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

Tulane University

Status: Not yet enrolling

Conditions: Human Papilloma Virus Related Cervical Carcinoma

Treatments: Diagnostic Test: HPV DNA testing be self-collected vaginal swab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06810739

2024-1641

U01CA294674 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,445 estimated patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8,445 participants in 1 patient group

HPV DNA testing from self-collected vaginal swab

Experimental group

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.

Treatment:

Diagnostic Test: HPV DNA testing be self-collected vaginal swab