| CTRI Number |
CTRI/2025/06/089264 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving Cervical Cancer Screening in Women Living with HIV |
|
Scientific Title of Study
|
Integration Of Cervical Cancer Screening With HPV Self Sampling Into Routine HIV Health Care Services Among Women Living With HIV In Maharashtra: An Implementation Research Mixed Methods Study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharmila Pimple |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Preventive Oncology. 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges Road Parel,
400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9223207939 |
| Fax |
|
| Email |
pimplesharmila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila Pimple |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Preventive Oncology. 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges Road Parel,
400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9223207939 |
| Fax |
|
| Email |
pimplesharmila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila Pimple |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Preventive Oncology. 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges Road Parel,
400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9223207939 |
| Fax |
|
| Email |
pimplesharmila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital Department of Preventive Oncology 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges road Parel, Mumbai400012, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Sharmila Pimple |
| Address |
Tata Memorial Hospital 3rd floor, Service block building, Dr. Ernest Borges road, Parel, Mumbai 400012, Maharshtra |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sharmila Pimple |
Tata Memorial Hospital |
3rd Floor Service Block building
Department of Preventive Oncology
Tata Memorial Hospital Dr E Borges Marg Mumbai 400012
Mumbai
MAHARASHTRA |
9223207939
pimplesharmila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Lab diagnosed HIV-positive women
Female patients aged 25-65 years
Non pregnant women |
|
| ExclusionCriteria |
| Details |
Past history of Cervical Cancer
Pregnant Women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Sociodemographic Profile
2. Reproductive & Sexual history
3. High risk HPV prevalenceHPVDNA 16, HPV DNA18, Other High-risk types
4. Conventional PAP cytologyASCUS, LSIL, HSIL, AGC, ASC-H, SCC
5. Prevalence of Acetowhite lesions through VIA with Mobile ODT
6. Acceptability of HPV self-sampling and Mobile ODT-
- % of eligible women aware of cervical cancer screening.
- % of eligible women screened through hrHPV self-testing.
- % of eligible women screened through VIA with Mobile ODT.
7. Feasibility of HPV self-sampling and VIA with Mobile ODT:
- Self-sample HPV DNA screening coverage
- VIA with Mobile ODT screening coverage
- Screen positive compliance with Reference diagnosis: Conventional Cytology |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
01/08/2025 |
| 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
|
Women living with HIV (WLWH) are at significantly higher risk of persistent high-risk HPV infection and cervical cancer. However, cervical cancer screening uptake in this population remains low in India. This cross-sectional mixed methods study, conducted at Tata Memorial Hospital, Mumbai, aims to assess the feasibility and acceptability of integrating HPV self-sampling into routine HIV care services in Maharashtra.
A total of 600 WLWH aged 25–65 years will be enrolled over 24 months. Participants will undergo HPV DNA testing through self-sampling. Those testing positive will be triaged with VIA using Mobile ODT and/or PAP cytology. Screen-positive women will receive thermal ablation, and suspected cancer cases will be referred to TMH for further management.
The study also includes qualitative interviews to explore barriers and facilitators to screening uptake. Findings will inform scalable models for cervical cancer prevention among WLWH within the public health system. |