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

NCT ID: NCT05359016

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

14600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2027-02-02

Brief Summary

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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

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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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HPV testing of women for cervical cancer screening

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

* Physical or mental impairment that inhibits participation in the study
* Pregnant women
Minimum Eligible Age

30 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Population Services International

OTHER

Sponsor Role collaborator

Eduardo Mondlane University

OTHER

Sponsor Role collaborator

William Marsh Rice University

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Schmeler, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mila Salecedo, MD, PHD

Role: CONTACT

832-696-6794

Facility Contacts

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Kathleen Schmeler, MD

Role: primary

713-854-9150

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2022-03767

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0651

Identifier Type: -

Identifier Source: org_study_id

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