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.

Self-reported 'abnormal vaginal discharge' (AVD) is a common clinical symptom of sexually transmitted infections (chlamydia, gonorrhoea or trichomoniasis) or endogenous reproductive tract infections (bacterial vaginosis or candidiasis) and its clinical management is done through the syndromic management approach. This approach was advocated by WHO for low resource settings where laboratory diagnostics is unavailable. However, it is now accepted that AVD (or vaginal discharge syndrome) is neither sensitive nor specific for sexually transmitted infections (STIs), leading to considerable over treatment with antibiotics (up to 65% for gonorrhoea and chlamydia). While more cases of AVD may be attributed to RTIs (bacterial vaginosis and candidiasis) than to STIs, there may be other cultural and psychosocial factors leading to the complaint. In South Asia, a large body of literature suggests that self-reported AVD may be associated with mental health risk factors including stress, social conflict, marital discord, gender disadvantage and poverty. Studies in India and Pakistan have found a strong association between AVD and scores on mental health screening instruments, suggesting a link between AVD and common mental disorders (CMDs). This further confounds the management of AVD in S. Asia.

Our aim is to develop an intervention to overcome the limitations of syndromic management by (1) introducing rapid diagnostic tests to detect and manage BV, TV and CA (2); introducing gold-standard PCR tests for NG,CT for those with sexual risk assessment scores (as PCR tests are comparatively expensive); and (3) adding CMD screening and management to identify high mental health risk individuals and use additional assessment tools for these. The intervention will be implemented in Tehri Garhwal in India, with 20 selected health workers and 40 women seeking care for AVD; a review of the outcomes and a process evaluation will lead to an intervention pilot in the next stage.

This is an early phase study to develop an intervention that can holistically address the public health issue of self-reported 'abnormal vaginal discharge'(AVD) among women in South Asia. AVD, also referred to a 'white discharge' or 'leucorrhea', is a common and frequent gynaecological complaint reported by women in countries like India, Bangladesh, Pakistan, Sri Lanka and Nepal. This is a complex condition to manage in healthcare settings because the underlying causes maybe difficult to detect. Clinically AVD is indicative of a reproductive tract infection but it could also be tied up in complex ways with psychosocial factors such as stress due to marital discord and economic adversity; it may be the manifestation of a common mental disorder such as depression or anxiety.

In India AVD is an important indicator of women's reproductive health; it has been captured in DHS type national health surveys. However, the proportion of infections in the general population as well as among those who report AVD in the primary care setting is low, and currently available clinical protocols, which follow a syndromic management approach often without a laboratory diagnosis, result in unnecessary over treatment with antibiotics while the psychosocial factors may go undetected. We propose to develop (and test in a future trial) an integrated risk assessment protocol that combines new rapid diagnostics to detect the most likely underlying reproductive tract infections, together with a screening tool to detect underlying mental health problems and risk factors for these. For management of psychosocial factors, we will adapt a stepped care model of mental healthcare that utilises frontline health workers for delivering a basic level of psychosocial counselling with supervising doctors and specialists managing severe cases. Our study will generate new knowledge on treatment guidelines and a tested model for comprehensive reproductive and mental health care for women who present with AVD in primary care. If successful, study recommendations will lead to policy changes in the syndromic guidelines that are currently considered best practice.

This integrated protocol will have a positive impact on women's sexual, reproductive and mental health outcomes and their quality of life, not only in the study sites but also in other countries of South Asia. Women who have limited health seeking options for both physical and mental health will benefit the most. There will be fewer complications of pregnancy and fewer low birth weight new-borns that can be attributed to recurrent infections and poor maternal mental health. The intervention will reduce the economic costs and societal burden of increasing antibiotic resistance due to unnecessary treatment with antibiotics and address the hidden burden of mental health problems. It will also reduce unnecessary worries by women and their partners about having a sexually transmitted infection. The stepped-care model of managing infections and psychosocial conditions will harness the skills and presence of frontline health workers and strengthen the capacity of doctors and specialists to effectively deliver mental healthcare. This will contribute to strengthening the existing health workforce and referral linkages between the primary and secondary levels.

Our study will also generate important findings about operationalising the use of rapid diagnostic tests for vaginal infections. At present, laboratory facilities are inadequate in many rural settings in the region. Rapid tests could usher in a transformation in diagnostics, once the implementation challenges have been assessed and negotiated. Initially, costs of these tests may present a barrier but if the tests prove useful, their scaling up would bring down the costs. This could be another important health system strengthening impact of this study.