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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN28557578
Date of registration: 13/08/2008
Prospective Registration: Yes
Primary sponsor: International Development Research Centre (IDRC) (Canada)
Public title: Acquired immune deficiency syndrome (AIDS) prevention through reduced choice disability
Scientific title: Acquired immune deficiency syndrome (AIDS) prevention in favour of the choice disabled: a randomised controlled trial to reduce human immunodeficiency virus (HIV) risk in southern Africa
Date of first enrolment: 01/09/2008
Target sample size: 79
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN28557578
Study type:  Interventional
Study design:  Cluster randomised controlled four-arm factorial trial (Treatment)  
Phase: 
Countries of recruitment
Botswana Namibia Swaziland
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Neil    Andersson
Address:  1 Stewart Street Room 319 K1N 6N5 Ottawa Canada
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 79 nationally representative clusters (100 - 120 households) randomly selected (from population census) enumeration areas.
Exclusion criteria: Does not comply with inclusion criteria

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
Infections and Infestations
Unspecified human immunodeficiency virus [HIV] disease
Intervention(s)
Four interventions, alone and in combination:
1. Optimises local private-public networks to reduce HIV risk in favour of those who cannot implement their prevention choices
2. Sexual violence education through schools, youth groups, granny groups, church groups and local radio, geared to generate endogenous community-specific solutions to reduce sexual violence
3. Focuses on empowerment of the choice disabled through the Organisational Workshop approach
4. Promotion of male circumcision

The interventions will run concurrently for three years, with a follow-up survey in the fourth year.
Primary Outcome(s)
The 2007 baseline and follow-up survey in year 4 will measure reduced sexual violence and HIV infection in women aged 18 - 29 years. Follow-up of a male (18 - 29 years) cohort established in 2008 will establish the impact of promoting male circumcision (MC), alone and in combination with other activities.

All will be measured in the fourth year.
Secondary Outcome(s)
All will be measured in the fourth year:
1. Protective knowledge
2. Attitudes
3. Subjective norms
4. Intention to change
5. Agency
6. Discussion of prevention
7. Practices related to sexual violence

Likely side effects of the intervention include reduced criminal delinquency and substance abuse.
Secondary ID(s)
N/A
Source(s) of Monetary Support
International Development Research Centre (IDRC) (Canada)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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