Community-Driven Cervical Cancer Prevention in Western Kenya

NCT02124252 | Completed

• 1 other identifier: Pro00077442
• Study Type: interventional
• Target: 7,200
• Locations: 1 country
• Sites: 1

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

Conditions

Human Papilloma Virus Infection; Carcinoma in Situ of Uterine Cervix

Keywords

cervical cancer screening; human papillomavirus testing; Kenya; implementation science

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Determine the Efficacy of the cervical cancer prevention program

  4 years

Other Outcomes (1)

• Determine the cost-effectiveness

  4-5 years

Study Arms (3)

Control

NO INTERVENTION

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).

Standard Intervention

ACTIVE COMPARATOR

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).

Behavioral: Community-based testing with standard linkage to care

Enhanced Intervention

ACTIVE COMPARATOR

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.

Behavioral: Community-based HPV testing with enhanced linkage to care

Interventions

Community-based testing with standard linkage to care 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).

Standard Intervention

Community-based HPV testing with enhanced linkage to care 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.

Enhanced Intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior hysterectomy

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Kenya Medical Research Institute

Nairobi, 00202, Kenya

Location

Related Publications (6)

• 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.

  PMID: 33109637 DERIVED

• 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.

  PMID: 31345973 DERIVED

• 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.

  PMID: 29970063 DERIVED

• 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.

  PMID: 29801496 DERIVED

• 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.

  PMID: 29207966 DERIVED

• 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.

  PMID: 29197067 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Megan J Huchko, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-01

Locations

KE (1)