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Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique

Primary Purpose

Cervical Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HPV testing of women for cervical cancer screening

About this trial

This is an interventional screening trial for Cervical Cancer

Eligibility Criteria

30 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women 30 - 49 years or all women living with HIV
Not currently pregnant
Patients with a cervix (women who have undergone a total hysterectomy with removal of the cervix are not eligible)
Living in Maputo or Gaza
Willing and able to provide informed consent for services.

Exclusion Criteria:

Not meeting the inclusion criteria
Physical or mental impairment that inhibits participation in the study
Pregnant women

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HPV testing of women for cervical cancer screening

Arm Description

Women enrolled in this study will receive HPV testing for cervical cancer screening. They will be offered self-sampling. And also they will be offered voluntary Family Planning services, as appropriate.

Outcomes

Primary Outcome Measures

Number of women who will undergo Cervical Cancer Screening by HPV testing

Secondary Outcome Measures

Full Information

NCT ID

NCT05359016

First Posted

April 25, 2022

Last Updated

May 25, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

Population Services International, Eduardo Mondlane University, William Marsh Rice University

1. Study Identification

Unique Protocol Identification Number

NCT05359016

Brief Title

Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique

Official Title

Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 14, 2020 (Actual)

Primary Completion Date

February 2, 2027 (Anticipated)

Study Completion Date

February 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Population Services International, Eduardo Mondlane University, William Marsh Rice University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this operational research study is to develop, implement and test integrated CCS&PT and voluntary FP service delivery models to evaluate whether integrated service delivery can optimize uptake and health impact of both services. The study objectives and learning questions are listed below, along with key outcomes that will be measured.

Detailed Description

Objectives: The study objectives are outlined below: To quantify the health impact of CCS&PT on the uptake of voluntary FP services. To quantify the health impact of voluntary FP on the uptake of CCS&PT services. To determine which promotional strategies are most effective to increase uptake of CCS&PT services. To identify cost to deliver high quality CCS&PT services integrated into existing voluntary FP programs. To determine client and provider acceptability of integrated CCS&PT and voluntary FP services using new screen and treat technologies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HPV testing of women for cervical cancer screening

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

HPV testing of women for cervical cancer screening

Intervention Description

Primary Outcome Measure Information:

Title

Number of women who will undergo Cervical Cancer Screening by HPV testing

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women 30 - 49 years or all women living with HIV Not currently pregnant Patients with a cervix (women who have undergone a total hysterectomy with removal of the cervix are not eligible) Living in Maputo or Gaza Willing and able to provide informed consent for services. Exclusion Criteria: Not meeting the inclusion criteria Physical or mental impairment that inhibits participation in the study Pregnant women

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mila Salecedo, MD, PHD

Phone

832-696-6794

mpsalcedo@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen Schmeler, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathleen Schmeler, MD

Phone

713-854-9150

kschmele@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Kathleen Schmeler, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

M D Anderson Cancer Center

Learn more about this trial

Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique

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