Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CIET-LPEC
Study information
Scientific title
Acronym
Grannies
Study hypothesis
Empowering female elders through discussion of results for a national youth survey can increase their engagement in and support of young people in their communities.
Ethics approval
Approval received from Community Information, Empowerment and Transparency (CIET) Africa. Separate ethics approvals were also obtained for Limpopo (ref: LIM2-2006) dated 21st February 2006 and Eastern Cape (ref: CAG1-2006) dated 26th October 2006.
Study design
Cluster pragmatic randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) prevention
Intervention
After the baseline surveys, communities were randomised to intervention and control sites (unit of randomisation is the school with its attendant community). In Limpopo, there were 15 such intervention communities, 9 Xitsonga and 6 Sepedi speaking. There were 15 control communities, also 9 of them Xitsonga and 6 Sepedi speaking. In Amathole district in the Eastern Cape, also after the baseline survey, there were 13 intervention and 15 control communities.
Communities were randomised after youth baseline survey to early and late initiation of intervention.
Intervention:
1. AIDS prevention education
2. Sexual violence education
Based on national youth survey
Control:
Usual education
The intervention lasts 3 - 5 months with follow-up study 12 months after intervention.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
HIV-related protective attitudes and practices among youth, measured 12 months after intervention, in a school-based study in communities where the granny groups took place.
Secondary outcome measures
1. Conscious knowledge of HIV risk and related attitudes
2. Positive deviations from subjective norms
3. Intention to change
4. Sense of agency
5. Discussion of HIV risks
All measured 12 months after intervention, in a school-based study in communities where the granny groups took place.
Overall trial start date
01/05/2006
Overall trial end date
30/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Female elders in target community
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1000 female elders
Participant exclusion criteria
Men
Recruitment start date
01/05/2006
Recruitment end date
30/04/2008
Locations
Countries of recruitment
South Africa
Trial participating centre
CIET Trust Botswana
Gaborone
-
Botswana
Sponsor information
Organisation
Community Information, Empowerment and Transparency (CIET) Trust (South Africa)
Sponsor details
c/o Neil Andersson
CIET Trust Botswana
PO Box 1240
Gaborone
-
Botswana
Sponsor type
Charity
Website
Funders
Funder type
Government
Funder name
Australia's Overseas Aid Program (AusAID) (Australia) - Addressing Domestic Violence in Limpopo
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Conflict and Governance Facility (CAGE) (South Africa) - funded by the South African Government and The European Commission
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary