- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05869864
Schools Championing Safe South Africa
Schools Championing Safe South Africa: An Intervention Engaging Teachers and Students in Adolescent Prevention of HIV Risk and Intimate Partner Violence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Cape Town, South Africa
- South African Medical Research Council
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- identifies as boy
- 15-17 years of age inclusive
- attends school where study is occurring
Exclusion Criteria:
- unable to secure parental consent
- unable to secure parental consent child assent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Half of the participants in the pilot will receive the experimental behavioral intervention.
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The intervention consists of 2 parts - a poster campaign with social norms messages on violence and HIV risk, and 2 lessons in life orientation (a health curriculum delivered during school).
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No Intervention: Control
Half of the participants in the pilot will receive nothing, and serve as the control.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Expressed Satisfaction With the Intervention
Time Frame: 6 months
|
Client Satisfaction Questionnaire - Using the client satisfaction questionnaire, investigators will measure satisfaction using likert scale responses that range from 1 to 5 with 5 aligning with high satisfaction with the intervention. Investigators are aiming for 80% of more of participants with rankings of satisfied or higher. The questionnaire is based off of the following measure: Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: Development of a general scale. Evaluation and Program Planning. 1979;2:197-207. Only participants in the intervention arm answer questions on satisfaction with the intervention. |
6 months
|
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Number of Participants Who Were Retained At the 6-month Time Point
Time Frame: 6 months
|
There is no scale for feasibility.
Investigators will look at retention rates.
Feasibility will be aligned with 75% or higher retention rates at the 6 month timepoint.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use.
Time Frame: 6 months
|
This is an underpowered outcome because the primary goal of this study is not to evaluate efficacy.
There is no scale for these behaviors.
For this secondary outcome, investigators will examine the percent of participants who engaged in lifetime condom use.
This will be reported for each arm, comparing percentages engaged in lifetime condom use at the 6-month time point for each arm separately.
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6 months
|
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Prevention or Reduction of Attempted or Completed Acts of Intimate Partner Violence Using Mary Koss's Short Form Sexual Violence Perpetration Scale At the 1-month Time Point
Time Frame: 1 month
|
This is an underpowered outcome because the primary goal of this study is not to evaluate efficacy.
For this secondary outcome, investigators will examine if there is a decrease in incidents of attempted and completed acts of sexual violence.
The percentage of participants engaged in any completed act of sexual perpetration - defined as 1 or more acts of forced touching, oral sex, anal sex, and/or vaginal sex - will be compared for the intervention arm, looking at baseline versus 1 month.
Similarly, the percentage of participants engaged in any completed act of sexual perpetration - defined as 1 or more acts of forced touching, oral sex, anal sex, and/or vaginal sex - will be compared for the control arm, looking at baseline versus 1 month.
|
1 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Schools Championing
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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