| CTRI Number |
CTRI/2024/12/078011 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
High-risk HPV testing by Guided Uptake of self-sampling technique for Accessible and Reliable Detection of cervical cancer in HIV positive women - The HPV-GUARD study. |
|
Scientific Title of Study
|
Evaluation of high-risk Human Papilloma Virus (hrHPV) testing in self-collected vaginal and urine samples of Human Immunodeficiency Virus (HIV) positive women for primary screening of cervical cancer in selected Anti-Retroviral Therapy (ART) centres of Belagavi district, Karnataka |
| 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 Swati Goudar |
| Designation |
Assistant Professor of Gynaecological Oncology |
| Affiliation |
J N Medical College, KLE Academy of Higher Education and Research, Belagavi |
| Address |
Department of Surgical Oncology, KLE Academy of Higher Education and Research, J N Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9606834060 |
| Fax |
|
| Email |
swati.goudar90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Goudar |
| Designation |
Assistant Professor of Gynaecological Oncology |
| Affiliation |
J N Medical College, KLE Academy of Higher Education and Research, Belagavi |
| Address |
Department of Surgical Oncology, KLE Academy of Higher Education and Research, J N Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9606834060 |
| Fax |
|
| Email |
swati.goudar90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivaprasad S Goudar |
| Designation |
Professor of Physiology |
| Affiliation |
J N Medical College, KLE Academy of Higher Education and Research, Belagavi |
| Address |
Department of Physiology, KLE Academy of Higher Education and Research J N Medical College Nehru Nagar Belgaum Principal Investigator Womens and Childrens Health Research Unit Wing Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9448126371 |
| Fax |
|
| Email |
sgoudar@jnmc.edu |
|
|
Source of Monetary or Material Support
|
| Department of Health Research, 2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001 and Indian Council of Medical Research, Government of India V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029 India and KLE Academy of Higher Education and Research (Deemed-to-be-University), JNMC Campus, Nehru Nagar, Belagavi-590010, Karanataka, India |
|
|
Primary Sponsor
|
| Name |
Department of Health Research, Ministry of Health and Family Welfare, Government of India |
| Address |
Department of Health Research
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - 110001 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swati Goudar |
J N Medical College, KLE Academy of Higher Education and Research, Belagavi |
Department of Surgical Oncology, KLE Academy of Higher Education and Research, J N Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
9606834060
swati.goudar90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KLE Academy of Higher Education and Research, Belagavi, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z21||Asymptomatic human immunodeficiency virus [HIV] infection status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women who are aged more than 18 years up to the age of 65 years and diagnosed HIV positive |
|
| ExclusionCriteria |
| Details |
Women who are pregnant
Women after hysterectomy
Women diagnosed with premalignant condition of CIN2 and above earlier
Post-surgical intervention of any kind on the cervix
Known case of carcinoma cervix |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate Sensitivity and Specificity of self-collected vaginal sample for high-risk Human Papilloma Virus (HPV) in Human Immunodeficiency Virus (HIV) positive women versus Clinician administered cervical sample for detection of CIN2+ lesions in a community setting across ART centres in Belagavi District |
At the time of data analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the sensitivity and specificity of first-void urine sample for high-risk Human Papilloma Virus (HPV) in Human Immunodeficiency Virus (HIV) positive women for detection of CIN2+ lesions in a community setting across ART centres in Belagavi District |
At the time of data analysis |
| To estimate the test concordance between self-collected samples (vaginal and urine) versus clinician administered cervical sample for detection of high-risk HPV in HIV positive women |
At the time of data analysis |
| To explore the utility of Cytology, HPV and HIV viral load and CD4 counts as strategies for triage |
At the time of data analysis |
| To document HPV genotypes among all CIN2+ cases in HIV positive women |
At the time of data analysis |
|
|
Target Sample Size
|
Total Sample Size="1800"
Sample Size from India="1800"
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)
|
07/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Rationale: In 2023 India
reported 77,348 deaths due to cervical cancer and 1,23,907 new cases.
Prevalence of HPV is higher in women living with HIV(WLHIV). Primary HPV based
cervical cancer screening program and self-sampling as a technique has been
validated in developed countries with limited evidence in resource poor
settings where majority of the disease burden lies.
Objectives: To estimate
sensitivity and specificity of self-sampled hr-HPV testing (vaginal and urine)
in WLHIV compared to clinician administered cervical sample for detection of
cervical intra-epithelial neoplasia (CIN)2+ in a community setting.
Additionally, their concordance will also be assessed. Exploration of utility
of cytology, HPV and HIV viral load and CD4 counts as strategies for triage in
screen positive patients.
Methods: Following
training of Health Care Workers (HCWs) at ART (Antiretroviral Therapy) centres,
research team will approach WLHIV. Eligible participants will be approached
individually for screening and consented women will be asked to provide random
FV urine samples and self-collected vaginal sample, followed by
clinician-administered cervical sample collection. hr-HPV DNA detection will be
done by QIAscreen HPV PCR test, which has been validated as per Meijer and
VALGENT 4 panel criteria and Liquid based cytology (LBC) will be processed on
the same sample by SurePathTMDirect to Slide Kit - 480 T by BDSurepath. To
identify the HPV genotypes associated with high grade lesions, all colposcopy
and guided biopsy specimens reported as CIN2 or CIN3 will be subjected to
INNO-LiPA HPV genotyping by HPV Amp II and HPV Genotyping Extra II Kit.
Management of screen positive patients will be as per Federation of Obstetrics
and Gynaecologic Societies of India (FOGSI) guidelines
Expected outcome:
Self-sampling technique and assay by a highly sensitive PCR based HPV test will
increase test uptake rates and early detection of cervical cancer. This
cervical cancer screening model can be incorporated within existing ART
centres. The project will provide proof of concept for this approach. This will
enable in the reduction of morbidity and mortality from cervical cancer in
WLHIV |