Protecting Our Future Generation: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention

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.

Conditions

• Self Evaluation
• Sexual Behavior
• Unprotected Sex
• Gonorrhea
• Chlamydia
• Trichomonas
• Sexually Transmitted Diseases
• Adolescent Behavior

Interventions

BEHAVIORAL

Sexual Health Risk Assessment

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.

BEHAVIORAL

Sexual Health Score

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.

BEHAVIORAL

Sexual Health Messaging

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.'

BEHAVIORAL

Water SSB Quiz

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).

BEHAVIORAL

Water SSB Score

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).

BEHAVIORAL

Water SSB Messaging

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.'

BEHAVIORAL

STI Screening

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).

Sponsors & Collaborators

• Native American Research Center for Health

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Francene Larzelere, D BH · Johns Hopkins Bloomberg School of Public Health

• Rachel Chambers, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

26 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2022-03-31

Completion

2022-03-31

Countries

• United States

Study Locations