Thermocoagulation for Treatment of Precancerous Cervical Lesions
Condition: Human Immunodeficiency Virus; HPV Infection; CIN 2/3
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Papillomavirus Infections
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety, acceptability, and efficacy of
      Thermocoagulation for treatment of precancerous lesions among HIV-positive women in a
      screen-and-treat program in Western Kenya.
    

Detailed description: 
      Thermocoagulation is endorsed as an alternative to Cryotherapy for treatment of Visual
      Inspection with Acetic Acid (VIA) or Human Papillomavirus (HPV)-positive women by the 2018
      Kenya national cancer guidelines.32 Data primary from Western countries demonstrate similar
      efficacy for the treatment of precancerous lesions between Cryotherapy and Thermocoagulation.
      Data on safety, acceptability, and efficacy, particularly linked to gold-standard pathology,
      among HIV-positive women in low-resource settings are scare. Given the demonstrated benefits
      over cryotherapy including increased portability and availability hence easier
      implementation, use of thermal coagulation for the treatment of precancerous lesions in low
      resource settings could significantly improve access to treatment compared with cryotherapy.

      This study seeks to fill a critical data gap by evaluating the efficacy of thermocoagulation
      among HIV-positive positive women using gold-standard biopsy for disease verification at
      baseline and follow-up, as indicated. We will also assess the safety and acceptability of
      this treatment modality among patients and providers

      Aim 1: To evaluate the efficacy of thermal coagulation for the treatment of HIV-positive,
      HPV-positive women by assessing rates of HPV persistence and CIN2/3 rate at 12 months after
      treatment

      Aim 2: To evaluate the safety and acceptability of thermal coagulation for treatment of
      abnormal cervical lesions within a screen-and-treat program among HIV-positive women in
      Western Kenya.

      Aim 3: Evaluate provider acceptability of thermal coagulation for the treatment of
      precancerous cervical lesion within a screen-and-treat program in Western Kenya.

      Outline:

      Counseling on HPV, cervical cancer, and the screening process was offered during routine HIV
      clinics in group and individual settings. Participants will then be provided self-sampling
      instructions, a collection kit, and a private area to perform self-collection. The
      self-collected HPV samples will be labeled, stored, and processed for DNA of 14 high-risk HPV
      types. HPV-positive participants were invited for a return visit, including a pelvic
      examination and visual inspection with acetic acid (VIA) to determine eligibility for
      ablative therapy. After ablation, a questionnaire will be administered to participants to
      evaluate treatment experience. All participants will be given a 4- to 6-week phone or
      in-person follow-up appointment, per participant preference
    

Intervention name(s): Thermocoagulation
Intervention type(s): Device
Intervention description(s): Treatment of positive screening results will be performed using the Liger Thermocoagulator device
Other intervention name(s): Liger thermocoagulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention