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Transgender Youth and PrEP: PK, Safety, Uptake & Adherence

Award Number: R01MH114753
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/15/2018
PERIOD OF PERFORMANCE END DATE: 11/30/2023

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Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PROJECT SUMMARY/ABSTRACT Transgender women (TW) are one of the most vulnerable populations for acquiring HIV infection, and the scant available data on transgender men (TM) suggests they are also at risk. TW have accounted for only 0.2% of all participants in bio-behavioral HIV prevention trials using pre-exposure prophylaxis (PrEP), and TM have typically not been included. TW and TM adolescents have received even less attention in PrEP trials. Although tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), the FDA-approved PrEP drug, would not be expected to interact with cross-sex hormone therapy (cs-HT; estradiol and testosterone) based on known mechanisms and data from studies with hormonal contraceptives, there are no data that prove this. Given this lack of data, TW and TM youth on cs-HT have decreased PrEP uptake and adherence due to concerns that PrEP may reduce the effectiveness of cs-HT. To address these critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation we propose the following study in 3 integrated phases. In Phase 1, we will conduct a PK study exploring the interactions of cs-HT for both TW and TM on TDF/FTC. Simultaneously, in Phase 2, we will collect ethnographic data via focus groups and in-depth interviews to inform the development of a tailored gender-affirmative intervention to improve uptake and adherence to PrEP in transgender youth. In Phase 3, we will conduct a small demonstration trial of PrEP use in TW and TM youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes. The project has the following specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender- affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. We will conduct FGs with young TW (N=20- 30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). We will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.


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: 2024 ( Subtotal = -$304,246 )
2024	2022	THE HEKTOEN INSTITUTE FOR MEDICAL RESEARCH	1339 S WOOD ST	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	001	5	4/12/2024	SUPPLEMENT FOR EXPANSION	-$28,556
2024	2022	THE HEKTOEN INSTITUTE FOR MEDICAL RESEARCH	1339 S WOOD ST	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	000	5	4/12/2024	NON-COMPETING CONTINUATION	-$275,690
														Subtotal = -$304,246

Issue Date FY: 2022 ( Subtotal = $623,703 )
2022	2022	HEKTOEN INSTITUTE FOR MEDICAL RESEARCH, THE	1339 S WOOD ST # G	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	001	5	2/8/2022	SUPPLEMENT FOR EXPANSION	$58,540
2022	2022	HEKTOEN INSTITUTE FOR MEDICAL RESEARCH, THE	1339 S WOOD ST # G	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	000	5	2/7/2022	NON-COMPETING CONTINUATION	$508,644
2022	2022	HEKTOEN INSTITUTE FOR MEDICAL RESEARCH, THE	1339 S WOOD ST # G	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	002	5	8/3/2022	NON-COMPETING CONTINUATION	$56,519
														Subtotal = $623,703

Issue Date FY: 2021 ( Subtotal = $743,856 )
2021	2021	HEKTOEN INSTITUTE FOR MEDICAL RESEARCH, THE	1339 S WOOD ST # G	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	001	4	8/17/2021	SUPPLEMENT FOR EXPANSION	$132,996
2021	2021	HEKTOEN INSTITUTE FOR MEDICAL RESEARCH, THE	1339 S WOOD ST # G	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	000	4	4/8/2021	NON-COMPETING CONTINUATION	$610,860
														Subtotal = $743,856

Issue Date FY: 2020 ( Subtotal = $638,352 )
2020	2020	HEKTOEN INSTITUTE FOR MEDICAL RESEARCH, THE	1339 S WOOD ST # G	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	000	3	12/5/2019	NON-COMPETING CONTINUATION	$574,516
2020	2020	HEKTOEN INSTITUTE FOR MEDICAL RESEARCH, THE	1339 S WOOD ST # G	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	001	3	3/11/2020	NON-COMPETING CONTINUATION	$63,836
														Subtotal = $638,352

Issue Date FY: 2019 ( Subtotal = $627,560 )
2019	2019	HEKTOEN INSTITUTE FOR MEDICAL RESEARCH, THE	1339 S WOOD ST # G	CHICAGO	IL	60608	COOK	USA	Mental Health Research Grants	000	2	12/12/2018	NON-COMPETING CONTINUATION	$627,560
														Subtotal = $627,560

Issue Date FY: 2018 ( Subtotal = $665,381 )
2018	2018	HEKTOEN INSTITUTE FOR MEDICAL RESEARCH, THE	2240 W OGDEN AVE FL 2	CHICAGO	IL	60612	COOK	USA	Mental Health Research Grants	000	1	1/15/2018	NEW	$665,381
														Subtotal = $665,381

Grand Total All Awards = $2,994,606

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Transgender Youth and PrEP: PK, Safety, Uptake & Adherence

Award Number: R01MH114753

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/15/2018

PERIOD OF PERFORMANCE END DATE: 11/30/2023

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