Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06810739

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Human Papilloma Virus Related Cervical Carcinoma Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Site RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

25 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Eduardo Mondlane (UEM)

Maputo, Mozambique

Location status: Recruiting

Location contact

Jahit Sacarlal, MD, PhD

CONTACT

[email protected]

Jahit Sacarlal, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral.

    Time frame: 2.5 Years

    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.

Secondary outcomes

  1. Test Result Notification Rate

    Time frame: 2.5 Years

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

  2. Treatment Rate

    Time frame: 2.5 Years

    The proportion of screen-positive women who were treated with thermal ablation, if appropriate, or referred for higher level of care or return appointment.

Study contacts

Contact information is provided by the study sponsor or research team.

Harriett Myers, MPH

CONTACT

[email protected]

828-292-1742

Kathryn Kampa, MPH

CONTACT

[email protected]

651-983-1076

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

A Hybrid Type III Effectiveness - Implementation, Pragmatic Intervention Trial for Cervical Cancer Screen and Treat in Mozambique

Acronym: PROMETA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.