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

NCT04661566 | Completed

• 1 other identifier: USUHS.2020-055
• Study Type: interventional
• Target: 549
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexually Transmitted Infections; Pregnancy, Unplanned; Military Personnel

Keywords

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

Outcome Measures

Primary Outcomes (33)

• 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.

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

• 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.

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

• 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.

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

• 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).

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Within 3 weeks post-intervention

• 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.

  Within 3 weeks post-intervention

• 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.

  Within 3 weeks post-intervention

• 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.

  Within 3 weeks post-intervention

• 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.

  Within 3 weeks post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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.

  Baseline and 30-to-90 days post-intervention

• 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)

  Baseline

• 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" \[worse outcome\])

  Baseline and 30-to-90 days post-intervention

• 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)

  Baseline and 30-to-90 days post-intervention

• 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.

  Within 3 weeks post-intervention

• 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.

  Within 3 weeks post-intervention

• 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.

  Within 3 weeks post-intervention

Study Arms (32)

Education+Narratives+Skills+Scenarios+Future+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Narratives+Skills+Scenarios+Future

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future")

Education+Narratives+Skills+Scenarios+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Narratives+Skills+Scenarios

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios")

Education+Narratives+Skills+Future+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Narratives+Skills+Future

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Future Life Planning Tool ("Future")

Education+Narratives+Skills+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Narratives+Skills

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills")

Education+Narratives+Scenarios+Future+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Narratives+Scenarios+Future

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future")

Education+Narratives+Scenarios+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Narratives+Scenarios

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Interactive Scenarios ("Scenarios")

Education+Narratives+Future+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Narratives+Future

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Future Life Planning Tool ("Future")

Education+Narratives+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Narratives

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives")

Education+Skills+Scenarios+Future+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Skills+Scenarios+Future

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future")

Education+Skills+Scenarios+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Skills+Scenarios

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios")

Education+Skills+Future+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Skills+Future

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Future Life Planning Tool ("Future")

Education+Skills+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Skills

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills")

Education+Scenarios+Future+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Scenarios+Future

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future")

Education+Scenarios+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Scenarios

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Interactive Scenarios ("Scenarios")

Education+Future+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education+Future

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Future Life Planning Tool ("Future")

Education+Risk

EXPERIMENTAL

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

Behavioral: Basic Education ("Education"); Behavioral: Epidemiological Risk Scenario ("Risk")

Education

EXPERIMENTAL

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

Behavioral: Basic Education ("Education")

Interventions

Basic Education ("Education") BEHAVIORAL

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.

Education; Education+Future; Education+Future+Risk; Education+Narratives; Education+Narratives+Future; Education+Narratives+Future+Risk; Education+Narratives+Risk; Education+Narratives+Scenarios; Education+Narratives+Scenarios+Future; Education+Narratives+Scenarios+Future+Risk; Education+Narratives+Scenarios+Risk; Education+Narratives+Skills; Education+Narratives+Skills+Future; Education+Narratives+Skills+Future+Risk; Education+Narratives+Skills+Risk; Education+Narratives+Skills+Scenarios; Education+Narratives+Skills+Scenarios+Future; Education+Narratives+Skills+Scenarios+Future+Risk; Education+Narratives+Skills+Scenarios+Risk; Education+Risk; Education+Scenarios; Education+Scenarios+Future; Education+Scenarios+Future+Risk; Education+Scenarios+Risk; Education+Skills; Education+Skills+Future; Education+Skills+Future+Risk; Education+Skills+Risk; Education+Skills+Scenarios; Education+Skills+Scenarios+Future; Education+Skills+Scenarios+Future+Risk; Education+Skills+Scenarios+Risk

Narrative Videos ("Narratives") BEHAVIORAL

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.

Education+Narratives; Education+Narratives+Future; Education+Narratives+Future+Risk; Education+Narratives+Risk; Education+Narratives+Scenarios; Education+Narratives+Scenarios+Future; Education+Narratives+Scenarios+Future+Risk; Education+Narratives+Scenarios+Risk; Education+Narratives+Skills; Education+Narratives+Skills+Future; Education+Narratives+Skills+Future+Risk; Education+Narratives+Skills+Risk; Education+Narratives+Skills+Scenarios; Education+Narratives+Skills+Scenarios+Future; Education+Narratives+Skills+Scenarios+Future+Risk; Education+Narratives+Skills+Scenarios+Risk

Skills Building Videos ("Skills") BEHAVIORAL

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.

Education+Narratives+Skills; Education+Narratives+Skills+Future; Education+Narratives+Skills+Future+Risk; Education+Narratives+Skills+Risk; Education+Narratives+Skills+Scenarios; Education+Narratives+Skills+Scenarios+Future; Education+Narratives+Skills+Scenarios+Future+Risk; Education+Narratives+Skills+Scenarios+Risk; Education+Skills; Education+Skills+Future; Education+Skills+Future+Risk; Education+Skills+Risk; Education+Skills+Scenarios; Education+Skills+Scenarios+Future; Education+Skills+Scenarios+Future+Risk; Education+Skills+Scenarios+Risk

Interactive Scenarios ("Scenarios") BEHAVIORAL

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.

Education+Narratives+Scenarios; Education+Narratives+Scenarios+Future; Education+Narratives+Scenarios+Future+Risk; Education+Narratives+Scenarios+Risk; Education+Narratives+Skills+Scenarios; Education+Narratives+Skills+Scenarios+Future; Education+Narratives+Skills+Scenarios+Future+Risk; Education+Narratives+Skills+Scenarios+Risk; Education+Scenarios; Education+Scenarios+Future; Education+Scenarios+Future+Risk; Education+Scenarios+Risk; Education+Skills+Scenarios; Education+Skills+Scenarios+Future; Education+Skills+Scenarios+Future+Risk; Education+Skills+Scenarios+Risk

Future Life Planning Tool ("Future") BEHAVIORAL

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.

Education+Future; Education+Future+Risk; Education+Narratives+Future; Education+Narratives+Future+Risk; Education+Narratives+Scenarios+Future; Education+Narratives+Scenarios+Future+Risk; Education+Narratives+Skills+Future; Education+Narratives+Skills+Future+Risk; Education+Narratives+Skills+Scenarios+Future; Education+Narratives+Skills+Scenarios+Future+Risk; Education+Scenarios+Future; Education+Scenarios+Future+Risk; Education+Skills+Future; Education+Skills+Future+Risk; Education+Skills+Scenarios+Future; Education+Skills+Scenarios+Future+Risk

Epidemiological Risk Scenario ("Risk") BEHAVIORAL

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).

Education+Future+Risk; Education+Narratives+Future+Risk; Education+Narratives+Risk; Education+Narratives+Scenarios+Future+Risk; Education+Narratives+Scenarios+Risk; Education+Narratives+Skills+Future+Risk; Education+Narratives+Skills+Risk; Education+Narratives+Skills+Scenarios+Future+Risk; Education+Narratives+Skills+Scenarios+Risk; Education+Risk; Education+Scenarios+Future+Risk; Education+Scenarios+Risk; Education+Skills+Future+Risk; Education+Skills+Risk; Education+Skills+Scenarios+Future+Risk; Education+Skills+Scenarios+Risk

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• The Miriam Hospital: collaborator

Study Sites (1)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases; Coitus

Interventions

Educational Status; Risk

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ryan R Landoll, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

• Sara E Vargas, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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)
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: December 10, 2020
• Study Start: September 2, 2021
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)