Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02253719

Enrollment

1000

Registered

2014-10-01

Start date

2014-10-31

Completion date

2015-09-30

Last updated

2015-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Cervical Neoplasia

Keywords

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

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).

Interventions

PROCEDUREcryotherapy, 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Cambodia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026