UnknownNot Applicable

A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women

South Africa480 participantsStarted 2012-10

Plain-language summary

Based on the high incidence of cervical cancer and high grade dysplasia and increased progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have had a colposcopic biopsy for persistent LSIL as per standard of care.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * HIV -infected women whose biopsy proves CIN1 and who consent to study participants and procedures * CIN1 with no visible lesion * The entire ectocervical lesion should cover less than 75% of the cervix and not more than 2 - 3mm into the endocervical canal Exclusion Criteria: * Pregnant women * Known and previous treatment for HSIL by any method (Cryotherapy, LEEP or cone biopsy) * Women who are menstruating or who have active pelvic inflammatory disease will be deferred from the study until the infection is cleared or the menstrual cycle has ended; the patient may then participate in the study. * Unsatisfactory colposcopic examination defined as inability to see the extent of the lesion in the endocervical canal and lesions deemed ineligible for cryotherapy by an OB/GYN specialist. * Previous hysterectomy with removal of the cervix

What they're measuring

Regresson of CIN1 to a normal biopsy

Timeframe: 12 month

Trial details

NCT IDNCT02250716

SponsorUniversity of Witwatersrand, South Africa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08