Condition category
Infections and Infestations
Date applied
12/06/2008
Date assigned
13/08/2008
Last edited
02/09/2013
Prospective/Retrospective
Prospectively 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

1 Stewart Street
Room 319
Ottawa
K1N 6N5
Canada

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2008

Overall trial end date

30/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

79 nationally representative clusters (100 - 120 households) randomly selected (from population census) enumeration areas.

Participant type

Patient

Age group

Other

Gender

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, Namibia, Swaziland

Trial 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

Funders

Funder type

Research organisation

Funder name

International Development Research Centre (IDRC) (Canada)

Alternative name(s)

Centre de recherches pour le développement international, IDRC

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23987126

Publication citations

  1. Protocol

    Andersson N, Cockcroft A, Thabane L, Marokoane N, Laetsang D, Masisi M, HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial., Trials, 2013, 14, 274, doi: 10.1186/1745-6215-14-274.

Additional files

Editorial Notes