Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 9:25 AM
Study NCT ID:
NCT04661566
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2020-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing a Multi-Modal Intervention to Reduce Health-Risking Sexual Behaviors: Component Selection
Sponsor:
Uniformed Services University of the Health Sciences
Organization:
Study Overview
Official Title:
Optimizing a Multi-Modal Intervention to Reduce Health-Risking Sexual Behaviors: Component Selection
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this project is to evaluate the components of the app-based intervention Mission Wellness to reduce health-risking sexual behaviors (HRSBs; e.g., condom non-use, multiple sexual partners) in active-duty members of the US Military to improve their sexual and reproductive health (SRH) and readiness to serve. Following the multiphase optimization strategy (MOST) framework, factorial component selection experiments (CSEs) will be conducted to evaluate which five experimental intervention components (i.e., Narratives, Skills, Scenarios, Future, and Risk) elicit the greatest improvements in the outcomes of interest given key constraints.
Detailed Description:
Negative SRH outcomes (e.g., sexually transmitted infections \[STIs\], unintended pregnancy, STI-related cancers) reduce human performance and undermine military readiness. Service members face unique challenges to maintaining SRH during their military service. HRSBs (e.g., multiple sexual partners, unprotected sexual behavior) offer potential intervention targets to improve SRH. Electronic-health interventions are cost-effective and dynamic, and have the potential to reach millions of users as part of an overall strategy for individual behavior and systems change. In civilian populations, e-health interventions have demonstrated success in reducing HRSBs. However, effective HRSB-prevention interventions must consider the specific values, mission, and context of military populations and settings. The MOST framework is used to develop highly effective, efficient, and economic behavioral interventions that is particularly well suited to be used in this context.
This project aims to address this problem by delivering an optimized app-based prevention intervention package ready for evaluation via a subsequent randomized controlled trial (RCT). The specific purpose of this project is to determine which component(s) should be included in the packaged app-based intervention Mission Wellness for US service members based on their effects on the outcomes of interest (i.e., improved knowledge, motivation, and behavior skills related to SRH and reduced HRSBs) in no more than 25 minutes of content. The components tested in the factorial CSEs include: Narratives; Skills; Scenarios; Future; and Risk. Each component has two levels: "on" (included) or "off" (not included). Main and interaction effects of components will be measured to determine the components constituting the packaged intervention.
This project aims to address this problem by delivering an optimized app-based prevention intervention package ready for evaluation via a subsequent randomized controlled trial (RCT). The specific purpose of this project is to determine which component(s) should be included in the packaged app-based intervention Mission Wellness for US service members based on their effects on the outcomes of interest (i.e., improved knowledge, motivation, and behavior skills related to SRH and reduced HRSBs) in no more than 25 minutes of content. The components tested in the factorial CSEs include: Narratives; Skills; Scenarios; Future; and Risk. Each component has two levels: "on" (included) or "off" (not included). Main and interaction effects of components will be measured to determine the components constituting the packaged intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: