Thursday, November 21, 2024 11/21/2024

Expanding a pragmatic randomized trial to assess mailed self-sample HPV testing to increase cervical cancer screening participation among Asian immigrant women in a safety net health system

Award Number: R01MD013715
ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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SUMMARY Clinic-based screening for cervical cancer has dramatically reduced the incidence of this disease in the U.S. and other countries with widespread screening programs. However, almost 20% of U.S. women remain at high risk for cervical cancer due to non- and under-participation in screening. Testing self-collected cervicovaginal samples for high-risk human papillomavirus (HR-HPV) is known to be an effective strategy for addressing barriers to clinic-based screening in global settings. However, there are limited data on its effectiveness and implementation in U.S. health systems, particularly in safety net health systems that serve socioeconomically disadvantaged minority populations who carry the highest burden of cervical cancer. In the context of safety net health systems, pairing mailed self-sample HPV testing with patient navigation, an evidence-based outreach intervention, may have a synergistic effect for increasing screening participation among underscreened women. The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) trial is the first trial to evaluate mailed self-sample HPV testing in U.S. safety net health settings. The patient population of the safety net health system where the PRESTIS trial is embedded is predominantly Hispanic and non-Hispanic Black. Reflecting this demographic composition and logistical constraints of implementing the trial, eligibility is currently limited to patients who speak English or Spanish. Asian/Asian American women who speak English currently comprise a small proportion of trial participants (4%). Furthermore, Asian/Asian American women who speak languages other than English (particularly Vietnamese, the primary language of 68% of Asian patients) are currently ineligible for the trial. The small number of Asian/Asian American patients in the trial is problematic as it precludes their inclusion in subgroup analyses and limits the generalizeability of trial findings. The inclusion of Asian/Asian American women in self-sampling trials is critical given that cervical cancer screening participation is low among Asian/Asian American women and certain Asian subpopulations, notably Vietnamese women, have higher cervical cancer incidence compared to women of other race/ethnicities. With the proposed Administrative Supplement, we will expand the PRESTIS trial by adapting patient education materials and navigation strategies to broaden the trial’s population and recruit Asian/Asian American women who are not up-to-date with cervical cancer screening. In doing so, we will ensure that the PRESTIS trial is powered to rigorously assess and compare screening participation across racial/ethnic and linguistic subpopulations inclusive of Asian/Asian American women. We will also assess acceptability and experiences with self-sampling among Asian/Asian American women, as well as barriers and facilitators to clinical follow-up among Asian/Asian American women who test positive for HR-HPV.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $36,237 )
2025	2023	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	001	5	11/14/2024	SUPPLEMENT FOR EXPANSION	$0
2025	2023	THE UNIVERISTY OF TEXAS MD ANDERSON CANCER CENTER, A COMPONENT OF THE UNIVERISTY OF TEXAS SYSTEM	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	002	6	11/14/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$622,876
2025	2023	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	000	5	11/14/2024	NON-COMPETING CONTINUATION	-$586,639
														Subtotal = $36,237

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	000	4	11/22/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $707,793 )
2023	2023	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	000	5	12/11/2022	NON-COMPETING CONTINUATION	$527,976
2023	2023	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	003	5	2/6/2023	NON-COMPETING CONTINUATION	$58,664
2023	2023	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	001	5	12/22/2022	SUPPLEMENT FOR EXPANSION	$109,039
2023	2023	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	002	5	1/20/2023	SUPPLEMENT FOR EXPANSION	$12,114
														Subtotal = $707,793

Issue Date FY: 2022 ( Subtotal = $1,121,704 )
2022	2022	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	001	4	4/27/2022	NON-COMPETING CONTINUATION	$0
2022	2022	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	000	4	12/17/2021	NON-COMPETING CONTINUATION	$636,719
2022	2022	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	003	4	9/22/2022	SUPPLEMENT FOR EXPANSION	$383,065
2022	2022	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	002	4	7/21/2022	SUPPLEMENT FOR EXPANSION	$101,920
														Subtotal = $1,121,704

Issue Date FY: 2021 ( Subtotal = $470,246 )
2021	2021	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	001	3	12/18/2020	NON-COMPETING CONTINUATION	$533,241
2021	2021	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	002	3	3/16/2021	NON-COMPETING CONTINUATION	-$62,995
2021	2020	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	000	2	11/10/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $470,246

Issue Date FY: 2020 ( Subtotal = $558,334 )
2020	2020	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	000	2	12/24/2019	NON-COMPETING CONTINUATION	$558,334
														Subtotal = $558,334

Issue Date FY: 2019 ( Subtotal = $512,059 )
2019	2019	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Minority Health and Health Disparities Research	000	1	4/16/2019	NEW	$512,059
														Subtotal = $512,059

Grand Total All Awards = $3,406,373

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Expanding a pragmatic randomized trial to assess mailed self-sample HPV testing to increase cervical cancer screening participation among Asian immigrant women in a safety net health system

Award Number: R01MD013715

ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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