Clinical trial · Interventional
The Women's Screening and Self-Testing Program (PROMETA) Study
A Hybrid Type III Effectiveness - Implementation, Pragmatic Intervention Trial for Cervical Cancer Screen and Treat in Mozambique
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV DNA testing be self-collected vaginal swab | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV DNA testing from self-collected vaginal swab
- description
- 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.
- interventionNames
- Diagnostic Test: HPV DNA testing be self-collected vaginal swab
Primary outcomes (1)
- measure
- The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral.
- timeFrame
- 2.5 Years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMoon 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. PMID 41291606