Overcoming Ethical Challenges to Engaging Men Who Have Sex with Women in HIV Research

Abstract

Men who have sex with women are understudied in HIV research despite the extent to which they experience HIV-related mortality and contribute to the epidemic among women. During our experience of developing and piloting an HIV prevention intervention for men living with HIV in South Africa, and planning to have a child with an HIV negative woman, ethical questions were posed regarding implementation of a male-centered intervention that did not require female partner participation. Two overarching ethical issues were 1) the potential for compromising women’s reproductive and sexual autonomy and 2) potentially increasing HIV-acquisition risks for the woman because the efficacy of the intervention was unknown. We describe here how these concerns were addressed to facilitate development of a male-centered HIV-prevention intervention. We hope this process manuscript will support researchers, clinicians, and reviewers to engage men who have sex with women in HIV prevention and care.

Introduction

Men from Sub-Saharan Africa are less likely than women to complete HIV testing, start antiretroviral therapy (ART), remain on ART and in care, and suppress HIV-RNA (1,2). In South Africa, men are older at time of first testing, have more advanced HIV at diagnosis, and have lower rates of engagement at all points of the HIV treatment cascade (3). Researchers, UNAIDS, the World Health Organization, and the NIH all recognize and advocate for the need to increase the engagement of men who have sex with women in HIV prevention and treatment (4,5). Including men in sexual and reproductive health programs can facilitate communication around contraception, increase women’s access to antenatal care, improve maternal health outcomes, and reduce the risk of infant HIV infection (6,7,8,9,10). Nevertheless, HIV health programming is often organized in ways that can create substantial, multilevel barriers to HIV testing in men who have sex with women and reinforce perceptions that they are absent and/or “difficult” (11). For example, public health care in many settings is focused on maternal and child health; care is offered during hours when men are working or seeking work, men who are seen as problematic may receive less empathic care; and men who successfully access these HIV services are perceived as portraying traditionally feminine characteristics (11,12,13). In addition, due to high levels of HIV stigma, men may avoid seeking care at facilities known to provide HIV care. In South Africa, because of these barriers, men are disadvantaged in their access to and use of HIV services, are less likely to be linked to HIV care and start ART, and more likely to die from HIV (3). These gaps in HIV care contribute to poor health outcomes for men, while increasing HIV transmission to women and, therefore, children (14).

In 2015, the research team was funded to develop and test an intervention for men living with HIV in Durban, South Africa who wanted to have a child with an uninfected or unknown serostatus partner (R34-MH100948 PI Matthews). Based on formative work, we designed the ‘Helping Men have Healthy Babies’ intervention to leverage men’s motivations to have healthy children in order to promote HIV-serostatus disclosure, ART uptake, and delaying condomless sex until HIV-RNA suppression in order to maximize the health of men while reducing HIV acquisition risks for their pregnancy partners. (During this time, PrEP was neither approved nor available for use in South Africa.) Earlier work by our team demonstrated that most women with recent pregnancies in an urban community in KwaZulu-Natal did not know their partners’ serostatus and highlighted many challenges to HIV-serostatus disclosure for men (15,16). Additionally, our formative work suggested that MLWH were motivated to have healthy (i.e. HIV-uninfected) children, were interested in counseling that helped them safely meet reproductive goals, and modified risk behavior once pregnancy was achieved to protect the baby from HIV acquisition (17). Due to the gap in male involvement in sexual and reproductive health care resulting in poor outcomes for both men and women, our study design recruited men as individuals. We aimed to understand serodiscordance and HIV transmission norms, and promote safer conception strategies, planning and problem solving, communication, and HIV-serostatus disclosure for a broader population of Men Living with HIV (MLWH), including those who might not yet be in a mutually-disclosed partnership (18).

Study Design and Ethical Concerns Raised

The study enrolled men who wanted to have children with uninfected or unknown status partners to participate in three intervention (and two booster) sessions offering information, the use of motivational strategies, and problem solving skills to help them develop a healthy baby plan. The goal of the intervention was to promote ART uptake and adherence for men such that HIV-RNA suppression could be achieved prior to conception attempts. We also promoted couples-based HIV counseling and testing and worked with men to build communication skills to promote disclosure to their partner. While our team designed a male-centered intervention to promote the health of men and their partners, two major ethical concerns were raised regarding the potential harms of enrolling men without requiring their female partner’s participation.

The first concern involved the potential for a male-centered intervention to further compromise women’s reproductive and sexual autonomy in the context of local and, at times, problematic gender power dynamics. In a society where dominant social traditions often favor men, prioritizing the needs of women who are disproportionately affected by HIV becomes even more critical (19). Women with reduced autonomy are less able to negotiate HIV prevention practices (e.g. partner HIV testing, ART uptake, ART adherence, PrEP, HIV-RNA suppression, condom use, additional partnerships, etc.) or other reproductive health decisions (contraception, conception) with their partners which may increase their risk of HIV acquisition (20, 21).

Our study proposed to recruit men to participate in our intervention but did not require female participation. As a result, our intervention did not directly provide female partners with the same access to information regarding safer conception strategies that the index male partner was offered. Ethics-focused reviewers raised concerns that sharing this information with men without engaging their partners prevented the partner from learning and being part of decision-making processes about acceptable risk behavior in the partnership to meet reproductive goals. This difference could limit a woman’s opportunity to make informed decisions for herself and worsen her already circumscribed autonomy. Studies have pointed to the importance of incorporating women’s autonomy into HIV-prevention strategies to improve equity in decision making and control within dyadic partnerships (22,23). A study such as ours, which leveraged gender norms, could be understood to continue to unjustifiably privilege men over women. This may be particularly salient in settings such as South Africa, where intimate partner violence and gender inequity is highly prevalent and associated with HIV (24).

The second ethical concern involved the possibility of inadvertently being complicit in harming women if the men who enrolled in our study did not adopt the recommended HIV risk-mitigating strategies proposed in our intervention. HIV disproportionately affects women and girls due to both biological reasons and women’s unequal cultural, social and economic status as described above (19). Ethics reviews of the protocol observed that the risks of the intervention to the female partner could not be predicted because the male uptake of HIV treatment and prevention strategies was unknown: indeed, understanding their uptake was the research question. This intervention was proposed early in the days of the scientific understanding that undetectable HIV-RNA means that the virus is not transmittable (U=U). The concerns were that teaching about U=U as one prevention strategy might lead to risk compensation. Furthermore, if the female partner was living with HIV, then she should access ART and suppress HIV RNA before trying to conceive a child; by not requiring her participation, there was a risk that she would not test and know her status.

How Did We Address These Ethical Concerns?

We outline here how the research team conceived of our ethical responsibility in light of the ethical and clinical standards at the time and describe how concerns were addressed. Couples-based interventions in South Africa have had limited success as a result of low levels of couple involvement and recruitment, lack of environments that are welcoming to couples and men, or unwillingness to disclose HIV serostatus (25,26). In our formative work in this community, we attempted to reach male partners through partner referrals from 209 pregnant women, but only one man was recruited (17). The content of our intervention was designed to support men to recognize that having a healthy baby would require working with the female partner. We supported men’s communication skills development and evaluated how their traditional decision-making dominance might change over time (17,24). Thus, we worked with men to support them in engaging their partners. Our preliminary data suggested that limiting our intervention to men in mutually-disclosed partnerships would limit reach and thus fail to offer HIV prevention strategies to a large proportion of the target population (MLWH not yet virally suppressed). In the absence of our intervention, the autonomy of women would remain circumscribed and their health would continue to be affected by being partnered with a man living with HIV without virologic suppression. Based on our formative work, we felt there was contextual equipoise to ask if a male-centered intervention could promote positive outcomes such as HIV-RNA suppression and partner disclosure.

We highlighted that the local standard of care did not provide men with information on how to safely meet reproductive goals (17). By promoting treatment as prevention, early ART (this was before test and treat was standard of care in South Africa), and safer conception strategies, our intervention would reduce the female partner’s pregnancy-related risks and (potentially) protect future children. Even if she was unable to participate in the intervention, having a partner on treatment dramatically reduces a woman’s risk for HIV acquisition (hence the motivation for a test-and-treat public health policy). Using this mode of consequentialist reasoning, we highlighted that by reducing an individual man’s risk of transmission of HIV to all uninfected sexual partners regardless of pregnancy plans, there would also be greater public health benefits in reducing community HIV acquisition rates. Rather than waiting for the norms themselves to change or ignoring the gender hierarchies that inform the social roles of men and women in our study, we acknowledged these norms and adapted our study to engage the individual with the most influence in safer conception care.

While risk compensation is a commonly-articulated concern in HIV prevention research, it is rarely substantiated by data. Cross-sectional studies and observational cohort studies suggest that improved access to ART has not led to significant risk compensation (27,28). Substantial increases in condom use amongst HIV-serodifferent couples have been recorded as a result of interventions promoting HIV counselling and testing (29). At the time of enrollment, men were not accessing ART and trying to have a child (e.g. having condomless sex), so we maintained that it was unlikely the counseling content might further increase HIV-transmission risk behavior.

While exploring our obligation to protect the rights of women, we believed that, in order to protect the rights of the enrolled male participant, we could not ethically inform unenrolled partners of their partner’s serostatus without consent from the male participants. The clinical standard of care in South Africa encourages men to disclose their serostatus to partners and to include their partners in clinic-based HIV counseling and testing but does not require it (30). Even in well-resourced countries with substantially fewer numbers of persons living with HIV, government policies and partner notification laws regarding HIV are diverse. Countries like Denmark and Norway, for example, do not have mandatory partner notification laws, whereas physicians are legally obliged to inform the partners of a newly diagnosed person living with HIV in Iceland, Finland, as well as many states in the United States (31).

Our aim in this study was not to disregard the rights and status of women, but rather, to assist men in a pre-existing, complex, hierarchical social order (that we had no ability to drastically alter in the short term) to protect their partners and develop a healthy baby plan. In order to maximize the likelihood of this happening, and in order to optimize chances of engaging women, we developed letters for men to provide to their pregnancy partners informing women of their potential risk of acquiring HIV, and encouraged them to seek HIV counseling and testing (17). Men were reminded that these letters would effectively disclose their HIV-serostatus to the partners. Men were encouraged to include their female partners in safer conception counseling sessions. We also designed a separate information session for women, led by a separate gender-concordant interventionist (17).

Overall, given the limitations of safer conception programming in clinical settings, we made the case that the risks taken through our intervention would be less than risks taken without them. By acknowledging societal realities, our program posed little risk of maleficence and the potential for beneficence among our male participants and their vulnerable, female partners.

Conclusions

Currently, women, mutually-disclosed serodifferent couples, sex workers, transgender people, and Gay, Bisexual, and other Men who have Sex with Men (GBMSM) are considered key populations to prioritize for HIV interventions. Very little research is conducted with men who have sex with women. Several ethical concerns arise whenever the inclusion of men as individuals is considered in research, despite the key role men play in the HIV epidemic. Nevertheless, by solely engaging men who are in mutually-disclosed couples or who identify as GBMSM, we only reach a portion of the population and limit the impact of male behavioral change on outcomes that could ultimately improve the reproductive health of both men and women (32,40). In addition, by denying men access to sexual and reproductive health research without their partner’s participation, we leave men behind despite evidence that many desire this knowledge and want to achieve fatherhood (17,33,34).

Our approach prioritized individual men as the focus of our study intervention. Offering men services to father healthy families is considered a novel, patient-centered approach to engaging men in accessing HIV care and treatment services. Supporting men to meet important personal and sociocultural reproductive goals could potentially increase demand for services resulting in increased HIV testing, engagement in care, ART uptake, and HIV RNA suppression. Providing safer conception services to men may also promote disclosure and facilitate linking HIV-exposed women to HIV prevention opportunities. In the absence of these services, female pregnancy partners and children will remain vulnerable to HIV infection.

We understand our work is controversial because it accepted injustice as a background condition. Researchers often do not have a primary obligation or practical ability to affect this injustice, and we appealed to a consequentialist risk/benefit analysis as an ethical paradigm to justify our intervention. It is reasonable for people to reject our position and argue that the limited resources in this world should not be devoted to research and instead devoted to repairing the structural and social determinants of health inequity. We acknowledge that our ethical arguments are imperfect, but they do offer a means to create a context-sensitive solution to a largely unarticulated problem in HIV care and research.

The work of organizations like Sonke Gender Justice (which works to change behaviors of men that are harmful to women such as gender-based violence) has shown that patriarchal privileges come at a high cost to men in South Africa in the form of compromised physical and mental health, heightened risk for injury, and limited intimacy (35). These costs, combined with the love and solidarity many men feel for women in their lives, can motivate men to work for attitude transformation (35). Decisions relating to partner disclosure and female autonomy in this project were not made to disempower women, but to leverage local social realities and the context of existing gender dynamics. Women and key populations can be equipped with the information and resources to navigate HIV care in environments where they are treated unequally, but this does not negate the underlying barriers to achieving fair treatment. Women partnered with men who want to have a child and are not taking ART (and therefore not virally suppressed), face great risks in the absence of interventions that promote male partner viral suppression or PrEP uptake for women.

Interestingly, studies that focus on women living with HIV or Men who have Sex with Men often do not encounter the same ethical concerns relating to partner notification and partner involvement. Despite the privileges bestowed upon men due to patriarchy, destructive normative definitions of manhood are harmful to them as well (36). Studies have demonstrated an increasing awareness for the need to implement strategies that are specific to the context in which interventions are being implemented (36,37,38). Studies continue to recognize the exclusion of men from reproductive counselling and care, and the treatment of men as adjuncts to women, rather than as clients in need of reproductive services (12,34). We must be able to engage men who have sex with women in order to advocate for interventions to address harmful masculine norms (24, 40). Our thought process described in this manuscript could be helpful to these, and many other researchers with similar goals of planning context-specific, norm-sensitive HIV interventions that engage men.

Ultimately, the innovation of our approach, a contextual acceptance of equipoise, and agreement about the risk/benefit calculus led to its approval by the relevant stakeholders. The primary findings from this intervention have been presented in abstract form and a manuscript is being prepared. There was evidence of an increase in HIV-RNA suppression and no evidence of social harm based on the pilot intervention. While this work was proposed and conducted several years ago, our group continues to encounter similar barriers when proposing work with individual men without requiring partner participation. By discussing the ethical concerns we encountered in proposing this work and how we addressed them, we hope that this commentary serves as a tool for other researchers hoping to conduct research centered around, or engaging, men who have sex with women.