Clinical trial NCT02124252: 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
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus Infection
Carcinoma in Situ of Uterine Cervix
Keywords: cervical cancer screening
human papillomavirus testing
Kenya
implementation science
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 7200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Prior hysterectomy

Primary outcomes:
measure: Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics
timeFrame: 2 years
Secondary outcomes:
measure: Determine the Efficacy of the cervical cancer prevention program
timeFrame: 4 years
Other outcomes:
measure: Determine the cost-effectiveness
timeFrame: 4-5 years
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: University of California, San Francisco
name: Megan J Huchko, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.