A Randomized Intervention Trial to Increase Access to Reproductive Health Services Among Adolescents and Young Adults With Intellectual and Developmental Disabilities

The goal of this clinical trial is to test the effectiveness of a 6-week socialization and sex education curriculum (STEPS2) among 856 adolescent and young adults (aged 16-27 years) with mild to moderate intellectual or developmental disabilities (I/DD), including people with Down syndrome.

The investigators are recruiting participants through collaboration with the New York State Office of People with Developmental Disabilities (OPWDD), Service Providers, Care Coordination Organizations and special programs, such as the Special Olympics. For participants who meet eligibility criteria and have consented or assented (as appropriate), a video call meeting is arranged to complete the baseline interview survey of socio-demographic characteristics and sexual and reproductive health knowledge and behaviors. The interview takes up to 45 minutes to complete. Once the baseline interview is completed the participant is randomly assigned to either the STEPS2 or the STYH arm of the study. Half of the participants will be randomized to STEPS2, and half to the STYH arm. Participants begin the intervention within 2 weeks of having completed the baseline survey.

For the intervention, participants in both arms receive virtual video call one hour weekly health education sessions for 6 weeks. The STEPS2 socialization and sexuality curriculum (experimental arm) is provided during one-on-one sessions between a Study Health Educator and the participant. The STYH curriculum (comparison arm) is provided during group sessions with 6-10 participants and a Study Health Educator. For both arms, participants choose whether they wish for a guardian or helper to also attend for a given session.

Participants have follow-up interview surveys at month 2 (after completing the health education intervention), month 6, and month 12, with the same sexual and reproductive health measures as included in the baseline survey. The month 2 interviews also include measures of participant satisfaction with the curriculum and with the Study Health Educator. Each survey takes up to 45 minutes to complete. Survey interviewers are blinded to which curriculum participants have received.

The investigators are comparing the proportion of participants who have had a conversation with a doctor about sex, know their HPV vaccination status, have had the HPV vaccine, and show an understanding of sex and pregnancy at the month 12 interview between the two arms, after adjusting for baseline measures of these indicators, to test whether participation in the STEPS2 arm had an effect on these measures. Analysis will include intention-to-treat estimates, as well as instrumental variable estimates to adjust for incomplete attendance to the 6-week curricula. Analyses will also be stratified by gender, age, and mild versus moderate I/DD.