We are proposing an innovative multi-level, multi-component, structural intervention to promote the female condom that will take advantage of the organizational infrastructure, training, and capacity-building mechanisms in place for HIV/STI counselors of a major governmental system-the New York State AIDS Institute. The AIDS Institute coordinates all HIV public health initiatives in a state with 1 of the highest number of HIV/AIDS cases among women. The focus on the female condom in the proposed study is driven by women's steadily increasing vulnerability to HIV/AIDS and the lack of methods that enable them to protect themselves from HIV/AIDS and other STIs. Despite the fact the female condom is the only barrier alternative to the male condom and that numerous studies document its acceptability, utilization remains low. While some user-level barriers have been identified and some effective strategies to reduce these impediments have been implemented, there have been no U.S. interventions to address structural barriers, such as agency policies and widespread counseling practices that appear to impede female condom adoption and use. We propose a 4-year study to test the impact of a statewide female condom promotional intervention, targeted at the level of Agencies and Agency Counselors. We will conduct a randomized controlled trial (RCT) of 60 Agencies that receive AIDS Institute funding to compare the efficacy of an Enhanced to a Minimal FC promotion intervention among Agency Directors and HIV sexual risk-reduction Counselors.(N =400). The Minimal Intervention, targeted to the Agency-level only, consists of a regional Directors' meeting and provision of free female condoms to the Agencies. The Enhanced Intervention, targeted to both the Agency-and Counselor-levels, consists of the same 2 components, but also includes (1) at the Agency-level, the distribution of a """"""""Female Condom Program and Policy Tool-Kit"""""""" to Agency Directors and 12 months of technical support; and (2) at the Counselor-level, a 1-day FC training workshop, 12 months of technical support, and provision of FC materials to Counselors for use with Clients. Our primary Agency-level outcome will be a composite measure of policies and practices reflecting integration of the FC at the Agency; our primary Counselor-level outcome will be the proportion of Clients reported to have been counseled on the FC. Through a nested case study in 2 urban areas, we also will directly assess the impact of the intervention at the Client-level (N = 640). The study will yield important data on implementation of a large scale structural public health initiative. If effective, the intervention program, integrated into an existing statewide public health infrastructure, could serve as a model for the promotion of the FC as well as for emerging prevention.
| Mantell, Joanne E; Dworkin, Shari L; Exner, Theresa M et al. (2006) The promises and limitations of female-initiated methods of HIV/STI protection. Soc Sci Med 63:1998-2009 |
