Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03895320
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sexual Behavior Unprotected Sex Gonorrhea Chlamydia Trichomonas Sexually Transmitted Diseases Adolescent Behavior Self Evaluation Behavioral: Sexual Health Risk Assessment Behavioral: Sexual Health Score Behavioral: Sexual Health Messaging Behavioral: Water SSB Quiz Behavioral: Water SSB Score Behavioral: Water SSB Messaging Behavioral: STI Screening Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : October 1, 2021

Arm Intervention/treatment
Experimental: Intervention Program
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.
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: 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).

Control Program
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.
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).




Primary Outcome Measures :
  1. Completion of STI Screening [ Time Frame: 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


Secondary Outcome Measures :
  1. Sex without condom [ Time Frame: 3-months and 6-months ]
    CHANGE IN SEX WITHOUT A CONDOM, BETWEEN INTERVENTION AND CONTROL GROUPS AT 3-MONTHS AND 6-MONTHS, AS MEASUSED BY A SELF-REPORT QUESTIONNAIRE

  2. Sex without birth control [ Time Frame: 3-months and 6-months ]
    CHANGE IN SEX WITHOUT BIRTH CONTROL, BETWEEN INTERVENTION AND CONTROL GROUPS AT 3-MONTHS AND 6-MONTHS, AS MEASUSED BY A SELF-REPORT QUESTIONNAIRE

  3. Multiple partners [ Time Frame: 3-months and 6-months ]
    CHANGE IN NUMBER OF SEXUAL PARTNERS, BETWEEN INTERVENTION AND CONTROL GROUPS AT 3-MONTHS AND 6-MONTHS, AS MEASUSED BY A SELF-REPORT QUESTIONNAIRE

  4. New partners [ Time Frame: 3-months and 6-months ]
    CHANGE IN NUMBER OF NEW SEXUAL PARTNERS, BETWEEN INTERVENTION AND CONTROL GROUPS AT 3-MONTHS AND 6-MONTHS, AS MEASUSED BY A SELF-REPORT QUESTIONNAIRE

  5. Concurrent partners [ Time Frame: 3-months and 6-months ]
    CHANGE IN NUMBER OF NEW SEXUAL PARTNERS, BETWEEN INTERVENTION AND CONTROL GROUPS AT 3-MONTHS AND 6-MONTHS, AS MEASUSED BY A SELF-REPORT QUESTIONNAIRE

  6. Current symptoms of STI [ Time Frame: 3-months and 6-months ]
    CHANGE IN CURRENT SYMPTOMS OF STI, BETWEEN INTERVENTION AND CONTROL GROUPS AT 3-MONTHS AND 6-MONTHS, AS MEASUSED BY A SELF-REPORT QUESTIONNAIRE

  7. Alcohol and drug use [ Time Frame: 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 MEASUSED BY A SELF-REPORT QUESTIONNAIRE

  8. Alcohol and drug use before sex [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895320


Contacts
Layout table for location contacts
Contact: Lauren Tingey, PhD 443-287-5170 ltingey1@jhu.edu
Contact: Rachel Chambers, MPH 410-955-6931 rstrom3@jhu.edu

Locations
Layout table for location information
United States, Arizona
Johns Hopkins Center for American Indian Health Recruiting
Whiteriver, Arizona, United States, 85941
Contact: Lauren Tingey, PhD    410-955-6931    ltingey1@jhu.edu   
Contact: Rachel Chambers, MPH    4109559631    rstrom3@jhu.edu   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Layout table for investigator information
Principal Investigator: Lauren Tingey, PhD Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03895320    
Other Study ID Numbers: 8964
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Native American
Youth
Young Adults
STI Screening
Self Administered Sample Collection
Additional relevant MeSH terms:
Layout table for MeSH terms
Sexually Transmitted Diseases
Gonorrhea
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Virus Diseases
Neisseriaceae Infections