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

Not Applicable

Completed

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

• Registration Number: NCT03895320
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief 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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-29
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in self-reported STI screening at 3-months and 6-months	3-months and 6-months	Difference in completion of self-administered screening kit for gonorrhea, chlamydia, and trichomonas between intervention and control groups at 3-months and 6-months. Participants report if they completed a self-administered test at each time point.

Secondary Outcome Measures

Name	Time	Method
Multiple partners	3-months and 6-months	Change in number of sexual partners, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Current symptoms of STI	3-months and 6-months	Change in current symptoms of STI, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Alcohol and drug use	3-months and 6-months	Change in frequency of alcohol and drug use, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Concurrent partners	3-months and 6-months	Change in number of new sexual partners, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Sex without condom	3-months and 6-months	Change in sex without a condom, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Sex without birth control	3-months and 6-months	Change in sex without birth control, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
New partners	3-months and 6-months	Change in number of new sexual partners, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Alcohol and drug use before sex	3-months and 6-months	Change in frequency of alcohol and drug use before sex, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.

Trial Locations

Locations (1)

Johns Hopkins Center for American Indian Health; 🇺🇸 Whiteriver, Arizona, United States