Improving Cervical Cancer Screening in Women Living with HIV

Not yet recruiting

• Conditions: Human immunodeficiency virus [HIV]disease,

• Registration Number: CTRI/2025/06/089264
• Lead Sponsor: Dr Sharmila Pimple

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-08
• Last Update Posted: 2025-06-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

Lab diagnosed HIV-positive women Female patients aged 25-65 years Non pregnant women.

Exclusion Criteria

Past history of Cervical Cancer Pregnant Women.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
7. Feasibility of HPV self-sampling and VIA with Mobile ODT:	24 months
- Self-sample HPV DNA screening coverage	24 months
- VIA with Mobile ODT screening coverage	24 months
- Screen positive compliance with Reference diagnosis: Conventional Cytology	24 months
1. Sociodemographic Profile	24 months
5. Prevalence of Acetowhite lesions through VIA with Mobile ODT	24 months
6. Acceptability of HPV self-sampling and Mobile ODT-	24 months
- % of eligible women aware of cervical cancer screening.	24 months
- % of eligible women screened through hrHPV self-testing.	24 months
- % of eligible women screened through VIA with Mobile ODT.	24 months
2. Reproductive & Sexual history	24 months
3. High risk HPV prevalenceHPVDNA 16, HPV DNA18, Other High-risk types	24 months
4. Conventional PAP cytologyASCUS, LSIL, HSIL, AGC, ASC-H, SCC	24 months

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Sharmila Pimple

Principal investigator

9223207939

pimplesharmila@gmail.com