Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

Completed

• Conditions: Cervical Neoplasia; Cervical Cancer
• Interventions: Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated

• Registration Number: NCT02253719
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-28
• Study Start: 2014-10
• Study First Posted: 2014-10-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV positive women	cryotherapy, further biopsy, LEEP, surgery as indicated	500 HIV women will be recruited from the hospital's current patient base as well as the community
HIV negative women	cryotherapy, further biopsy, LEEP, surgery as indicated	500 HIV women will be recruited from the hospital's current patient base as well as the community

Primary Outcome Measures

Name	Time	Method
Prevalence of cervical neoplasia in HIV positive women	up to 12 months	500 HIV positive women will be screened for cervical neoplasia using direct visualization with acetic acid
Prevalence of cervical neoplasia in HIV negative women	up to 12 months	500 HIV negative women will be screened for cervical neoplasia using direct visualization with acetic acid

Secondary Outcome Measures

Name	Time	Method
Treatment of HIV positive women who screen as positive	up to 12 months	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.
Treatment of HIV negative women who screen as positive	up to 12 months	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.

Trial Locations

Locations (1)

Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara; 🇰🇭 Phnom Pehn, Cambodia