A community randomized controlled trial to investigate impact of improved STD management and behavioural interventions on HIV incidence in rural Masaka, Uganda: trial design, methods and baseline findings

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Abstract
Summary: objective  To describe study design, methods and baseline findings of a behavioural intervention alone and in combination with improved management of sexually transmitted diseases (STDs) aimed at reducing HIV incidence and other STDs.design  A three‐arm community randomized controlled trial (RCT) of 18 rural communities (approximately 96 000 adults) in SW Uganda. A standardized behavioural intervention was implemented in 12 communities (arms A and B) through community‐based education, meetings and information leaflets. Six of these communities in addition received improved STD management through government and private health units (arm B). Arm C communities received routine government health services. Impact assessment was through three questionnaire and serological surveys of 750–1000 adults in each community at 18–24‐month intervals. The primary outcome measure was HIV incidence and secondary measures were syphilis and herpes simplex virus type 2 incidence, prevalence of Neisseria gonorrhoea and Chlamydia trachomatis and sexual behaviour changes.results  Approximately 15 000 adults (72% of eligible population) were enrolled at baseline. HIV baseline prevalence rates were 9–10% in all arms and demographic and behavioural characteristics and STD prevalence were also similar. In intervention communities, there were 391 995 attendance at 81 502 activities (6.1 per target adult), 164 063 leaflets distributed (2.6 per person) and 1 586 270 condoms (16.5 condoms per adult). In the STD communities a total of 12 239 STD cases (65% women) were seen over a 5‐year period (7.7 per 100 adults/year).conclusion  This is the first community RCT of its type with a behavioural component. There is fair baseline comparability between study arms and process data suggest that interventions were adequately implemented.