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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.

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/12/078011
Enrollment
1800
Registered
2024-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z21- Asymptomatic human immunodeficiency virus [HIV] infection status

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Department of Health Research, Ministry of Health and Family Welfare, Government of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women who are aged more than 18 years up to the age of 65 years and diagnosed HIV positive

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 DistrictTimepoint: At the time of data analysis—

Secondary

MeasureTime frame
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 DistrictTimepoint: 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 womenTimepoint: At the time of data analysis;To explore the utility of Cytology, HPV and HIV viral load and CD4 counts as strategies for triageTimepoint: At the time of data analysis;To document HPV genotypes among all CIN2+ cases in HIV positive womenTimepoint: At the time of data analysis—

Countries

India

Contacts

Public ContactDr Shivaprasad S Goudar

J N Medical College, KLE Academy of Higher Education and Research, Belagavi

swati.goudar90@gmail.com9606834060

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026