Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

NCT02253719 | Completed DMC

• 1 other identifier: SHCH-Cervical Screening-VIA
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Neoplasia; Cervical Cancer

Keywords

cervical neoplasia; cervical cancer'; visual inspection acetic acid; cryotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

cryotherapy, further biopsy, LEEP, surgery as indicated PROCEDURE

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; HIV positive women

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• female, age 30-49, able to give informed consent

You may not qualify if:

• pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid

Sponsors & Collaborators

• Sihanouk Hospital Center of HOPE: lead

Study Sites (1)

Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara

Phnom Pehn, Cambodia

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cryotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Thay Sovanarra, MD

  Sihanouk Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: October 1, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

CA (1)