This cluster randomised controlled trial tests interventions to reduce the effects of choice disability, aiming to reduce gender violence and HIV infection rates, particularly among young women. The primary outcome measure is HIV infection among young women aged 15-29 years. Secondary outcomes include rates of gender violence, risky sexual behaviours, and relevant attitudes and beliefs.
Following a baseline survey in 2008, 77 communities in Botswana, Namibia and Swaziland were randomly allocated to receive one or more of three interventions, alone or in combination, or no interventions. The three interventions are an educational docudrama; a programme to support and empower young women; and work to help local services become aware of and better serve the needs of the choice disabled. The impact survey for the trial took place in late 2012 and results are expected in the first half of 2013.
This survey took place in 10 Southern African countries: Botswana, Lesotho, Malawi, Mozambique, Namibia, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe. In each country field workers interviewed adults aged 16-60 in households in a representative sample of communities, covering some 24,000 people across the 10 countries. In schools serving the same communities, more than 93,000 school going youth completed their own questionnaires, with the questions read out by facilitators in the classrooms. The questionnaires covered knowledge, attitudes and behaviours related to gender, gender violence and HIV.
In eight of the countries, a 2002 survey had used the same instruments in the same sites, allowing an analysis of changes over time. Publications arising from the 2007 survey have described factors related to having multiple sexual partners in Botswana, changes over time in the practice of multiple sexual partners in Swaziland, HIV related stigma in Tanzania, and changes over time and factors related to the experience of forced sex among school going youth in 2007.
We used the findings from the 2007 survey in Botswana, Namibia and Swaziland to update the material in the Beyond Victims and Villains radio docudrama, originally based on evidence from earlier surveys in South Africa.
Prior to randomising clusters to interventions for the Choice Disability Trial, we undertook a baseline survey in all the sites. Trained fieldworkers in each country (Botswana, Namibia, and Swaziland) interviewed young women and men aged 15-29 in households in representative clusters (enumeration areas): 25 each in Botswana and Swaziland and 27 in Namibia. In each cluster they interviewed approximately 100 young men and women; about 7,300 in total.
After securing informed, signed consent from each person (or a parent for those under 18 years), each fieldworker obtained a finger prick blood sample to create dried blood spots (DBS) for anonymous HIV testing and administered the questionnaire. A short video helped in training the fieldworkers to obtain the blood samples. The questionnaire, translated into the appropriate local language, covered attitudes and practices about gender violence and HIV, including information on sexual behaviour, forced sex, and male circumcision.
Double data entry, with validation of discordant entries to minimise key stroke errors, created an electronic database of questionnaire responses. The National Institute for Communicable Diseases in Johannesburg analysed the DBS samples for HIV antibodies. Barcode labels linked the HIV test results to individual questionnaire records.
Following the 2008 baseline survey, in 2009 we randomised the 77 clusters included in the survey: 25 each in Botswana and Swaziland and 27 in Namibia. At the time of the baseline survey, we sought and obtained informed consent from community leaders for their community to participate in the trial, including being randomised to receive one or more of trial interventions or to be initially a control site for the trial.
An epidemiologist not involved in the fieldwork randomised the clusters within each country separately, using a random number sequence generator. Within each country, we first stratified the clusters
- into urban and rural clusters
- by HIV prevalence in the baseline survey (above or below the average for the stratum) within urban and rural strata
In a factorial design, we assigned clusters to receive no intervention, or combinations of one or more of the three interventions. The resulting pattern of a control and three intervention arms allows each intervention to be tested on its own and in combination with others.
We developed three interventions to be tested in the trial, all related to the concept of choice disability and the hypothesis that reducing choice disability or its worst effects can reduce HIV infection.
The Beyond Victims and Villains (BVV) intervention is an educational programme around gender violence and HIV, implemented in different sectors of the population. The Focused Workshop (FW) is a supportive, empowerment programme aimed at young women aged 18-24 years. The third intervention, Concerting, involves introducing service providers in the community to the idea of choice disability and encouraging them to find ways to serve the choice disabled better, including working with other service providers to do this.
The BVV and Concerting interventions began in mid 2009 in the clusters allocated to receive them, while the FW intervention began in early 2010. All the interventions continued up until the time of the impact survey in late 2012.
The impact survey in all the 77 trial clusters took place from August to November 2012. In each cluster, trained fieldworkers interviewed and obtained finger prick dried blood spot (DBS) samples from approximately 100 young women and men aged 15-29 years. The questionnaire covered: attitudes about gender, gender violence and HIV; sexual behaviour; and experience or perpetration of intimate partner violence and forced sex.
The fieldworkers undertaking the interviews in the impact survey were unaware of the intervention status of each cluster.
Data entry for all three countries took place in Botswana, using double data entry with validation to minimise keystroke errors. Further cleaning will look for logical inconsistencies and out of range responses and check back to the data collection registers as necessary.
The National Institute for Communicable Diseases in Johannesburg
The National Institute for Communicable Diseases in Johannesburgwill test the DBS samples for HIV antibodies, and test the confirmed positive samples for evidence of recent (“incident”) infection. Barcode labels will link the HIV test results to individual questionnaire records. HIV testing results are expected in early 2013.
Analysis in 2013 will compare the primary outcome (HIV incidence among young women aged 15-29 years) between the intervention and control communities. We will also examine impact on intermediate outcomes, including gender violence, sexual behaviour, and relevant attitudes.