uptake and impact of HIV combination (HIVCOMB) interventions on HIV incidence among fishing communities in Uganda. (360G-Wellcome-102237_Z_13_Z)

This is a five-year trial that aims estimate the effectiveness of a combined package of HIV interventions (biomedical,behavioural and structural) on HIV incidence in adults among most-at-risk populations in 12 fishing communities in Uganda. The trial will use a stepped-wedge community-randomised trial (CRT) design in which the unit of randomisation will be a community. Communities will be randomised into 4 equally-sized groups, and the time at which each group first receives the intervention is randomised. Primary outcome measure will be HIV incidence estimated from a random sample of 2880 adults tested for HIV status at baseline and over 6 periods of 8 months each. Secondary outcomes will be: i) Mean and total community viral load (CVL), ii) reported behaviour change iii) process indicators iv) cost per HIV infection, death and DALY averted, v) predicted HIV incidence and impact of single and combined intervention and cost effectiveness obtained from modelling of empirical data from the trial. HIV incidence will be estimated among HIV-negative participants at baseline and determined at follow-up serological surveys. The primary analysis will be at cluster level. For each period we will estimate the HIV incidence rate for each community. CVL and reported behaviour will be analysed using analogous clusterlevel methods. The uptake of each intervention will be estimated restricting the analysis to communities in the periods in which they receive the interventions. Qualitative research and ethnographic techniques will be used to assess structural factors that facilitate HIV transmission. Cost per HIV infection, death and DALY averted will be estimated by combining the benefits of HIV prevention with the benefits from uptake of HIV treatment and care. We will use a mathematical model to assess the effect of a combination of interventions and hence determine the benefit of combined over singly applied interventions. This trial complements other ongoing trials in Africa.