Cervical Cancer
Conditions
Keywords
Screen, self-sampler, cervical, cancer, women, community health workers, Hispanic/ Latinas, Haitian, Focus of study is cervical cancer
Brief summary
The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.
Interventions
BEHAVIORALCHW and Self-sampling for Cervical Cancer
Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
BEHAVIORALMailed Self Sampler
Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
Sponsors
Health Choice Network
Center for Haitian Studies
National Cancer Institute (NCI)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women * Haitian, Hispanic, or African American * Ages 30-65 years * Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade
Exclusion criteria
* Women who report having had a hysterectomy * Women who have a history of cervical cancer * Women who plan to move outside of Miami-Dade county during the next six months * Women who are enrolled in any other cancer prevention/outreach related study * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing a Self-sampling Test | 2 to 6 months | The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Change in Cervical Cancer Knowledge Among Participants | Baseline, 6 months | Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly. |
| Proportion of Participants With a Change in Access to Care | Baseline, 6 months | Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CHWs Facilited Self-Sampling CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes. | 302 |
| Mailed Self-Sampler Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling; | 300 |
| Total | 602 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 88 | 87 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | CHWs Facilited Self-Sampling | Mailed Self-Sampler | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 302 Participants | 300 Participants | 602 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 198 Participants | 197 Participants | 395 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 103 Participants | 206 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 106 Participants | 113 Participants | 219 Participants |
| Race (NIH/OMB) More than one race | 54 Participants | 47 Participants | 101 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 141 Participants | 138 Participants | 279 Participants |
| Sex: Female, Male Female | 302 Participants | 300 Participants | 602 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 302 | 0 / 300 |
| other Total, other adverse events | 0 / 302 | 0 / 300 |
| serious Total, serious adverse events | 0 / 302 | 0 / 300 |
Outcome results
Primary
Number of Participants Completing a Self-sampling Test
The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.
Time frame: 2 to 6 months
Population: Participants were given up to 6 months to complete HPV self-sampling.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHWs Facilited Self-Sampling | Number of Participants Completing a Self-sampling Test | 272 Participants |
| Mailed Self-Sampler | Number of Participants Completing a Self-sampling Test | 257 Participants |
Secondary
Proportion of Change in Cervical Cancer Knowledge Among Participants
Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.
Time frame: Baseline, 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHWs Facilited Self-Sampling | Proportion of Change in Cervical Cancer Knowledge Among Participants | 0.033 proportion of participants |
| Mailed Self-Sampler | Proportion of Change in Cervical Cancer Knowledge Among Participants | 0.089 proportion of participants |
Secondary
Proportion of Participants With a Change in Access to Care
Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).
Time frame: Baseline, 6 months
Population: Only participants with complete information on access to care were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHWs Facilited Self-Sampling | Proportion of Participants With a Change in Access to Care | 0.160 proportion of participants |
| Mailed Self-Sampler | Proportion of Participants With a Change in Access to Care | 0.166 proportion of participants |