Cervical cancer prevention in HIV infected women in Pune, India

Completed

• Conditions: HIV-infected women

• Registration Number: CTRI/2013/11/004132
• Lead Sponsor: Prayas

Brief Summary

Invasive cervicalcancer is an AIDS defining illness. Observational studies in different regionsof the world indicate that human immunodeficiency virus (HIV) infected womenare at high risk for oncogenic human papillomavirus (HPV) infection and at 5-to 10-fold increased risk of developing cervical cancer. HPV infection amongHIV infected women is more persistent and progressive than in HIV-negativewomen. Cervical cancers in HIV infected women present with aggressive naturalhistory, advanced disease and with metastasis in unusual sites and oftenrespond poorly to treatment due to the large volume clinical disease. Thus,cervical cancer prevention among HIV-infected women assumes major priority,given the high risk of HPV infection, cervical precursor, and malignant lesionsamong them. In spite of large burden of both HIV infection and cervical cancer,there are very few studies in Indiathat have addressed the association between them and the ways and means tocontrol the disease. This project proposal is intended to comprehensivelyaddress prevention of cervical neoplasia in HIV-infected women in low- andmedium-resourced settings.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-09
• Study Completion: 2020-09-30
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1153

Inclusion Criteria

• HIV-infected women 2.
• Willing to sign an informed consent form 3.
• Having an intact uterus.

Exclusion Criteria

• Women who have undergone hysterectomy 2.
• Women having a debilitating health condition 3.
• Women with prior history of any procedure on the cervix.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Test performance of cytology, VIA, VILI and HPV testing to detect CIN 2-3 lesions	Baseline at screening
2. Prevalence and type distribution of high-risk HPV types in HIV-infected women and its correlation with cervical abnormalities	Baseline at screening
3. Distribution of HPV types in CIN and in cervical cancer specimens in HIV-infected	Baseline at screening

Secondary Outcome Measures

Name	Time	Method
Effectiveness of cold coagulation in curing and preventing recurrence of CIN 2-3 lesions in HIV-infected women	Initially after 6 months and then every year thereafter

Trial Locations

Locations (2)

Hirabai Cowasji Jehangir Medical Research Institute; 🇮🇳 Pune, MAHARASHTRA, India

Prayas; 🇮🇳 Pune, MAHARASHTRA, India

Hirabai Cowasji Jehangir Medical Research Institute

🇮🇳Pune, MAHARASHTRA, India

Dr Smita Joshi

Principal investigator

919881132506

smitanjoshi@gmail.com