Community-Driven Cervical Cancer Prevention in Western Kenya

NCT ID: NCT02124252

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Human Papilloma Virus Infection Carcinoma in Situ of Uterine Cervix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard Intervention

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).

Group Type ACTIVE_COMPARATOR

Community-based testing with standard linkage to care

Intervention Type BEHAVIORAL

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).

Enhanced Intervention

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.

Group Type ACTIVE_COMPARATOR

Community-based HPV testing with enhanced linkage to care

Intervention Type BEHAVIORAL

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.

Interventions

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Community-based testing with standard linkage to 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).

Intervention Type BEHAVIORAL

Community-based HPV testing with enhanced linkage to care

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

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Prior hysterectomy
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan J Huchko, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Kenya Medical Research Institute

Nairobi, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type DERIVED
PMID: 33109637 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31345973 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29970063 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29801496 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29207966 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29197067 (View on PubMed)

Other Identifiers

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Pro00077442

Identifier Type: -

Identifier Source: org_study_id

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