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HPTN SDMC: HPTN 096 Getting to Zero among Highest HIV Incidence (HHI) Men who have Sex with Men (MSM) in the American South: Testing an Integrated Strategy

Award Number: UM1AI068617
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/29/2006
PERIOD OF PERFORMANCE END DATE: 11/30/2027

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HPTN SDMC: HPTN 096 Getting to Zero among Highest HIV Incidence (HHI) Men who have Sex with Men (MSM) in the American South: Testing an Integrated Strategy - Abstract (30 lines) The Southern United States continues to experience the highest HIV incidence in the country, with men who have sex with men (MSM) disproportionately affected. HPTN 096 is a multi-component, community-based implementation-efficacy trial designed to reduce HIV incidence among the highest HIV incidence (HHI) MSM in three urban American South communities. The primary study outcomes are increasing the number of HHI MSM accessing prevention and treatment services, increasing uptake and use of pre-exposure prophylaxis (PrEP) among those living without HIV, and increasing retention in care, and thus viral suppression among those living with HIV. Intervention process outcomes will assess implementation fidelity, reach, acceptability, and provider training effects. HPTN 096 is a hybrid implementation-efficacy trial that uses a single-arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. The four components of the ITS are: Health access coalitions, Social media, Peer support, and Promoting Human Autonomy Supportive Environments (PHASE). ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year lookbacks of EMR data. The integrated strategy will be delivered in three communities (Dallas, TX; Montgomery, AL; Ft Lauderdale/ Miami, FL) in the American South. Additionally, a subset of HHI MSM at PHASE healthcare facility (HCF) sites, as well as PHASE HCF staff, community coalition members, peer supporters, and both HHI MSM and other individuals who engage with the intervention’s social media content will be assessed for secondary outcomes and primary intervention process outcomes. By integrating multiple intervention strategies at the community and healthcare facility levels, HPTN 096 aims to generate evidence for scalable approaches that reduce HIV incidence in high-burden populations in the American South. The use of electric health records from participating health care clinics to assess the HPTN 096 study outcomes is an innovation for the HPTN.


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 = $27,971,899 )
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	20	11/21/2024	NON-COMPETING CONTINUATION	$10,424,663
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	20	6/25/2025	NON-COMPETING CONTINUATION	$2,531,633
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	20	4/15/2025	NON-COMPETING CONTINUATION	$7,035,990
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	20	8/20/2025	SUPPLEMENT FOR EXPANSION	$8,473,830
2025	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	17	11/25/2024	SUPPLEMENT FOR EXPANSION	-$3,376
2025	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	14	10/1/2024	NON-COMPETING CONTINUATION	-$490,841
														Subtotal = $27,971,899

Issue Date FY: 2024 ( Subtotal = $22,081,371 )
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	19	4/2/2024	NON-COMPETING CONTINUATION	$9,959,956
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	19	11/14/2023	NON-COMPETING CONTINUATION	$10,926,304
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	19	3/5/2024	SUPPLEMENT FOR EXPANSION	$1,195,111
														Subtotal = $22,081,371

Issue Date FY: 2023 ( Subtotal = $14,385,924 )
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	18	12/7/2022	NON-COMPETING CONTINUATION	$6,634,301
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	18	6/6/2023	NON-COMPETING CONTINUATION	$1,680,043
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	18	3/10/2023	NON-COMPETING CONTINUATION	$6,071,580
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	17	4/6/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	15	6/21/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $14,385,924

Issue Date FY: 2022 ( Subtotal = $14,598,797 )
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	011	17	9/16/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$3,633,824
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	010	17	8/31/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$3,384,794
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	17	5/27/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$5,773,385
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	16	2/28/2022	NON-COMPETING CONTINUATION	$1,853,211
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	17	5/31/2022	SUPPLEMENT FOR EXPANSION	$389,142
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	007	16	8/29/2022	NON-COMPETING CONTINUATION	-$3,384,794
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	008	17	8/29/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$8,472,297
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	16	11/30/2021	NON-COMPETING CONTINUATION	$2,949,235
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	009	17	8/31/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$8,472,297
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	16	5/27/2022	NON-COMPETING CONTINUATION	$0
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	15	7/14/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	15	12/17/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $14,598,797

Issue Date FY: 2021 ( Subtotal = $18,762,698 )
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	15	3/24/2021	COMPETING CONTINUATION	$862,744
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	007	15	8/10/2021	COMPETING CONTINUATION	$502,788
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	15	5/27/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	15	4/2/2021	SUPPLEMENT FOR EXPANSION	$486,494
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	15	6/9/2021	COMPETING CONTINUATION	$6,314,295
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	009	15	8/24/2021	COMPETING CONTINUATION	$2,842,278
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	15	7/12/2021	SUPPLEMENT FOR EXPANSION	$492,189
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	15	11/20/2020	COMPETING CONTINUATION	$7,764,698
2021	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	14	8/10/2021	NON-COMPETING CONTINUATION	-$502,788
2021	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	008	14	8/10/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $18,762,698

Issue Date FY: 2020 ( Subtotal = $11,827,895 )
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	14	11/21/2019	NON-COMPETING CONTINUATION	$3,675,010
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	14	8/24/2020	NON-COMPETING CONTINUATION	$2,673,539
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	14	9/15/2020	SUPPLEMENT FOR EXPANSION	$295,993
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	14	2/14/2020	NON-COMPETING CONTINUATION	$2,705,543
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	14	5/20/2020	NON-COMPETING CONTINUATION	$2,477,810
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	14	5/28/2020	NON-COMPETING CONTINUATION	$0
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	14	9/23/2020	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $11,827,895

Issue Date FY: 2019 ( Subtotal = $12,822,234 ) (Continued on the next page)
Grand Total All Awards = $184,818,105

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HPTN SDMC: HPTN 096 Getting to Zero among Highest HIV Incidence (HHI) Men who have Sex with Men (MSM) in the American South: Testing an Integrated Strategy

Award Number: UM1AI068617

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 06/29/2006

PERIOD OF PERFORMANCE END DATE: 11/30/2027

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