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04 February 2012
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| [ Print-friendly version ] |
| Acquired immune deficiency syndrome (AIDS) prevention through reduced choice disability |
| ISRCTN | ISRCTN28557578 |
| ClinicalTrials.gov identifier | |
| 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 |
| Acronym | NOCHOICE |
| Serial number at source | N/A |
| 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'. |
| Lay summary | |
| 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 |
| Countries of recruitment | Botswana, Namibia, Swaziland |
| Disease/condition/study domain | Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) |
| Participants - inclusion criteria | 79 nationally representative clusters (100 - 120 households) randomly selected (from population census) enumeration areas. |
| Participants - exclusion criteria | Does not comply with inclusion criteria |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 30/08/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 79 clusters |
| Interventions |
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 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. |
| 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. |
| Sources of funding | International Development Research Centre (IDRC) (Canada) |
| Trial website | |
| Publications | |
| Contact name | Dr Neil Andersson |
| Address |
1 Stewart Street
Room 319 |
| City/town | Ottawa |
| Zip/Postcode | K1N 6N5 |
| Country | Canada |
| Sponsor | International Development Research Centre (IDRC) (Canada) |
| Address | PO Box 8500 |
| City/town | Ottawa |
| Zip/Postcode | K1G 3H9 |
| Country | Canada |
| Sponsor website: | http://www.idrc.ca/index_en.html |
| Date applied | 12/06/2008 |
| Last edited | 24/02/2009 |
| Date ISRCTN assigned | 13/08/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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