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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Trichomonas; Self Evaluation; Sexually Transmitted Diseases; Gonorrhea; Chlamydia; Unprotected Sex; Sexual Behavior; Adolescent Behavior

Treatments: Behavioral: Water SSB Score; Behavioral: Water SSB Messaging; Behavioral: Water SSB Quiz; Behavioral: Sexual Health Risk Assessment; Behavioral: Sexual Health Messaging; Behavioral: STI Screening; Behavioral: Sexual Health Score

Study type: Interventional

Funder types: Other

Identifiers

NCT03895320

IRB00008964 (Other Identifier)

8964

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 14 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 14-26
2. Native American ethnicity
3. Membership in the participating Native American community. (Study participation is open to all Native American individuals who live on the participating Tribe's Reservation, on/near the border, and/or are employed on the participating Tribe's Reservation).
4. Have had sex at least once in their lifetime (vaginal)
5. Participant must have their own cell phone and agree to receiving generic text messages and phone calls from study staff
6. All participants must sign informed consent

Exclusion criteria

1. Unwilling to be randomized
2. Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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219 participants in 2 patient groups

Intervention Program

Experimental group

Description:

The intervention and control programs will consist of similar, but not identical components. The intervention will include a) a brief self-assessment (also called 'quiz'), b) score, and c) personalized messaging. For the intervention program, the self-assessment ('Sexual Health Quiz'), score ('Sexual Health Score') and messaging ('Sexual Health Messaging') will pertain to sexual and reproductive health. For the intervention program, the self-assessment, will include a valid clinical prediction tool, established to predict STI positivity. Short messages that indicate key steps the person can take to lower their risk for STIs will be displayed on the screen after the risk score. The program will be delivered via tablet. All participants regardless of randomization group, will be offered a STI screening kit immediately after receipt of their respective program.

Treatment:

Behavioral: Sexual Health Score

Behavioral: STI Screening

Behavioral: Sexual Health Messaging

Behavioral: Sexual Health Risk Assessment

Control Program

Other group

Description:

The intervention and control programs will consist of similar, but not identical components. The Control Program will include a) a brief self-assessment (also called 'quiz'), b) score, and c) personalized messaging. For the Control Program, the self-assessment ('Water Sugar Sweetened Beverages (SSB) Quiz'), score ('Water SSB Score') and messaging ('Water SSB Messaging') 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. However, based on the answers given on the control quiz, steps the control participant can take to meet the recommended daily intake of water and sugar sweetened beverages will be displayed on the screen after they complete the quiz. The control program will be delivered via tablet. All participants regardless of randomization group, will be offered a STI screening kit immediately after receipt of their respective program.

Treatment:

Behavioral: Water SSB Messaging

Behavioral: Water SSB Score

Behavioral: STI Screening

Behavioral: Water SSB Quiz