Condition category
Infections and Infestations
Date applied
18/05/2007
Date assigned
10/09/2007
Last edited
10/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Andersson

ORCID ID

Contact details

CIET Trust Botswana
PO Box 1240
Gaborone
-
Botswana

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

http://www.ciet.org/

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

Publication citations

Additional files

Editorial Notes