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

Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

Sponsors

Lead sponsor: Sihanouk Hospital Center of HOPE

Source Sihanouk Hospital Center of HOPE
Brief Summary

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).

Overall Status Completed
Start Date October 2014
Completion Date September 2015
Primary Completion Date September 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Prevalence of cervical neoplasia in HIV positive women up to 12 months
Prevalence of cervical neoplasia in HIV negative women up to 12 months
Secondary Outcome
Measure Time Frame
Treatment of HIV positive women who screen as positive up to 12 months
Treatment of HIV negative women who screen as positive up to 12 months
Enrollment 1000
Condition
Intervention

Intervention type: Procedure

Intervention name: cryotherapy, further biopsy, LEEP, surgery as indicated

Description: 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.

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: Female

Minimum age: 30 Years

Maximum age: 49 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thay Sovanarra, MD Principal Investigator Sihanouk Hospital
Location
facility Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara
Location Countries

Cambodia

Verification Date

October 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: HIV positive women

Description: 500 HIV women will be recruited from the hospital's current patient base as well as the community

Arm group label: HIV negative women

Description: 500 HIV women will be recruited from the hospital's current patient base as well as the community

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov