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HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV (COVENANT)

Primary Purpose

AIDS-Related Human Papillomavirus Infection, High Grade Cervical Squamous Intraepithelial Neoplasia, HIV Infection

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Recombinant Human Papillomavirus Nonavalent Vaccine
Saline
Sponsored by
AIDS Malignancy Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for AIDS-Related Human Papillomavirus Infection

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load, or documentation of receipt of antiretroviral therapy; Note: the term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally; WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a western blot or a plasma HIV-1 RNA viral load
  • HPV positive by the GeneXpert hrHPV assay with HPV16, HPV 18/45, or HPV31/33/35/52/58 detected; Note: participants who are hrHPV positive with only HPV51/59 or HPV 39/68/56/66 detected are not eligible
  • Receipt of ART for at least 180 days prior to randomization
  • Participants of childbearing potential, defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception or hormonal contraception), delaying pregnancy for at least 12 months and ideally for the duration of the study; Note: those willing to participate delay pregnancy for at least 6 months, while receiving the recombinant human papillomavirus nonavalent (9vHPV) vaccine (or placebo)
  • If the participant is of childbearing potential, she should be at least 3 months postpartum
  • Karnofsky score >= 70%
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Current sexually transmitted infection (STI) requiring treatment (women may participate after adequate treatment, at the discretion of the treating provider)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gardasil or Gardasil 9
  • Uncontrolled intercurrent illness that would limit compliance with study requirements
  • Prior hysterectomy with removal of the cervix
  • Prior treatment for cervical HSIL
  • Prior history of cervical, vulvar, or vaginal cancer
  • Cervical, vulvar, or vaginal lesions suspicious for cancer based on clinical appearance (e.g. necrotic, ulcerated, and/or fungating masses), unless biopsies show no invasive cancer
  • Known bleeding diathesis
  • Prior HPV vaccination
  • Current or planned use of anticoagulants other than aspirin or non-steroidal anti-inflammatory agents

Sites / Locations

  • Moi University School of Medicine
  • UNC Project MalawiRecruiting
  • African Cancer Institute at StellenboschRecruiting
  • University of the WitwatersrandRecruiting
  • Uganda Cancer Institute
  • University of ZimbabweRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I, recombinant HPV 9-valent vaccine

Arm II, saline

Arm Description

Patients receive Recombinant Human Papillomavirus Nonavalent Vaccine (Gardasil 9) IM at baseline, 4, and 26 weeks in the absence of disease progression or unacceptable toxicity, with sample collection for Laboratory Biomarker Analysis.

Patients receive saline placebo vaccine IM at baseline, 4, and 26 weeks, with sample collection for Laboratory Biomarker Analysis.

Outcomes

Primary Outcome Measures

Occurrence of cervical high-grade squamous intraepithelial lesions (HSIL) or cervical cancer
For each arm (vaccine and placebo), the event rate will be estimated using its point estimate and 95% Poisson confidence intervals. Poisson regression analyses will be used to compare the two arms with respect to event rate. In addition, time to event from week 4 to 52 will be described using the Kaplan-Meier method for each arm, and the two arms will be compared with respect to time to event using the log-rank test.

Secondary Outcome Measures

Occurrence of cervical HSIL from weeks 52-104
The event rate for each arm from week 52 to week 104 for women who are event-free at 52 weeks will be estimated using its point estimate and 95% Poisson confidence interval. Poisson regression will be used to compare the two groups with respect to the event rate from week 52 to 104.
Role of baseline types and quantity of HPV as predictors of sustained absence
Poisson regression analyses will be used to determine if baseline HPV types are associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Role of presence of HSIL at baseline as a predictor of sustained absence
Poisson regression analyses will be used to determine if the presence of HSIL at baseline is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Role of CD4+ cell count as a predictor of sustained absence
Poisson regression analyses will be used to determine if baseline CD4+ cell count is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Role of plasma HIV-1 RNA as a predictor of sustained absence
Poisson regression analyses will be used to determine if baseline plasma HIV-1 RNA count is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Role of ART use as a predictor of sustained absence
Poisson regression analyses will be used to determine if ART use is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Role of age as a predictor of sustained absence
Poisson regression analyses will be used to determine if age is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Role of sexual behavior as a predictor of sustained absence
Poisson regression analyses will be used to determine if sexual behavior is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Role of vaccination use as a predictor of sustained absence
Poisson regression analyses will be used to determine if vaccine use is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Incident cervical vaccine type HPV infections defined as infections at 2 consecutive timepoints and assessed using type specific HPV DNA polymerase chain reaction (PCR)
Vaccine and placebo participants will be compared with respect to these proportions using the chi-square test corrected for continuity.
Abnormal cervical cytology
The proportion of women with abnormal cervical cytology at baseline, week 26, 52, and 104 will be reported and compared between arms.
Prevalent vulvar HSIL or cancer
The prevalence of vulvar HSIL or cancer at baseline will be estimated using the binomial proportion and its 95% confidence interval.
Incident vulvar HSIL or cancer
The proportion of women who acquire vulvar HSIL or cancer among those negative for vulvar HSIL or cancer at baseline for both intervention arms will be estimated as a binomial proportion for both groups. The chi-square test corrected for continuity will be used to compare arms with respect to the proportions who acquire vulvar HSIL during the study.
Clinical and demographic factors associated with incident vulvar HSIL or cancer
Logistic regression analyses will be used to evaluate associations with incident vulvar HSIL or cancer acquisition with clinical and demographic factors and arm.

Full Information

First Posted
May 4, 2017
Last Updated
May 16, 2023
Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), University of Arkansas, AIDS and Cancer Specimen Resource, Merck Sharp & Dohme LLC, The Emmes Company, LLC, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03284866
Brief Title
HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV
Acronym
COVENANT
Official 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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), University of Arkansas, AIDS and Cancer Specimen Resource, Merck Sharp & Dohme LLC, The Emmes Company, LLC, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized phase III trial studies how well human papillomavirus (HPV) vaccine therapy works in reducing high-grade cervical lesions in patients with human immunodeficiency virus (HIV) and HPV. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill the HPV virus and prevent cervical lesions from developing or coming back after being removed.
Detailed Description
At screening, potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy to confirm the absence of cervical cancer. 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 for the second dose of vaccine or placebo. 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 before the treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at weeks 26, 52, 78, and 104, and will have cervical cytology and colposcopy with biopsies at weeks 26, 52, and 104.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS-Related Human Papillomavirus Infection, High Grade Cervical Squamous Intraepithelial Neoplasia, HIV Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
536 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I, recombinant HPV 9-valent vaccine
Arm Type
Experimental
Arm Description
Patients receive Recombinant Human Papillomavirus Nonavalent Vaccine (Gardasil 9) IM at baseline, 4, and 26 weeks in the absence of disease progression or unacceptable toxicity, with sample collection for Laboratory Biomarker Analysis.
Arm Title
Arm II, saline
Arm Type
Placebo Comparator
Arm Description
Patients receive saline placebo vaccine IM at baseline, 4, and 26 weeks, with sample collection for Laboratory Biomarker Analysis.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Biological
Intervention Name(s)
Recombinant Human Papillomavirus Nonavalent Vaccine
Other Intervention Name(s)
Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine, Recombinant HPV 9-valent Vaccine
Intervention Description
Given IM
Intervention Type
Other
Intervention Name(s)
Saline
Other Intervention Name(s)
Sodium Chloride 0.9%
Intervention Description
Given IM
Primary Outcome Measure Information:
Title
Occurrence of cervical high-grade squamous intraepithelial lesions (HSIL) or cervical cancer
Description
For each arm (vaccine and placebo), the event rate will be estimated using its point estimate and 95% Poisson confidence intervals. Poisson regression analyses will be used to compare the two arms with respect to event rate. In addition, time to event from week 4 to 52 will be described using the Kaplan-Meier method for each arm, and the two arms will be compared with respect to time to event using the log-rank test.
Time Frame
After week 4 study visit to week 52 post-randomization
Secondary Outcome Measure Information:
Title
Occurrence of cervical HSIL from weeks 52-104
Description
The event rate for each arm from week 52 to week 104 for women who are event-free at 52 weeks will be estimated using its point estimate and 95% Poisson confidence interval. Poisson regression will be used to compare the two groups with respect to the event rate from week 52 to 104.
Time Frame
After week 52 to week 104
Title
Role of baseline types and quantity of HPV as predictors of sustained absence
Description
Poisson regression analyses will be used to determine if baseline HPV types are associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Time Frame
At baseline and week 4
Title
Role of presence of HSIL at baseline as a predictor of sustained absence
Description
Poisson regression analyses will be used to determine if the presence of HSIL at baseline is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Time Frame
At baseline and week 4
Title
Role of CD4+ cell count as a predictor of sustained absence
Description
Poisson regression analyses will be used to determine if baseline CD4+ cell count is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Time Frame
At baseline and week 4
Title
Role of plasma HIV-1 RNA as a predictor of sustained absence
Description
Poisson regression analyses will be used to determine if baseline plasma HIV-1 RNA count is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Time Frame
At baseline and week 4
Title
Role of ART use as a predictor of sustained absence
Description
Poisson regression analyses will be used to determine if ART use is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Time Frame
At baseline and week 4
Title
Role of age as a predictor of sustained absence
Description
Poisson regression analyses will be used to determine if age is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Time Frame
At baseline and week 4
Title
Role of sexual behavior as a predictor of sustained absence
Description
Poisson regression analyses will be used to determine if sexual behavior is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Time Frame
At baseline and week 4
Title
Role of vaccination use as a predictor of sustained absence
Description
Poisson regression analyses will be used to determine if vaccine use is associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. This analysis will also control for use of LEEP or cryotherapy.
Time Frame
At baseline and week 4
Title
Incident cervical vaccine type HPV infections defined as infections at 2 consecutive timepoints and assessed using type specific HPV DNA polymerase chain reaction (PCR)
Description
Vaccine and placebo participants will be compared with respect to these proportions using the chi-square test corrected for continuity.
Time Frame
Up to week 104
Title
Abnormal cervical cytology
Description
The proportion of women with abnormal cervical cytology at baseline, week 26, 52, and 104 will be reported and compared between arms.
Time Frame
Baseline, week 26, 52, and 104
Title
Prevalent vulvar HSIL or cancer
Description
The prevalence of vulvar HSIL or cancer at baseline will be estimated using the binomial proportion and its 95% confidence interval.
Time Frame
Up to week 4
Title
Incident vulvar HSIL or cancer
Description
The proportion of women who acquire vulvar HSIL or cancer among those negative for vulvar HSIL or cancer at baseline for both intervention arms will be estimated as a binomial proportion for both groups. The chi-square test corrected for continuity will be used to compare arms with respect to the proportions who acquire vulvar HSIL during the study.
Time Frame
Up to week 104
Title
Clinical and demographic factors associated with incident vulvar HSIL or cancer
Description
Logistic regression analyses will be used to evaluate associations with incident vulvar HSIL or cancer acquisition with clinical and demographic factors and arm.
Time Frame
Up to week 104
Other Pre-specified Outcome Measures:
Title
HPV type distributions
Description
Will characterize the HPV type distribution in baseline histology specimens and compare this to the types observed among incident cervical and vulvar HSIL lesions. Specifically, will compare the number and proportion of vaccine-type and non-vaccine type lesions between arms.
Time Frame
Up to week 104
Title
HPV strain variant analysis of cervical and vulvar HSIL specimens
Description
For study participants who have the same HPV type in HSIL specimens at baseline and follow-up time points, sequencing will be performed to determine whether or not HSIL is caused by an identical HPV strain. Will use all available pairs of baseline and follow-up HSIL caused by the same HPV type. Will report the proportion of these pairs with the same HPV strain in both treatment arms. Additionally, will report the rates of HSIL caused by new vaccine type infections. We will compare the two study groups using a chi-square test. This will be a descriptive analysis only as no sufficient data on which to power this analysis.
Time Frame
Up to week 104
Title
Tissue microarray library of cervical specimens for biomarker analysis and discovery
Description
Specimen banking objective. There is no pre-specified statistical analysis plan for this objective. Any future studies using these specimens will need to receive separate approval by NCI and CTEP.
Time Frame
Up to week 104
Title
hrHPV type distribution in the anus
Description
McNemar's chi-square test to compare the prevalence of that type in the anus and cervix will be used. For each hrHPV type, chi-square analyses will be used to compare the two HPV vaccination groups with respect to the distribution of that type in the (anus, cervix). Will report the proportion of incident cervical infections that were preceded by anal detection of the same type.
Time Frame
Up to week 104
Title
hrHPV type prevalence in the anus
Description
McNemar's chi-square test to compare the prevalence of that type in the anus and cervix will be used. For each hrHPV type, chi-square analyses will be used to compare the two HPV vaccination groups with respect to the distribution of that type in the (anus, cervix). Will report the proportion of incident cervical infections that were preceded by anal detection of the same type.
Time Frame
Up to week 104
Title
Vaccine-induced antibody titers
Description
Will explore the antibody titers for the vaccine type found in the HSIL in these women as compared to those without HSIL caused by that type. Analysis of vaccine titers between those with incident vaccine type HPV infections that persist for 2 or more study visits and those that do not will be performed.
Time Frame
Up to week 104

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load, or documentation of receipt of antiretroviral therapy; Note: the term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally; WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a western blot or a plasma HIV-1 RNA viral load HPV positive by the GeneXpert hrHPV assay with HPV16, HPV 18/45, or HPV31/33/35/52/58 detected; Note: participants who are hrHPV positive with only HPV51/59 or HPV 39/68/56/66 detected are not eligible Receipt of ART for at least 180 days prior to randomization Participants of childbearing potential, defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception or hormonal contraception), delaying pregnancy for at least 12 months and ideally for the duration of the study; Note: those willing to participate delay pregnancy for at least 6 months, while receiving the recombinant human papillomavirus nonavalent (9vHPV) vaccine (or placebo) If the participant is of childbearing potential, she should be at least 3 months postpartum Karnofsky score >= 70% Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Current sexually transmitted infection (STI) requiring treatment (women may participate after adequate treatment, at the discretion of the treating provider) History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gardasil or Gardasil 9 Uncontrolled intercurrent illness that would limit compliance with study requirements Prior hysterectomy with removal of the cervix Prior treatment for cervical HSIL Prior history of cervical, vulvar, or vaginal cancer Cervical, vulvar, or vaginal lesions suspicious for cancer based on clinical appearance (e.g. necrotic, ulcerated, and/or fungating masses), unless biopsies show no invasive cancer Known bleeding diathesis Prior HPV vaccination Current or planned use of anticoagulants other than aspirin or non-steroidal anti-inflammatory agents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Chibwesha, MD, MSc
Phone
27-11-276-8850
Email
carla_chibwesha@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Chibwesha
Organizational Affiliation
University of Witwatersrand, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moi University School of Medicine
City
Eldoret
Country
Kenya
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elkanah Omenge Orang'o
Phone
+254 722 609 132
Email
bworango@mu.ac.ke
First Name & Middle Initial & Last Name & Degree
Elkanah Omenge Orang'o
Facility Name
UNC Project Malawi
City
Lilongwe
Country
Malawi
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lameck Chinula
Phone
265 88 248 3220
Email
lchinula@unclilongwe.org
First Name & Middle Initial & Last Name & Degree
Lameck Chinula
Facility Name
African Cancer Institute at Stellenbosch
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikash Sewram
Phone
+27 021 927 7001
Email
vsewram@sun.ac.za
First Name & Middle Initial & Last Name & Degree
Hennie Botha
Facility Name
University of the Witwatersrand
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla J. Chibwesha
Phone
+27-11-276-8800
Email
carla_chibwesha@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Carla J. Chibwesha
Facility Name
Uganda Cancer Institute
City
Kampala
Country
Uganda
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Nakisige
Phone
256-414-540-410
Email
carolynnakisige@yahoo.com
First Name & Middle Initial & Last Name & Degree
Carolyn Nakisige
Facility Name
University of Zimbabwe
City
Harare
Country
Zimbabwe
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Muhlanga
Phone
+263 772 335 232
Email
fmhlanga@uz-ucsf.co.zw
First Name & Middle Initial & Last Name & Degree
Felix Muhlanga

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV

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