Protecting Our Future Generation: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
Condition: Sexual Behavior; Unprotected Sex; Gonorrhea; Chlamydia; Trichomonas; Sexually Transmitted Diseases; Adolescent Behavior; Self Evaluation
MeSH terms: Sexually Transmitted Diseases; Gonorrhea
Study type: Interventional

Summary: 
      The aim of this research protocol is to test the efficacy of a self-care intervention through
      a randomized controlled trial (RCT), for increasing protective sexual health behaviors among
      youth in the participating Native American community. The investigators will randomize 450
      youth and young adults ages 14-26 to the self-care intervention or a control program.
      Efficacy data will be collected up to 6 months post-intervention. The primary outcome will be
      uptake of sexually transmitted infection (STI) screening. Secondary outcomes will include: a)
      sexual risk and protective behaviors; and b) psychosocial assets and resources. The
      investigators hypothesize the self-care intervention will increase protective behaviors by:
      i) helping youth gain knowledge of their own sexual health risks, assets and resources; ii)
      motivating protection of those assets and resources; and iii) encouraging good health
      practices and making responsible choices.
    

Detailed description: 
      The proposed study is a RCT to test the efficacy of a self-care intervention for sexual
      health promotion among youth and young adults in a participating Native American community.
      The goal of the intervention is to increase protective sexual health practices. The
      investigators will compare outcomes between two groups: the 1) experimental group and the 2)
      comparison group. Youth will be enrolled in the study and assessed at baseline, 3-months and
      6-months post-intervention. Participants ages 14-26 will be enrolled through a
      non-probability sampling frame at: a) the local Indian Health Service (IHS) facility,
      including the Emergency Department waiting room; b) local schools; c) during health fairs and
      other community-based events; and d) other community gathering spots. Eligible individuals
      will be of Native American ethnicity, 14-26 years of age, and have primary residence and/or
      employment within the participating tribe's reservation. Research staff will screen potential
      participants for inclusion/exclusion criteria, explain study goals and procedures, and
      administer informed consent. After obtaining participant consent, participants will complete
      a baseline assessment and then be randomized to receive the self-care intervention or a
      control program. Follow-up assessments will be administered at 3-months and 6-months
      post-intervention for all study participants. Each assessment is expected to take 20-30
      minutes to complete. The baseline assessment will take place at the location of recruitment
      and consent; follow-up assessments will take place at home or in a private location. All
      assessments will be self-administered on tablets using REDCap mobile technology.
    

Intervention name(s): Sexual Health Risk Assessment; Sexual Health Score; Sexual Health Messaging; Water SSB Quiz; Water SSB Score; Water SSB Messaging; STI Screening
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The self-assessment ('Sexual Health Risk Assessment'), will pertain to sexual and reproductive health. The self-assessment, will include a valid clinical prediction tool, established to predict STI positivity.; The results of the 'Sexual Health Risk Assessment' will produce a score ('Sexual Health Score'). The 'Sexual Health Score' will be presented as a number (0/10) and will be organized by category: Low, Medium or High Risk.; After the score ('Sexual Health Score') the participant will receive personalized messaging ('Sexual Health Messaging') that relates to their score and risk level (i.e. Low, Medium or High). Short messages that indicate key steps the person can take to lower their risk for STIs will be displayed on the screen that correspond to their 'Sexual Health Score.'; The self-assessment ('Water SSB Quiz') will pertain to consumption of water, soda and sugar sweetened beverages. There will not be a comparable clinical prediction tool in the control self-assessment ('Water SSB Quiz).; The results of the 'Water SSB Quiz' will produce a score ('Water SSB Score'). The 'Water SSB Score' will be presented as a number (0/10).; After the score ('Water SSB Score') the participant will receive personalized messaging ('Water SSB Messaging') that relates to their score. Short messages that indicate key steps the person can take to meet the recommended daily intake for water and sugar sweetened beverages will be displayed on the screen that correspond to their 'Water SSB Score.'; All participants regardless of group, will be offered a STI screening kit immediately after receipt of their respective program (intervention or control). Participants will have the option of completing the kit at the first study visit, taking it with them after the first study visit is over, or receiving it later from one of our staff either at our local project office or the kit can be dropped off at a location the participant chooses. Completed kits can be returned to our office or picked up by a study staff. (NOTE: while the STI screening kit will be available to all participants should they request it at subsequent study visits, e.g. the 3- and 6-month follow-ups, the STI screening kit will only be explicitly offered by the study team at the first study visit immediately after participants complete their respective quiz).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Native American; Youth; Young Adults; STI Screening; Self Administered Sample Collection