Protecting Our Future Generation: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
NCT ID: NCT03895320
Last Updated: 2024-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
219 participants
INTERVENTIONAL
2019-03-01
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
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.
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.
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.'
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.
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).
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).
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.'
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).
Interventions
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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.
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.
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.'
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).
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).
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.'
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).
Eligibility Criteria
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Inclusion Criteria
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
2. Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
14 Years
26 Years
ALL
Yes
Sponsors
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Native American Research Center for Health
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Francene Larzelere, D BH
Role: STUDY_DIRECTOR
Johns Hopkins Bloomberg School of Public Health
Rachel Chambers, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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Johns Hopkins Center for American Indian Health
Whiteriver, Arizona, United States
Countries
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References
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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.
Other Identifiers
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IRB00008964
Identifier Type: OTHER
Identifier Source: secondary_id
8964
Identifier Type: -
Identifier Source: org_study_id
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