A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in H… (NCT02250716) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.