Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02509572
Other study ID # 00004169
Secondary ID
Status Completed
Phase N/A
First received July 21, 2015
Last updated June 6, 2016
Start date October 2014
Est. completion date June 2016

Study information

Verified date June 2016
Source Children's Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The goal of this trial is to test a novel means of collecting patient-entered sexual health information for the provision of clinical decision support to increase the testing and detection of sexually transmitted infections (STI) in adolescent emergency department (ED) patients at high risk for STIs.


Description:

The investigators have developed a novel means of collecting sexual health information from adolescents in the emergency department (ED) through the use of an audio-computer assisted self-interview (ACASI). This information can then be used to provide clinical decision support to clinicians for targeted sexually transmitted infection (STI) screening in the ED for adolescents. This randomized trial randomizes patients to whether or not the clinician receives the decision support and tests whether provision of decision support results in increased STI screening for patients who report high risk sexual activity. Secondary outcomes include evaluation of whether the clinical decision support results in increased STI detection, and identifying factors associated with adapting the clinical decision support.


Recruitment information / eligibility

Status Completed
Enrollment 720
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 19 Years
Eligibility Inclusion Criteria:

- Aged 14-19 presenting to the emergency department.

Exclusion Criteria:

- history of developmental delay,

- medical instability,

- altered mental status,

- unable to understand English

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening


Intervention

Behavioral:
Sexual health screen (SHS)
Decision support for STI screening through a novel sexual health screen

Locations

Country Name City State
United States Children's National Medical Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Children's Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group. an expected average of 4-6 hours. No
Secondary The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group. Baseline No
See also
  Status Clinical Trial Phase
Completed NCT01144871 - Parental Knowledge and Attitudes of Confidential Sexually Transmitted Infections (STI) Services for Teens N/A
Completed NCT04661566 - Optimizing a Multi-Modal Intervention to Reduce Health-Risking Sexual Behaviors: Component Selection N/A
Completed NCT01842100 - To Compare the Strategies of Universal Antibiotic Prophylaxis Versus Screen-and-treat in Reducing Infective Complications and Re-infection in Women Who Undergo Termination of Pregnancy N/A
Completed NCT04867798 - Transgender Men and HIV in Uganda: PrEP Uptake and Persistence
Active, not recruiting NCT04328025 - Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP for Transgender Women in Uganda N/A
Active, not recruiting NCT04758390 - A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women N/A
Completed NCT03528135 - Project PRIDE (Promoting Resilience In Discriminatory Environments) N/A
Recruiting NCT04547413 - STI/HIV Intervention Behavioral Intervention Program N/A
Completed NCT01136850 - Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea Phase 3
Completed NCT02461940 - STI/HIV Prevention Intervention for Adolescents in Singapore N/A
Completed NCT01784809 - The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders Phase 2
Completed NCT00469547 - 62% & 15% Ethanol in Emollient Gel as Topical Male Microbicides Phase 1
Completed NCT01285349 - HIV/STI Prevention for Drug-Involved Couples N/A
Completed NCT02391233 - Multimedia WORTH With Black Drug-Involved Women on Probation N/A
Completed NCT02183909 - Connecting Resources for Urban Sexual Health N/A
Completed NCT02882607 - Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women N/A
Completed NCT00362375 - Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women Phase 1/Phase 2
Active, not recruiting NCT04710784 - A Pragmatic Trial to Expand Youth-friendly HIV Self-testing N/A
Recruiting NCT06223165 - Optimizing the Floreciendo Sexual and Reproductive Health Workshop for Latina Teens and Female Caregivers: A Pilot N/A
Completed NCT05319613 - Reducing Disparities in Rural HIV Prevention N/A