Clinical trial · Interventional
Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi
UNCPM 21904 - Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi: a Cluster Randomized Trial
- 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)
The purpose of the study is to determine the acceptability, appropriateness, and feasibility of implementing new strategies to screen and treat eligible women for cervical cancer through a cluster randomized trial of two different models. Both models offer the same screening and treatment algorithm, but one will be based in Voluntary Family Planning (VFP) or other clinics and the second will be based in the community. Participants will be recruited from two districts in Malawi with the highest HIV prevalence in the country: Lilongwe in the Central Region and Zomba in the Southern Region.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinic-based HPV screening strategy | Other | — | UNRESOLVED |
| Community-based HPV screening strategy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Model 1 - Clinic Based Screening
- description
- Model 1 involves: 1) cervico-vaginal self-sampling for high-risk HPV (hr-HPV) while waiting for appointments at the VFP clinic or other clinics, 2) same-day VIA for those women found to be hr-HPV-positive by rapid GeneXpert HPV testing, and 3) same-day thermocoagulation treatment for HPV-positive women who are eligible for ablative therapy by VIA
- interventionNames
- Other: Clinic-based HPV screening strategy
- type
- EXPERIMENTAL
- label
- Model 2 - Community Based Screening
- description
- Model 2 will offer women the same services as in Model 1, but they will also be given the option to perform cervico-vaginal self-sampling in the community, via Heath Surveillance Assistants (HSAs) who will bring their HPV sample to the clinic and notify them to return to the clinic for VIA and possible same-day thermocoagulation if their hr-HPV test is positive
- interventionNames
- Other: Community-based HPV screening strategy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Health care providers In-Depth Interviews (IDIs) and Focus Group Discussions: * Health care staff member must be currently working at one of the 16 health facilities selected for the study. Client In-Depth Interviews: * Woman must have participated in cervical cancer screening via HPV self-sampling through one of the 16 health facilities during the study period. Client Exit Surveys: * Woman who received or declined VFP and/or CCS services in the catchment area of the targeted facilities. Endline Household survey: * Woman must be between the ages of 15-50 years. Exclusion Criteria: Endline Household survey: * Woman who has had her cervix removed.
References
Publications (1)
- DERIVEDTang JH, Smith JS, McGue S, Gadama L, Mwapasa V, Chipeta E, Chinkhumba J, Schouten E, Ngwira B, Barnabas R, Matoga M, Chagomerana M, Chinula L. Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: protocol for a cluster randomized feasibility trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):98. doi: 10.1186/s40814-021-00839-7. PMID 33879259