Prevalence of Sexually Transmitted Infections (STIs) among the patients presenting with vaginal discharge and their partners:

A hospital based study

Vinay Rawat Supervisor Dr N K Saini Co Supervisor- Dr Sanjay Chaturvedi Dr S N Bhattacharya Dr Bineeta Kashyap

Objectives
Objectives:
To find out the prevalence of sexually transmitted infections (STIs) among the patients with vaginal discharge attending the STD Clinic in GTBH, Delhi and their male partners
To ascertain various factors associated with infection status of patients and their partners

Material and Methods

Study Design:
It will be an OPD based cross sectional study

Study Period:
The period of study will be from November 2011 to April 2013.

Study Subjects:
Female patients complaining of vaginal discharge, reporting in the STD Clinic of Dermatology department of Guru Teg Bahadur hospital, Delhi and their partners, will be the study subjects.

 Inclusion Criteria:
The patients complaining of vaginal discharge and their partners will be included in the study.

Exclusion Criteria:
Patients or partners who had received antibiotic treatment for whatever reason within the preceding four weeks.

Sample size:
The prevalence of STI among patients presenting with vaginal discharge was found to be 40% ( STIs among patients with vaginal discharge syndromes, South Africa, 2010). For 95% confidence level and 10% absolute error, minimal n was calculated as 86 for the patients.(Epi Info 2000). Same number of partners will also be included in the study. Considering that only 40% of patients would refer their partners,(Patient
led partner referral in a district hospital based STD Clinic, J of PG Medicine,2002), a total of 215 patients will be included in the study. So

the total sample size will be 215 patients + 86 Partners)

 Sampling:
The investigator will visit the STD clinic twice a week for nearly 10 months (approx. 80 visits) Three consecutive, consenting, patients with vaginal discharge reporting to STD Clinic at or after 10 AM, will give a yield of 240 subjects after factoring for 60% attrition of male partners (n=215). * In exceptional situations, if <3 eligible subjects are available on a particular day, the available subjects would be recruited. Data collection weeks shall be increased accordingly.

Sampling contd..
The patients and their partners will be screened for the presence of Chlamydia, Gonococcal and Trichomonas infection as follows :
Genital swab and blood sample will be collected from the patients and will be labeled with a unique surveillance number, not linked to any patient-identifying information and will be analyzed by microscopy, culture and serology.

Epidemiologic information will be collected using structured interviewer-administered questionnaire. In case the partners are not accompanying the patients, the patients will be counseled to bring their partners for assessment/screening during next visit, pre-scheduled on thesis days.

 Study Tools
The study subjects will be administered a pretested structured, interviewer administered questionnaire for collection of epidemiological and other relevant information. Afterwards various microbiological/serological tests will be conducted.

Statistical Analysis
The data will be entered into Microsoft-Excel 2007 and after cleaning, would be subsequently analyzed using SPSS 17.0 software for descriptive statistics as well as using z-test, ChiSquare and Fishers exact test for inter-group comparisons.

 Ethical Considerations
Each eligible subject would be explicitly explained about the purpose of the study by the investigator and an informed written consent would be obtained, prior to inclusion. The study does not involve any method that goes beyond less than minimal risk to the subjects, family members or the investigator. Privacy of subjects and confidentiality of information would be maintained and this would also be explained to the subjects, prior to inclusion. No funding agency is involved in this study. There is no conflict of interest. The protocol is subject to clearance from the institutional ethics committee constituted for the purpose.