Cervical CancerNCT05359016
Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique
A study testing HPV testing of women for cervical cancer screening in people with Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 49 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV testing of women for cervical cancer screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,014 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Not meeting the inclusion criteria
- Physical or mental impairment that inhibits participation in the study
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objectives:
The study objectives are outlined below:
- To quantify the health impact of CCS\&PT on the uptake of voluntary FP services.
- To quantify the health impact of voluntary FP on the uptake of CCS\&PT services.
- To determine which promotional strategies are most effective to increase uptake of CCS\&PT services.
- To identify cost to deliver high quality CCS\&PT services integrated into existing voluntary FP programs.
- To determine client and provider acceptability of integrated CCS\&PT and voluntary FP services using new screen and treat technologies.
- Conditions
- Cervical Cancer
- Being tested
- HPV testing of women for cervical cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV testing of women for cervical cancer screeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HPV testing of women for cervical cancer screening | Experimental | 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. Receives: Behavioral: HPV testing of women for cervical cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women who will undergo Cervical Cancer Screening by HPV testing
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start22 Dec 2020
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9,014 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Population Services International, Eduardo Mondlane University, William Marsh Rice University
- Responsible party
- Sponsor
- Investigators
- Kathleen Schmeler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359016
- Sponsor's protocol ID
- 2020-0651
- Other IDs
- NCI-2022-03767
- Status last verified
- May 2026
- First submitted
- 25 Apr 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique
- ClinicalTrials.gov ID
- NCT05359016
- Acronym / sponsor ID
- 2020-0651
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,014 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Population Services International, Eduardo Mondlane University, William Marsh Rice University
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To quantify the health impact of CCS\&PT on the uptake of voluntary FP services.
- To quantify the health impact of voluntary FP on the uptake of CCS\&PT services.
- To determine which promotional strategies are most effective to increase uptake of CCS\&PT services.
- To identify cost to deliver high quality CCS\&PT services integrated into existing voluntary FP programs.
- To determine client and provider acceptability of integrated CCS\&PT and voluntary FP services using new screen and treat technologies.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV testing of women for cervical cancer screening | Experimental | Behavioral: HPV testing of women for cervical cancer screeningWomen 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. |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Not meeting the inclusion criteria
- Physical or mental impairment that inhibits participation in the study
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV testing of women for cervical cancer screeningWomen 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. | Behavioural | HPV testing of women for cervical cancer screening |
Primary outcome
Number of women who will undergo Cervical Cancer Screening by HPV testing
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Schmeler, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV testing of women for cervical cancer screening in people with Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women who will undergo Cervical Cancer Screening by HPV testing (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.