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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Behavioral: HPV testing of women for cervical cancer screening

Study type: Interventional

Funder types: Other

Identifiers

NCT05359016

NCI-2022-03767 (Other Identifier)

2020-0651

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14,600 estimated patients

Sex: Female

Ages: 30 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14,600 participants in 1 patient group

HPV testing of women for cervical cancer screening

Experimental group

Description:

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.

Treatment:

Behavioral: HPV testing of women for cervical cancer screening