Human Papilloma Virus Related Cervical CarcinomaPROMETANCT06810739
The Women's Screening and Self-Testing Program (PROMETA) Study
A study testing HPV DNA testing be self-collected vaginal swab in people with Human Papilloma Virus Related Cervical Carcinoma, run by Tulane University at 1 site in Mozambique.
Trial summary
This proposal directly addresses the ability to safely scale-up a Screen-Triage-Treat approach to cervical cancer screening. The investigators propose to capitalize on a pool of screen-eligible women accessing routine care within targeted human immunodeficiency virus (HIV) care and treatment services. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women only
- Conditions the study is for
- Human Papilloma Virus Related Cervical Carcinoma
- What is being tested?
- HPV DNA testing be self-collected vaginal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,445 participants
- Where
- 1 siteMozambique
- Study dates
- 13 Jul 2026to 31 Aug 2028
- 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 25 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 25-49 years
- Accessing HIV care and treatment services
- Not being pregnant
- Patients with a cervix
Who cannot join
- Physical or mental impairment that inhibits participation in the study
- Pregnant women or <6 weeks post-partum
- Women who have undergone a total hysterectomy with removal of the cervix
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mozambique1 site, 1 recruiting
- Recruiting
University Eduardo Mondlane (UEM)
Maputo
Jahit Sacarlal, MD, PhD, jahityash2002@gmail.com
Jahit Sacarlal, MD, PhD
About this study
Official title: A Hybrid Type III Effectiveness - Implementation, Pragmatic Intervention Trial for Cervical Cancer Screen and Treat in Mozambique
This proposal directly addresses the ability to safely scale-up a Screen-Triage-Treat approach to cervical cancer screening. The investigators propose to capitalize on a pool of screen-eligible women accessing routine care within targeted human immunodeficiency virus (HIV) care and treatment services. The primary outcome of interest is the number of women screened and the proportion of screen-positive women undergoing treatment. Secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.
Read the detailed description
This study will use a hybrid type III effectiveness-implementation design. In a hybrid type III design, the primary focus is on testing of an implementation strategy, while simultaneously continuing to observe and gather information on the effectiveness of a clinical intervention, under real world conditions, for which effectiveness data has already largely been determined. Best practices for deploying the Screen-Triage-Treat approach to cervical cancer screening utilizing self-collected human papilloma virus (HPV) deoxyribonucleic acid (DNA) testing within Mozambique´s HIV care and treatment services will be evaluated. The study will employ a mixed-methods approach, collecting both quantitative and qualitative data. The primary outcome of interest is the number of women screened and the proportion of HPV screen-positive women undergoing treatment, while secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.
- Being tested
- HPV DNA testing be self-collected vaginal swab
- Keywords
- Human Immunodeficiency Virus, Self swab, Mozambique, Cervical cancer, Implementation science
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV DNA testing be self-collected vaginal swabDiagnostic test
Directly following collection of the vaginal self-swab sample, the participant will be taken back to the waiting area and her sample will be taken to the laboratory for HPV testing using the Xpert HPV Test on the GeneXpert platform (Cepheid, Sunnyvale, CA, USA). This point-of-care test takes approximately 45 minutes to get results.
| Study group | Role | What they receive |
|---|---|---|
| HPV DNA testing from self-collected vaginal swab | Experimental | After providing informed consent, the study clinician will open a Case Report Form (CRF) for each patient which starts with a brief questionnaire which will include the participant's demographic information and medical history, including HIV viral load and CD4 counts, previous cervical cancer screening results if previously screened, and result of rapid pregnancy test performed that day with a urine sample. Each participant will then be accompanied to a private location where the study nurse will provide counseling and instruction on how to appropriately perform the self-collection vaginal swab technique. Data on HPV testing, VAT results, and referrals along each step of the process will be documented in the CRF. Receives: Diagnostic Test: HPV DNA testing be self-collected vaginal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral.
Baseline data will be retrospectively collected for the prior 12 months at each of the selected study sites, including the number of women accessing care for HIV care and treatment services each month; the number of women screened for cervical cancer through standard of care protocols; the proportion of screen-positive women who then received treatment or referral for treatment, and the length of time between screening positive and receiving treatment if appropriate.
Measured: 2.5 Years
Secondary outcomes (2)
Test Result Notification Rate
The proportion of women who were notified of their HPV DNA test result on the same day as sample collection.
Measured: 2.5 Years
Treatment Rate
The proportion of screen-positive women who were treated with thermal ablation, if appropriate, or referred for higher level of care or return appointment.
Measured: 2.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start13 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma Virus Related Cervical CarcinomaStudies of the same condition, open and under way.
- 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
- 8,445 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- D. Troy Moon, MD, MPH, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810739
- Sponsor's protocol ID
- 2024-1641
- Other IDs
- U01CA294674
- Acronym
- PROMETA
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moon TD, Salcedo MP, Mavume-Mangunyane E, Sidat M, Lorenzoni C, Baker E, Amorim G, Paz-Soldan VA, Kampa KT, Condon K, Myers H, Sacarlal J. A hybrid type III effectiveness-implementation study designed to test implementation best practices of deploying a Screen-Triage-Treat approach to cervical cancer screening and management utilizing self-collected HPV DNA testing in Chokwe District, Mozambique. BMC Public Health. 2025 Nov 25;26(1):6. doi: 10.1186/s12889-025-25730-5.
PubMed 41291606
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Type III Effectiveness - Implementation, Pragmatic Intervention Trial for Cervical Cancer Screen and Treat in Mozambique
- ClinicalTrials.gov ID
- NCT06810739
- Acronym / sponsor ID
- PROMETA / 2024-1641
- Keywords
- Human Immunodeficiency Virus, Self swab, Mozambique, Cervical cancer, Implementation science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,445 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 6 Feb 2025 (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.
This proposal directly addresses the ability to safely scale-up a Screen-Triage-Treat approach to cervical cancer screening. The investigators propose to capitalize on a pool of screen-eligible women accessing routine care within targeted human immunodeficiency virus (HIV) care and treatment services. The primary outcome of interest is the number of women screened and the proportion of screen-positive women undergoing treatment. Secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.
Detailed description
This study will use a hybrid type III effectiveness-implementation design. In a hybrid type III design, the primary focus is on testing of an implementation strategy, while simultaneously continuing to observe and gather information on the effectiveness of a clinical intervention, under real world conditions, for which effectiveness data has already largely been determined. Best practices for deploying the Screen-Triage-Treat approach to cervical cancer screening utilizing self-collected human papilloma virus (HPV) deoxyribonucleic acid (DNA) testing within Mozambique´s HIV care and treatment services will be evaluated. The study will employ a mixed-methods approach, collecting both quantitative and qualitative data. The primary outcome of interest is the number of women screened and the proportion of HPV screen-positive women undergoing treatment, while secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV DNA testing from self-collected vaginal swab | Experimental | Diagnostic Test: HPV DNA testing be self-collected vaginal swabAfter providing informed consent, the study clinician will open a Case Report Form (CRF) for each patient which starts with a brief questionnaire which will include the participant's demographic information and medical history, including HIV viral load and CD4 counts, previous cervical cancer screening results if previously screened, and result of rapid pregnancy test performed that day with a urine sample. Each participant will then be accompanied to a private location where the study nurse will provide counseling and instruction on how to appropriately perform the self-collection vaginal swab technique. Data on HPV testing, VAT results, and referrals along each step of the process will be documented in the CRF. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women 25-49 years
- Accessing HIV care and treatment services
- Not being pregnant
- Patients with a cervix
Key exclusion criteria (3 listed)
- Physical or mental impairment that inhibits participation in the study
- Pregnant women or <6 weeks post-partum
- Women who have undergone a total hysterectomy with removal of the cervix
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 DNA testing be self-collected vaginal swabDirectly following collection of the vaginal self-swab sample, the participant will be taken back to the waiting area and her sample will be taken to the laboratory for HPV testing using the Xpert HPV Test on the GeneXpert platform (Cepheid, Sunnyvale, CA, USA). This point-of-care test takes approximately 45 minutes to get results. | Diagnostic test | HPV DNA testing from self-collected vaginal swab |
Primary outcome
The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral.
Time frame: 2.5 Years
Baseline data will be retrospectively collected for the prior 12 months at each of the selected study sites, including the number of women accessing care for HIV care and treatment services each month; the number of women screened for cervical cancer through standard of care protocols; the proportion of screen-positive women who then received treatment or referral for treatment, and the length of time between screening positive and receiving treatment if appropriate.
2 secondary outcomes
Test Result Notification Rate
Time frame: 2.5 Years
Treatment Rate
Time frame: 2.5 Years
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 20 Jul 2026.
- Derived from this study: PubMed 41291606Moon TD, Salcedo MP, Mavume-Mangunyane E, Sidat M, Lorenzoni C, Baker E, Amorim G, Paz-Soldan VA, Kampa KT, Condon K, Myers H, Sacarlal J. A hybrid type III effectiveness-implementation study designed to test implementation best practices of deploying a Screen-Triage-Treat approach to cervical cancer screening and management utilizing self-collected HPV DNA testing in Chokwe District, Mozambique. BMC Public Health. 2025 Nov 25;26(1):6. doi: 10.1186/s12889-025-25730-5.
- Individual participant dataSharing planned: No
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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.
D. Troy Moon, MD, MPH principal investigator
Tulane University
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 DNA testing be self-collected vaginal swab in people with Human Papilloma Virus Related Cervical Carcinoma, run by Tulane University at 1 site in Mozambique.
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 4 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: looking for participants now, as of the sponsor's last update on 20 Jul 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 Mozambique. 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?
Contact Kathryn Kampa, MPH (651-983-1076, kkampa@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral. (time frame: 2.5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06810739, which also lists 1 linked publication.
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 20 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.