Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

Study Overview
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Brief Summary
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The prevalence of cervical neoplasia in Cambodia is not known. There are no screening programs in place. The investigators plan on introducing a screening program based on WHO criteria and utilizing visualization with acetic acid. Patients who are positive will be offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).

Official Title
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Screening for Prevention of Cervical Cancer in HIV-positive and HIV-negative Cambodian Women Using Direct Visualization With Acetic Acid

Conditions
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Cervical Neoplasia, Cervical Cancer

Intervention / Treatment
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* Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female, age 30-49, able to give informed consent Exclusion Criteria: pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV positive women<br>500 HIV women will be recruited from the hospital's current patient base as well as the community | Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated<br>* These interventions and their outcomes are not part of this study. However, we will be offering at no charge appropriate treatment for neoplasia or cancer that is diagnosed.<br>|
| HIV negative women<br>500 HIV women will be recruited from the hospital's current patient base as well as the community | Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated<br>* These interventions and their outcomes are not part of this study. However, we will be offering at no charge appropriate treatment for neoplasia or cancer that is diagnosed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of cervical neoplasia in HIV positive women | 500 HIV positive women will be screened for cervical neoplasia using direct visualization with acetic acid | up to 12 months | 
| Prevalence of cervical neoplasia in HIV negative women | 500 HIV negative women will be screened for cervical neoplasia using direct visualization with acetic acid | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of HIV positive women who screen as positive | Patients who screen positive will be offered same-day cryotherapy, further diagnostic work-up, and further therapeutic options such as LEEP and hysterectomy as clinically indicated. | up to 12 months | 
| Treatment of HIV negative women who screen as positive | Patients who screen positive will be offered same-day cryotherapy, further diagnostic work-up, and further therapeutic options such as LEEP and hysterectomy as clinically indicated. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical neoplasia, cervical cancer', visual inspection acetic acid, cryotherapy