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

Faculty of Social Work, University of Calgary, Calgary, Alberta, Canada.
BMJ Open (Impact Factor: 2.27). 07/2012; 2(4). DOI: 10.1136/bmjopen-2012-001634
Source: PubMed


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, registration number NCT01492829.


Available from: Carmen Logie, May 19, 2014
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    ABSTRACT: Little evidence exists regarding efficacious HIV and sexually transmitted infections (STI) prevention interventions with internally displaced populations. Internally displaced women are at elevated risk for HIV/STI due to limited access to health services, heightened poverty and social network breakdown. The FASY (Famn an Aksyon Pou Sante' Yo) (Women Taking Action For Their Health) study examined the effectiveness of a peer health worker (PHW) delivered psycho-educational HIV/STI pilot study with internally displaced women in Leogane, Haiti. This was a non-randomized cohort pilot study. Participants completed a computer-assisted pre-test programmed on Android tablet PCs followed by an HIV/STI educational video-based session and a 6-week psycho-educational group program of weekly meetings. Participants completed a post-test upon completion of group sessions. The primary outcome was HIV knowledge; our pre-specified index of clinically significant change was an effect size of 0.30. Secondary outcomes included: STI knowledge, condom use, social support, resilient coping, depression and relationship control. We used mixed-effects regression to calculate mean outcome pre-post score change. This study was registered (, NCT01492829). Between January 1-April 30, 2012 we assigned 200 participants to the study. The majority of participants (n = 176, 88%) completed the study and were followed up at 8 weeks, finishing April 30, 2012. Adjusted for socio-demographic characteristics, HIV knowledge (β = 4.81; 95% CI 4.36-5.26), STI knowledge (β = 0.84; 95% CI 0.70-0.99), condom use (AOR = 4.05, 95% CI 1.86-8.83), and depression (β = -0.63, 95% CI -0.88--0.39) scores showed statistically significant change post-intervention (p<0.05). This pilot study evaluated a PHW psycho-educational HIV/STI prevention intervention among internally displaced women in post-earthquake Haiti. Pilot studies are an important approach to understand feasibility and scientific impacts of HIV prevention strategies in disaster contexts. Study results may inform HIV prevention interventions among internally displaced women in Haiti and can be tested for applicability with internally displaced women globally. Identifier NCT01492829, URL:
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