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

ISRCTN	ISRCTN28557578
DOI	https://doi.org/10.1186/ISRCTN28557578
Protocol serial number	N/A
Sponsor	International Development Research Centre (IDRC) (Canada)
Funder	International Development Research Centre (IDRC) (Canada)

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 of protocol

Not provided at time of registration

Contact information

Dr Neil Andersson
Scientific

1 Stewart Street
Room 319
Ottawa
K1N 6N5
Canada

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled four-arm factorial trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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)
Health condition(s) or problem(s) studied	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(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.
Key secondary outcome measure(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.
Completion date	30/08/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	79
Key inclusion criteria	79 nationally representative clusters (100 - 120 households) randomly selected (from population census) enumeration areas.
Key exclusion criteria	Does not comply with inclusion criteria
Date of first enrolment	01/09/2008
Date of final enrolment	30/08/2012

Locations

Countries of recruitment

Botswana
Canada
Eswatini
Namibia

Study participating centre

1 Stewart Street

Ottawa
K1N 6N5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes