Clinical trial NCT03895320: Protecting Our Future Generation: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
Official title: Protecting Our Future: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Unprotected Sex
Gonorrhea
Chlamydia
Trichomonas
Sexually Transmitted Diseases
Adolescent Behavior
Self Evaluation
Keywords: Native American
Youth
Young Adults
STI Screening
Self Administered Sample Collection
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Native American Research Center for Health
First posted: 2019-03-29
Enrollment: 219
Sex: ALL
Minimum age (years): 14
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Change in self-reported STI screening at 3-months and 6-months
timeFrame: 3-months and 6-months
Secondary outcomes:
measure: Sex without condom
timeFrame: 3-months and 6-months
measure: Sex without birth control
timeFrame: 3-months and 6-months
measure: Multiple partners
timeFrame: 3-months and 6-months
measure: New partners
timeFrame: 3-months and 6-months
measure: Concurrent partners
timeFrame: 3-months and 6-months
measure: Current symptoms of STI
timeFrame: 3-months and 6-months
measure: Alcohol and drug use
timeFrame: 3-months and 6-months
measure: Alcohol and drug use before sex
timeFrame: 3-months and 6-months
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Francene Larzelere, D BH
role: STUDY_DIRECTOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Rachel Chambers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauren T, Catherine S, Rachel C, Hima P, Angelita L, Shauntel L, Laura M, Anna S, Anne R, Mariddie C, Charlotte G. Protecting our future generation: study protocol for a randomized controlled trial evaluating a sexual health self-care intervention with Native American youth and young adults. BMC Public Health. 2019 Dec 2;19(1):1614. doi: 10.1186/s12889-019-7956-x.