HPV InfectionNCT04092257
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
A study testing VIA and thermocoagulation in people with HPV Infection and Cervical Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Malawi.
Trial summary
The purpose of this study is to assess completion and performance of the following novel invasive cervical cancer (ICC) screen-and-treat algorithm among 625 HIV-positive women in Lilongwe, Malawi: 1) rapid testing of self-collected vaginal brush for primary high risk (hr)-human papillomavirus (HPV), 2) same-day visual… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Cervical Cancer, HIV Infections
- What is being tested?
- VIA and thermocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 1 siteMalawi
- Study dates
- 24 Jun 2020to 28 Feb 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening).
- Ability and willingness of participant to provide written informed consent.
Who cannot join
- Current or prior history of cervical, vaginal, or vulvar cancer or dysplasia
- Current symptomatic sexually transmitted infection requiring treatment (women will be allowed to be in the study upon successful treatment)
- Prior HPV vaccination.
- Participants with known allergy to acetic acid.
- Participants with a history of total hysterectomy.
- Participants who are pregnant or plan on becoming pregnant during the study period.
- Participants who are less than 12 weeks postpartum.
- Participants with other illnesses that would limit compliance with study requirements or in the opinion of the investigator or designee, have a problem that would make participation in the study unsafe or complicate interpretation of study findings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for Women in Lilongwe Malawi
The purpose of this study is to assess completion and performance of the following novel invasive cervical cancer (ICC) screen-and-treat algorithm among 625 HIV-positive women in Lilongwe, Malawi: 1) rapid testing of self-collected vaginal brush for primary high risk (hr)-human papillomavirus (HPV), 2) same-day visual inspection with acetic acid (VIA) for women who are hr-HPV positive, and 3) thermocoagulation for VIA positive/ablation-eligible (by cervical colposcopy) women.
Read the detailed description
This is a single arm, prospective study of 1,250 women (625 HIV-positive and 625 HIV-negative) enrolled from outpatient clinics that provide sexual and reproductive health (SRH) services and/or HIV care services in Lilongwe, Malawi. The primary objectives of this study are to assess completion of a novel ICC screen-and-treat strategy among HIV-positive women in Lilongwe, Malawi, using self-collected vaginal brush for hr-HPV testing, followed by same-day NIA and thermocoagulation for HPV-positive/NIA-positive/ablation-eligible (by colposcopy) women, and to determine the 24-week efficacy of thermocoagulation among HIV-positive women with CIN2/3. The secondary objective will be to evaluate the performance of the ICC screen-and-treat strategy by estimating overtreatment for women who are HPV-positive/NIA-positive/ablation-eligible, and undertreatment among HPV-positive/NIA-negative women.
- Conditions
- HPV Infection, Cervical Cancer, HIV Infections
- Being tested
- VIA and thermocoagulation
- Keywords
- Visual inspection with acetic acid (VIA)
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIA and thermocoagulationProcedure or surgery
Participants will self-collect a vaginal brush for hr-HPV testing. HPV-positive women and every 10th consecutive HPV-negative woman will complete same-day VIA with colposcopically-directed cervical biopsy and ECC (if lesion seen), and thermocoagulation if ablation-eligible by colposcopy. If no lesion is seen on colposcopy, the woman will have a cervical pap smear and ECC collected, and no thermocoagulation will be performed. Finally, women who are suspicious for cancer at VIA will undergo colposcopically-directed cervical biopsies.
| Study group | Role | What they receive |
|---|---|---|
| VIA and thermocoagulation | Experimental | Participants will undergo same day VIA and thermocoagulation Receives: Procedure: VIA and thermocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Same-day Visual Inspection With Acetic Acid (VIA) Rate
The proportion of women who were HPV-positive and underwent same-day VIA following self-collected vaginal sampling was assessed, including both HIV-positive and HIV-negative participants. As per the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day VIA completion by HIV status.
Measured: Baseline
Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage
Among women who tested HPV-positive through primary screening, those eligible for thermocoagulation by colposcopy triage received thermocoagulation treatment on the same day as self-collection. As specified in the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day colposcopy completion by HIV status.
Measured: Baseline
High Risk (hr)-Human Papillomavirus (HPV) Positive Rate
The proportion of women who tested High risk (hr)-human papillomavirus (HPV) positive on a self-collected vaginal brush among enrolled participants.
Measured: Baseline
Secondary outcomes (1)
HPV Screen-triage-treat Algorithm for Cervical Cancer Screening
To evaluate the performance of the proposed ICC screen-and-treat strategy for cervical carcinoma screening among women who are HIV- positive, the rates of overtreatment and undertreatment rates were estimated. Overtreatment for women who are HPV-positive VIA- positive/ablation-eligible and would have received thermocoagulation but had no cervical precancer (i.e., high-grade cervical intraepithelial neoplasia), and undertreatment among HPV-positive with high-grade cervical intraepithelial neoplasia but were VIA-positive and eligible for thermocoagulation, and those who were VIA-negative.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start24 Jun 2020
- Primary completion28 Feb 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Lameck Chinula, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092257
- Sponsor's protocol ID
- LCCC 1905
- Other IDs
- R21CA236770, AID-OAA-A-11-00012
- Status last verified
- Jul 2025
- First submitted
- 13 Sep 2019
- Last updated
- 6 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No