Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

October 6, 2015 updated by: Sihanouk Hospital Center of HOPE

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cambodia
      • Phnom Pehn, Cambodia
        • Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The 1000 women will be recruited from the current patient base of Sihanouk hospital and the surrounding community.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV positive women
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
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.
HIV negative women
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of cervical neoplasia in HIV positive women
Time Frame: up to 12 months
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
Time Frame: up to 12 months
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
Time Frame: 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.
up to 12 months
Treatment of HIV negative women who screen as positive
Time Frame: 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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sihanouk Hospital Center of HOPE

Investigators

  • Principal Investigator: Thay Sovanarra, MD, Sihanouk Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 28, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCH-Cervical Screening-VIA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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