Acquired immune deficiency syndrome (AIDS) prevention through reduced choice disability

ISRCTN	ISRCTN28557578
DOI	https://doi.org/10.1186/ISRCTN28557578
Secondary identifying numbers	N/A

Submission date: 12/06/2008
Registration date: 13/08/2008
Last edited: 02/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Neil Andersson
Scientific

1 Stewart Street
Room 319
Ottawa
K1N 6N5
Canada

Study information

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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study 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)
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

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	79 clusters
Participant inclusion criteria	79 nationally representative clusters (100 - 120 households) randomly selected (from population census) enumeration areas.
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
Eswatini
Namibia

Study participating centre

1 Stewart Street

Ottawa
K1N 6N5
Canada

Sponsor information

International Development Research Centre (IDRC) (Canada)
Research organisation

PO Box 8500
Ottawa
K1G 3H9
Canada

Website	http://www.idrc.ca/index_en.html
"ROR"	https://ror.org/0445x0472

Funders

Funder type

Research organisation

International Development Research Centre (IDRC) (Canada)
Government organisation / Local government

Alternative name(s): Centre de recherches pour le développement international, IDRC, CRDI
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/08/2013		Yes	No