This Campbell systematic review examines the empirical research on the effectiveness of female genital mutilation/cutting (‘FGM/C’) interventions to reduce the occurrence of FGM/C practices in the 28 African countries that carry out FGM/C practices. The review also examines the empirical research on contextual factors that may help explain the effectiveness, or lack thereof, of such interventions. It summarises findings from 8 effectiveness studies and 27 context studies conducted in seven different African countries: Burkina Faso, Egypt, Ethiopia, Somalia/Kenya, Mali, Nigeria and Senegal. Interventions to encourage the abandonment of FGM/C have positive effects on attitudes, but no effect was found on the practice of FGM/C itself. The lack of effects may be due to weak study design, including small samples, and high heterogeneity among the included studies. The main factors that supported FGM/C were tradition, religion, and reduction of women's sexual desire. The main factors that hindered FGM/C were medical complications and prevention of sexual satisfaction. Key messages This systematic review aimed to answer the following research questions: 1.What is the effectiveness of interventions designed to reduce the prevalence of female genital mutilation/cutting (FGM/C) compared to no or other active intervention? 2.How do factors related to the continuance and discontinuance of FGM/C help explain the effectiveness of interventions designed to reduce the prevalence of FGM/C? We used an integrative evidence approach, whereby analyses of effectiveness data and context data were completed in separate streams, but where we in the final step integrated the results from the two sets of data in a realist synthesis approach. We included eight effectiveness studies (research question 1). All employed a controlled before‐and‐after study design. The quality assessment resulted in a final decision of weak study quality for all eight studies, which involved 7,042 participants residing in seven different African countries: Burkina Faso, Egypt, Ethiopia, Somalia/Kenya, Mali, Nigeria, and Senegal. We could perform four meta‐analyses but there was doubt about the validity of all results. The results showed that the effectiveness of the included interventions was limited, although they pointed to potential advantageous developments, such as positive changes in attitudes and knowledge regarding FGM/C, as a result of the FGM/C abandonment interventions. We included 27 context studies (research question 2) from the countries where an effectiveness study had taken place (we did not identify any studies from Ethiopia). The synthesis of context studies showed that the factors related to the continuance and discontinuance of FGM/C varied across contexts, but the main factors that supported FGM/C were tradition, religion, and reduction of women's sexual desire. The main factors that hindered FGM/C were medical complications and prevention of sexual satisfaction. Our ability to conclude regarding both the question of effectiveness of FGM/C abandonment interventions and how factors related to FGM/C help explain the effectiveness of interventions was hampered by a general lack of information. However, through the realist synthesis we identified that all of the interventions were based on a theory that dissemination of information improves cognitions about FGM/C, but the interventions' success was contingent upon a range of contextual factors. Executive summary/Abstract BACKGROUND Female Genital Mutilation/ Cutting (FGM/C) is a traditional practice that involves partial or total removal of the external female genitalia or other injury to the female genital organs for non‐medical reasons. FGM/C is mainly practiced on prepubescent girls in 28 countries in Africa. Recent figures for African countries show a prevalence of FGM/C of more than 70% in Burkina Faso, Djibouti, Egypt, Eritrea, Ethiopia, Guinea, Mali, Mauritania, Northern Sudan, Sierra Leone, and Somalia. However, there is considerable variation in prevalence between and within countries, reflecting ethnicity and tradition. The practice is also rooted in religio‐social beliefs within a frame of psycho‐sexual and personal reasons such as control of women's sexuality and family honour, which is enforced by community mechanisms. Girls exposed to FGM/C are at risk of immediate physical consequences, such as severe pain, bleeding, and shock, difficulty in passing urine and faeces, and infections. Long term consequences can include chronic pain and infections. For many girls and women, undergoing FGM/C is a traumatic experience that may adversely affect their mental health. OBJECTIVES We aimed to review the empirical research on the effectiveness of interventions to reduce the prevalence of FGM/C in African countries (question 1), and the empirical research on contextual factors that may help explain the effectiveness, or lack thereof, of such interventions (question 2). SEARCH STRATEGY The primary method of study identification was electronic searches in 13 international databases up to March 2011: African Index Medicus, Anthropology Plus, British Nursing Index and Archive, the Cochrane Library (CENTRAL, CDR, DARE), EMBASE, EPOC, MEDLINE, PILOTS, POPLINE, PsychINFO, Social Services Abstracts, Sociological Abstracts, and WHOLIS. Databases for grey literature included the Demographic and Health Surveys, British Library for Development Studies, IDEAS, JOLIS, Google Scholar, and Google. The electronic searches were supplemented with searches in databases of six international organizations that are engaged in projects regarding FGM/C, communication with FGM/C experts, forward citation tracking through ISI Web of Knowledge, and bibliographic back‐referencing. Lastly, we conducted a manual search of the journal Social Science & Medicine covering the years 1993 to 2003. SELECTION CRITERIA The inclusion criteria for question 1 were: Population: girls and/or young women at risk of FGM/C and other members of communities practicing FGM/C. Intervention: any intervention intended to prevent, or reduce the prevalence of, FGM/C. Comparison: no FGM/C intervention, wait list, or other active FGM/C intervention. Outcomes: rates of FGM/C as well as behaviours, intentions, attitudes, beliefs, and knowledge of FGM/C, and awareness of rights. Study designs: randomized controlled trials, quasi‐randomized trials, controlled before‐and‐after studies, and interrupted time series designs. The inclusion criteria for question 2 were: Population: members of communities practicing FGM/C. Interest: factors related to the continuance and discontinuance of FGM/C. Context: geographical context was African countries in which controlled studies of interventions to reduce the prevalence of FGM/C had been carried out. Historical context meant that the context studies had to have collected data no more than five years prior to the intervention to be relevant. Study designs: cross‐sectional quantitative study designs, qualitative study designs, or a combination of the two (mixed‐methods studies). DATA COLLECTION AND ANALYSIS The data collection and analysis processes proceeded in several steps. We used an integrative evidence approach, whereby data extraction and analyses of effectiveness data and context data were completed in separate streams. Two reviewers extracted data from the included sources using a pre‐designed data extraction form for each of the two review questions. The same reviewers assessed the quality of studies, using appropriate checklists for included study designs. For effectiveness data, we estimated effects of interventions by the adjusted absolute risk difference and the relative risk and 95% confidence interval. For continuous outcomes, we calculated mean difference and 95% confidence interval. We used Mantel‐Haenszel random effects meta‐analysis for dichotomous outcomes and inverse‐variance random effects meta‐analysis for continuous outcomes. Analysis of context data was based on published examples and guidelines from the Evidence for Policy and Practice Information and Co‐ordinating Centre. For quantitative context studies we used a generic inverse variance approach. We had planned to use thematic analysis for qualitative context data but only one qualitative study was included. In the final step of the integrative evidence approach, the results from the effectiveness studies were integrated with the results from the context studies in a realist synthesis. This realist synthesis approach addressed context‐mechanisms‐outcome configurations that underlie interventions. RESULTS We included eight effectiveness studies (research question 1) and 27 context studies (research question 2). Regarding the effectiveness studies, all employed a controlled before‐and‐after study design. The quality assessment resulted in a final decision of weak study quality for all eight studies, which involved 7,042 participants residing in seven different African countries: Burkina Faso, Egypt, Ethiopia, Somalia/Kenya, Mali, Nigeria, and Senegal. We could perform four meta‐analyses, each with two studies synthesised, but there was doubt about the validity of all results. The results showed that the effectiveness of the included interventions was limited but they pointed to potential advantageous developments as a result of the FGM/C abandonment interventions. Once we had identified that controlled effectiveness studies had taken place in seven contexts, we searched for and included a total of 27 eligible studies from these contexts (we did not identify any studies from Ethiopia). We judged that nine of the context studies had high methodological quality, 12 had moderate and six had low methodological quality. The synthesis of context studies showed that the factors related to the continuance and discontinuance of FGM/C varied across contexts, but the main factors that supported FGM/C were tradition, religion, and reduction of women's sexual desire. The main factors that hindered FGM/C were medical complications and prevention of sexual satisfaction. The extent to which we could conclude regarding how factors related to the continuance and discontinuance of FGM/C help explain the effectiveness of interventions was limited. However, based on the context‐mechanism‐outcome configurations we identified that all of the interventions were based on a theory that dissemination of information improves cognitions about FGM/C, but the interventions' success was contingent upon a range of contextual factors. For example, in contexts where FGM/C and Islam were closely related, the failure to involve religious leaders and base the program on the beneficiary community's needs and wants triggered low attendance and program drop‐out. AUTHORS' CONCLUSIONS Our ability to conclude regarding both the question of effectiveness of FGM/C abandonment interventions and how factors related to FGM/C help explain the effectiveness of interventions was hampered by a general lack of information. The findings show that much work remains to be conducted regarding the evaluation of FGM/C abandonment efforts. There is a need to conduct methodologically rigorous intervention evaluations. Such studies should address the local communities' enforcement systems that support FGM/C and be based on a sound theory of behaviour change.