An HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: study protocol for an N-of-1 pilot study.

INTRODUCTION: Haiti has the highest HIV infection rate in the Western hemisphere, with approximately one in 50 people infected. The January 2010 earthquake led to the collapse of Haiti's social, economic and health infrastructure, exacerbating social and structural HIV risk factors. Internally displaced (ID) women are particularly at high risk for HIV infection due to breakdown of community networks, increased poverty and sexual violence. The authors present the rationale and study protocol for pilot-testing FASY (Famn an Aksyon Pou Santé Yo) (Women Taking Action For Their Health), a psychoeducational HIV/STI prevention intervention with ID women in Haiti.

METHODS AND ANALYSIS: This is a single-centre pragmatic N-of-1 pilot study. The target population is ID women in Leogane, Haiti. The authors aim to recruit 200 participants using purposive peer-driven recruitment methods. ID women will be trained as community health workers to deliver the FASY intervention in Kreyol. Participants will conduct a pretest that involves an individual HIV/STI educational video-based component followed by a 6-week group programme of 2 h women's health meetings. The primary outcome is HIV knowledge; our prespecified index of clinically significant change is an effect size of 0.30. Secondary outcomes include: sexually transmitted infections knowledge, condom use, social support, resilient coping, depression and relationship control. Multivariate analysis of variance will be used to compare pretest and post-test differences across variables to assess if the intervention influenced primary or secondary outcomes. Significant multivariate analysis of variance will be followed up with both univariate tests and discriminant function analyses to understand significant effects.

ETHICS AND DISSEMINATION: Research Ethics Board approval (2011-0033-E) was attained from the Women's College Hospital, University of Toronto, Toronto, Ontario, Canada. Trial results will be published according to the CONSORT statement, modified for the N-of-1 pilot study design, regardless of the outcomes.

TRIAL REGISTRATION NUMBER: This study is registered at https://clinicaltrials.gov, registration number NCT01492829.