The Women's Screening and Self-Testing Program (PROMETA) Study

NCT ID: NCT06810739

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8445 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-08-31

Brief 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. 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.

Conditions

Human Papilloma Virus Related Cervical Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

HPV DNA testing from self-collected vaginal swab

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.

Group Type: EXPERIMENTAL

HPV DNA testing be self-collected vaginal swab

Intervention Type: DIAGNOSTIC_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.

Interventions

HPV DNA testing be self-collected vaginal swab

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Women 25-49 years
• Accessing HIV care and treatment services
• Not being pregnant
• Patients with a cervix

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Tulane University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

D. Troy Moon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

University Eduardo Mondlane (UEM)

Maputo, , Mozambique

Countries

Mozambique

Central Contacts

Kathryn Kampa, MPH

Role: CONTACT

kkampa@tulane.edu

651-983-1076

Harriett Myers, MPH

Role: CONTACT

hmyers5@tulane.edu

828-292-1742

Facility Contacts

Jahit Sacarlal, MD, PhD

Role: primary

jahityash2002@gmail.com

References

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. doi: 10.1186/s12889-025-25730-5. Online ahead of print.

Reference Type: DERIVED

PMID: 41291606 (View on PubMed)

Other Identifiers

U01CA294674

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-1641

Identifier Type: -

Identifier Source: org_study_id