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

Phase 2

Recruiting

• Conditions: Cervical Cancer
• Interventions: Behavioral: HPV testing of women for cervical cancer screening

• Registration Number: NCT05359016
• Lead Sponsor: M.D. Anderson Cancer Center

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:

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-12-22
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 14600

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPV testing of women for cervical cancer screening	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.

Primary Outcome Measures

Name	Time	Method
Number of women who will undergo Cervical Cancer Screening by HPV testing	through study completion, an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States