Trial Outcomes & Findings for Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention (NCT NCT02970136)
NCT ID: NCT02970136
Last Updated: 2021-12-28
Results Overview
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.
COMPLETED
NA
754 participants
Baseline
2021-12-28
Participant Flow
Participant milestones
| Measure |
Home Based Screening
The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker
OraQuick Swab: OraQuick for oral fluid HIV antibody testing
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
|
Clinic Based Screening
The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests
|
|---|---|---|
|
Overall Study
STARTED
|
377
|
377
|
|
Overall Study
COMPLETED
|
297
|
282
|
|
Overall Study
NOT COMPLETED
|
80
|
95
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention
Baseline characteristics by cohort
| Measure |
Home Based Screening
n=377 Participants
The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker
OraQuick Swab: OraQuick for oral fluid HIV antibody testing
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
|
Clinic Based Screening
n=377 Participants
The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests
|
Total
n=754 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.33 years
STANDARD_DEVIATION 4.54 • n=99 Participants
|
57.40 years
STANDARD_DEVIATION 4.49 • n=107 Participants
|
57.37 years
STANDARD_DEVIATION 4.51 • n=206 Participants
|
|
Sex: Female, Male
Female
|
282 Participants
n=99 Participants
|
282 Participants
n=107 Participants
|
564 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
190 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
239 Participants
n=99 Participants
|
241 Participants
n=107 Participants
|
480 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=99 Participants
|
136 Participants
n=107 Participants
|
274 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
142 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
285 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
205 Participants
n=99 Participants
|
214 Participants
n=107 Participants
|
419 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
28 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.
Outcome measures
| Measure |
Home Based Screening
n=377 Participants
The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker
OraQuick Swab: OraQuick for oral fluid HIV antibody testing
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
|
Clinic Based Screening
n=377 Participants
The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests
|
|---|---|---|
|
Percentage of Participants Who Are Screened for All Conditions
Female Participants
|
25.18 Percentage of participants
Interval 20.22 to 30.24
|
8.16 Percentage of participants
Interval 5.24 to 11.99
|
|
Percentage of Participants Who Are Screened for All Conditions
Male Participants
|
32.63 Percentage of participants
Interval 23.36 to 43.02
|
15.79 Percentage of participants
Interval 9.02 to 24.7
|
SECONDARY outcome
Timeframe: Baseline, Up to 6 monthsPopulation: There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.
Outcome measures
| Measure |
Home Based Screening
n=377 Participants
The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker
OraQuick Swab: OraQuick for oral fluid HIV antibody testing
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
|
Clinic Based Screening
n=377 Participants
The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests
|
|---|---|---|
|
Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
HCV Screening Test
|
71.88 percentage of participants
Interval 67.35 to 76.42
|
31.56 percentage of participants
Interval 26.87 to 36.26
|
|
Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
HIV Screening Test
|
46.15 percentage of participants
Interval 41.12 to 51.19
|
20.95 percentage of participants
Interval 16.85 to 25.06
|
|
Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
HPV Screening Test
|
24.47 percentage of participants
Interval 19.45 to 29.49
|
12.06 percentage of participants
Interval 8.26 to 15.86
|
|
Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
FIT Screening Test
|
39.26 percentage of participants
Interval 34.33 to 44.19
|
18.57 percentage of participants
Interval 14.64 to 22.49
|
SECONDARY outcome
Timeframe: At baseline and at 6 monthsPopulation: There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.
Outcome measures
| Measure |
Home Based Screening
n=377 Participants
The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker
OraQuick Swab: OraQuick for oral fluid HIV antibody testing
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
|
Clinic Based Screening
n=377 Participants
The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests
|
|---|---|---|
|
Median Number of Screenings Completed
Female Participants at Baseline
|
1 screenings completed
Interval 1.0 to 2.0
|
1 screenings completed
Interval 0.0 to 2.0
|
|
Median Number of Screenings Completed
Female Participants at 6 months
|
4 screenings completed
Interval 2.0 to 4.0
|
2 screenings completed
Interval 1.0 to 3.0
|
|
Median Number of Screenings Completed
Male participants at Baseline
|
1 screenings completed
Interval 0.0 to 1.0
|
1 screenings completed
Interval 0.0 to 1.0
|
|
Median Number of Screenings Completed
Male Participants at 6 months
|
3 screenings completed
Interval 2.0 to 3.0
|
2 screenings completed
Interval 1.0 to 3.0
|
Adverse Events
Home Based Screening
Clinic Based Screening
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place