| Protocol No: | ECCT/19/10/01 | Date of Protocol: | 01-08-2018 |
| Study Title: | A Randomized, Placebo-Controlled Trial of HPV Vaccination to Reduce Cervical High-Grade Squamous Intraepithelial Lesions among HIV-Infected Women Participating in an HPV Test-and-Treat Program (COVENANT) |
| Study Objectives: |
Primary Objective
Secondary Objectives
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| Laymans Summary: | HIV-infected females 25 and older, currently receiving antiretroviral therapy for at least 6 months with no prior history of cervical, vulvar, or vaginal cancer. Participants must be HPV-positive by GeneXpert hrHPV assay with HPV16, 18/45, or 31/33/35/52/58 detected. Participants must not have had a hysterectomy, prior treatment for cervical HSIL or prior HPV vaccination. Regimen: Potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXperthrHPV assay and HPV DNA PCR) and undergo cervical colposcopy. If eligible the participant will be randomized to receive either the 9-valent HPV vaccine or saline placebo. Participants will return 4 and 26 weeks later to complete the vaccination (or placebo) series.At week 4, participants will have cervical colposcopy and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate. Participants undergoing cervical cryotherapy will have cervical biopsies obtained just prior to the treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at week 26, 52, 78, and 104, as well as with cytology and cervical colposcopy with biopsies at week 26, 52, and 104. |
| Abstract of Study: | Broad Objectives: To determine if HPV vaccination reduces the occurrence of cervical HSIL among HIV-infected women participating in anHPV test-and-treat strategy for cervical cancer prevention.
Specific Objectives: week 104. •To examine the predictors of sustained absence of cervical HSIL through week 104 and clearance of HPV infections after cervical treatment,including: baseline types and quantity of HPV, presence of HSIL at baseline, cryotherapy vs. LEEP, CD4+ cell count, plasma HIV-1 RNA,ART use, age, sexual behavior, and vaccination use. •To compare, between study arms, incident cervical vaccine type HPV infections and cervical cytology results. •To describe prevalent and incident vulvar HSIL or cancer in this population.
Study setting: [ MTRH Chandaria Cancer and Chronic Disease Centre, Cervical Cancer Screening Clinic] Study population: [HIV-infected females 25 and older, currently receiving antiretroviral therapy for at least 6 months with no prior history of cervical, vulvar, or vaginal cancer. Number of subjects to be contacted: 536 participants Stu Study procedures (main) done on participants: Potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy. If eligible, the participant will be randomized to receive either the 9-valent HPV vaccine or saline placebo. Participants will return 4 and 26 weeks later to complete the vaccination (or placebo) series. At week 4, participants will have cervical colposcopy and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate. Participants undergoing cervical Cryotherapy will have cervical biopsies obtained just prior to the treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at week 26, 52, 78, and 104, as well as with cytology and cervical colposcopy with biopsies at week 26, 52,and 104 |