Instruct trial design
The INSTRUCT trial uses a stepped-wedge design. It is difficult to roll out a new prevention approach everywhere at the same time. The stepped-wedge design divides all the districts into groups, and rolls out the new approach one group at a time. Randomising the order of implementation gives all districts the same chance to go first, and the same chance to benefit from experience of other districts that started earlier. As each new group of districts joins in, their baseline study provides a comparison point (control) for the group of districts that went just before them.
At the start of the trial in 2014, we randomly allocated the 30 administrative districts in the country into six intervention waves, each of five districts, stratified by development status and HIV prevalence (above or below the national average).
The first year of the trial saw implementation of the INSTRUCT interventions in one district of the first wave, allowing the team to operationalize the scaling up of interventions to the whole district. From 2016, all five first wave districts are receiving the intervention package. Later, a survey in a random sample of communities in the five first wave districts and the five second wave districts (controls for the first wave), will measure impact of the intervention on HIV infection among young women. The stepped-wedge design allows for repeating the trial process for subsequent waves of districts, with fine-tuning of the intervention package as necessary.
- FOCUSED WORKSHOPS FOR VULNERABLE YOUNG WOMEN (not in work and not in school) to build their self-esteem and communication skills, and put them in touch with officers of government structural support programmes, to help them access and benefit from these programmes.
- WORKING WITH GOVERNMENT SUPPORT PROGRAMMES to help to re-focus the programmes to become more accessible for vulnerable young women.
- BEYOND VICTIMS AND VILLAINS IS AN AUDIO-DRAMA discussed with schools and with groups of all ages and both sexes in communities throughout each intervention district. It attempts to build an enabling environment for young women in the communities to change and make protective choices. The eight episodes cover topics including gender roles, gender violence, transactional sex, choice disability and how these relate to HIV risk in Botswana.
The impact survey for INSTRUCT will include a questionnaire survey of young women and young men in randomly selected communities in intervention and control districts, and finger prick blood sampling to create dried blood spots for HIV testing.
INSTRUCT seeks to reduce new HIV infections, particularly among young women. The primary outcome of the trial is prevalence of HIV infection among women, aged 15-29 years, living in intervention districts compared with such women living in control districts. Because some of them could have been infected before the intervention started, INSTRUCT will also use newer tests to detect recent HIV infection, allowing an estimate of annual HIV incidence.
Secondary outcomes of INSTRUCT will be measured among young women and young men aged 15-29 years. They include protective knowledge, attitudes, subjective norms, intention to change, agency, discussion of prevention, and behaviours related to gender violence and HIV risk and prevention.