Presence of Human Papilloma virus and changes in the cervix in immunocompromised women in coastal Karnataka

Not yet recruiting

Conditions: Chronic kidney disease, stage 4 (severe), (2) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, (3) ICD-10 Condition: D848||Other specified immunodeficiencies,

Registration Number: CTRI/2023/03/050492

Lead Sponsor: university grant

Brief Summary: Primaryobjective:

Theprevalence of cervicovaginal Human Papilloma virus and cytologicalabnormalities of the cervix in immunocompromised women at a tertiary levelsetting in coastal Karnataka

Secondaryobjective:

Tocompare the HPV positivity/ cytological abnormalities against viral load, CD4count, adherence to HAART among retropositive women

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 220

Inclusion Criteria

Women on immunosuppressant therapy, including long term steroids (â‰¥6 months) Those with confirmed retro-positive status Women with chronic kidney disease.

Exclusion Criteria

Patients who underwent hysterectomy Virgin women Pregnant and postpartum upto 6 weeks.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV test reports (HPV 16/18/other high risk Positive/ negative	time bound
Cytologic report- negative/ ASCUS/ ASC-H/ LSIL/HSIL/Invasive carcinoma	time bound

Secondary Outcome Measures

Name	Time	Method
For objective 2, Above variables will be compared with the CD4 count, viral load, adherence to HAART among retropositive women	time bound

Trial Locations

Locations (1): Kasturba Medical College
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College
🇮🇳Udupi, KARNATAKA, India
Pooja Pai
Principal investigator
9963598509
poojanaravi2607@gmail.com