THE BURDEN OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) and other sexually transmitted diseases (STD) is disproportionately borne by women worldwide.1 Women are more biologically susceptible than men, and, behaviorally, women are more vulnerable because cultural and social values often promote male dominance and gender-power imbalances leading to little control over sexual relationships.2,3 As a result, women desperately need options to protect themselves. The diaphragm is one such option. Although it has been used for over a century as a family planning method,4 it has been newly “rediscovered” and is now being investigated as a potential female barrier for STD/HIV prevention.5,6
There is both epidemiologic evidence and biologic plausibility that protecting the cervix will decrease risk for HIV and other STD.7 Although, to date, no randomized, controlled trials have been completed that assess the efficacy of the diaphragm to prevent STD, results from observational studies suggest significant STD reduction in diaphragm (with spermicide) users, including chlamydia and gonorrhea, pelvic inflammatory disease, and cervical neoplasia.8–12 The diaphragm may prevent HIV acquisition indirectly through reducing STD, which increases susceptibility to HIV.13 Diaphragms may also directly prevent HIV by covering the cervix and upper genital tract, thereby blocking the area in the female genital tract with the highest concentration of HIV-susceptible cells.14–18
The diaphragm is female-controlled and does not require male cooperation for use. Unlike the female condom, which visibly covers part of the external genitalia, the diaphragm is discreet and unnoticeable from the outside. Thus, it may not require male knowledge and can potentially be used covertly.
Many contraceptive studies show that once women in developing countries as well as in industrialized ones are educated about diaphragms, they are willing to use them.19–25 Diaphragms seem well-accepted among partners too; a recent study of diaphragm users in the United States indicated that method discontinuation was mostly related to method characteristics (ie, difficulties with insertion and removal, disliking the diaphragm inside, and low perceived effectiveness) and only 13% reported partner refusal as a reason for discontinuation.26 A study in Colombia, the Philippines, and in Turkey indicated that less educated and poor women successfully used the diaphragm and demonstrated no discomfort with their bodies or concerns about lack of privacy. The diaphragm was popular among women who were unable to negotiate condom use with their partners and method continuation depended on covert use or on partner acceptance.20 Thus, although most women may prefer to inform their partner about the method they are using, for many women, covert use can be an attractive attribute of the diaphragm.27,28
Because cultural and social practices are likely to influence diaphragm acceptability and use, studies must be conducted in the countries with the greatest need for alternative prevention interventions. To date, diaphragms are virtually unused in Africa, the continent most affected by the HIV epidemic. The most recent demographic and health survey reported that although 20% of Zimbabwean women know about the diaphragm, only 0.1% ever used it.29
Zimbabwe has one of the highest HIV infection rates worldwide, with an estimated adult prevalence of approximately 25% and higher infection rates among females than males.1 We conducted a prospective intervention study to assess the acceptability of the diaphragm, used with K-Y jelly lubricant, as a potential STD/HIV preventative method. Over 6 months of follow up, we examined diaphragm uptake, use over time, and acceptability among urbanized, sexually active women in Harare, Zimbabwe. All participants were inconsistent condom users. We also identified predictors of 100% diaphragm use, because maximum effectiveness will only be achieved if a method is consistently used.
Materials and Methods
Women were recruited from public sector reproductive health and family planning clinics in Harare between December 2000 and December 2001. To participate in the study, women had to be between 16 and 48 years old, sexually active, and using condoms less than 100% of the time in the previous 2 months. Those who were allergic to latex, pregnant, or intending to get pregnant over the next 8 months were excluded from the study.
Study Visits and Procedures
Women were first enrolled in a 2-month condom intervention (phase I). Briefly, women received 2 counseling/educational sessions on how to negotiate and use male and female condoms. Women also received free condoms at every visit. Those who reported less than 100% male or female condom use at the end of the condom phase and who did not have contraindications to diaphragm use were then enrolled in a diaphragm acceptability phase (DA) and followed for another 6 months with 3 bimonthly follow-up visits (Fig. 1). Ethics approval for this study was granted by the Committee on Human Research, University of California San Francisco, the Biomedical Research and Training Institute, Zimbabwe, the Medical Research Council of Zimbabwe, and the Centers for Disease Control and Prevention Institutional Review Board.
Although it was not a requirement for participation into the study, women were offered HIV counseling and testing with trained HIV test counselors at any time after enrollment in the study. At every visit, demographic, behavioral, and medical information for the previous 2 months (ie, since the preceding study visit) were collected through face-to-face interviews with trained interviewers, including questions on diaphragm and condom use and methods acceptability. Sexual frequency and condom use information in the previous 2 weeks was also collected.
Diaphragm Intervention and Study Products
Although data are not conclusive, for contraceptive purposes, current clinical practice recommends using the diaphragm with a spermicidal gel.4,30–33 Because Nonoxynol-9 is no longer recommended for use by women at high risk of STD/HIV or in high prevalence areas,34 evaluation of diaphragms for STD/HIV prevention in these settings necessitates use of alternative lubrication products. At entry into the DA phase, women were fitted with a diaphragm, received instructions about diaphragm use with K-Y jelly on the rim to facilitate insertion, received a demonstration on a pelvic model, and practiced insertion of the diaphragm on themselves before leaving the clinic.
All women received a diaphragm education and counseling intervention followed by a booster 2 months later (Fig. 1). During the intervention, women were shown how to use, clean, and care for the diaphragm and were asked to use it each time they had sex. They were counseled on issues that may be related to use and compliance, including relationship issues and partner-related concerns such as disclosure or covert use. Women were also told about the unknown efficacy of the diaphragm against STD/HIV (and pregnancy when used without a spermicide). They were advised to use another method for pregnancy and, for STD/HIV prevention, were told to use male condoms every time they had sex (whether or not a diaphragm was used). Alternatively, women could use a female condom if they chose not to use the diaphragm for that particular sexual episode. Male and female condoms were distributed at every visit of the DA phase.
Ever Used Condoms.
At every visit, women were asked “Have you ever used (male or female) condoms with your partner since the last visit?” (yes/no). Women were also asked how often they had sex in the past 2 weeks, and of those times, how many times they had used a condom. Summary statistics were used to report the proportion of acts protected by condoms for each woman, and a categorical variable was created to report recent condom frequency (always: 100% of the time; inconsistent: 1–99% of the time, never: 0% of the time).
At every visit, women were asked “Have you used the diaphragm since the last visit?” (yes/no); and for those who did, “How often since the last visit did you use a diaphragm?” (response on a 5-point Likert scale from “every time I had sex” to “never”). These 2 variables were combined to create a binary indicator of consistent (100%) diaphragm use in the past 2 months (yes/no), which is the outcome variable in this article. A binary indicator was used to assess whether women ever felt the diaphragm move while inside them. Users were also asked “Have you had (other) problems when you used the diaphragm?” (yes/no). To assess timing of diaphragm insertion, women were asked “Which of the following describes when you usually inserted the diaphragm since the last visit? (5 responses categories: “after intercourse began but before ejaculation”; “after I was sure we were going to have sex, but before my partner entered me”; “before going to bed if I thought we were going to have sex”; “every night before going to bed”; “I wore the diaphragm all the time and removed it only to clean it”). A binary indicator of whether the diaphragm was inserted every night versus not was created.
To assess diaphragm preference over condoms, women were asked “Do you like diaphragms or condoms better?”; “Do you think diaphragms or condoms are easier to use?”; “Do you think your partner likes diaphragms or condoms better?”; and “Do you think your partner finds diaphragms or condoms easier to use?” (responses: diaphragms, condoms, no preference, neither). Binary indicators (prefers diaphragm vs. other responses) were created for each variable. To assess discreet use, women were asked at each visit “Have you told your partner that you were using a diaphragm when you had sex with him?” (never, sometimes, always); and “How often did your partner know you were using a diaphragm?” (responses were on a 5-point Likert scale and were further collapsed into 3 categories: never, sometimes, always).
Women were asked the following 6 questions to assess abuse or fear of abuse in the relationship since the last visit: “Have you ever been afraid that your partner might yell at you?” “Have you ever been afraid that he might shove, hit, slap, kick, or otherwise physically harm you?” “Has he either physically or verbally forced you to have sex?” “Has he emotionally or verbally hurt you? ”Has he shoved, hit, slapped, kicked, or otherwise physically hurt you?“ ”Has he used or threatened you with a weapon such as a gun or knife?“ A binary indicator of domestic violence (any yes for 1 or more of these questions) was created.
Other measures that were examined in the analyses included age, years in the current relationship, frequency of sex in the past 2 weeks, religion, lifetime number of children, lifetime number of sexual partners, education, marital status, and contraceptive method used since the last study visit.
Demographic characteristics of the sample were generated at entry into the diaphragm acceptability study. Behavioral and product use characteristics are presented for each of the follow-up study visits. Exploratory analyses of the association between consistent diaphragm use, demographic and behavioral factors, and other potential confounding variables (including years in the relationship, frequency of sex in the past 2 weeks, lifetime number of children) were based on bivariate comparisons by study visit and overall. Chi-squared and Fisher exact statistics were used to assess significance of observed associations at any given visit. An α level of 0.05 was used to judge the statistical significance of each effect. Further analyses were based on generalized estimating equation models (GEE) for consistent diaphragm use in the previous 2 months over the 6-month follow-up period. Factors that were significantly associated with the outcome variable were entered in a multivariate model controlling for age, frequency of sex, and years in the relationship. Other variables were retained in the model if they were statistically significant, if there was a conceptual justification for inclusion, or if removal of the diaphragm markedly altered the model fit, assessed through the change in log likelihood values, or associations between other variables and the outcome of interest. All analyses were conducted using SAS, version 8.02.
We screened 842 women; 424 were eligible, 405 enrolled, and 379 completed the condom run-in phase. Of these 379 women, 192 were eligible, 189 women enrolled in the DA phase, 186 had at least 1 follow-up visit and constitute the analytical sample for this article. One hundred eighty-one women (95.8%) completed the 6 months of follow up. Participants’ characteristics are shown in Table 1. Median age was 27 years (range, 16–46 years), most women were married and had children, and 56% had completed secondary education. All women were using contraception at entry into the DA phase, with 89.78% using a hormonal method.
The majority of HIV-positive women were successful condom users in the condom phase and thus were ineligible to enter the DA phase (HIV prevalence among the 326 women who were tested in the condom phase I was 21.6%). Of the women who participated in the DA phase, 152 (81.7%) chose to be tested for HIV, and of those, 22 (14.4%) tested HIV-positive. HIV status was not associated with diaphragm use in this sample, thus this variable was not included in the analyses presented.
The median number of lifetime partners was 1 (range, 1–10), and all women were monogamous at DA phase entry. Over one third of women reported domestic violence, defined as abuse or fear of abuse in the relationship in the previous 2 months. Specifically, 29.03% were afraid that her partner might yell at her, 15.59% reported that he had emotionally or verbally hurt her, 13.98% were afraid that he might physically harm her, 6.99% reported that he had either physically or verbally forced her to have sex, 6.45% reported that he had physically hurt her, and 0.54% reported that he had used or threatened her with a weapon. The proportion of women reporting domestic violence remained stable at 26% over the entire follow-up period.
Diaphragm Uptake and Use and Protected Sex Acts
No women had ever used the diaphragm at entry into the DA phase, whereas all but one had used condoms (in this study, “condom use” refers to male or female condoms) (Table 2). Most women were sexually active at every visit and diaphragm uptake was high, with 98% using the diaphragm at least once during the 2 months after DA phase entry. Almost all women continued to use the diaphragm over the entire study period. The majority used the diaphragm some of the time, and 13% to 16% used the diaphragm for every sex act at any given visit.
Women who did not use the diaphragm in the previous time interval were asked at each visit their reasons for not doing so. Only 1 woman never used the diaphragm throughout the 6-month study period. For the 5 women who reported not using the diaphragm at the 6-month visit, reasons included: being pregnant, not having a partner during that time interval, pain or discomfort at insertion, and feeling uncomfortable wearing it. Similar reasons were given by the 4 women at the 2-month visit and the 2 women at the 4-month visit that had not used it.
Only 4% to 6% of women reported never using condoms at any given follow-up visit. Frequency of condom use was not assessed for the entire 2-month time interval at DA follow-up visits. However, recent condom use was assessed at every visit: 39.7% of the women reported always using condoms in the 2 weeks preceding the visit at DA phase entry, and the proportion of recent consistent condom users stayed stable over the next 3 follow-up visits (Table 2).
Diaphragm Practice and Attitudes
At the 2-month follow up, the majority of women reported inserting the diaphragm before bedtime if they thought they were going to have sex, whereas 17.7% said that they inserted the diaphragm every night before bed regardless of whether they thought they were going to have sex (Table 3). These proportions did not significantly change over time. Only 1 woman reported using the diaphragm continuously at the 2-month follow up, and none reported continuous use thereafter.
Approximately 14.9% of those who used the diaphragm reported feeling it move inside at the 2-month visit, but this proportion significantly decreased over time to only 6% at the final visit (P = 0.0002). Similarly, almost one fourth of women reported other problems (mostly pain or discomfort during inserting, wearing, or removing it) at the 2-month follow up, and this proportion decreased to 9% at the final visit (P <0.0001).
Over the study period, a majority of women reported that they liked the diaphragm better than a condom and that they found it easier to use than condoms. These 2 attitudinal measures were highly correlated (r = 0.84, P <0.0001). Close to 40% also thought that their partner would 1) prefer and 2) find the diaphragm easier to use than condoms. Self-preference and perceived partner preference were also highly correlated (r = 0.57, P <0.0001). As shown in Table 3, discreet use of the diaphragm was stable over time as well, with 10% to 13% of women saying that their partner never knew when she was using the diaphragm, and 14% to 17% saying they never told their partner when they were using the diaphragm.
Predictors of Consistent Diaphragm Use
We examined associations between consistent diaphragm use in the previous 2 months for the 3 time intervals and the following categories of predictors: sociodemographic, contraceptive, risk behavior, diaphragm practice and attitudes, and partner-related factors. As shown in Table 4, in bivariate analyses, consistent diaphragm use was significantly associated with contraceptive method use, condom use frequency, discreet use of the diaphragm, timing of diaphragm insertion, preference for diaphragms over condoms, and domestic violence. Age was marginally associated with consistent diaphragm use. Other demographic and relationship factors examined, HIV status, or problems with using the diaphragm were not associated with the outcome variable.
Because all the variables measuring diaphragm preference were strongly correlated, only 1 measure (finding the diaphragm easier to use than condoms) was entered in the multivariate model. Similarly, based on the strength of the statistical association and on the timeframe of assessment, 1 measure of condom use (never used condoms in the previous 2 months) and 1 measure of discreet use (partner knowing when the participant used the diaphragm) were entered in the final model (Table 4). Other multivariate models that were constructed with the alternate predictor variables gave essentially the same results (data not shown).
Controlling for other factors in the multivariate model, consistent diaphragm use was most strongly associated with never having used condoms in the previous 2 months (adjusted odds ratio [AOR], 17.64; 95% confidence interval [CI], 5.42–57.41). Women whose partner never knew when they used the diaphragm were 3.96 times (95% CI, 1.63–9.62) more likely to use the diaphragm consistently compared with those whose partners sometimes knew. Additionally, women whose partners always knew when they used the diaphragm were 2.18 times (95% CI, 1.06–4.49) more likely to be consistent users. Those who found the diaphragm easier to use than condoms were 3.33 times (95% CI, 1.76–6.31) more likely, and those who inserted the diaphragm every night (regardless of whether they expected to have sex) were 3.52 times (95% CI, 1.98–6.26) more likely to be consistent diaphragm users. However, women who used diaphragms consistently were less likely to have experienced domestic violence (AOR, 0.38; 95% CI, 0.15–0.95). Finally, women who consistently used the diaphragm were significantly less likely to use injectables or Norplant (Wyeth Pharmaceuticals, Madison, NJ; AOR, 0.09; 95% CI, 0.02–0.37).
Among the women we studied, there was almost universal uptake of diaphragms, despite its unknown efficacy against STD/HIV. Overall, use and acceptability were stable over the 6 months of follow up. Over one third of the women used a diaphragm more than half the time at any given follow-up visit and the diaphragm was preferred to condoms by more than half of the women. This was a sample of unsuccessful condom users; diaphragm preference and use may be different in other populations. However, this is a relevant target population, because if found effective, diaphragms are likely to be promoted as alternatives or backup to condoms but not as a replacement. This sample was fairly homogeneous in terms of demographic factors; almost all women were married and in stable relationship, all were monogamous and using contraception. Thus, our findings may not be generalized to other populations.
Skills required to use a diaphragm were easily acquired with appropriate counseling and education. Problems with method use decreased over time, and qualitative data collected at study exit indicate that access to supportive staff and additional education and counseling after the initial intervention may help mitigate initial difficulties with method use.35 The most common side effects associated with diaphragm use are bacterial vaginosis and urinary tract infection, and they most likely result from the N-9 spermicide and not from the diaphragm alone.36–38 In this study, the diaphragm was used with K-Y jelly lubricant. We found no change in the prevalence of symptoms or signs for reproductive tract infections among the study participants after introduction of the diaphragm (data not shown). However, specific laboratory tests were not conducted to diagnose these side effects, because this was an acceptability study.
The proportion of women using a diaphragm for every sex act was low, but this is understandable because in this study, we emphasized its unknown efficacy against STD/HIV, and women were counseled about and provided with male and female condoms as well. In fact, given its unknown efficacy, we were surprised that use and acceptability was as high as it was. As reported elsewhere, a majority of women used a mix of various methods, and many (as advised) used the diaphragm together with male condoms.39 Importantly, the proportion of sex acts in which condoms were used did not change when the DA phase started and diaphragms were introduced. In the analyses presented here, we found that women were most likely to be consistent diaphragm users if they never used condoms. Alternative multivariate models in which frequency of recent condom use was included showed that both not using condoms or consistently using condoms in the previous 2 weeks was associated with consistent diaphragm use (data not shown). The latter category may include good compliers who are willing to adhere with all study procedures or may represent a subset of women who are willing to use a combination of methods to enhance their protection. Because of the small response groups, we did not conduct additional analyses on this group; however, it would be important for future studies to explore what are the characteristics of these “double compliers.”
Never using condoms was the strongest predictor of consistent diaphragm use. However, because very few women reported never using condoms, this estimate is imprecise and the confidence interval is large. This finding is important, and if it holds true in other studies, may indicate that the diaphragm can fill an important prevention niche among those who cannot or will not use condoms. Current contraceptive method used was also associated with consistent diaphragm use. Because women using long-term hormonal methods have their contraceptive needs met, their motivation to consistently use the diaphragm may be lowered. This may have been the case for injectable methods that are less user-dependent; however, no significant association with pill use was found. Exit focus group data suggested that women used diaphragms as a backup for the pill (Buck J, et al., unpublished data).
Daily insertion of the diaphragm was associated with increased likelihood of consistent use. This makes sense because women are less likely to forget if they make it a daily habit and if they disassociate insertion from coitus. This attribute of the diaphragm may be particularly helpful in situations in which women have little control over the circumstances in which they have sex. One advantage of the diaphragm is that it can be used both as a coital and noncoital method. In a population that has frequent sexual intercourse, it may help compliance to counsel women to insert the diaphragm each night irrespective of sexual intercourse or even to use it continuously.
The ability to use the method discreetly or secretly, as reflected by partners not knowing when the woman used the diaphragm, was strongly associated with consistent use. One of the major advantages of the diaphragm over other barrier methods is that it is placed internally, and thus it is unnoticeable for the woman and her partner. Our findings indicate that this feature may contribute to its potential effectiveness if it allows women to use it more consistently. Interestingly, partners always knowing when a diaphragm was used also increased the likelihood of consistent use, suggesting that for some women, cooperation between partners may enhance compliance even with female-controlled methods.
We found a high lifetime report of domestic violence in this population: 79% at entry into phase I. Additionally, over one third of the women reported abuse or fear of abuse in the 2 months preceding the DA phase entry. Consistent diaphragm use was inversely associated with domestic violence, suggesting that women who may be most at risk for STD/HIV may still not be “empowered” enough or feel they have the ability to take method use into their own hands. Although this method can be used without the partner’s knowledge and cooperation, fear of his reaction and concerns about consequences of his discovery may be a deterrent to using the method. The issue of secrecy or disclosure to partners should be included when counseling women about the diaphragm and other “women-controlled” methods. Women who fear abuse may not be able to refuse unwanted sexual advance or unprotected sex. Indeed, one study in Zimbabwe reported that a majority of women agreed that wife beating is justified if she refuses to have sex with her husband.40 This and other studies have reported high rates of gender-based violence and high acceptance of marital abuse in Zimbabwe.41,42 In addition to direct detrimental physical and psychologic health effects, partner-related violence or threat of violence may decrease women’s ability to use a prevention method, even one that is female-controlled, and thus increase her risk for HIV and STD.
We observed a trend suggesting that continued consistent barrier method use (both diaphragms and condoms) might be more difficult to achieve in younger age groups. Because our sample of adolescents was very small, it precluded further exploration of the association between age and consistent use. Because young women and sexually active adolescents are the population most vulnerable for HIV and STD, additional studies of barrier method use (including the diaphragm) in this population are essential to conduct.
Our findings indicate that women will use the diaphragm as an alternative to condoms. Diaphragms most likely will not provide the same degree of protection as condoms, because they only provide partial coverage of the genital area. However, as is the case for microbicides, if they can be used consistently, or if they provide an alternative when condoms cannot be used, they can help decrease unprotected sex and thereby have an important public health role to play.43 Diaphragms are already approved and marketed worldwide, they are safe and have few side effects, and they can be tested as prototypes for a number of internal female methods currently under development.5 We recently began a randomized, controlled trial to assess the effectiveness of the diaphragm against STD/HIV (http://pub.ucsf.edu/newsservices/releases/2003072258/). If effectiveness is supported by the results from this and other trials, a diaphragm used with or without a microbicide could become an important disease prevention option for women. In the study reported here, we stressed the fact that the diaphragm had unknown protection against STD/HIV and acceptability was high. Thus, because acceptability and use are inextricably bound to effectiveness, there is no doubt that use will increase if the method is found effective.
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