Impact of communication strategies to increase knowledge, acceptability, and uptake of a new Woman’s Condom in urban Lusaka, Zambia: study protocol for a randomized controlled trial

BACKGROUND Globally, 220 million women experience an unmet need for family planning. A newly designed female condom, the Woman's Condom (WC), has been developed featuring an improved design. It is the first dual-protection, female-initiated contraceptive that is a premium, higher price point product. However, market availability alone will not increase uptake. In February 2016 the WC will be distributed with a strong media campaign and interpersonal communication (IPC) outreach intervention. The impact of these on knowledge, acceptability, and use of the WC will be measured. METHODS/DESIGN A baseline survey of 2314 randomly selected 18- to 24-year-old sexually active men and women has been conducted. The WC and mass media will be introduced throughout 40 urban wards in and surrounding Lusaka, Zambia. The baseline survey will serve as a quasi-control arm to determine the impact of introducing the WC with mass media. Half of the wards will be randomly allocated to additionally receive the IPC intervention. A single-blind randomized controlled trial will determine the impact of the IPC intervention on knowledge, uptake, and use of the WC. After one year, another 2314 individuals will be randomly selected to participate in the endline survey. We hypothesize that (1) the distribution and media campaign of the WC will increase overall condom use in selected urban wards, and specifically use of the WC; (2) the IPC intervention will significantly impact knowledge, acceptability, and use of the WC. The primary outcome measures are use of the WC, use of any condom, and willingness to use the WC. Secondary outcomes include measures of knowledge, acceptability, and choice of contraception. Odds ratios will be estimated to measure the effect of the intervention on the outcomes with 95% confidence intervals. All analyses will be based on the intention-to-treat principle. DISCUSSION Increasing uptake of dual prevention measures (such as the WC) may reduce incidence of sexually transmitted infections/HIV and unplanned pregnancies. It is important to ensure young, urban adults have access to new contraceptive methods; and, understanding how mass media and IPC impact contraceptive knowledge, acceptability, and use is critical to reduce unmet need. TRIAL REGISTRATION AEARCTR-0000899 . Registered on 26 October 2015.