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Abstract
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 http://clinicaltrials.gov, registration number NCT01492829.
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.
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Footnotes
To cite: Logie CH, Daniel C, Newman PA, et al. An HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: study protocol for an N-of-1 pilot study. BMJ Open 2012;2:e001634. doi:10.1136/bmjopen-2012-001634
Contributors CL is the principal investigator, CD is the coinvestigator and PAN is the international mentor for the study. CL and CD conceived the idea for the trial. CL led writing the manuscript, CD contributed substantially to the writing of the manuscript. PAN and MRL contributed to the study design and methods. All authors reviewed the protocol.
Funding This trial is funded by a Grand Challenges Canada Rising Star in Global Health grant (grant number 0016-01-04-01-01). The funder has no role in study design, data collection, analysis or interpretation.
Competing interests None.
Patient consent A consent form that was approved by the Research Ethics Board was translated into Haitian Kreyol and signed with an X by participants to protect confidentiality and also to account for low literacy rates among women in Leogane, Haiti.
Ethics approval Ethics approval was provided by the Women's College Hospital, University of Toronto, Toronto, Ontario, Canada.
Provenance and peer review Not commissioned; internally peer reviewed.