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

Primary Purpose

Sexually Transmitted Infections, Pregnancy, Unplanned, Military Personnel

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Basic Education ("Education")

Narrative Videos ("Narratives")

Skills Building Videos ("Skills")

Interactive Scenarios ("Scenarios")

Future Life Planning Tool ("Future")

Epidemiological Risk Scenario ("Risk")

About this trial

This is an interventional prevention trial for Sexually Transmitted Infections focused on measuring Women's Health, Sexual and Reproductive Health, Military, Multiphase Optimization Strategy

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Uniformed Services University of the Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm 26

Arm 27

Arm 28

Arm 29

Arm 30

Arm 31

Arm 32

Arm Type

Experimental

Arm Label

Education+Narratives+Skills+Scenarios+Future+Risk

Education+Narratives+Skills+Scenarios+Future

Education+Narratives+Skills+Scenarios+Risk

Education+Narratives+Skills+Scenarios

Education+Narratives+Skills+Future+Risk

Education+Narratives+Skills+Future

Education+Narratives+Skills+Risk

Education+Narratives+Skills

Education+Narratives+Scenarios+Future+Risk

Education+Narratives+Scenarios+Future

Education+Narratives+Scenarios+Risk

Education+Narratives+Scenarios

Education+Narratives+Future+Risk

Education+Narratives+Future

Education+Narratives+Risk

Education+Narratives

Education+Skills+Scenarios+Future+Risk

Education+Skills+Scenarios+Future

Education+Skills+Scenarios+Risk

Education+Skills+Scenarios

Education+Skills+Future+Risk

Education+Skills+Future

Education+Skills+Risk

Education+Skills

Education+Scenarios+Future+Risk

Education+Scenarios+Future

Education+Scenarios+Risk

Education+Scenarios

Education+Future+Risk

Education+Future

Education+Risk

Education

Arm 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Change in SRH knowledge as assessed by measures of STI Knowledge

Change in SRH knowledge as assessed by STI Knowledge (Outcome 1) and Pregnancy and Birth Control Knowledge (Outcome 2). STI knowledge is measured on a dichotomous (true/false [outcome varies by item]) scale adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Change in SRH knowledge as assessed by measures of Pregnancy and Birth Control Knowledge

Change in SRH knowledge as assessed by STI Knowledge (Outcome 1) and Pregnancy and Birth Control Knowledge (Outcome 2). Pregnancy and Birth Control is measured on a dichotomous (true/false [outcome varies by item]) scale adapted from measures used in Frost's et al (2012) Young Adults' Contraceptive Knowledge, Norms, and Attitudes: Associations with Risk of Unintended Pregnancy and Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Change in perceived risk of having a negative SRH outcome as assessed by measures of Perceived Risk

Change in perceived risk of having a negative SRH outcome assessed by Perceived Risk on an 5-point ordinal scale (from "no risk" [better outcome] to "very high risk" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Change in attitudes about SRH as assessed by measures of Condom Attitudes on a likert scale

Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Condom Attitudes is a composite score of Outcome 5 and a 7-point likert scale (from "strongly disagree" [1] to "strongly agree" [7; outcome varies by item]) adapted from Crosby's et al (2008) Correct Condom Use Self-Efficacy Scale (CCUSS) and Helweg-Larson and Collins' (1994) UCLA Multidimensional Condom Attitudes Scale (MCAS).

Change in attitudes about SRH as assessed by measures of Condom Attitudes on an ordinal item

Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Condom Attitudes is a composite score of Outcome 4 and a 5-point ordinal item (from "very positive" [better outcome] to "very negative" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert-type scale

Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Birth Control Attitudes is a composite score of Outcome 7 and a 5-point likert-type scale (from "very positive" [better outcome] to "very negative" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert scale

Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Birth Control Attitudes is a composite score of Outcome 6 and a 5-point likert scale (from "strongly agree" [1; worse outcome] to "strongly disagree" [5; better outcome]) adapted from measures used in Guzza and Hayford's (2018) Adolescent Reproductive and Contraceptive Knowledge and Attitudes and Adult Contraceptive Behavior.

Change in attitudes about SRH as assessed by measures of Norms

Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Change in attitudes about SRH assessed by Norms on a 5-point likert scale (from "strongly agree" to "strongly disagree" [no better/worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Change in self-efficacy about SRH as assessed by measures of Condom/Birth Control Use

Change in self-efficacy about SRH assessed by Condom/Birth Control Use (Outcome 9) and Partner Communication/Negotiation (Outcome 10). Change in self-efficacy about SRH assessed by Condom/Birth Control Use on 5-point likert-type scales (from "not at all confident" [1; worse outcome] to "extremely confident" [5; better outcome]) adapted from Crosby's et al (2008) Correct Condom Use Self-Efficacy Scale (CCUSS) and Marin's et al (1997) Condom Self-Efficacy.

Change in self-efficacy about SRH as assessed by measures of Partner Communication/Negotiation

Change in self-efficacy about SRH assessed by Condom/Birth Control Use (Outcome 9) and Partner Communication/Negotiation (Outcome 10). Change in self-efficacy about SRH assessed by Partner Communication/Negotiation on a 4-point likert-type scale (from "very difficult" [1; worse outcome] to "very easy" [4; better outcome]) adapted from Noar's et al (2002) Condom Influence Strategy Questionnaire and Quinn-Nilas' et al (2016) Sexual Communication Self-Efficacy Scale.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on ordinal items

Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 12-16 and ordinal (from "never" [worse outcome] to "all the time" [better outcome]) items adapted from measures used in Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on yes/no/dont-know items

Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11 and 13-16, and yes/no/dont-know (nominal; outcome varies by item) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on no/yes,previously/yes,currently items

Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11-12 and 14-16 and no/yes,previously/yes,currently (nominal; no better/worse outcome) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on dichotomous items

Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11-13 and 15-16 and dichotomous (yes/no [outcome varies by item]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on open response (number input) items

Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11-14 and 16 and open response (number input) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on nominal items

Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11-15 and nominal items (main/casual other [no better/worse outcome]) adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on ordinal items

Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 18-21 and 5-point ordinal (from "never" [worse outcome] to "all of the time" [better outcome]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on yes/no/dont-know items

Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 17 and 19-21 and nominal (yes/no/dont-know [outcome varies by item]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on dichotomous items

Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 17-18 and 20-21 and dichotomous (yes/no [outcome varies by item]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on open response (number input) items

Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 17-19 and 21 and open response (number input) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions

Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 17-20 and a 7-point likert-type (from "definitely" [better outcome] to "not likely at all" [worse outcome]) scale adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "very helpful" to "not helpful at all")

Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 23-27 and on 5-point ordinal or likert-type (from "very helpful" [better outcome] to "not helpful at all" [worse outcome]) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "strongly agree" to "strongly disagree")

Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22 and 24-27 and on 5-point ordinal or likert-type (from "strongly agree" [better outcome] to "strongly disagree" [worse outcome]) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "to much" to "some to little")

Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22-23 and 25-27 and on 5-point ordinal or likert-type (from "too much" to "some too little" [no better/worse outcome]) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on yes/no/dont-know nominal items

Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22-24 and 26-27 and yes/no/dont-know (no better/worse outcome) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on no/yes,recent/yes,not-recent nominal items

Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22-25 and 27 and no/yes,recent/yes,not-recent (no better/worse outcome) nominal items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on a cumulative scale

Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22 and 24-26 and a cumulative (outcome varies by item) scales adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Quality and satisfaction of healthcare provider interactions as assessed by measures of Patient-Provider Communication

Quality and satisfaction of healthcare provider interactions as assessed by Patient-Provider Communication on a 5-point likert-type scale (from "I do not agree" [worse outcome] to "I fully agree" [better outcome]) adapted from Bieber's et al (2010) Questionnaire on the Quality of Physician-Patient Interaction (QQPPI)

Change in self-reported mental health as assessed by Depression (PHQ-2)

Change in mental health assessed by Depression on the Patient Health Questionnaire-2 (PHQ-2) (from "not at all" [better outcome] to "nearly every day" [worse outcome])

Change in self-reported mental health as assessed by Anxiety (HAI)

Change in mental health assessed by the Anxiety on the Health Anxiety Inventory (HAI)

Intervention acceptability as assessed by measures on Acceptability

Acceptability of the intervention assessed by composite measures on Acceptability (Outcomes 31-33). Acceptability is a composite score of Outcome 32-33 and a 5-point ordinal or likert-type scale (from "do not agree at all" [worse outcome] to "agree completely" [better outcome]) adapted from Stoyanov's et al (2015) Mobile App Rating Scale and measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Kelley's et al (2005) An Evaluation of a Sexual Assault Prevention and Advocacy Program for US Navy Personnel.

Intervention acceptability as assessed by measures on Acceptability as open-ended items

Acceptability of the intervention assessed by composite measures on Acceptability (Outcomes 31-33). Acceptability is a composite score of Outcome 31 and 33 and open-ended items adapted from Stoyanov's et al (2015) Mobile App Rating Scale and measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Kelley's et al (2005) An Evaluation of a Sexual Assault Prevention and Advocacy Program for US Navy Personnel.

Intervention acceptability as assessed by measures on Acceptability on a rating scale

Acceptability of the intervention assessed by composite measures on Acceptability (Outcomes 31-33). Acceptability is a composite score of Outcome 31-32 and a rating scale (from 1 ["not at all likely"; worse outcome] to 10 ["extremely likely"; better outcome]) adapted from Stoyanov's et al (2015) Mobile App Rating Scale and measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Kelley's et al (2005) An Evaluation of a Sexual Assault Prevention and Advocacy Program for US Navy Personnel.

Secondary Outcome Measures

Full Information

NCT ID

NCT04661566

First Posted

October 23, 2020

Last Updated

January 3, 2023

Sponsor

Uniformed Services University of the Health Sciences

Collaborators

The Miriam Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04661566

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

September 2, 2021 (Actual)

Primary Completion Date

December 9, 2022 (Actual)

Study Completion Date

December 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Uniformed Services University of the Health Sciences

Collaborators

The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sexually Transmitted Infections, Pregnancy, Unplanned, Military Personnel

Keywords

Women's Health, Sexual and Reproductive Health, Military, Multiphase Optimization Strategy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

The MOST framework will be used. This study follows the optimization phase of the MOST framework where component selection experiments are conducted to experimentally evaluate the effectiveness of individual intervention components. Using a factorial design in this phase allows the effect of each intervention component to be evaluated and for observation of interaction effects while maximizing statistical power using a smaller sample size compared to an randomized controlled trial (RCT) powered similarly to explore individual components of an intervention. The optimization phase then allows for time and resources to be saved by ensuring only optimized components are retained after the RCT in the final intervention package.

Masking

Participant

Masking Description

Participants will not know the exact intervention conditions (i.e., what all of the intervention components are and what all of the possible combinations of intervention components there are)

Allocation

Randomized

Enrollment

549 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Education+Narratives+Skills+Scenarios+Future+Risk

Arm Type

Experimental

Arm Description

Arm Title

Education+Narratives+Skills+Scenarios+Future

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Skills+Scenarios+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Skills+Scenarios

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Skills+Future+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Skills+Future

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Skills+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Skills

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Scenarios+Future+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Scenarios+Future

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Scenarios+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Scenarios

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Future+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Future

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Narratives

Arm Type

Experimental

Arm Description

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

Arm Title

Education+Skills+Scenarios+Future+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Skills+Scenarios+Future

Arm Type

Experimental

Arm 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

Arm Title

Education+Skills+Scenarios+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Skills+Scenarios

Arm Type

Experimental

Arm 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

Arm Title

Education+Skills+Future+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Skills+Future

Arm Type

Experimental

Arm Description

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

Arm Title

Education+Skills+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Skills

Arm Type

Experimental

Arm Description

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

Arm Title

Education+Scenarios+Future+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Scenarios+Future

Arm Type

Experimental

Arm 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

Arm Title

Education+Scenarios+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Scenarios

Arm Type

Experimental

Arm Description

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

Arm Title

Education+Future+Risk

Arm Type

Experimental

Arm 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

Arm Title

Education+Future

Arm Type

Experimental

Arm Description

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

Arm Title

Education+Risk

Arm Type

Experimental

Arm Description

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

Arm Title

Education

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Basic Education ("Education")

Intervention Description

All participants will receive the basic educational component in the Mission Wellness app. This component will contain text and media (e.g., images, videos) to teach basic SRH topics. The exact information in this component will be determined by an assessment of baseline SRH knowledge at the start of the intervention.

Intervention Type

Behavioral

Intervention Name(s)

Narrative Videos ("Narratives")

Intervention Description

The narrative video component is a motivation-based component that includes stories of individuals engaging in positive and negative SRH behaviors that lead to either positive or negative outcomes, respectively, in a video format.

Intervention Type

Behavioral

Intervention Name(s)

Skills Building Videos ("Skills")

Intervention Description

The skills-building videos component is a component rooted in behavioral skills that involves the provision of information on how to perform or engage positive SRH behaviors (e.g., correctly using a condom, what to expect when having a Pap smear) via instructional videos.

Intervention Type

Behavioral

Intervention Name(s)

Interactive Scenarios ("Scenarios")

Intervention Description

The interactive scenarios are a behavioral skills-building component that walks through conversations surrounding SRH with select individuals (e.g., partner, healthcare provider), providing suggestions on how to have these conversations and why these conversations are important to have.

Intervention Type

Behavioral

Intervention Name(s)

Future Life Planning Tool ("Future")

Intervention Description

The future life planning tool is a motivation-based component contains a series of questions to help users plan future goals to put current decision making related to SRH into perspective and provide suggestions on how to stay healthy now to be able to achieve those goals later.

Intervention Type

Behavioral

Intervention Name(s)

Epidemiological Risk Scenario ("Risk")

Intervention Description

The risk component is an information- and motivation-based component with tailored epidemiological risk information about relative risk of contracting a specific STI and/or having an unintended pregnancy. Relative risk information will be determined by adjusting variables within the component (e.g., number of partners within the last month, percent of time using condoms).

Primary Outcome Measure Information:

Title

Change in SRH knowledge as assessed by measures of STI Knowledge

Description

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in SRH knowledge as assessed by measures of Pregnancy and Birth Control Knowledge

Description

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in perceived risk of having a negative SRH outcome as assessed by measures of Perceived Risk

Description

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in attitudes about SRH as assessed by measures of Condom Attitudes on a likert scale

Description

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in attitudes about SRH as assessed by measures of Condom Attitudes on an ordinal item

Description

Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Condom Attitudes is a composite score of Outcome 4 and a 5-point ordinal item (from "very positive" [better outcome] to "very negative" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert-type scale

Description

Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Birth Control Attitudes is a composite score of Outcome 7 and a 5-point likert-type scale (from "very positive" [better outcome] to "very negative" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert scale

Description

Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Birth Control Attitudes is a composite score of Outcome 6 and a 5-point likert scale (from "strongly agree" [1; worse outcome] to "strongly disagree" [5; better outcome]) adapted from measures used in Guzza and Hayford's (2018) Adolescent Reproductive and Contraceptive Knowledge and Attitudes and Adult Contraceptive Behavior.

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in attitudes about SRH as assessed by measures of Norms

Description

Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Change in attitudes about SRH assessed by Norms on a 5-point likert scale (from "strongly agree" to "strongly disagree" [no better/worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in self-efficacy about SRH as assessed by measures of Condom/Birth Control Use

Description

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in self-efficacy about SRH as assessed by measures of Partner Communication/Negotiation

Description

Change in self-efficacy about SRH assessed by Condom/Birth Control Use (Outcome 9) and Partner Communication/Negotiation (Outcome 10). Change in self-efficacy about SRH assessed by Partner Communication/Negotiation on a 4-point likert-type scale (from "very difficult" [1; worse outcome] to "very easy" [4; better outcome]) adapted from Noar's et al (2002) Condom Influence Strategy Questionnaire and Quinn-Nilas' et al (2016) Sexual Communication Self-Efficacy Scale.

Time Frame

Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on ordinal items

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on yes/no/dont-know items

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on no/yes,previously/yes,currently items

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on dichotomous items

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on open response (number input) items

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on nominal items

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on ordinal items

Description

Time Frame

Within 3 weeks post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on yes/no/dont-know items

Description

Time Frame

Within 3 weeks post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on dichotomous items

Description

Time Frame

Within 3 weeks post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on open response (number input) items

Description

Time Frame

Within 3 weeks post-intervention

Title

Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions

Description

Time Frame

Within 3 weeks post-intervention

Title

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "very helpful" to "not helpful at all")

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "strongly agree" to "strongly disagree")

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "to much" to "some to little")

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on yes/no/dont-know nominal items

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on no/yes,recent/yes,not-recent nominal items

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on a cumulative scale

Description

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Quality and satisfaction of healthcare provider interactions as assessed by measures of Patient-Provider Communication

Description

Time Frame

Baseline

Title

Change in self-reported mental health as assessed by Depression (PHQ-2)

Description

Change in mental health assessed by Depression on the Patient Health Questionnaire-2 (PHQ-2) (from "not at all" [better outcome] to "nearly every day" [worse outcome])

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Change in self-reported mental health as assessed by Anxiety (HAI)

Description

Change in mental health assessed by the Anxiety on the Health Anxiety Inventory (HAI)

Time Frame

Baseline and 30-to-90 days post-intervention

Title

Intervention acceptability as assessed by measures on Acceptability

Description

Time Frame

Within 3 weeks post-intervention

Title

Intervention acceptability as assessed by measures on Acceptability as open-ended items

Description

Time Frame

Within 3 weeks post-intervention

Title

Intervention acceptability as assessed by measures on Acceptability on a rating scale

Description

Time Frame

Within 3 weeks post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan R Landoll, PhD

Organizational Affiliation

Uniformed Services University of the Health Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sara E Vargas, PhD

Organizational Affiliation

The Miriam Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uniformed Services University of the Health Sciences

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20814

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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