinical and Behavioral Studies. The HIV Center for Clinical and Behavioral Studies is supported by the National Institute of Mental Health (grant P30 MH43520) to Anke A. Ehrhardt, PhD.

We thank the participants in this study and acknowledge the outstanding support provided by colleagues and volunteers at Gay Men's Health Crisis, New York, New York.

Human Participant Protection

The study procedures were approved by the institutional review boards at the New York State Psychiatric Institute–Columbia University Department of Psychiatry and the Gay Men's Health Crisis research advisory committee.

References

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