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

November 7, 2023 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

The study objectives are outlined below:

  1. To quantify the health impact of CCS&PT on the uptake of voluntary FP services.
  2. To quantify the health impact of voluntary FP on the uptake of CCS&PT services.
  3. To determine which promotional strategies are most effective to increase uptake of CCS&PT services.
  4. To identify cost to deliver high quality CCS&PT services integrated into existing voluntary FP programs.
  5. To determine client and provider acceptability of integrated CCS&PT and voluntary FP services using new screen and treat technologies.

Study Type

Interventional

Enrollment (Estimated)

14600

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Schmeler, MD

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

28 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPV testing of women for cervical cancer screening
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.
Behavioral: HPV testing of women for cervical cancer screening
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of women who will undergo Cervical Cancer Screening by HPV testing
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Collaborators

William Marsh Rice University
Population Services International
Eduardo Mondlane University

Investigators

  • Principal Investigator: Kathleen Schmeler, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

December 22, 2020

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0651
  • NCI-2022-03767 (Other Identifier: NCI-CTRP-Clinical Trial Reporting Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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