Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Inclusion criteria |
13/02/2017 |
On review we realized further clarification was needed |
Primary school girls class 6-7
Secondary schools girls form 1-4
|
Primary school girls class 5-7
Secondary schools girls form 1-3
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Exclusion criteria |
13/02/2017 |
On review we realized further clarification was needed |
Primary schools girls class 8
Randomised out by beads method |
Primary schools girls class 8
Secondary school girls Form 4
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Age group |
13/02/2017 |
Upon further review, realized that it needed further clarification |
26 |
26 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Age group |
13/02/2017 |
Upon further review, realized that it needed further clarification |
8 |
8 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Allocation sequence |
13/02/2017 |
On review we realized further clarification was needed |
Beads in opaque plastic containers |
Allocation was determined by the holder of the sequence who is situated off site |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Allocation sequence |
13/02/2017 |
On review we realized further clarification was needed |
Randomization was done at the school level using a probabilistic algorithm that assigned schools into either the control or treatment arms based on school sizes. At participant level students were randomly chosen using colored beads selection method. These randomisation were done separately for all districts covered (3) |
Stratified randomization was done at the district and school level. Using a probabilistic algorithm, we assigned schools into either the control or treatment arms based on school size. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
InterventionTypeID |
23/02/2017 |
previously combined sample size |
Experimental group |
Experimental group |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Inclusion criteria |
13/02/2017 |
Upon further review, realized that it needed further clarification |
Primary school girls class 6-7
Secondary schools girls form 1-4
|
Primary school girls class 5-7
Secondary schools girls form 1-3
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Exclusion criteria |
13/02/2017 |
Upon review, realized that it needed further clarification |
Primary schools girls class 8
Randomised out by beads method |
Primary schools girls class 8
Secondary schools Form 4 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
23/02/2017 |
correction |
6644 |
7832 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Exclusion criteria |
13/02/2017 |
Upon further review, realized that it needed further clarification |
Primary schools girls class 8
Randomised out by beads method |
Primary schools girls class 8
Secondary school girls form 4 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Inclusion criteria |
13/02/2017 |
Upon review, realized that it needed further clarification |
Primary school girls class 6-7
Secondary schools girls form 1-4
|
Primary school girls class 5-7
Secondary schools girls Form 1-3
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial phase |
26/02/2019 |
edit |
|
Not Applicable |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Other disease |
26/02/2019 |
edit |
violence against women and girls (VAWG) |
violence against women and girls |