Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors

Abstract

BackgroundStudies of implementation of efficacious human immunodeficiency virus (HIV) prevention interventions are rare, especially in resource-poor settings, but important, because they have the potential to increase the impact of interventions by improving uptake and sustainability. Few studies have focused on provider and organizational factors that may influence uptake and fidelity to core intervention components. Using a hybrid design, we will study the implementation of an efficacious intervention to reduce sexually transmitted infections (STIs) among female sex workers (FSWs) in 12 cities across Mexico. Our protocol will test a ‘train-the-trainer’ implementation model for transporting the Mujer Segura (Healthy Woman) intervention into community-based organizations (CBOs).MethodsWe have partnered with Mexican Foundation for Family Planning (Mexfam), a non-governmental organization that has CBOs throughout Mexico. At each CBO, trained ethnographers will survey CBO staff on characteristics of their organization and on their attitudes toward their CBO and toward the implementation of evidence-based interventions (EBIs). Then, after CBO staff recruit a sample of 80 eligible FSWs and deliver a standard-care, didactic intervention to 40 women randomly selected from that pool, a Mexfam staff person will be trained in the Mujer Segura intervention and will then train other counselors to deliver Mujer Segura to the 40 remaining participating FSWs. FSW participants will receive a baseline behavioral assessment and be tested for HIV and STIs (syphilis, gonorrhea, and chlamydia); they will be reassessed at six months post-intervention to measure for possible intervention effects. At the same time, both qualitative and quantitative data will be collected on the implementation process, including measures of counselors’ fidelity to the intervention model. After data collection at each CBO is complete, the relative efficacy of the Mujer Segura intervention will be analyzed, and across CBOs, correlations will be examined between individual and organizational provider characteristics and intervention efficacy.DiscussionThis cooperative, bi-national research study will provide critical insights into barriers and facilitating factors associated with implementing interventions in CBOs using the ‘train the trainer’ model. Our work builds on similar scale-up strategies that have been effective in the United States. This study has the potential to increase our knowledge of the generalizability of such strategies across health issues, national contexts, and organizational contexts.Trial registrationNCT01465607

Prevalence of HIV/STIs and correlates with municipal characteristics among female sex workers in 13 Mexican cities

“…Data for this analysis were obtained from baseline interviews and HIV/STI screenings of 1 092 FSWs enrolled in the Mujer Segura implementation study. 8 This hybrid type-2 study simultaneously tested the efficacy of the Mujer Segura safer-sex intervention and a train-the-trainer implementation strategy at multiple sites. 9 The protocol was reviewed and approved by the Institutional Review Boards of the University of California, San Diego; Universidad Autónoma de Ciudad Juárez, which provided training to staff; and the Mexican Foundation for Family Planning (Mexfam), which operates the clinics at which the study was carried out.…”

Gender-Specific HIV Prevention Interventions for Women Who Use Alcohol and Other Drugs

“…46 Several third-generation interventions are currently being tested, and while some of their research protocols are available, no outcomes have been published yet. 46,47 …”

Correlates of unprotected sex with male clients among female sex workers in 13 Mexican cities

“…Our intervention, Mujer Segura (Safe Woman), focused on HIV prevention for HIV-negative female sex workers (Patterson et al, 2012). To be eligible, women had to be biologically female, at least 18 years of age, self-identify as a female sex worker, report having traded sex for drugs, money, shelter or other material benefit in the previous month, have had unprotected vaginal or anal sex with a client at least once during the previous month, and HIV-negative.…”

“…Outreach workers in each city compiled a map of bars, brothels, hotels and motels, shooting galleries, alleys, and street corners, and subsequently canvassed those venues. Interested women were referred to the local Mexfam clinic, and, if eligible, provided written informed consent and proceeded to a face-to-face interview, followed by the Mujer Segura intervention or a time-equivalent, standard-counseling comparison condition (Patterson et al, 2012). …”