Integrating female sexual and reproductive health screening in Zambia: one-stop self-sampling for schistosomiasis and other genital infections.

The 'BILHIV in YourSELF' (pronounced; believe in YourSelf) study, is a novel one-stop approach for improving young women's sexual and reproductive health through community-based infection screening in Zambia, a country known to have high prevalence of HIV and cervical cancer. This novel strategy aims to integrate, in a single home visit and for the first time, self-sampling (genital and oral swabs) for the detection of multiple infections with serious consequences for female's sexual and reproductive health. The BILHIV in YourSELF study mainly focuses on the detection of female genital schistosomiasis (FGS), a chronic and disabling parasitic gynaecological disease that gets often confused with sexually transmitted diseases (STIs) due to their similarities in clinical presentations such as infertility, ectopic pregnancies, vaginal discharge and pain with coitus. An estimated 40 million women suffer from FGS in sub-Saharan Africa, and most of them are unaware of harbouring the disease. This is partly because detection of FGS is challenging, as it relies on expensive equipment and expertise that are seldom available in sub-Saharan Africa, where the disease is common. Small studies have documented an increased risk of acquiring HIV and cervical cancer in women with FGS, underlying the importance of approaching diagnosis of all genital infections in a comprehensive and holistic manner closer to the user.

Genital self-sampling has been successfully implemented for the detection of different genital infections, including the work pioneered by the lead applicant in Zambia, validating genital self-swabs for the diagnosis of FGS. Results revealed acceptable sensitivity of genital swabs for the DNA detection of the parasite from women's genital tract, potentially offering, for the first time, a scalable diagnostic approach for a parasitic disease that has been unacceptably neglected. Also, self-sampling strategies have been used and validated for the detection of human papillomavirus (HPV), the causal agent for cervical cancer, allowing for possible community-based screening. All of these infections lead to serious downstream consequences for the sexual and reproductive health of women in SSA. As a consequence, multi-pathogen self-sampling and testing constitutes an unmissable opportunity to offer potentially life-changing health services closer to the users. An integrated wider approach for genital infection detection can also be a cost-effective strategy.

The BILHIV in YourSELF study has as a holistic approach to FGS detection in the community within the wider scope of female sexual and reproductive health surveillance and linkage to care in Zambia. It will aim to validate genital self-sampling strategies in a large cohort of women in Zambia and follow them up for three years. At follow up, we will measure clinical progression or resolution of infection and lesions in addition to adherence and response to treatment. A thorough cost-effectiveness analysis will be performed aiming to find economically feasible ways to scale-up community based programmes that will integrate detection and care of FGS, HIV, cervical cancer and other STIs for women of reproductive age in SSA.

There are an estimated 40 million women unknowingly living with female genital schistosomiasis (FGS), with dire consequences for their sexual and reproductive lives that include infertility, pain with sexual relations, ectopic pregnancies and increased risk of HIV acquisition, mostly in countries with high prevalence of sexually transmitted infections (STIs). Moreover, there is growing evidence of a possible link between FGS and cervical cancer. The clear interplay between genital infections highlights the urgent need to bolster programmes that jointly integrate strategies to screen and detect multiple genital infections with simple, affordable and as close to the point-of-care as possible. Some of these infections (i.e. FGS) have been more neglected than others as shown in the level of commitment from governments and ongoing programmes. This neglect can also be reversed by integrating FGS in strong national ongoing programmes for women of reproductive age who will be the main beneficiaries at large in countries in sub-Saharan Africa such as Zambia.For all of the above, it is therefore unsurprising that sexual and reproductive health is a critical area of development highlighted in the United Nations Sustainable Development Goal 3. Genital self-sampling and self-testing through community based programmes are widely accepted strategies for the detection of devastating diseases like HIV. They empower women and protect their privacy since self-swabs can be performed at home or in other private places and increases compliance with testing. HIV self-testing programmes have been shown to be cost-effective.

The outcomes of part of this research developing a new multiplex assay for the detection of human papillomavirus and FGS will be of direct interest to industrial partners such as PATH, who is developing diagnostic assays for neglected tropical diseases for low resource settings. All data will be made available as soon as possible in a freely available and widely accessible format as per UKRI policies to enable data analysis across platforms and to compare results from different studies. In this way, it is anticipated that the impact may be achieved through intellectual property protection (e.g. patenting) and subsequent commercialisation through licensing out the novel assay to an external commercial partner, thereby making the assay available to the market to benefit society.

The close collaboration with WHO through my membership on advisory panels will ensure that international policy-makers are kept fully informed of the findings of the work as it progresses. We anticipate annual stakeholder meetings to present our findings. Additionally, the data generated from Zambia will be of direct benefit to the Zambian government in deciding whether an integrated self-sampling programme can be adopted onto the extended programme on HIV and cervical cancer screening including a thorough cost-effectiveness analyses. Important as well will be the data generated on HPV prevalence across different age groups and settings in Zambia before and the vaccine roll-out for school aged girls in 2021.