Clinical trial NCT04661566: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
Pregnancy, Unplanned
Military Personnel
Keywords: Women's Health
Sexual and Reproductive Health
Military
Multiphase Optimization Strategy
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: The Miriam Hospital
First posted: 2020-12-10
Enrollment: 549
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in SRH knowledge as assessed by measures of STI Knowledge
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in SRH knowledge as assessed by measures of Pregnancy and Birth Control Knowledge
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in perceived risk of having a negative SRH outcome as assessed by measures of Perceived Risk
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in attitudes about SRH as assessed by measures of Condom Attitudes on a likert scale
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in attitudes about SRH as assessed by measures of Condom Attitudes on an ordinal item
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert-type scale
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert scale
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in attitudes about SRH as assessed by measures of Norms
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in self-efficacy about SRH as assessed by measures of Condom/Birth Control Use
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in self-efficacy about SRH as assessed by measures of Partner Communication/Negotiation
timeFrame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on ordinal items
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on yes/no/dont-know items
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on no/yes,previously/yes,currently items
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on dichotomous items
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on open response (number input) items
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on nominal items
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on ordinal items
timeFrame: Within 3 weeks post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on yes/no/dont-know items
timeFrame: Within 3 weeks post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on dichotomous items
timeFrame: Within 3 weeks post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on open response (number input) items
timeFrame: Within 3 weeks post-intervention
measure: Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions
timeFrame: Within 3 weeks post-intervention
measure: Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "very helpful" to "not helpful at all")
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "strongly agree" to "strongly disagree")
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "to much" to "some to little")
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on yes/no/dont-know nominal items
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on no/yes,recent/yes,not-recent nominal items
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on a cumulative scale
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Quality and satisfaction of healthcare provider interactions as assessed by measures of Patient-Provider Communication
timeFrame: Baseline
measure: Change in self-reported mental health as assessed by Depression (PHQ-2)
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Change in self-reported mental health as assessed by Anxiety (HAI)
timeFrame: Baseline and 30-to-90 days post-intervention
measure: Intervention acceptability as assessed by measures on Acceptability
timeFrame: Within 3 weeks post-intervention
measure: Intervention acceptability as assessed by measures on Acceptability as open-ended items
timeFrame: Within 3 weeks post-intervention
measure: Intervention acceptability as assessed by measures on Acceptability on a rating scale
timeFrame: Within 3 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Ryan R Landoll, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Sara E Vargas, PhD
role: PRINCIPAL_INVESTIGATOR
References: