Introduction
The majority of HIV infected persons live in sub-Saharan Africa: approximately 23 million out of a worldwide 33 million at the end of 2007 [
1]. Within sub-Saharan Africa, women, especially young women, are disproportionately affected due to their biological and socio-cultural vulnerability [
1]. To address this imbalance, extensive research has been directed towards the urgent need to identify female-initiated HIV prevention methods, such as vaginal microbicides and/or barrier methods that would enable women to protect themselves from disease acquisition while potentially overcoming the obstacles that they may face when negotiating use of male condoms.
Male partner support is perceived as an essential component of women’s successful use of female-initiated methods in a research study context, and more generally, the involvement of men in women’s reproductive health has been endorsed by multinational agencies [
2‐
17]. However, the risks and benefits of partner involvement are not well understood, nor are effective strategies for engaging male partners in women’s health well established. Studies that have taken the approach of enrolling couples to garner partner support have reported improvement in women’s reproductive health outcomes as measured by decreased abortions and unplanned pregnancies in China [
18]; modern contraceptive uptake in Ethiopia [
19]; uptake of nevirapine to prevent mother-to-child transmission of HIV in Kenya [
20]; increased safe sex behaviour and decreased HIV incidence following voluntary counselling and testing (VCT) for HIV in Africa and the US [
21‐
26].
However, other observational studies have demonstrated the inverse: negative male involvement, as measured by relationship-level factors such as intimate partner violence, relationship power and decision-making, is associated with HIV risk among women [
27‐
29]. Indeed, only a handful of studies have considered the potential adverse effects of involving men on women’s health and empowerment, on relationships and family dynamics, or discussed its cost, difficulty, and possible lack of effect [
30,
31]. For example, in Zimbabwe following a nationwide social marketing campaign to involve men and promote joint decision-making among couples in family planning, men were more likely to consider themselves the primary decision-makers regarding family planning and parity [
16]. Involving male partners in female-initiated HIV/STI prevention could similarly have the unintended effect of further disempowering women or putting them at risk for HIV: women’s use of female-initiated products could “excuse” their male partners from condom use and reduce their responsibility for safe-sex, as has been anecdotally reported in Zimbabwe and Turkey [
2,
9].
We conducted an ancillary study among Zimbabwean women participating in a multi-site clinical trial of the effectiveness of a female-initiated HIV prevention method (the diaphragm and lubricant gel) to describe the extent to which they involved their male partners in the decision to join the study and to use products. This is the first large study in the context of a phase III HIV prevention trial to systematically capture detailed prospective information about the role of the male partner in women’s study participation and product use. We also examined the association among different aspects of male involvement with women’s attitudes and behaviour regarding the use of female-initiated methods.
Discussion
This is the first study to measure how female participants in a large trial of female-initiated HIV prevention methods chose to involve their male partners, and the first to attempt to measure an association between measures of male partner involvement and product acceptability and adherence in such a study. Our hypothesis, which was confirmed, was that female study participant’s behaviors and decision-making in a patriarchal setting such as Zimbabwe, were influenced by the attitudes and actions—whether perceived or actual—of her male partner, even though the investigational products were meant to be “female-initiated”.
By better understanding the role of the male partner on women’s participation and behaviors in a HIV prevention trial, and assessing his influence, we can devise appropriate HIV prevention strategies that adapt to these socio-cultural realities. “Male involvement” is sometimes narrowly defined as the physical participation of men in study activities, or his physical presence/accompaniment to the clinic [
37]. Here, we also assessed several measures of partner communication and support that extended beyond attendance, to better understand those aspects of “male involvement” which are salient to women’s attitudes and behaviour. While several of the variables we examined may appear conceptually linked, i.e. if a woman reports that he was supportive of her participation in the study, one might expect he was also
interested in it, we took several measures to rule out collinearity through examination of correlation matrices, and the inclusion of an intermediate step between the bivariate analyses and the final multivariate models in which the outcome was regressed against individual items within each domain
, which lends insight into the complex nuances of male partner involvement.
This study identified three key findings about male partner involvement in women’s clinical trial participation and the use of female-initiated methods for disease prevention. First the majority of female study participants involved their partners largely by: (a) requesting permission of their primary male partners to join the study; (b) involving their partner in the routine aspects of the study including test results disclosure and visit reminders, and (c) notifying them regularly about use of the diaphragm and gel. Other smaller and shorter studies of female-initiated methods have also reported high levels of partner communication, where women almost universally disclose participation and use of products to their partners, despite the fact that the investigational products—whether diaphragms or gels—could be used without partner knowledge [
2,
10,
35]. Our findings also support previous qualitative work in the region where women and male partners have discussed the importance of involving the male partner in the research study process [
33,
34,
38]. Only about 10% of women reported
ever using the diaphragm and gel secretly, and a smaller proportion did so consistently throughout the study [
39].
Here, we didn’t specifically explore the motivation for women’s decision to involve her male partner. However, our qualitative data and the finding that approximately 70% of women reported that would “face problems at home” if they did not first ask permission to join the study suggest that a major impetus is rooted in a fear of negative consequences if the male partner was
not involved [
39]. This interpretation is corroborated by other qualitative work indicating that men in Zimbabwe want to remain the “decision-makers” in matters of reproductive health [
2].
Secondly, women who openly reminded their partner, or whose partners knew she was using the diaphragm and gel every time were significantly more likely to strongly like
, and consistently use both products. Similarly, those who never used them secretly were more likely to report strongly liking the diaphragm and gel. These results corroborate, in part, the findings of a 6-month diaphragm acceptability study in Zimbabwe among 186 women, where women who either always or never disclosed use were significantly more likely to be consistent diaphragm users [
10]. As has been discussed previously, disclosure of product use and discrete use is a nuanced continuum where partners’ knowledge of product use might range from complete awareness at each episode, to implied use (i.e. male partner knows in general that his partner is using the diaphragm, but she does not tell him at every act of sex), to occasional covert use, to complete covert use [
39,
40]. Our findings suggest that open and successful dialogue about product use with partners—both in terms of disclosure and negotiation for use—enhance women’s acceptability and use of the products in a trial setting.
Our third key finding is that when women perceived that their male partners strongly liked the study products they were also more likely to strongly like and use them. This has been reported in smaller studies in the region, and a study in the United States among diaphragm-users [
41,
42]. It is perhaps intuitive that if one member of a sexual dyad felt strongly in either direction about the use of a contraceptive or disease prevention method, this would be likely to influence the other member. However, in this and other studies of female-initiated HIV prevention methods, acceptability is often assessed as the female study participant’s attitudes, and/or her perception of her partner’s attitudes, with little to no measurement of whether and how her attitudes might change or affect her partner’s, and vice versa. Although we were able to independently assess whether the women’s own strong liking of a product, and her perception of her partners liking the product were independently associated with consistent use, we could not disentangle the interdependent effect of one partner’s attitudes and behaviors on the other.
So as to better capture the effect of one partner’s attitude on the other, future research with women in stable partnerships should use study designs that incorporate the couple as well as more sophisticated measurements and analytical techniques that capture the interdependence of attitudes and behaviors between partners. Although potentially resource-intensive, enrolling discordant couples may be the most effective and efficient means of gaining male partner support for product use, measuring male partner influence, and assessing efficacy of an investigational product for the prevention of heterosexual HIV transmission in women. While the recently completed Partners in Prevention study demonstrated that enrolling large numbers of serodiscordant couples is feasible [
43], other less-intensive approaches to involving male partners in women’s prevention trials could also be considered, for example study teams might offer couples counseling and information sessions for men to encourage open partner-communication and approval for investigational products; and present various techniques for initiating conversations such as role-playing exercises. The effort to involve men in such interactions might empower them to be more positively involved in their female partner’s health in general and specifically, more supportive of protocol activities. Sessions could further provide venues to address concerns and highlight potentially positive aspects of product characteristics, such as enhanced lubrication and sexual pleasure.
There are a number of potential limitations in this study. The first is related to the inherent difficulty in defining and quantifying “male involvement”, as no set standard exists. We measured several different types of male involvement, but the positive or negative nature of each aspect of involvement was not quantified. Further, while we broadened our conceptual definition of male partner involvement from physical presence in the clinic to include such concepts as women’s perceptions of her partner’s support and effective couples communication, we only focused on the primary male partner, and this limits the generalizability of our findings.
The second limitation is potential selection bias—because the sample is comprised of women who have opted (or been allowed) to join a clinical trial to begin with, they may be different from women in the general community in significant ways, and particularly with regard to their partnerships. Women who enrolled in the study may be in partnerships with inherently more cooperative partners with whom more open communication can occur compared to women who do not (or cannot) participate. Of note, the majority of this population was married (97%) and had less than 2 lifetime sexual partners. In light of these first two limitations, an important consideration for future research is how “male involvement” would influence different sub-populations of women (i.e. commercial sex workers, unmarried women, widows); women in different cultural settings and in regards to different partnership types (casual partners vs. husbands vs. clients, both serially and concurrently). In addition, participants that were classified as lost-to follow-up (LTFU) were not included in this analysis, and reasons for LTFU may have been partner-related. This bias was minimized by our overall retention rate of 96%, and our inclusion of Month 3 data for those that did not have a Closing visit. A third limitation is that the exposure and outcome variables for this study are based on self-reported data collected through interviewer-administered questionnaires, and subject to both recall and social desirability biases. The latter may have been partially overcome through use of a more confidential data collection modality, such as ACASI. However, we knew from previous analyses that the adherence outcome measure used here (collected face-to-face) yielded almost identical results to our ACASI data on consistent product use throughout the trial [
32,
44]. Further, because of the way in which the data were collected, we were able to assess the effect of male involvement on women’s acceptability of the diaphragm or gel, and on use of the products in combination, but unable to measure how MI was associated with acceptability of the combination product, or use of the products individually. These measures may have yielded different results, and future studies of combination products should measure acceptability and use of all components individually and in combination.
As with all studies, there may be other confounding factors not measured, considered or controlled for in this analysis. Importantly, it should also be noted that in this study, the products evaluated were coitally-dependent which may have necessitated more dialogue and disclosure of use with the male partner. Other coitally independent approaches, such as diaphragms worn continuously, vaginal rings or daily insertion of gels, are currently under investigation; such methods will undoubtedly have an effect on the nature of male involvement and level of discussion between partners.
Potentially the most significant limitation is that we measured male involvement from the perspective of the women only. Although this may seem counterintuitive in a study about men, we were interested in women’s attitudes and behaviours as influenced by her perceptions of her partner, irrespective of the accuracy of these perceptions. Even if a male partner had told us he was very supportive of diaphragm use, his partner might not know or perceive this to be true, and would act in response to her own beliefs. Finally, because this study was nested within a clinical trial it was not possible to explore the effect of an intervention to promote male involvement on women’s behaviour. To measure such an effect, it would be ideal to offer a male partner intervention in a randomized design.
However, because there was no formalized intervention or procedure to involve male partners, not surprisingly, only a small proportion of partners came to the clinic: 13.6% came inside to wait or have services, 17.1% dropped off or met her outside. Clearly we had too little power to detect the effect of bringing men to the clinic on women’s behavioral outcomes, however, it is also possible that encouraging men to be involved by the commonly discussed strategy of inviting them to attend a clinic visit is not efficacious. Qualitative data from this study suggest that an important barrier for men coming to the study clinic was the perception that they would have to learn their HIV status, and that this information might be shared with their female partner. There is a paucity of evidence-based strategies to effectively engage male partners in women’s health research, particularly those in which HIV testing and novel female-initiated methods are introduced.
In conclusion, this study confirmed that even in the context of a clinical trial of a female-initiated HIV prevention method in Zimbabwe, male partners play a critical role in women’s discussions and decisions regarding joining the study, study activities, test results and investigational product use. Women’s report of full disclosure of study product use and partner approval for products were significantly associated with their acceptability and consistent use; an essential component of determining the efficacy of an investigational prevention method. Our results also support the need for more sophisticated measurement of how couples interact to make decisions that affect study-related behaviors as well as more concerted efforts to encourage male partner involvement in female-related HIV prevention trials. Mandatory counseling or education sessions with male partners and/or couples, or even couples-based enrollment should be important considerations for future studies.
Acknowledgments
We would first and foremost like to acknowledge the women who participated in this study. In addition, we are indebted to the efforts of the administrative and data coordination staff at the University of California, San Francisco; and staff at Ibis Reproductive Health; The University of Zimbabwe—University of California, San Francisco Collaborative Research Programme; the Medical Research Council, HIV Prevention Research Unit (Durban); and Perinatal HIV Research Unit of the University of the Witwatersrand. ET Montgomery was the Principal Investigator for the Male Involvement study and the Protocol Director for the MIRA Study, wrote the majority of the paper, and conducted the analysis for this manuscript. A. van der Straten was the co-principal investigator of MIRA and provided scientific guidance and interpretation on this study and the analysis. A. Chidanyika was the Project Director at the research sites and reviewed and edited each draft of the manuscript. T. Chipato was the Site Investigator for MIRA at the University of Zimbabwe and provided overall guidance to the study, and reviewed each draft of this manuscript. S. Jaffar was the PhD Supervisor to ET Montgomery, and provided scientific guidance on the development of the project, analysis and interpretation of findings. He reviewed each version of the manuscript. N. Padian was the overall MIRA trial principal investigator and provided scientific leadership in the analysis and presentation of this paper, and reviewed and edited each draft. For E.T. Montgomery, A. van der Straten and N. Padian most work for this study was conducted at the University of California San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences.
This research was funded by the Bill and Melinda Gates Foundation.