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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05359016
• Collaborator: Population Services International (Other), Eduardo Mondlane University (Other), William Marsh Rice University (Other)
• Enrollment: 14,600
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35.5
• Patients Per Site Per Month: 411.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Behavioral: HPV testing of women for cervical cancer screening	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 14600 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique
• Actual Study Start Date: Jan 14, 2020
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of women who will undergo Cervical Cancer Screening by HPV testing [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• Population Services International
• Eduardo Mondlane University
• William Marsh Rice University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05359016
• Other Study ID Numbers: 2020-0651; NCI-2022-03767
• First Posted: May 3, 2022
• Last Update Posted: May 3, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of May 3, 2022