Male involvement (MI) is a critical issue, especially in maternal and child health (MCH) and in the Prevention of Mother to Child Transmission (PMTCT) of HIV in Sub-Saharan Africa (SSA). In this continent, men plays an relevant role in the decision-making process within the household and this often impacts women's access to healthcare, contraception, food, and work, and, as a consequence, pregnancy outcomes (1–4). Low male involvement can impact on treatment refusal, delayed enrollment, and dropout of pregnant and breastfeeding women (5). Previous literature suggests that male partner support is expressed by providing transport to the clinic, reminding the clinical visits or the medications, and accompaniment to appointments (6–9). Previous studies and reports have found several definitions and attempt to develop a composite index of male support/involvement (10–12), but a unanimous and well-accepted measure has not been found in the literature.

Qualitative studies suggest that women are not supported enough by their male partners in many aspects; some of the barriers reported are access to transport to the clinic, lack of accompaniment to appointments, sometimes men are even reported to hinder female access to the clinic and female retention in care itself (13–16). Gender norms and roles significantly limit women's ability to access healthcare independently of male support (17) since men are often the decision-makers and gatekeepers for the family (18). Potential harms associated with increasing male involvement should be carefully considered to engage them. Increasing men's power over a traditional women's sphere might mean encroaching upon women's domain and may change the hoitausehold's dynamic and the relationship between partners, exacerbate gender asymmetry, and reinforce the patriarchy (10, 19).

In 2020, an estimated 990,000 Malawians were living with HIV, and 12,000 Malawians died from AIDS-related illnesses in the same year. More than 98% of pregnant women were tested for HIV, and more than 95% of those testing positive were on treatment (20). In Option B+ programs, scarce adherence, retention and loss-to-follow-up (LTFU) are still serious issues and keeping patients on long-term therapy is a critical element of HIV care. Two larger studies conducted in Malawi showed that 70% of the 29,313 women who started Antiretroviral Therapy (ART) under Option B+ by June 2012 were still in care 3 years later, and about 30% of the retained women did not adequately adhere during the first 2 years of ART (21, 22). Previous studies extensively describe barriers to adherence (23, 24); among these barriers, male partner support is one critical factor affecting adherence and retention to therapy (13, 14, 16, 25–27).

In Malawi, male involvement in MCH and PMTCT ranges from 3.2 to 74% (28). One study run from January 2004 to December 2006 at Mwanza district hospital reported that only 63 (13.7%) out of 467 HIV-positive women enrolled in PMTCT attended the clinic with their partner (29). A second observational study found that 10.7% of women attended with their partners in Bwaila Hospital in Lilongwe in 2009 (30). A third unblinded randomized controlled trial (RCT) comparing the adoption of the invitation slip vs. the use of invitation slip plus tracing reported that 74 vs. 52% of couples presented to the clinic, respectively (31). Another RCT study showed that among 462 women (June and December 2013), 230 received an invitation card, and of these, 65 (28%) came accompanied. Of the 232 women in the standard of care group, 44 (18%) arrived accompanied (32). A recent observational study showed that a relatively higher portion of HIV-positive women was accompanied by their male partners (64.1%) when the healthcare workers provided an invitation card to women (33).

Similar data are reported in other SSA countries: a Ugandan study reported a high prevalence (74%) of low male involvement, and only 5% of men escorted their partners to the Antenatal Care (ANC) clinic (27). In Kenya, the level of MI amounts to 36% (25) and 53.5% in Tanzania (26).

Several health interventions and strategies have been implemented in Sub-Saharan Africa and Malawi. However, most of these programs have not shown success. Few studies and with variegate study design were conducted as shown by a recent systematic review (34). A previous review shows that psychosocial interventions and complex community interventions increase male partner involvement compared to the invitation letter (35).

Our research aims to assess the impact of three different interventions on male partners' involvement in HIV+ women's care in Malawi (36).

We conducted a controlled before-and-after intervention study in Malawi in 3 clinics managed by the DREAM program (Disease Relief through Excellence and Advanced Means) in Kapire, Kapeni and Balaka. Each clinic piloted a different intervention: Kapire, the use of male champions; in Balaka, the introduction of a special day for male patients; in Kapeni incentives (nudges; a food package) for male partners attending the clinic. The study protocol originally included a control center where no intervention was performed. This center was later removed from the study as we encountered some technical problems that affected the collection of data.

DREAM is a health program run by the Community of Sant'Egidio aimed at addressing a wide range of health challenges according to the needs of different contexts (37–40). The program is now operating in 10 African countries in several sectors (HIV care, TB treatment, cervical cancer screening and prevention, hypertension and diabetes control, neurological disorders treatment), and its peculiarity is the holistic and personalized approach adopted by the healthcare workers and staff.

The paper is the first output of a pilot project, called “WeMen,” that aims to evaluate the impact of three different interventions on adherence and the retention to Antiretroviral therapy (ART) of HIV-positive women (36). The methodology and protocol of the study were extensively presented elsewhere (36), and the study's protocol was registered at ClinicalTrials.gov (ID: NCT04356157 URL: https://clinicaltrials.gov/ct2/show/NCT04356157).

The baseline analysis was conducted from July 2019 to March 2020; the interventions took place from August 2020 to January 2021 and the post-intervention from October 2020 to March 2021. We included HIV+ women in both the pre-and post-intervention periods who agreed to join the study. Women younger than 18 years and with no stable partner were excluded.

In the healthcare centers where we carried out the interventions, we asked women to invite their male partners to the health center for HIV testing and counseling, and we administered a questionnaire to the woman at the subsequent visit (Supplementary File 1). The questionnaire explored various dimensions related to partner support and sexual and reproductive health, including the level of support each woman received from their partner in terms of accompaniment or emotional support, their satisfaction, and any harms the women faced within the household, as detailed described in the protocol. The final questionnaire consisted of 29 questions. A selection of questions is reported in Box 1. Trained medical doctors and clinical officers administered this questionnaire before and after the interventions in all the health centers. Through this survey, we evaluated the impact of the interventions on the male partner involvement in each facility adopting the following intermediate outcomes: (i) the number of women accompanied by male partners after invitation, (ii) number of men accepting to be tested for HIV, (iii) perceived partner involvement and (iv) presence of gender-based violence in the family.

As described in the protocol paper, the primary outcomes evaluated in the WeMen project are women's retention in care and adherence to treatment at 6 months, 1 and 2 years. These are still under evaluation and will be published in a following paper.

The study showed that each intervention enhanced the proportion of women accompanied by their male partners to the facility. However, this increment significantly increased only after implementing the special day for men in Balaka. Women felt safer at home after the special day and male champions intervention. Moreover, the male champions may have improved the proportion of partners supporting the women's access to the clinics and antenatal visits.

Previous literature reviews on approaches adopted to enhance male support reported that psychosocial interventions and complex community interventions (or multi-component) are promising interventions in the uptake of maternal antiretroviral therapy and male support (34, 35). Complex community interventions usually reported an effect on multiple levels of the health behavior model; several approaches, such as the adoption of male champions (45, 46), the adoption of the male-friendly clinic (30, 46), the use of drama and talks during daily life (47, 48), and the adoption of household couples' support (49) showed a substantial effect on male involvement. In a pre-and post-intervention study in 116 antenatal clinics in Kenya where a package of interventions (including health education activities in the facilities, the delivery of the invitation letters to the women, and adoption of peer-to-peer educators) has been delivered, the number of men accompanied by their female partners increased from 7.4% at the baseline to 54.2% 3 months after the intervention (RD = 0.47, CI 0.45–0.48) (50). Our findings show that multi-component interventions such as adopting male champions that roll out educational activities within the communities and opening the facilities for men providing targeted clinical and education services for men may be helpful to promote male partner support. Moreover, our findings showed a higher proportion of men accompanying their female partner to the facilities (above 67%) than most previous interventions in Malawi and SSA (25–30, 32, 33). This result may be explained by several factors, such as the gender-sensitive approach adopted throughout the interventions and the increasing number of interventions and increasing attention on the male engagement within the country (51).

However, since these are multi-component interventions, it is difficult to attribute the effect of an intervention to one component both in our study and in previous studies where the effect of every single component was not reported (34, 52).

Complex public health interventions acting on multiple levels could effectively increase the male involvement in the health of their female partners, as reported by the same women. In particular, the realization of special opening days of clinics reserved for men with health education services and awareness campaigns in the communities with male champions proved to be the most promising interventions. The ecological approach used in these interventions, which also act on the environment/context and not only on individuals, and having acted both at the clinical facility level and at community and social network level, are the aspects that probably have increased the effectiveness of the interventions. However, the ecological approach does not elicit the direct causal mechanisms and the effectiveness of the individual components of the interventions. Moreover, it is necessary to adopt standard and validated criteria to measure male involvement in health services. It is recommended to replicate interventions of this type in other contexts to produce more evidence of their effectiveness and observe the impact on final health outcomes such as adherence and retention in care in programs for the treatment of chronic diseases. Given the limitations of the context and the availability of time and resources, the results should be interpreted with caution. They should be intended as a first step in order to test the most promising interventions in more extensive studies to verify their validity.

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

The studies involving human participants were reviewed and approved by College of Medicine Research and Ethics Committee (COMREC) under Malawi's National Health Science Research Committee (NHSRC) with approval number 2021. The patients/participants provided their written informed consent to participate in this study.

IT, FC, IP, and SO: conceptualization, methodology, and writing—original draft. BM and DT: data curation. BM and SO: formal analysis. SO: funding acquisition and visualization. IT and SO: investigation. FC: project administration. FC and SO: resources. LP and SO: supervision. MM, LP, and GT: validation and writing—review & editing. All authors have read and agreed to the published version of the manuscript.

This research was funded by the Italian Ministry of Foreign Affairs through the Italian Agency for International Cooperation within the Global Fund 5% program aimed at providing evidence on how to improve the interventions of the Global Fund against tuberculosis, HIV, and malaria in the countries where the fund operates. Grant WeMen! Improving womens access to health care system through mens inclusion AID 011587/08/05.

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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