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OpenTrials
Completed

NCT Number: NCT02124252

Community-Driven Cervical Cancer Prevention in Western Kenya

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

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Key information

Conditions

Human Papilloma Virus Infection Carcinoma in Situ of Uterine Cervix Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Virus Diseases

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute

Nairobi, 00202, Kenya

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prior hysterectomy

Treatment and study plan

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).

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.

Primary outcomes

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

    Time frame: 2 years

    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 outcomes

  1. Determine the Efficacy of the cervical cancer prevention program

    Time frame: 4 years

    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.

Other outcomes

  1. Determine the cost-effectiveness

    Time frame: 4-5 years

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2019
First posted
Apr 28, 2014
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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