An interventional study of SexHealth in Sexually Transmitted Diseases and Reproductive Behavior, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged 14 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Health services research
This is an adaptive trial with an initial Formative Revision Process followed by a Randomized Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6 completed subjects for the formative process and 86 completed subjects for the RCT.
In a randomized controlled trial at a pediatric emergency department, sexually active adolescents will receive the control (i.e., printed materials) or intervention (i.e., motivationally-guided facilitation) arm delivered by a health educator. The tablet-based, interactive intervention includes motivational techniques to promote risk reduction, condom skills training, and tailored service recommendations. The primary outcome is uptake of ≥1 service at the index visit (i.e., counseling, condoms, emergency contraception for immediate or future use, pregnancy/sexually transmitted infection (STI)/HIV testing, STI treatment, and clinic referral). We assess feasibility (i.e., intervention completion, recommendations discussed, and satisfaction). Participants report sexual risk and care-seeking behaviors at 2, 4, and 6 months. We compare uptake between arms using Fisher exact tests.
523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.
This study's enrollment of 91 is below the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
They will receive the same pamphlet as controls and the enhanced ED SexHealth intervention with the educator. Based on behaviors, CDS system recommendations (generated from screening survey responses only for intervention participants), and discussions, participants may be offered testing (for pregnancy, gonorrhea/chlamydia, and /or HIV), hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, and a scheduled appointment at Adolescent Clinic (for ongoing care, including repeat STI/HIV testing if needed). All services will be provided at point of care, costs will be covered by the study.
Behavioral: SexHealth
They will receive a printed health pamphlet and a list of local resources with the phone number for Adolescent Clinic. Participants will then be referred back to their ED provider, who will provide their standard care.
To enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care.
Number of Participants With Uptake of 1 or More Health Services
Any 1 or more of the following services: Testing for pregnancy, gonorrhea/chlamydia, and/or HIV, hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, appointment for clinic referral.
Time frame: Index visit
| Milestone | Intervention | Control |
|---|---|---|
| Started | 44 | 47 |
| Completed | 44 | 47 |
| Not completed | 0 | 0 |
Any 1 or more of the following services: Testing for pregnancy, gonorrhea/chlamydia, and/or HIV, hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, appointment for clinic referral.
| Participants | Intervention | Control |
|---|---|---|
| Number of Participants With Uptake of 1 or More Health Services | 43 | 33 |
Collected over Information was collected at index visit and at six month follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Control | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 16.8 ± 0.7 | 17.0 ± 0.8 | 16.9 ± 1.0 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 31 | 34 | 65 |
| Male | 13 | 13 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 11 | 18 |
| Not Hispanic or Latino | 37 | 36 | 73 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 28 | 30 | 58 |
| White | 10 | 10 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 7 | 13 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 44 | 47 | 91 |
| Commercial Insurance(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 8 | 9 | 17 |
| Genitourinary complaint(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 21 | 21 | 42 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Apr 2020, 28 months.
Results were first posted in Feb 2021, 9 months after primary completion.
Of 172 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's 28 months is below that.
Counting every sponsor, half of 182 studies reached it within 31 months; a quarter within 16 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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