Trial Outcomes & Findings for Schools Championing Safe South Africa (NCT NCT05869864)

NCT ID: NCT05869864

Last Updated: 2025-06-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 282 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-06-18

Participant Flow

While teachers were exposed to the intervention (including the poster campaign), they were not the main target of the intervention.Thus, data on the primary outcomes of the study was not gathered from teachers.

Participant milestones

Measure	Intervention Half of the participants in the pilot will receive the experimental behavioral intervention. Schools Championing Safe South Africa: 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).	Control Half of the participants in the pilot will receive nothing, and serve as the control.
Overall Study STARTED	142	140
Overall Study COMPLETED	142	140
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Schools Championing Safe South Africa

Baseline characteristics by cohort

Measure	Intervention n=142 Participants Half of the participants in the pilot will receive the experimental behavioral intervention. Schools Championing Safe South Africa: 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).	Control n=140 Participants Half of the participants in the pilot will receive nothing, and serve as the control.	Total n=282 Participants Total of all reporting groups
Age, Categorical Participants under 18 years · <=18 years	142 Participants n=5 Participants	140 Participants n=7 Participants	282 Participants n=5 Participants
Age, Categorical Participants under 18 years · Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Participants under 18 years · >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	140 Participants n=7 Participants	282 Participants n=5 Participants
Race/Ethnicity, Customized Black African	142 Participants n=5 Participants	136 Participants n=7 Participants	278 Participants n=5 Participants
Race/Ethnicity, Customized Coloured	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment South Africa	142 participants n=5 Participants	140 participants n=7 Participants	282 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants assigned to the intervention arm, and who were exposed to the experimental intervention, answered questions on satisfaction with the intervention.

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.

Outcome measures

Measure	Intervention n=140 Participants Half of the participants in the pilot will receive the experimental behavioral intervention. Schools Championing Safe South Africa: 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).	Control Half of the participants in the pilot will receive nothing, and serve as the control.
Number of Participants Who Expressed Satisfaction With the Intervention	113 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=142 Participants Half of the participants in the pilot will receive the experimental behavioral intervention. Schools Championing Safe South Africa: 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).	Control n=140 Participants Half of the participants in the pilot will receive nothing, and serve as the control.
Number of Participants Who Were Retained At the 6-month Time Point	140 Participants	139 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=142 Participants Half of the participants in the pilot will receive the experimental behavioral intervention. Schools Championing Safe South Africa: 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).	Control n=140 Participants Half of the participants in the pilot will receive nothing, and serve as the control.
Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use. Number of participants engaged in lifetime condom use at 1 month	95 Participants	92 Participants
Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use. Number of participants engaged in lifetime condom use at 6 months	98 Participants	99 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=142 Participants Half of the participants in the pilot will receive the experimental behavioral intervention. Schools Championing Safe South Africa: 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).	Control n=140 Participants Half of the participants in the pilot will receive nothing, and serve as the control.
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	78 Participants	81 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Intervention n=142 participants at risk Half of the participants in the pilot will receive the experimental behavioral intervention. Schools Championing Safe South Africa: 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).	Control n=140 participants at risk Half of the participants in the pilot will receive nothing, and serve as the control.
General disorders Death of study participant	0.00% 0/142 • Adverse events were tracked from the date of enrollment until 6 month followup (the last followup timepoint).	0.71% 1/140 • Number of events 1 • Adverse events were tracked from the date of enrollment until 6 month followup (the last followup timepoint).

Other adverse events

Adverse event data not reported

Additional Information

Caroline Kuo, DPhil, MPhil

American University

Phone: 2028857385

Email: ckuo@american.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place