Development of an intervention for improved management of self-reported abnormal vaginal discharge by women in rural north India.

Background: We propose an early phase study to develop an intervention to address the public health issue of self-reported 'abnormal vaginal discharge'(AVD), a highly prevalent syndrome worldwide and in South Asia in particular. AVD is a public health concern as it may signal a sexually transmitted infection like gonorrhoea, chlamydia or trichomoniasis, or an endogenous reproductive tract infection like bacterial vaginosis or candida.

The World Health organization has advocated use of syndromic management guidelines for AVD (referred to as vaginal discharge syndrome in the syndromic guidelines) which follows a stepwise approach to detect and manage infections in low resource settings where laboratory facilities are unavailable. However it is now accepted that the syndromic approach is a poor predictor of infections, especially the sexually transmitted ones and the flowcharts lead to considerable over treatment with antibiotics.

Moreover in South Asia, there are complex cultural and psychosocial factors associated with the complaint of an AVD. It may be linked with traditional Ayurvedic beliefs about the importance of bodily fluids. AVD signifies the loss of vital bodily fluids resulting from various physical and psychosocial causes like weakness, worry, 'melting of bones' and 'sexual promiscuity', as expressed by women in different studies in India, Bangladesh and Sri Lanka.

Studies in India and Pakistan have found strong associations between AVD and mental health problems (mostly mild and moderate ones) that could be linked with stress, social conflicts, gender disadvantage, poverty and marital discord that women experience. In fact it has been suggested that AVD is a cultural idiom of distress among women in S.Asia where seeking care for mental health is stigmatised.

AVD is a common reproductive complaint of women in India, Bangladesh, Nepal and Sri Lanka, reported by up to 30% women in the general population in India and nearly 50% of pregnant women in Bangladesh. So its management should be a healthcare priority in these settings.

With the availability of (a) Rapid Diagnostics or Point of Care tests for bacterial vaginosis, candida and trichomoniasis, (b) validated tools for mental health screening in primary care setting and (c) proven success of a stepped care model of mental healthcare (in which trained lay health workers provide a basic level of psychosocial counselling to patients with mild mental health problems and doctors and specialists manage the severe cases), the management of AVD in S. Asia calls for a transformation.

Our aim in this study is to develop an intervention that integrates these three elements (together with molecular testing for chlamydia and gonorrhoea for those assessed to be at sexual risk) in a novel risk assessment tool or protocol and compare this revised tool with syndromic management in a future trial.

Methods: Using qualitative research methods we will explore AVD perceptions and current practices amongst women in the community and health workers who are most sought by them for AVD. Interviews with other stakeholders in the health system including medical officers, women's health specialists, mental health experts and laboratory staff will be conducted to understand health system needs with respect to operationalising the laboratory and patient management procedures.

Working closely with a small group of selected local experts and health department staff, we will develop the revised assessment tool and implement this with 20 health workers (identified through consultations with women and health department staff) and 40 women presenting with an AVD, who will be followed up at 3 and 6 months. Their outcomes (self-reported AVD, infections and mental health) will be analysed and a final process evaluation using stakeholder interviews will lead to an outline of a plan for piloting the intervention.