Health Trials

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

ConditionHuman Papilloma Virus Related Cervical Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-49
SponsorTulane University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women 25-49 years

Accessing HIV care and treatment services

Not being pregnant

Patients with a cervix

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • HPV DNA testing be self-collected vaginal swab

    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.

Treatment groups

8,445 Participants
are divided into 1 treatment group
Group A: HPV DNA testing from self-collected vaginal swabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2.5 Years

Secondary outcomes

1

Test Result Notification Rate

The proportion of women who were notified of their HPV DNA test result on the same day as sample collection.

Time frame
2.5 Years
2

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.

Time frame
2.5 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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