Carcinoma in Situ of Uterine Cervix, Human Papilloma Virus Infection
Conditions
Keywords
cervical cancer screening, human papillomavirus testing, Kenya, implementation science
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
Interventions
BEHAVIORALCommunity-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).
BEHAVIORALCommunity-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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, ages 25-65 Willing to sign informed consent Lives in community where randomization arm is
Exclusion criteria
* Prior hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics | 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
| Measure | Time frame | Description |
|---|---|---|
| Determine the Efficacy of the cervical cancer prevention program | 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
| Measure | Time frame | Description |
|---|---|---|
| Determine the cost-effectiveness | 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. |
Countries
Kenya
Outcome results
None listed