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CTRI Number  CTRI/2024/11/076221 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Womens Perspectives on Testing Positive for HPV :Insight into their Reactions and Perceptions 
Scientific Title of Study   Understanding perception of women towards Human Papilloma Virus screen positive status 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Janhavi D Talathi  
Designation  Junior Resident 
Affiliation  Kasturba Medical College  
Address  Department of OBG,Kasturba Medical College ,Manipal

Udupi
KARNATAKA
576104
India 
Phone  7498904598  
Fax    
Email  janhavitalathi6416@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shyamala G 
Designation  Professor and Head  
Affiliation  Kasturba Medical College  
Address  Department of OBG,Kasturba Medical College ,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844551037  
Fax    
Email  shyamala.g@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Janhavi D Talathi  
Designation  Junior Resident 
Affiliation  Kasturba Medical College  
Address  Department of OBG,Kasturba Medical College ,Manipal

Udupi
KARNATAKA
576104
India 
Phone  7498904598  
Fax    
Email  janhavitalathi6416@gmail.com  
 
Source of Monetary or Material Support  
Department of OBG, Kasturba Medical College, Manipal-576104 
 
Primary Sponsor  
Name  Department of OBG Kasturba Medical College Manipal 576104 
Address  Department of OBG Kasturba Medical College Manipal 576104 Karnataka India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Janhavi D Talathi  Kasturba Medical College Manipal  Department of OBG Kasturba Medical College Manipal 576104 Udupi District Karnataka
Udupi
KARNATAKA 
7498904598

janhavitalathi6416@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hosital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R87||Abnormal findings in specimens from female genital organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  A HPV positive women attending the clinic for
1 Evaluation based on HPV positivity report
2 Follow up visit after evaluation on treatment
3 HPV positive women with or without pre malignant lesion

B HPV positive women in community settings at household or health centres 
 
ExclusionCriteria 
Details  1 Women attending the clinic for first counseling with a fresh report
2 Women with diagnosed cancer cervix 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Evaluation of womens understanding of HPV its transmission and associated risks
2 To understand reactions after receiving an HPV-positive screening result and their expectation from Healthcare providers regarding communication 
Cross Sectional Study 
 
Secondary Outcome  
Outcome  TimePoints 
To understand reactions after receiving an HPV-positive screening result and their expectation from Healthcare providers regarding communication  Cross Sectional Study 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
1. Title of the project: Understanding Perception of Women Towards Human Papillomavirus screen positive status.

2. Type of Study: Prospective study- cross sectional study

3. Aims & objectives 
AIM-
The study aims to understand the perceptions of Human Papilloma virus positive women regarding their HPV-positive status.
OBJECTIVES -
1)To assess awareness of women regarding HPV testing and HPV positive status.
2)To explore the needs and expectations of HPV positive women from the Healthcare providers.

4. Justification for study
Significance of the Study: Human papillomavirus (HPV) is a widespread infection with significant implications for women’s health. By delving into the patient-provider communication dynamics among HPV-positive women, my study addresses a critical gap in the existing literature. The experiences of these women in navigating their healthcare journeys provide valuable insights into the multifaceted challenges they face.

Patient-Centered Approach: Effective patient-provider communication is the cornerstone of quality healthcare. Your qualitative approach allows for a deep understanding of the subjective experiences of HPV-positive women. This exploration goes beyond quantitative data, providing a nuanced perspective on the emotional and informational needs of patients in the context of HPV.

Improving Healthcare Outcomes: By unravelling the communication issues between HPV-positive women and healthcare providers,the study lays the groundwork for targeted interventions. The findings have the potential to inform strategies that enhance communication, trust, and mutual understanding. Ultimately, this can lead to improved health outcomes, adherence to medical recommendations, and overall satisfaction with healthcare experiences for this specific demographic.

Policy and Practice Implications: The insights gained from the research may have broader implications for healthcare policies and practices. Your recommendations could influence the development of guidelines or training programs for healthcare professionals, fostering a patient-centered approach that acknowledges and addresses the unique needs of HPV-positive women.

Contribution to Scientific Knowledge: The qualitative study contributes to the scientific understanding of the interpersonal dynamics between patients and healthcare providers in the context of HPV. This knowledge not only advances academic research but also provides a foundation for future studies, creating a ripple effect in improving healthcare communication across various medical domains.

In summary, my thesis not only sheds light on the specific challenges faced by HPV-positive women but also holds the promise of positively impacting healthcare practices, policies, and the overall wellbeing of the targeted patient population.

5. Departments involved: 
1)Department of Obstetrics and Gynecology, Kasturba Hospital, Manipal.
2)Department of Community Medicine,Kasturba Hospital ,Manipal.

6. Study period: March 2024 to April 2026

7. Sample size:
SAMPLE SIZE FOR QUALITATIVE STUDY: 20 – 30 (till data saturation)
SAMPLE SIZE FOR QUANTITATIVE STUDY : 20 - 30

8. Materials and methods:
a) Inclusion and exclusion criteria:
• Inclusion criteria:-
1) HPV-positive women attending the clinic for-
a)Evaluation based on HPV positivity report
b) Follow-up visits after evaluation/treatment
c) HPV-positive women with or without premalignant lesions.

2) HPV- positive women in community settings (at households / Health centers)


• Exclusion criteria:-
1)Women attending the clinic for first counseling with a fresh report
2)Women with daignosed Cancer cervix

b) Biological materials required (type - blood, tissue etc, and quantity): No

c) Statistical methods: The collected data will entered in the Microsoft Excel 2016 and will be analysed with IBM SPSS Statistics for Windows, Version 29.0.(Armonk, NY: IBM Corp). To describe about the data descriptive statistics frequency analysis, percentage analysis will
be used for categorical variables and for continuous variables the mean and S.D will be used. To find the association of significance in categorical data the Chi-Square test or Fisher’s exact test will be used. Any other necessary test found appropriate will be dealt at the time of
analysis, based on the data distribution.In all the above statistical tools the probability value 0.05 will be considered as significant level.

d) Tools used: 
1)Sociodemographic Porforma
2)Interview guide-Qualitative questionnaire
3)Quantitative questionnaire

9. Detailed description of procedure/processes: A Cross-Sectional --Mixed methodology exploratory approach(Qualitative + Quantitative) study will be conducted at the Department of Obstetrics and Gynecology, Kasturba Hospital, Manipal and at selected PHCs where women in the community can visit for an interview. Ethical clearance by the Institutional Ethical Committee (IEC) , Kasturba Hospital Manipal will be taken. Development and Pre-testing of the questionnaire will be done. Qualitative interview guide: Developed after an interview with two HPV-positive women and expert opinion. Quantitative questionnaire: Validated by experts and Pre-tested among 2 HPV-positive women. For the Qualitative Study - the interview will be conducted after Written Informed Consent. The researcher and the facilitator well versed in the local language( Kannada)/ English will conduct in-depth interviews. The conversations will be audio recorded. The participant will be provided with a unique Identification number and the recording will be saved as per the unique ID. Transcription will be done in English and data will be coded and analysed. For the Quantitative study- a questionnaire will be administered before or after the qualitative interview. The data will be then organized in Excel sheets and analyzed. No follow-up is required. 

10. Outcome measures: The likely outcome measures of my study are as follows- 
1)Evaluation of women’s understanding of HPV, its transmission, and associated risks.
2)To understand reactions after receiving an HPV-positive screening result and their expectation from Healthcare providers regarding communication.

11. Potential risks and benefits: Potential risks - study carries minimal or minor over minimal risk that may add to some discomfort/ anxiety due to the nature of the questions asked. Appropriate counseling and explanation will be provided if required. Potential Benefits- Providing accurate
information, will help to understand patient’s awareness and perceptions regarding HPV-positive status; to explore the needs and expectations of HPV-positive women. Thus aiding the development of a better patient-provider communication strategy.

12. Ethical considerations and methods to address issues: The study protocol was approved by the Local Ethics Committee and written informed consent will be taken from each patient before the
interview.

13. Budget and proposed funding source: No additional cost is required for this study.

14. Review of literature: Understanding the myriad emotions, knowledge gaps, and cultural nuances that shape the perceptions of HPV-positive women towards their screen-positive status is imperative for tailoring effective healthcare strategies. The emotional impact is multifaceted, encompassing heightened anxiety and fear, often stemming from uncertainty about the implications of a positive HPV screening result. This literature review aims to meticulously analyze and synthesize existing research, providing a nuanced understanding of the factors influencing these women’s perspectives.
Emotional Responses: The emotional responses among HPV-positive women are intricate, involving a spectrum of feelings from heightened anxiety to profound fear. The psychological distress is not merely a result of the positive screening but is also linked to concerns about the potential development of cervical cancer. Coping mechanisms are explored in the literature, revealing diverse strategies such as seeking social support, engaging in health-promoting behaviors, and navigating complex emotional terrain. Knowledge Gaps and Information Needs: A recurring theme in the literature is the pervasive knowledge gaps among HPV-positive women. Studies emphasize the critical need for comprehensive information on various facets, including HPV transmission dynamics, effective prevention methods, and the actual risk of developing cervical cancer. Addressing these knowledge gaps emerges as a cornerstone not only for informed decision making but also for mitigating the anxiety and uncertainty intrinsic to a positive screening result. 
Communication and Disclosure: The communication process during the disclosure of HPV-positive results is a pivotal factor shaping women’s perceptions. Clear and empathetic communication is highlighted as instrumental in alleviating psychological distress and empowering women to actively participate in their healthcare decisions. The literature underscores the role of healthcare professionals in not only providing accurate information but also offering emotional support to guide women through challenging experiences.
Cultural and Social Factors: Cultural and social influences are significant determinants of HPV-positive women’s perceptions, introducing a layer of complexity to their experiences. The literature delves into the impact of cultural backgrounds, societal norms, and community attitudes on how women interpret and cope with their screen-positive status. Recognizing and incorporating cultural sensitivity into healthcare practices is emphasized as crucial for developing interventions that resonate with the diverse cultural background of the affected population.
Interventions and Support: Research proposes a spectrum of interventions to support HPV-positive women, addressing both the informational and emotional dimensions. Educational programs are suggested to bridge knowledge gaps and correct misconceptions, empowering women with accurate information. Beyond this, community-based initiatives, such as support groups or counseling services, are highlighted as beneficial in fostering resilience and providing practical support. The literature consistently advocates for collaborative efforts involving healthcare providers, public health initiatives, and community organizations to create a comprehensive and empathetic support network for women navigating the challenges of a positive screening result. This detailed exploration provides a nuanced and comprehensive view of various aspects influencing the
perceptions of HPV-positive women towards their screen-positive status.
 
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