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RCT of a parent-focused intervention to reduce HIV risk in adolescent MSM

Award Number: R01MH129169
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/14/2022
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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RCT of a parent-focused intervention to reduce HIV risk in adolescent MSM - Project Summary Adolescent men who have sex with men (AMSM) accounted for 79% of new HIV infections among youth ages 13-19 in the United States (US) in 2018. Less than a quarter of AMSM have ever taken an HIV test. Despite these stark disparities in HIV incidence and testing, interventions to reduce sexual risk and increase HIV testing among AMSM remain extremely limited. Notably, the very few intervention approaches that are currently being explored for AMSM exclude parents. The omission of parent-focused approaches represents a glaring gap in national efforts to end the HIV epidemic given parents’ well-documented ability to shape adolescent sexual health, including for AMSM. Consistent with NIH priorities (PA-20-144) the goal of the proposed research is to test the efficacy of a parent-focused intervention designed to reduce HIV risk and increase HIV testing among AMSM. Parents and Adolescents Talking about Healthy Sexuality (PATHS) is an online intervention we created for parents of AMSM that works to increase parent communication about sexuality and HIV, as well as other parent behaviors supportive of sexual risk reduction. Our NIH-funded pilot RCT with a national sample of 61 racially/ethnically diverse parent-AMSM dyads revealed that PATHS increased both parent and child reports of multiple parent behaviors supportive of sexual health. Building on the promising effects PATHS had on parent behaviors, the goal of the proposed study is to test whether PATHS improves sexual health outcomes in AMSM ages 14-19. We will conduct an RCT of PATHS with 350 parent-AMSM dyads recruited online (50% racial/ethnic minority). Parents will be randomized to receive either PATHS or an active control, and then assessed every 3 months over a 1-year period. Primary outcomes will be evaluated at 6 months post-intervention, and then the control arm will crossover and receive PATHS, and dyads will be followed for another 6 months. This allows us to further test the effects of PATHS in the control arm while simultaneously modeling the longer 9- and 12-month effects in the original intervention arm. The primary (P) specific aims are to: (P1) Test the efficacy of PATHS in improving the degree to which AMSM are prepared for intercourse (operationalized as: having access to condoms, demonstrating accurate condom skills, expressing intentions to use condoms, receiving HIV testing, understanding what PrEP is, and expressing positive attitudes toward PrEP); and (P2) Test the efficacy of PATHS in reducing condomless anal/vaginal intercourse. Secondary (S) aims are to: (S1) Examine the degree to which intervention effects observed in P1 and P2 persist to 1-year post intervention; and (S2) Examine how parent behaviors mediate effects of PATHS on AMSM outcomes. If proven efficacious, PATHS will be among the first interventions demonstrated to reduce sexual risks and increase HIV testing for AMSM – the population of youth at highest risk for HIV infection in the US. Moreover, as other adolescent-focused interventions emerge, PATHS’ unique focus on parents will offer a complementary, additional means for reaching AMSM who are not touched by other intervention options.


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 = $652,702 )
2025	2025	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Mental Health Research Grants	000	4	4/12/2025	NON-COMPETING CONTINUATION	$652,702
														Subtotal = $652,702

Issue Date FY: 2024 ( Subtotal = $761,056 )
2024	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Mental Health Research Grants	001	3	8/15/2024	NON-COMPETING CONTINUATION	$76,105
2024	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Mental Health Research Grants	000	3	2/15/2024	NON-COMPETING CONTINUATION	$684,951
														Subtotal = $761,056

Issue Date FY: 2023 ( Subtotal = $771,856 )
2023	2023	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Mental Health Research Grants	000	2	2/15/2023	NON-COMPETING CONTINUATION	$771,856
														Subtotal = $771,856

Issue Date FY: 2022 ( Subtotal = $832,367 )
2022	2022	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Mental Health Research Grants	000	1	3/11/2022	NEW	$753,742
2022	2022	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Mental Health Research Grants	001	1	9/1/2022	NEW	$78,625
														Subtotal = $832,367

Grand Total All Awards = $3,017,981

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RCT of a parent-focused intervention to reduce HIV risk in adolescent MSM

Award Number: R01MH129169

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/14/2022

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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