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A Randomized Intervention Trial to Increase Access to Reproductive Health Services among Adolescents and Young Adults with intellectual and Developmental Disabilities

Award Number: R01HD111044
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/02/2023
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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A Randomized Intervention Trial to Increase Access to Reproductive Health Services among Adolescents and Young Adults with intellectual and Developmental Disabilities - Project Summary/Abstract We propose updating, piloting and testing a socialization and sex education curriculum (STEPS-2) designed for adolescents and young adults with intellectual and developmental disabilities (I/DD). We will test this updated curriculum in a randomized controlled trial (RCT) among 856 adolescents and young adults (aged 18- 27 years) with mild to moderate I/DD who receive services from disability providers in four of the five Developmental Disabilities Regions of the New York State Office for People with Developmental Disabilities. Randomization will be stratified by region, sex (male/female) and age (18-22, 23-27). Half of the participants will be randomized to receive the updated STEPS-2 socialization and sex education curriculum in individualized sessions during home visits, and the other half will receive a group-based intervention on physical exercise and nutrition in a local community center; only one roommate will be eligible to be enrolled from any group living arrangement to minimize spillover effects. Regional Coordinat ors will provide the 6-week long interventions, with interview data collected at baseline (prior to intervention), month 2 (completion of intervention), month 6 and month 12. We project completing recruitment into the RCT during the second quarter of year 3, and completion of month 12 assessments in the third quarter of year 4. The primary outcome will be proportion of participants reporting having had a conversation about sex/reproductive health with a medical provider by month 12, with secondary outcomes including HPV vaccination status, receipt of sex and age-specific preventive health screening, social sexual behaviors, agency over decisions, and, among those sexually active, use of contraception (if not desiring a pregnancy), and use of sexually transmitted infection/HIV protection. Interim measures will be used to assess knowledge and to reduce the likelihood of recall bias for the primary endpoint. Specifically, we aim to: (1) Update and pilot an existing socialization and sex education curriculum (STEPS-2) for 18-27 year olds with I/DD in New York State through a participatory process centering the voices of diverse lived experiences; (2) Test the efficacy of this socialization and sex education curriculum in a randomized intervention trial using intention-to-treat and instrumental variable analyses to adjust for compliance. We hypothesize that at least an additional 10% of the individuals in the experimental group will have had a reproductive health discussion with a medical provider by month 12 compared with the control group; and (3) Test whether the efficacy of the intervention differs by sex and age in stratified analyses. We have powered the study for sex-specific efficacy estimates and will explore whether efficacy differs by age. The findings from this translational study will inform practitioners, advocates, and self-advocates about best practices for reproductive and sexual health education for adolescents and young adults with I/DD as they transition to adulthood.


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 = $786,839 )
2026	2026	RESEARCH FOUNDATION OF THE CITY UNIVERSITY OF NEW YORK	55 W 125TH ST FL 7	NEW YORK	NY	10027	NEW YORK	USA	Child Health and Human Development Extramural Research	001	4	3/2/2026	NON-COMPETING CONTINUATION	$0
2026	2026	RESEARCH FOUNDATION OF THE CITY UNIVERSITY OF NEW YORK	55 W 125TH ST FL 7	NEW YORK	NY	10027	NEW YORK	USA	Child Health and Human Development Extramural Research	002	4	4/1/2026	NON-COMPETING CONTINUATION	$78,683
2026	2026	RESEARCH FOUNDATION OF THE CITY UNIVERSITY OF NEW YORK	55 W 125TH ST FL 7	NEW YORK	NY	10027	NEW YORK	USA	Child Health and Human Development Extramural Research	000	4	2/11/2026	NON-COMPETING CONTINUATION	$708,156
														Subtotal = $786,839

Issue Date FY: 2025 ( Subtotal = $770,438 )
2025	2025	RESEARCH FOUNDATION OF THE CITY UNIVERSITY OF NEW YORK	55 W 125TH ST FL 7	NEW YORK	NY	10027	NEW YORK	USA	Child Health and Human Development Extramural Research	000	3	4/7/2025	NON-COMPETING CONTINUATION	$770,438
2025	2025	RESEARCH FOUNDATION OF THE CITY UNIVERSITY OF NEW YORK	55 W 125TH ST FL 7	NEW YORK	NY	10027	NEW YORK	USA	Child Health and Human Development Extramural Research	001	3	4/29/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $770,438

Issue Date FY: 2024 ( Subtotal = $764,417 )
2024	2024	RESEARCH FOUNDATION OF THE CITY UNIVERSITY OF NEW YORK	55 W 125TH ST FL 7	NEW YORK	NY	10027	NEW YORK	USA	Child Health and Human Development Extramural Research	001	2	5/23/2024	NON-COMPETING CONTINUATION	$69,493
2024	2024	RESEARCH FOUNDATION OF THE CITY UNIVERSITY OF NEW YORK	55 W 125TH ST FL 7	NEW YORK	NY	10027	NEW YORK	USA	Child Health and Human Development Extramural Research	000	2	2/5/2024	NON-COMPETING CONTINUATION	$694,924
														Subtotal = $764,417

Issue Date FY: 2023 ( Subtotal = $791,325 )
2023	2023	RESEARCH FOUNDATION OF THE CITY UNIVERSITY OF NEW YORK	55 WEST 125TH ST FL 7	NEW YORK	NY	10027	NEW YORK	USA	Child Health and Human Development Extramural Research	000	1	2/2/2023	NEW	$791,325
														Subtotal = $791,325

Grand Total All Awards = $3,113,019

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A Randomized Intervention Trial to Increase Access to Reproductive Health Services among Adolescents and Young Adults with intellectual and Developmental Disabilities

Award Number: R01HD111044

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/02/2023

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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