ClinicalTrials.gg
Active, not recruitingNCT05133661HPVUpdated Sep 17, 2025

SUCCESS - Feasibility of HPV Testing and Treatment of Pre-cancerous Cervical Cancer Lesions (HPV Study)

An observational study in Cervical Cancer, sponsored by Jhpiego. Active, not recruiting at 4 sites in 4 countries. Open to participants aged 25 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Jhpiego · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17,602
Ages
25 Years to 49 Years
Sex
All
01

Study summary

The goal is to assess the feasibility and acceptability of integrating into existing health systems, provision of HPV screening and treatment of pre-cancerous cervical cancer lesions with ablative treatments in Burkina Faso, Côte d'Ivoire, Guatemala, and the Philippines. Study findings will inform implementation of cervical cancer prevention and treatment services as part of a global effort to eliminate cervical cancer, with particular relevance for low-and-middle income countries. This will inform country strategy and guidelines on offering integrated cervical cancer prevention and treatment services in a manner that is culturally sensitive, client oriented, and system appropriate.

Read the detailed description

Research question:

  1. How feasible is it to implement integrated HPV testing (including self-collection of samples) and ablative treatment of lesions precancerous cervical cancer lesions among HPV+ women aged 30-49 years (general population) and 25-49 years (WLHIV), leveraging on the existing health systems in the four study countries?
  2. What is the acceptability of HPV screening through self-collection or clinician collection of sample, and ablative treatment of precancerous lesions among women accessing cervical cancer services in the study sites?
  3. What is the cost of implementing integrated cervical cancer screening and precancer treatment services (Supply: counselling, HPV testing, treatment, training health care providers, etc.), and user-related costs (travel, out of pocket expenses opportunity costs, etc.) in the SUCCESS project supported sites?
  4. Which factors influence the successful implementation of integrated HPV screening and treatment services (e.g. perceptions, experience of care, religious beliefs, culture, individual characteristics, availability of services, cost, etc.)?

Methodology:

We will utilize a hybrid effectiveness implementation Type III study design, using mixed methods approach. In Phase I, 2,227 women are enrolled in health facilities in each of the four countries (disaggregated by general population and WLHIV) and follow those who are HPV positive to determine the completion of screen-to-treat within three months. In Phase II focusing on community self-sampling, 8,694 are enrolled in Burkina Faso, Guatemala and the Philippines.

Quantitative and qualitative data will be collected from clients, service providers, key stakeholders, and secondary analysis of service delivery including laboratory data will be analyzed to assess acceptability and feasibility of implementing integrated cervical cancer screening and treatment services.

02

Conditions studied

  • Cervical Cancer

Keywords

  • HPV Screening
  • Precancerous lesions
  • Thermal ablation
03

In context

Uterine Cervical Neoplasms

2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.

This study's planned enrollment of 17,602 is above the median of 225 across 529 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Jhpiego is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  • Women: Participants will be drawn from women seeking care at the SUCCESS project supported sites. For the general population, women aged 30-49 years will be enrolled while for HIV+ women, those aged 25-49 years will be enrolled. Women who do not know their HIV status at enrolment will have an opportunity to be tested.
  • Key informants will be identified from among the stakeholder holding positions that allows them to provide information that is relevant to the assessment of acceptability, feasibility, and costs related to implementation of cervical cancer prevention and treatment services in the four countries. from seeking care in health facilities in the four countries.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women: Participants will be women residing in the study area, seeking services at SUCCESS project-supported health facilities, and meet the eligibility criteria to be enrolled in one of the components of the study (i.e, prospective component, client exit interviews and/or in-depth interviews).
  • Service providers: Health care personnel working in the project facilities at the time of the study providing services related to cervical cancer screening and treatment. Facility in-charges and laboratory personnel are included in this category.
  • Key informants: Health program managers, and community mobilizers at either local or national level in Burkina Faso, Cote d'Ivoire, Guatemala, and Philippines.
  • Men: Male members of the community (married or cohabiting with female partners) to gather their perspectives on the implementation of the cervical cancer prevention and treatment activities.

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Individuals unwilling to participate or unable to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17,602 participants (estimated)
Patient registry
No

Groups and cohorts

  • HPV positive women

    Women aged 25-49 years seeking offered HPV testing (either self-collection or clinician collection of samples) and treatment of precancerous lesions as part of service package in study facilities will be enrolled in the study and interviewed at different time points. A subset of the women screened will be selected for in-depth interview to gather data on: ease of use of self-collection kits for cervical cancer screening, receipt of the test results, and treatment for precancer. Another subset of women will be selected after HPV screening to participate in client exit interview.

    Diagnostic Test: HPV testing

Interventions

  • Diagnostic testHPV testing

    Interviews will be conducted among women from the general population and HIV+ women after screening for HPV. A small subset of participants will be interviewed after receiving treatment for precancer. HPV test results and outcome of the precancer treatment if indicated will be documented.

    Also known as: Thermal ablation of precancerous lesion

06

What researchers measure

Primary outcomes

  1. Percentage of HPV positive women who complete screen to treatment within 3 months

    Proportion of HPV positive women who undergo treatment for precancerous cervical lesions within three months of screening

    Time frame: Three months

Secondary outcomes

  1. Acceptability - Percentage of women screened for HPV who report positive experience of care

    Assess the adoption, satisfaction, and uptake of the cervical cancer services by the users and the providers

    Time frame: 18 months

  2. Feasibility - Turnaround time from screening to treatment

    Assess the adoption and practicability of providing the cervical cancer services through the mechanisms that exist in of each of the four countries

    Time frame: 18 months

  3. Unit cost of providing HPV screening and treatment of precancerous cervical cancer lesion

    The cost of providing the services and the user costs

    Time frame: 18 months

07

Study locations

4 sites
  • CMA de Do
    Ouagadougou, Burkina Faso
  • FSU Koko
    Bouaké, Côte d’Ivoire
  • Quetzaltenango
    Quetzaltenango, Guatemala
  • Metro-Manila
    Quezon City, Philippines 1103, Philippines
08

References and documents

Publications

  • Kabue M, Gauvreau CL, Daceney N, Bertram MM, Shissler T, Reis V, Dodo M, Garces A, Llave C, Dao B, Mohan D, Huang L. Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d'Ivoire, Guatemala and Philippines: study protocol. Reprod Health. 2023 Nov 13;20(1):167. doi: 10.1186/s12978-023-01696-8. PubMed 37957689 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05133661
Lead sponsor
Jhpiego
Collaborators
UNITAID, Expertise France, World Health Organization
Responsible party
Mark Kabue (Sr. Monitoring Evaluation and Research Advisor, Jhpiego) — Principal investigator
First posted
Nov 24, 2021
Start date
Apr 19, 2022
Primary completion
Sep 5, 2025
Completion
Dec 31, 2025 (estimated)
Last update
Sep 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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