About this trial
The goal of this clinical trial is to test the effectiveness of a 6-week socialization and sex education curriculum (STEPS2) in young people (aged 16-27 years) with intellectual and developmental disabilities (I/DD), including people with Down syndrome.
The main question it aims to answer is:
Does the STEPS2 health education curriculum increase the proportion of individuals who:
1. have had a discussion with a medical professional about their sexual health (including sexually transmitted infection testing for those who are sexually active); 2. know whether they have had the HPV vaccination; 3. have had the HPV vaccination; 4. know what sex is; and 5. know how people get pregnant.
These are the primary outcomes which are being measured one year after study enrollment. Secondary outcomes include knowledge around sexual health and behaviors around contraception and STI prevention among those sexually active at baseline, as well as satisfaction with the intervention.
Participants are randomized to receive either the socialization and sex education curriculum in the experimental group, called the STEPS2 curriculum, or a nutrition and physical exercise curriculum in the comparison group, called Steps To Your Health (STYH).
Participants in the STEPS2 experimental group meet with a health educator in one-on-one individually tailored sessions virtually once a week for one hour for 6 weeks. Participants in the STYH comparison group meet with a health educator in small group sessions of 6-10 participants virtually once a week for one hour for 6 weeks.
Researchers will compare sexual and reproductive health knowledge and behaviors one year after study enrollment to see if the STEPS2 curriculum is effective at increasing knowledge and healthy behaviors.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
16-27 years of age
resides in New York State
mild/moderate I/DD
willing to receive either STEPS2 or STYH curricula
Disqualifiers
if female sex, self-reports pregnant at screening
Trial design
Parallel
Treatments tested in this trial
STEPS2
BehavioralOne of the two health education curricula as described in arm/group descriptions.
STYH
BehavioralOne of the two health education curricula as described in arm/group descriptions.
Treatment groups
Trial outcomes
Primary outcomes
Proportion who have had a sexual health discussion with medical professional
Have had a sexual health discussion with medical professional
Proportion who know their HPV vaccination status
Know whether they have been vaccinated for HPV
Proportion who have been vaccinated for HPV
Have been vaccinated for HPV (self-report with verification using NYS and NYC immunization registry when possible)
Proportion who can accurately describe what sex is
Understand what sex is based on response to an open-ended question
Secondary outcomes
Average sexual health knowledge score (1-25, with 25 being high knowledge)
Score based on sexual health knowledge survey questions
Average sexual health knowledge score (1-25, with 25 being high knowledge)
Score based on sexual health knowledge survey questions
Average sexual health knowledge score (1-25, with 25 being high knowledge)
Score based on sexual health knowledge survey questions
Proportion using birth control among those reporting vaginal sex
Self-reported use of birth control among those reporting vaginal sex
Sponsors and contacts
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City University of New York, School of Public Health
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institutes of Health INCLUDE Project
Collaborator
National Institutes of Health Office of Disease Prevention
Collaborator