Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Symptoms and General Pathology

Immune System Diseases

Uterine Cervical Neoplasms

Communicable Diseases

Papillomavirus Infections

Acquired Immunodeficiency Syndrome

HIV Infections

Disease Attributes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

Genital Diseases

Urogenital Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

DNA Virus Infections

Tumor Virus Infections

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Acetic Acid

Retinol acetate

Participants will undergo same day VIA and thermocoagulation

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.

VIA and thermocoagulation

Lameck Chinula, MD

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.

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.

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

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

We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are HPV positive who have VIA performed same-day, and

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.

National Cancer Institute (NCI)

United States Agency for International Development (USAID)

UNC Lineberger Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe	NCT04092257	HPV Infection Cervical Cancer HIV Infections	VIA and thermoc...	25 Years - 50 Years	UNC Lineberger Comprehensive Cancer Center
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe	NCT04092257	HPV Infection Cervical Cancer HIV Infections	VIA and thermoc...	25 Years - 50 Years	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for via and thermocoagulation