Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
NOCHOICE
Study hypothesis
Why a trial is needed:
Almost all interventions currently addressing acquired immune deficiency syndrome (AIDS) are geared for those who can act on their prevention decisions. Although a recent randomised controlled trial (RCT) showed reduction of sexual violence with an economic intervention, it is not known how this might affect human immunodeficiency virus (HIV) rates. There is little research on complex interventions in AIDS prevention, yet all countries in the region implement multiple intervention prevention programmes.
The issue:
Reduce HIV risk through reducing choice disablement or ameliorating its worst effects on AIDS though sensitisation of local AIDS prevention efforts and economic empowerment. After implementation in Botswana, the eventual objective is a 10-country controlled trial to demonstrate the impact of concerting public services in favour of the choice disabled, primary prevention of sexual violence and economic empowerment.
Please note that as of 24/02/2009 this record has been amended to include a new end date; the inital information at time of registration was as follows:
Initial anticipated end date: 01/09/2012
At this time, the acronym was also changed from 'BART2' to 'NOCHOICE'.
Ethics approval(s)
Added 24/02/2009:
1. Botswana Ministry of Health gave approval on the 26th August 2008 (ref: PPME-13/18/1 Vol IV(4))
2. Namibia Ministry of Health and Social Services gave approval on the 22nd July 2008 (ref: 17/3/3AP)
3. Swaziland Ministry of Health gave approval on the 26th August 2008 (ref: MH/599B)
Study design
Cluster randomised controlled four-arm factorial trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
Intervention
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.
Intervention type
Other
Primary outcome measure
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 measures
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.
Overall study start date
01/09/2008
Overall study end date
30/08/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
79 nationally representative clusters (100 - 120 households) randomly selected (from population census) enumeration areas.
Participant type(s)
Patient
Age group
Other
Sex
Both
Target number of participants
79 clusters
Participant exclusion criteria
Does not comply with inclusion criteria
Recruitment start date
01/09/2008
Recruitment end date
30/08/2012
Locations
Countries of recruitment
Botswana, Canada, Namibia, Swaziland
Study participating centre
1 Stewart Street
Ottawa
K1N 6N5
Canada
Sponsor information
Organisation
International Development Research Centre (IDRC) (Canada)
Sponsor details
PO Box 8500
Ottawa
K1G 3H9
Canada
Sponsor type
Research organisation
Website
http://www.idrc.ca/index_en.html
ROR
Funders
Funder type
Research organisation
Funder name
International Development Research Centre (IDRC) (Canada)
Alternative name(s)
Centre de recherches pour le développement international, IDRC, CRDI
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/08/2013 | Yes | No |