search
Back to results

Community-Driven Cervical Cancer Prevention in Western Kenya

Primary Purpose

Human Papilloma Virus Infection, Carcinoma in Situ of Uterine Cervix

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Community-based testing with standard linkage to care
Community-based HPV testing with enhanced linkage to care
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Papilloma Virus Infection focused on measuring cervical cancer screening, human papillomavirus testing, Kenya, implementation science

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female, ages 25-65 Willing to sign informed consent Lives in community where randomization arm is

Exclusion Criteria:

  • Prior hysterectomy

Sites / Locations

  • Kenya Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Standard Intervention

Enhanced Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics
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.

Secondary Outcome Measures

Determine the Efficacy of the cervical cancer prevention program
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.

Full Information

First Posted
April 24, 2014
Last Updated
April 9, 2019
Sponsor
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT02124252
Brief Title
Community-Driven Cervical Cancer Prevention in Western Kenya
Official Title
Evaluation of a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus Infection, Carcinoma in Situ of Uterine Cervix
Keywords
cervical cancer screening, human papillomavirus testing, Kenya, implementation science

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Arm Title
Standard Intervention
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Enhanced Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community-based testing with standard linkage to care
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Community-based HPV testing with enhanced linkage to care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Determine the Efficacy of the cervical cancer prevention program
Description
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.
Time Frame
4 years
Other Pre-specified Outcome Measures:
Title
Determine the cost-effectiveness
Description
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.
Time Frame
4-5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female, ages 25-65 Willing to sign informed consent Lives in community where randomization arm is Exclusion Criteria: Prior hysterectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan J Huchko, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kenya Medical Research Institute
City
Nairobi
ZIP/Postal Code
00202
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33109637
Citation
Olwanda EE, Kahn JG, Choi Y, Islam JY, Huchko M. Comparison of the costs of HPV testing through community health campaigns versus home-based testing in rural Western Kenya: a microcosting study. BMJ Open. 2020 Oct 27;10(10):e033979. doi: 10.1136/bmjopen-2019-033979.
Results Reference
derived
PubMed Identifier
31345973
Citation
Huchko M, Adewumi K, Oketch S, Saduma I, Bukusi E. 'I'm here to save my life': a qualitative study of experiences navigating a cryotherapy referral system for human papillomavirus-positive women in western Kenya. BMJ Open. 2019 Jul 24;9(7):e028669. doi: 10.1136/bmjopen-2018-028669.
Results Reference
derived
PubMed Identifier
29970063
Citation
Swanson M, Ibrahim S, Blat C, Oketch S, Olwanda E, Maloba M, Huchko MJ. Evaluating a community-based cervical cancer screening strategy in Western Kenya: a descriptive study. BMC Womens Health. 2018 Jul 3;18(1):116. doi: 10.1186/s12905-018-0586-0.
Results Reference
derived
PubMed Identifier
29801496
Citation
Shen J, Olwanda E, Kahn JG, Huchko MJ. Cost of HPV screening at community health campaigns (CHCs) and health clinics in rural Kenya. BMC Health Serv Res. 2018 May 25;18(1):378. doi: 10.1186/s12913-018-3195-6.
Results Reference
derived
PubMed Identifier
29207966
Citation
Huchko MJ, Kahn JG, Smith JS, Hiatt RA, Cohen CR, Bukusi E. Study protocol for a cluster-randomized trial to compare human papillomavirus based cervical cancer screening in community-health campaigns versus health facilities in western Kenya. BMC Cancer. 2017 Dec 6;17(1):826. doi: 10.1186/s12885-017-3818-z.
Results Reference
derived
PubMed Identifier
29197067
Citation
Huchko MJ, Ibrahim S, Blat C, Cohen CR, Smith JS, Hiatt RA, Bukusi E. Cervical cancer screening through human papillomavirus testing in community health campaigns versus health facilities in rural western Kenya. Int J Gynaecol Obstet. 2018 Apr;141(1):63-69. doi: 10.1002/ijgo.12415. Epub 2018 Jan 3.
Results Reference
derived

Learn more about this trial

Community-Driven Cervical Cancer Prevention in Western Kenya

We'll reach out to this number within 24 hrs