HPV-Based Screen-and-Treat Demonstration Project in Lilongwe

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a single arm, prospective study of 625 HIV-positive women attending ART clinics 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 VIA and thermocoagulation for HPV-positive/VIA-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/VIA-positive/ablation-eligible, and undertreatment among HPV-positive/VIA-negative women.

Official Title
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A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for HIV-infected Women in Lilongwe Malawi

Conditions
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HPV Infection, Cervical Cancer, HIV Infections

Intervention / Treatment
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* Procedure: VIA and thermocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening). Females with confirmed HIV-1 infection. FDA-approved testing methods should be used when possible. Ability and willingness of participant to provide written informed consent. Exclusion Criteria: Current or prior history of cervical, vaginal or vulvar cancer or dysplasia Current symptomatic sexual 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIA and thermocoagulation<br>Participants will undergo same day VIA and thermocoagulation | Procedure: VIA and thermocoagulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (and %) of women with HPV-positive results who receive VIA same-day | We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are HPV positive who have VIA performed same-day, and | 2 years | 
| Number (and %) of women with VIA positive results and are ablation-eligible by colposcopy who receive thermocoagulation same-day | We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are VIA positive/ablation-eligible (by colposcopy) who have thermocoagulation performed the same-day. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual inspection with acetic acid (VIA)