Optimizing a Multi-Modal Intervention to Reduce Health-Risking Sexual Behaviors: Component Selection

Uniformed Services University (USU)

Status

Completed

Conditions

Sexually Transmitted Infections

Military Personnel

Pregnancy, Unplanned

Treatments

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Narrative Videos ("Narratives")

Behavioral: Future Life Planning Tool ("Future")

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT04661566

USUHS.2020-055

Details and patient eligibility

About

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.

Full 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.

Enrollment

549 patients

Sex

All

Ages

17+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 17 or older,
currently serving as active duty in the US military, and
willing to participate in all study activities if eligible and enrolled

Exclusion criteria

Does not meet eligibility criteria,
unable to read, speak, or comprehend English, or
unable or unwilling to give informed consent

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

549 participants in 32 patient groups

Education+Narratives+Skills+Scenarios+Future+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, Scenarios, Future, and Risk

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Narrative Videos ("Narratives")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Narratives+Skills+Scenarios+Future

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, Scenarios, and Future

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Narrative Videos ("Narratives")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Narratives+Skills+Scenarios+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, Scenarios, and Risk

Treatment:

Behavioral: Narrative Videos ("Narratives")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Narratives+Skills+Scenarios

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, and Scenarios

Treatment:

Behavioral: Narrative Videos ("Narratives")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Narratives+Skills+Future+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, Future, and Risk

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Narrative Videos ("Narratives")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Narratives+Skills+Future

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, and Future

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Narrative Videos ("Narratives")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Narratives+Skills+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, and Risk

Treatment:

Behavioral: Narrative Videos ("Narratives")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Narratives+Skills

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives and Skills

Treatment:

Behavioral: Narrative Videos ("Narratives")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Narratives+Scenarios+Future+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives. Scenarios, Future, and Risk

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Narrative Videos ("Narratives")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Basic Education ("Education")

Education+Narratives+Scenarios+Future

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Scenarios, and Future

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Narrative Videos ("Narratives")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Basic Education ("Education")

Education+Narratives+Scenarios+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Scenarios, and Risk

Treatment:

Behavioral: Narrative Videos ("Narratives")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Basic Education ("Education")

Education+Narratives+Scenarios

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives and Scenarios

Treatment:

Behavioral: Narrative Videos ("Narratives")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Basic Education ("Education")

Education+Narratives+Future+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Future, and Risk

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Narrative Videos ("Narratives")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Basic Education ("Education")

Education+Narratives+Future

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives and Future

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Narrative Videos ("Narratives")

Behavioral: Basic Education ("Education")

Education+Narratives+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives and Risk

Treatment:

Behavioral: Narrative Videos ("Narratives")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Basic Education ("Education")

Education+Narratives

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives

Treatment:

Behavioral: Narrative Videos ("Narratives")

Behavioral: Basic Education ("Education")

Education+Skills+Scenarios+Future+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills, Scenarios, Future, and Risk

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Skills+Scenarios+Future

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills, Scenarios, and Future

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Skills+Scenarios+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills, Scenarios, and Risk

Treatment:

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Skills+Scenarios

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills and Scenarios

Treatment:

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Skills+Future+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills, Future, and Risk

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Skills+Future

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills Future

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Skills+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills and Risk

Treatment:

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Skills

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills

Treatment:

Behavioral: Skills Building Videos ("Skills")

Behavioral: Basic Education ("Education")

Education+Scenarios+Future+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Scenarios, Future, and Risk

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Basic Education ("Education")

Education+Scenarios+Future

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Scenarios and Future

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Basic Education ("Education")

Education+Scenarios+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Scenarios and Risk

Treatment:

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Basic Education ("Education")

Education+Scenarios

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Scenarios

Treatment:

Behavioral: Interactive Scenarios ("Scenarios")

Behavioral: Basic Education ("Education")

Education+Future+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Future and Risk

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Basic Education ("Education")

Education+Future

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Future

Treatment:

Behavioral: Future Life Planning Tool ("Future")

Behavioral: Basic Education ("Education")

Education+Risk

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Risk

Treatment:

Behavioral: Epidemiological Risk Scenario ("Risk")

Behavioral: Basic Education ("Education")

Education

Experimental group

Description:

Participants will receive a version of the Mission Wellness app (intervention) that only includes the static educational component.

Treatment:

Behavioral: Basic Education ("Education")

Trial documents