Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Symptoms and General Pathology

Immune System Diseases

Uterine Cervical Neoplasms

Communicable Diseases

Papilloma

Acquired Immunodeficiency Syndrome

HIV Infections

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Vaccines

Children receiving HPV vaccine will be studies for seroconversion to HPV types, and aflatoxin levels in blood will be measured and compared to seroconversion.

Vaccination against HPV will be offered to 900 children/grandchildren aged 9 through 18 of women attending the Community Meetings.

HPV vaccine, Merck

This is a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of HPV vaccination in a region of Kenya where half of all children are chronically exposed to aflatoxin.

Cervical cancer is caused by oncogenic HPV, and is the main cause of cancer-related death among Kenyan women. This malignancy is preventable through a combination of screening of adult women and vaccination of children and adolescents against HPV infection. However, only 5% of Kenyan women are regularly screened, and only 14% have ever been screened, which in Kenya is done by a method known as Visual Inspection with Acetic Acid (VIA). Obstacles to screening include travel to clinics, costs, poor specificity of VIA, lack of trained personnel, and others. In addition, while safe and effective HPV vaccines have been available for 15 years, very few (\<1%) Kenyan children and adolescents have been vaccinated. Obstacles to vaccination include costs, delivery infrastructure, lack of education, travel to clinics, and others. In addition, there are few studies of HPV vaccination in African children, and two-dose regimens may not provide adequate protective antibody levels among children chronically exposed to aflatoxin, a potent immunosuppressive agent found in contaminated corn. Investigators propose a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of HPV vaccination in a region of Kenya where half of all children are chronically exposed to aflatoxin.

Objective 1 (Cervical cancer screening): Evaluate High-Risk (HR)-HPV DNA testing of self-collected vaginal swabs as a triage step for VIA among rural Kenyan women.

Hypothesis: All women with negative HR-HPV DNA tests will have normal VIA examinations or falsely-abnormal VIA examinations based on cervical biopsy results. The rationale is that if this hypothesis is correctly proven, it will suggest that VIA is unnecessary for women with negative HR-HPV DNA tests in self-collected vaginal swabs.

Objective 2 (HPV vaccination): Determine the effects of chronic aflatoxin exposure among Kenyan children/adolescents on the likelihood of seroconversion to HPV types represented in the HPV vaccine.

Hypothesis: Compared to children/adolescents without detectable plasma aflatoxin, children/adolescents with evidence of chronic aflatoxin exposure will have a reduced likelihood of seroconversion to HPV types represented in the HPV vaccine. The rationale is that if this hypothesis is correctly proven, it will suggest that adjustments in vaccination doses/schedules may be needed for children with chronic exposure to aflatoxin to assure adequate protection against HPV infection.

Children of mothers in the study will receive the HPV vaccine as per Kenya guidelines.

ERADICATING CERVICAL CANCER IN KENYA

ERADICATING CERVICAL CANCER IN KENYA: Benefits of Community-based Prevention, and the Effects of Aflatoxin on HPV Vaccination (MISP 60403) (MISP2)

De-identified data will be available on request to researchers.

Rate and relative risk of biopsy-proven VIA abnormality between women with positive HR-HPV and women with negative HR-HPV.

Rate and relative risk of seroconversion to all HPV types combined and to each of the nine HPV types represented in the nine-valent HPV vaccine between children with and without plasma aflatoxin detection.

Moi University

Indiana University

Professor of Medicine

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All women and girls eligible for the study.

There is no control arm.

Women will collect vaginal swabs for HPV testing, then undergo standard of care screening for cervical cancer

Self-collection of vaginal swabs

Cervical cancer is caused by oncogenic, or "high-risk" (HR) human papillomavirus (HPV), and is the main cause of cancer-related death among Kenyan women. This malignancy is theoretically preventable through a combination of screening of adult women and treating those with cervical premalignancies and vaccination of children and adolescents against HPV infection. However, only 5% of Kenyan women are regularly screened, and only 14% have ever been screened, which in Kenya is done by a method known as Visual Inspection with Acetic Acid (VIA). Possible obstacles to current screening include long travel to clinics, high costs, poor sensitivity and specificity of VIA, the need for extensive training for VIA, variability among providers in their interpretation of VIA, lack of trained personnel, and others. In addition, while safe and effective HPV vaccines have been available for 15 years, very few (\<1%) Kenyan children and adolescents have been vaccinated. Obstacles to vaccination include high costs, poor delivery infrastructure, lack of education, long travel to clinics, and others. The investigators began a community-based program to develop a framework for eradication of cervical cancer by screening adult women and vaccinating female children. This program is becoming accepted in the Webuye region of Western Kenya, but there is still a great deal to learn.

Going forward, this initiative will be known as the Kenya Mother-Daughter Cervical Cancer Eradication Program, or the Mother-Daughter Program (MDP) for short. The investigators propose a continuation of the MDP that will allow them to accumulate additional data needed to solidify the overall project and to answer additional questions as described below. To accomplish this goal the investigators will first enroll an additional 300 adult women to the program. This will increase the strength of the analysis of HR-HPV testing in detecting premalignant lesions of the cervix, especially in HIV-infected women. Second, the investigators will identify the positive and negative features of the MDP from the viewpoint of both the adult women and the girls enrolled in the program. Third, because anogenital warts (AGWs) may serve as a reservoir for HR-HPV, especially in women living with HIV/AIDS, the investigators will examine the prevalence, HPV type distribution, and treatment of these lesions among adult women participating in the MDP.

Girls ages 9-15 will be vaccinated against HPV per Kenya Guidelines Adult women 30-55 will be tested for HPV and undergo cervial cancer screening per Kenya Guidelines

A Cervical Cancer Prevention Program Kenya: Overcoming Obstacles to Care, Promoting Understanding of HPV Natural History

A Community-based Cervical Cancer Prevention Program in Kenya: Overcoming Obstacles to Care, Promoting Understanding of HPV Natural History

De-identified data may be shared upon reasonable request.

Genital warts will be removed and tested for HPV types

Investigators will report the acceptability rate of the Mother Daughter Program (MDP) in adult women screening among women and the 95% confidence intervals, and the acceptability rate of the MDP in HPV vaccination among girls

Self-collected swabs will be tested for HPV

Academic Model Providing Access to Healthcare (AMPATH)

Carcinoma

Papillomavirus Infections

Carcinoma in Situ

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Women will be offered HPV testing within the health facilities in the communities randomized to this arm. Women who test HPV positive will be referred to care at the sub-district and district hospitals (current standard of care).

Women will be offered HPV-based cervical cancer screening followed by standard linkage to care for women who test positive (to subdistrict or district hospitals).

Women will be offered HPV-based cervical cancer screening followed by enhanced linkage to care using the strategies determined in partnership with the key stakeholders in the communities.

Community-based testing with standard linkage to care

Community-based HPV testing with enhanced linkage to care

Megan J Huchko, MD, MPH

There are many challenges to implementation of cervical cancer prevention in resource-limited countries, despite evidence based screening and treatment strategies. The investigators hypothesize that self-collected HPV specimens offered in a community health campaign setting will

Community-Driven Cervical Cancer Prevention in Western Kenya

Evaluation of a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya

The investigators will determine the cost-effectiveness of the three strategies in this study: clinic-based testing with standard referral to care, community-health campaign testing w/ standard referral to care \& community based testing w/ enhanced linkage to care.

The investigators will compare the number of women who uptake HPV testing in the community health campaign arms compared to the number who uptake HPV testing in the clinic-based arms.

The investigators will compare the number of women accessing treatment for positive HPV results with standard linkage to care compared to the enhanced linkage to treatment strategy.

Duke University

Blood and Lymph Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Lymphoma

Herpes Simplex

Immunologic Deficiency Syndromes

Epstein-Barr Virus Infections

Lymphoproliferative Disorders

Hodgkin Disease

Sarcoma, Kaposi

Lymphoma, Non-Hodgkin

Lymphatic Diseases

Immunoproliferative Disorders

Soft Tissue Sarcoma

Lymphosarcoma

Hodgkin Lymphoma

Kaposi Sarcoma

Scot C Remick, MD

Walter O Mwanda, MD

This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will let the resesarchers look at their medical record, follow their normal cancer care, and have blood drawn to look at different proteins and viruses. Researchers would also like to look at part of the original tumor that was taken out of each patient. Some of these samples will be stored at Kenyatta National Hospital and research will be done on them later. This study does not involve any change in treatment, but only allows the study team to follow how a patient in Kenya with lymphoma is treated.

Comprehensive prospective cohort study of lymphoproliferative diseases in Nairobi, Kenya.

Tumor tissue, blood plasma and serum upon consent and suitability of sample preparation.

Prospective Study of Lymphoproliferative Diseases

A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya

To determine the spectrum and natural history of lymophoproliferative disorders in Nairobi, Kenya by prospectively recruiting subjects with biopsy-proven malignant lymphoma including non-Hodgkin's and Hodgkin's lymphoma regardless of age, sex and HIV-serostatus (cohort study), who are seen at the Kenyatta National Hospital for treatment.

To perform a comprehensive clinicopathological study in these subjects with complete virological, immunophenotypic, and molecular characterization of retrieved tumor tissues and peripheral blood samples for purposes of identifying prognostic and predictive biomarkers of clinical outcome (i.e. treatment response, freedom from disease progression, and overall survival) in which to begin to frame pragmatic, risk-adapted therapeutic interventions suitable for the resource constrained setting in sub-Saharan Africa.

* Aim 1: Determine the tissue biomarkers of EBV infection in AIDS-related lymphomas (ARL) in Kenya
* Aim 2: Compare the pattern of EBV persistence in patients with EBV+ and EBV- lymphoma
* Aim 3: Determine predictors of treatment outcome in AIDS-related lymphomas (ARL)

Kenyatta National Hospital

West Virginia University

Women living in western Kenya will be asked to complete a self collected vaginal sample for HPV DNA screening and asked to undergo a second screening by VIA. As per Kenyan standard of care, vaccination against HPV will be offered to children/grandchildren (boys and girls) of women, and to the women themselves if age 26 or younger. The second vaccine dose (for children ages 9 through 14) and third doses (for children and adult women ages 15 through 26) will be administered at subsequent visits. There will be no requirement for HPV vaccination (of children or mothers up to 26 years of age) for participation in the study. Results of the screening will be returned to participants and they will be referred to receive standard care as applicable.

Darron Brown, MD, MPH

Elkanah Omenge, MD

Darron Brown, MD

The purpose of this study is to determine if the human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care.

The purpose of this study is to test the hypothesis that effective cervical cancer screening can be performed in a high percentage of women, using HPV DNA of self-collected vaginal samples, provided by women attending either chamas (community groups) or in their own homes. HPV DNA testing will be used to triage women for a secondary screen by visual inspection with acetic acid (VIA) in a local clinic. The investigators will determine if HPV DNA testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care. In addition, women will bring their children to be vaccinated against HPV in these community meetings, using the standard of care for the approved HPV vaccine available in Kenya.

The investigators will test this approach by completing the following Specific Aims:

Specific Aim 1. Determine the percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.

Specific Aim 2. Following HPV DNA screening using self-collected swabs, determine the percentage of these women who will attend the local clinic.

Specific Aim 3. Evaluate the statistical correlation between HPV DNA testing of self-collected vaginal swabs and VIA (as all women in this pilot study will undergo VIA).

A New Approach to Cervical Cancer Prevention in Kenya

analyzed for the human reference gene (specimen adequacy), HPV 16/18, or any of 12 oncogenic HPV types.

Merck Sharp & Dohme LLC

Participants enrolled at intervention sites will receive CATSytem-supported cervical cancer screening and treatment services. Interventions received will include: text messages to patients and algorithm-driven alerts to providers when guideline-adherent cervical cancer screening and treatment services are required including: initial and follow up cervical cancer screening, on site treatment, and referral tracking.

Participants enrolled at control sites will receive standard of care PMTCT services, with no CATSystem tracking or follow up

The CATSystem provider dashboard highlights patients with overdue services or those in need of outreach and sends automated, customized texts to support screening and treatment follow-up per national guidelines. Points of intervention and alerts include: cervical cancer screening and treatment counseling, initial and follow up cervical cancer screening per national guidelines, treatment for precancer and cancer, referral tracking and follow up. In addition, the CATSystem can securely store images of the cervix taken with colposcopes to allow for remote expert consultation if needed to correctly diagnose a patient or can be reviewed at clinical team meetings for input. Primary goals of the CATSystem are to increase rates of guideline-adherent cervical cancer screening/ rescreening and improve guideline-adherent treatment, referral, and follow-up rates of women with positive screens.

Cancer Tracking System (CATSystem)

Catherine Wexler, MPH

May H Maloba, MCH

John Ochieng, BA

May H Maloba

John Ochieng

Sarah Finocchario-Kessler, PhD

Natabhona Mabachi, PhD

Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care).

To help address system level barriers to cervical cancer screening, treatment, and follow-up in Kenya, investigators worked with end-users (providers and patients) to develop the Cancer Tracking System (CATSystem), a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care). Specific aims (SA) of the study are to (1) Implement and evaluate the efficacy of CATSystem to improve guideline adherent cervical cancer screening, treatment, referral and follow up, (2) Assess feasibility and acceptability of implementation of CATSystem in government run facilities using a human centered design approach, and (3) Calculate the costs and cost-effectiveness of the CATSystem to increase quality adjusted life years gained. Cervical cancer deaths can be prevented with early detection and treatment. This study will evaluate the public health impact of the CATSystem in improving cervical cancer screening, treatment, referral, follow-up, and the feasibility of scale up to other low resource settings.

Matched, cluster randomized controlled design

Evaluation of the Cancer Tracking System (CATSystem)

Implementing and Evaluating the Cancer Tracking System (CATSystem): A Systems Level Intervention to Improve Cervical Cancer Screening, Treatment Referral and Follow up in Kenya

Investigators will make data collected for aims 1 \& 2 available only upon request from users who meet eligibility. Data from aim 3 includes costing data for PMTCT services. These data will be shared openly at the dissemination meetings planned at the end of the study, which will include county and national health personnel. Furthermore, these data will be placed in a readily accessible public database.

Provide guideline adherent treatment and rescreening for the range of possible positive screen results: cervicitis, precancerous lesions (mild, moderate, severe), invasive cervical cancer. Participants who receive the guideline adherent treatment for their positive screen result will be coded as 1 or "yes". Participants who do not receive the guideline adherent treatment for their positive screen will be coded as 0 or "no".

The cost and cost-effectiveness of the CATSystem to improve Quality-Adjusted Life-Years (QALYs).

Compare the number of women screened for cervical cancer pre (12 month retrospective review of screening rates) and throughout the two-year enrollment period at all intervention and control sites.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ERADICATING CERVICAL CANCER IN KENYA	NCT04774887	Human Papilloma... HIV Infections	HPV vaccine, Me...	9 Years - 60 Years	Indiana University
ERADICATING CERVICAL CANCER IN KENYA	NCT04774887	Human Papilloma... HIV Infections	HPV vaccine, Me...	9 Years - 60 Years	Indiana University
A Cervical Cancer Prevention Program Kenya: Overcoming Obstacles to Care, Promoting Understanding of HPV Natural History	NCT06411938	Cervical Cancer... Cervical Cancer	Self-collection...	9 Years - 55 Years	Indiana University
Community-Driven Cervical Cancer Prevention in Western Kenya	NCT02124252	Human Papilloma... Carcinoma in Si...	Community-based... Community-based...	25 Years - 65 Years	Duke University
A Cervical Cancer Prevention Program Kenya: Overcoming Obstacles to Care, Promoting Understanding of HPV Natural History	NCT06411938	Cervical Cancer... Cervical Cancer	Self-collection...	9 Years - 55 Years	Indiana University
Prospective Study of Lymphoproliferative Diseases	NCT01704742	Non-Hodgkin's L... Hodgkin's Lymph...		-	West Virginia University
A New Approach to Cervical Cancer Prevention in Kenya	NCT03942705	Healthy		18 Years - 60 Years	Indiana University
Prospective Study of Lymphoproliferative Diseases	NCT01704742	Non-Hodgkin's L... Hodgkin's Lymph...		-	West Virginia University
A Cervical Cancer Prevention Program Kenya: Overcoming Obstacles to Care, Promoting Understanding of HPV Natural History	NCT06411938	Cervical Cancer... Cervical Cancer	Self-collection...	9 Years - 55 Years	Indiana University
Evaluation of the Cancer Tracking System (CATSystem)	NCT06286462	Cervical Cancer	Cancer Tracking...	16 Years -	University of Kansas Medical Center

Spots Global Cancer Trial Database for kenya

Every month we try and update this database with for kenya cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for kenya

Every month we try and update this database with for kenya cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for kenya cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.