Effectiveness-implementation trial of an intervention to improve access to and use of family planning services - PROJECT SUMMARY/ABSTRACT Women in rural sub-Saharan Africa face disproportionate challenges to using contraception due to prohibitive social norms, lack of access to high quality information and healthcare, and concerns about side effects. Our and others’ studies emphasize the key facilitating role of positive peer support for helping women navigate these myriad challenges when they desire pregnancy prevention. Despite such documented benefits, tested approaches to deploying experienced contraception users to provide social support to other women are lacking. We developed the “I-CAN” intervention to train and deploy experienced users of contraception as “mentors” who provide tailored informational, instrumental, appraisal, and emotional support to other women in their villages (“mentees”) on contraception. I-CAN was co-developed with community advisory boards and health officials in rural areas of Uganda via participatory human-centered design. I-CAN mentors are local women with experience with multiple contraceptive methods, including the self-injectable (a novel yet underused self-care method). Underpinned by the Integrated Behavioral Model, Social Support Theory, and the Contraceptive Agency Framework, I-CAN is designed to increase women’s contraceptive knowledge, agency over contraceptive decision-making, and ability to access contraception, resulting in our primary objective of increasing women’s ability to overcome barriers to contraceptive use. Our secondary objective is to support adoption of self-injectable contraception, which <1% of women have tried in Uganda given widespread fear of self-administration. Mentors are trained to provide neutral support and respect women’s decisions about contraception without being directive. After promising findings in our pilot study, we propose to build on our strong, ongoing partnership between Makerere University in Uganda and the University of California, San Francisco to test I-CAN on a larger scale. In Aim 1, we will test the effectiveness of I-CAN in a hybrid (type 2) effectiveness-implementation cluster-randomized controlled trial, randomizing 52 rural villages in Uganda 1:1 to receive I-CAN or not. We will compare contraceptive use (primary endpoint), contraceptive agency, method satisfaction, and use of self-injection after 24 months between arms. Data will be collected via repeated cross- sectional village-level household surveys (N=1,560 each time). In Aim 2, we will examine the process of implementing I-CAN. Guided by the PRISM/RE-AIM framework we will conduct a mixed-methods study of I- CAN’s reach to mentees, differential effectiveness, adoption and maintenance by mentors, implementation fidelity and innovations, and contextual factors. In Aim 3, we will estimate the incremental cost-effectiveness ratio of I-CAN relative to standard of care using each of our primary and secondary endpoints as effectiveness measures and measuring costs from an implementation perspective. I-CAN holds promise for helping women in rural sub-Saharan Africa overcome contraceptive use barriers and increasing use of self-injectable contraception: an underutilized self-care method.
