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Evaluation of triage strategies and screening intervals in a human papillomavirus based cervical cancer screening program in women living with human immunodeficiency virus in Botswana

Award Number: K08CA271949
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 07/01/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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Evaluation of triage strategies and screening intervals in a human papillomavirus based cervical cancer screening program in women living with human immunodeficiency virus in Botswana - ABSTRACT Primary high-risk human papillomavirus (HPV) testing has become the gold standard for cervical screening. Women living with HIV (WLHIV) are amongst the highest risk group for cervical cancer, yet the optimal triage strategy for HPV positivity and optimal screening intervals for WLHIV are unclear. Evaluating the performance of cervical screening algorithms using primary HPV testing in high HIV prevalence settings like Botswana is essential for establishing an evidence-base to optimize cervical screening for WLHIV in the United States (US) and across the globe. Additionally, HPV screening has the potential to dramatically increase access to cervical screening through self-collection, yet WLHIV are excluded from current US self-collection guidelines. Evaluation of implementation strategies of HPV self-collection in WLHIV in Botswana will generate evidence to guide implementation of HPV self-collection in this high-risk group in the US. The proposed study evaluates innovative HPV-based cervical screening algorithms in WLHIV and builds a longitudinal cohort to evaluate long-term outcomes. I have begun recruitment of a cohort of 3,000 women, 50% of whom are living with HIV, in South East District, Botswana. Participants in this cohort undergo baseline cervical screening with high-risk HPV testing and 3 types of triage evaluation: 1) visual assessment with acetic acid, 2) colposcopy, and 3) HPV genotype restriction. Biopsy with histopathology is collected as the gold standard in comparing the efficacy of these HPV-based screening algorithms. Excisional treatment is offered as determined by colposcopy and biopsy results. Aim 1 of the proposed K08 will evaluate the performance of these HPV-based screening algorithms, as well as HPV testing alone in detecting cervical dysplasia in WLHIV. In Aim 2, I will conduct interval HPV-based cervical screening for the WLHIV in this cohort to evaluate optimal screening intervals. Specifically, I will repeat HPV testing at 2 years in WLHIV who tested baseline HPV positive and had concurrent benign pathology, and at 3 years in WLHIV who tested baseline HPV negative. Women will undergo triage testing according to the findings of the baseline screening study. Based on the data from baseline and interval screening, in Aim 3, I will develop a pilot implementation study to evaluate the incorporation of HPV self-collection into routine health services, in collaboration with the Ministry of Health of Botswana. This K08 will provide protected research time and build skills in advanced statistical analysis, clinical trial design, and implementation science to become an independent NIH-funded researcher. My career goal is to improve the health and wellness of women in the US and globally through evaluation and implementation of high-performance cervical screening that is within reach of all women. The research will be conducted with the support of the Beth Israel Deaconess Medical Center and through the Botswana Harvard Health Partnership with which the PI has a long-standing research appointment. Furthermore, this research will be done in collaboration with the Ministry of Health of Botswana, thus impacting national cervical screening policy. Finally, this research will inform cervical screening guidelines for WLHIV across the global, and particularly inform US guidelines for HPV self-collection in WLHIV.


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: 2026 ( Subtotal = $255,919 )
2026	2026	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Research Manpower	000	5	5/19/2026	NON-COMPETING CONTINUATION	$255,919
														Subtotal = $255,919

Issue Date FY: 2025 ( Subtotal = $255,961 )
2025	2025	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Research Manpower	000	4	6/16/2025	NON-COMPETING CONTINUATION	$255,961
														Subtotal = $255,961

Issue Date FY: 2024 ( Subtotal = $255,865 )
2024	2024	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Research Manpower	000	3	5/21/2024	NON-COMPETING CONTINUATION	$255,865
														Subtotal = $255,865

Issue Date FY: 2023 ( Subtotal = $255,865 )
2023	2023	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Research Manpower	000	2	5/11/2023	NON-COMPETING CONTINUATION	$255,865
														Subtotal = $255,865

Issue Date FY: 2022 ( Subtotal = $258,557 )
2022	2022	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Research Manpower	000	1	6/29/2022	NEW	$258,557
														Subtotal = $258,557

Grand Total All Awards = $1,282,167

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Evaluation of triage strategies and screening intervals in a human papillomavirus based cervical cancer screening program in women living with human immunodeficiency virus in Botswana

Award Number: K08CA271949

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 07/01/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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