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NCT05359016 Clinical Trial

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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05359016
Other study ID # 2020-0651
Secondary ID NCI-2022-03767
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 22, 2020
Est. completion date February 2, 2027

Study information
Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Mila Salecedo, MD, PHD
Phone 832-696-6794
Email mpsalcedo@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 14600
Est. completion date February 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 49 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (4)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center Eduardo Mondlane University, Population Services International, William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of women who will undergo Cervical Cancer Screening by HPV testing through study completion, an average of 1 year
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