Viewing Study NCT06482242



Ignite Creation Date: 2024-07-17 @ 11:02 AM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06482242
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-01
First Post: 2024-06-25

Brief Title: My Best Alaskan Life A Community-Designed Intervention to Improve YouthYoung Adults Sexual and Mental Health
Sponsor: University of Alaska Anchorage
Organization: University of Alaska Anchorage

Study Overview

Official Title: My Best Alaskan Life A Community-Designed Intervention to Improve YouthYoung Adults Sexual and Mental Health
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MBAL
Brief Summary: This project addresses critical public health disparities among Alaskan youth and young adults by developing and evaluating My Best Alaskan Life MBAL an innovative online tool aimed at improving sexual and mental health literacy and behaviors By integrating motivational interviewing and the Health Belief Model MBAL empowers individuals to make informed health decisions thereby potentially reducing rates of sexually transmitted infections HIV and associated mental health issues Long-term this project aims to enhance overall health outcomes particularly in underserved multicultural and Indigenous communities while building local research capacity through undergraduate and graduate student engagement and mentorship
Detailed Description: SPECIFIC AIMS Alaskan AK youthyoung adults YYA face significant sexual and reproductive health disparities leading the nation in sexually transmitted infections STI which increases risk of contracting HIV 1-5 AK has the third and fourth highest rates of chlamydia and gonorrhea in the US a 14 increase in syphilis cases compared to national rates between 2010-2020 and an estimated HIV prevalence of 1423 per 100000 versus 807 nationally 1 2 6-11 Concurrently AK YYA experience disproportionately high levels of hopelessness and depression increasing the likelihood of high-risk sexual behaviors 12-15 Some 358 of AK YYA did not use a condom during their last sexual intercourse and 169 do not use any pregnancy prevention method 12-14 The Centers for Disease Control and American College of Obstetricians and Gynecologists recommend use of Reproductive Life Plan RLP tools goal-setting guides for family planning 16 17 However in previous pilot studies YYAs expressed need for an interactive tool to go beyond pregnancy intentions and address sexual and mental health disparities and diverse gender and sexuality identities18 Gaps No RLP tools target sexual gender minority SGM YYA and the factors impacting their reproductive goals including mental health substance use or relationship health Recent systematic reviews of RLP tools note positive reception but lack evidence of efficacy in initiating knowledge or behavioral outcomes 19 Proposed Project To address these challenges the team will employ My Best Alaskan Life MBAL an online decision-making tool crafted through a 4-year youth-centered community-based participatory research effort CBPR Based on the Health Belief Model MBAL integrates motivational interviewing to empower YYA to define priorities identify supportive individuals and enhance health literacy for discussions with healthcare providers and trusted adults 20-28 This builds on two foundation and two implementation pilot studies where MBAL was refined by three youth advisory committees five focus groups and survey responses from 760 YYA 14-26 across AK18 Pilot outcomes endorsed MBALs acceptability appropriateness feasibility and capacity to enhance healthy sexual and mental beliefs particularly for SGM participants The proposed project builds on the CBPR approach an established 4-year relationship with YYA and supportive adult partners across state and local health agencies clinic and education health agencies across Alaska This randomized controlled trial RCT will use a step-wedge design to assess MBALs impact on Alaskan YYA through 8 clinical sites in rural and urban communities n40 participants per site total n320 This project will directly increase research capacity through annual cohorts of YYA co-investigators 5 undergraduate and 1 PhD student recruited from the University of Alaska who will be trained in qualitative research methods and mentored to lead the qualitative tool development analysis and dissemination

Central hypothesis MBAL has strong potential to effectively improve sexual mental health literacy and behavioral outcomes among Alaskan YYA through a self-guided personalized assessment of health motivations perceived threats behavior evaluations cultural factors that impact ones sexual choices inclusive of SGM Measures with are utilizing validated scales listed in Table 5 in C4 AIM 1 Evaluate Short- and Long-Term Impact of MBAL Methods PrePost Survey collected at enrollment30 days6 months 1A-1D Analysis Quantify changes in sexual health behaviors measures sexual health literacy condomcontraception use HIVSTI testing intention to delay sexual initiation Quantify changes in emotionalbehavioral health measures mental health and well-being self-efficacy hopelessness Quantify changes in commitment to factors impacting sexual health measures locus of controlperceived behavioral control motivation for change substance use Conduct analyses to identify potential variations in effectiveness of MBAL for diverse groups measures all AIM 2 Perform Process Evaluation Methods YYA co-investigator coordinated interviews semiannual anonymous surveys with all stakeholders feedback gathered at meetings annual anonymous survey with YYA co-investigators Analysis Understand participant experience and perception of MBAL tool measures cultural competence qualitative data YYA co-investigator interviews Understand experiences of research and community partners measures Investment in Process and Product qualitative feedback Understand experiences of YYA co-investigators Measures Student outcomes in research

AIM 3 Refine MBAL on Project Findings Methods Feedback gathered at meetings collaboration of research partners 3A Engage stakeholders in a collaborative process to make changes to MBAL based on RCT outcomes to ensure it addresses multifaceted aspects of sexual and mental health 3B YYA co-investigators will integrate insights from MBAL and evaluation to finalize MBAL for dissemination as 1 a free state-wide tool 2 for use by tribal and private health clinics and 3 by school integrated health providers

IMPACT The MBAL tool youth-developed dissemination and promotion campaign and the evidence provided for RLP adaptations may serve as a framework for similar regions ex low provider access multicultural and Indigenous youth high sexualmental health needs to improve health outcomes This proposal will also strengthen research opportunities by and for Alaskan YYA

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None