Clinical Trials Logo

Clinical Trial Summary

The hypothesis is that a behavioral intervention tool adapted for the US military population will be acceptable and associated with a decrease in incident sexually transmitted infection (STI)/HIV rates and high-risk sexual behaviors, and increased self-reported condom use compared to the standard of care at the Joint Base Lewis-McChord (JBLM) Preventive Medicine clinic and the Fort Bragg Department of Public Health (part of Womack Army Medical Center).

Clinical Trial Description

This is the Execution Phase which will be conducted as a multi-site randomized controlled trial. A previous Formative Phase study was conducted under a separate protocol which has been completed with preliminary data indicating positive outcomes. Participants in both arms will meet the same inclusion/exclusion criteria and will be randomized into the intervention and control arms at a ratio of 1:1. The intervention arm will receive the KISS (Knocking out Infections through Safer sex and Screening) intervention program in addition to standard STI prevention counselling routinely provided by military medical treatment facilities. The control arm will receive only standard STI prevention counselling. Both arms will receive follow-up educational messages via short message service (SMS)/text messaging monthly for 10 months, and have follow-up study visits at 6 months and 12 months. The KISS intervention is a 2-hour, small group (6-12 individuals) class-based interactive, educational session based on Social Cognitive Theory and the Theory of Gender and Power. The intervention is an adaptation of the HORIZONS intervention, which has shown efficacy are reducing sexual risk behavior and incident STIs among adolescents in the USA. HORIZONS has been reviewed by the U.S. Centers for Disease Control (CDC) Prevention Synthesis Research team and designated a CDC top-tier (Tier I) evidence-based intervention (EBI). To enroll in the study, participants must be categorized as "high risk" as determined by a positive test for an STI within the previous 180 days or has had STI screening during this time frame (specifically gonorrhea (GC), chlamydia (CT), M. genitalium, syphilis and/or HIV). Study subjects will be recruited from Madigan Army Medical Center (Madigan) Preventive Medicine Clinic and the Womack Army Medical Center (Womack) Preventive Medicine Clinic in Ft. Bragg, North Carolina (NC). In addition, promotional flyers for recruitment will be placed in public areas on both bases, and will be promoted through approved social media channels. Subjects may also refer up to 5 friends or colleagues for screening. Participants enrolled in the intervention arm will complete a total of four visits and those in the control arm will complete a total of three visits. Over the course of the study, participants in both groups will be asked to provide biological specimens and complete knowledge/behavioral surveys three times (at baseline, 6 and at 12 months). Those in the intervention group will also attend the KISS EBI (Evidence Based Intervention) program. Both arms will receive monthly (months 2-11) follow up text messages, but the content will defer between the two arms. Those in the intervention arm, will receive SMS/text messages targeting prevention maintenance interventions (PMI) messages reiterating information received during the EBI session. Those in the control arm, will receive SMS/text messages that will contain general health information. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04547413
Study type Interventional
Source Madigan Army Medical Center
Contact Heather Follen, CCRC
Phone 253.320.4397
Status Recruiting
Phase N/A
Start date November 4, 2020
Completion date March 2024

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
Recruiting 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
Completed NCT02509572 - Improvement of STI Detection in Adolescent Emergency Department Patients N/A
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
Completed NCT01784809 - The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders Phase 2
Completed NCT02461940 - STI/HIV Prevention Intervention for Adolescents in Singapore N/A
Completed NCT01136850 - Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea Phase 3
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
Not yet recruiting NCT05339412 - Technology-based Training Tool for PHAT Life N/A
Recruiting NCT05319613 - Reducing Disparities in Rural HIV Prevention N/A