Population Council Research that makes a difference

16th International Conference on AIDS
and Sexually Transmitted Infections in Africa (ICASA)
4–8 December 2011

Abstract

"Measuring and evaluating adverse events for male circumcision clients who were passively and actively followed post-MC in Swaziland"
Louis Apicella, Khumbulani Moyo, Gladys Magongo, Jessica Greene, and Paul C. Hewett

Background
Male circumcision (MC) is a surgical procedure that should produce few adverse events (AEs), when conducted by trained medical professionals in an aseptic operating environment. However, AEs (commonly post-operative bleeding, infection) do occur even under the most rigorous settings such as MC randomized controlled trials (RCT). National scale MC programs do not have regular, long-term contact with clients as do RCTs and are dependent upon clients voluntarily returning for recommended 2- and 7-day reviews. If a significant percentage of clients do not return for reviews or do not actively seek care for their AE, the AE rate reported by the program may be an underestimate.

Methods
Men 15 and older were sampled proportional to MCs performed during the first 7 months of 2010 from fixed and outreach MC sites in Swaziland for a total of 616 eligible males. Participants were interviewed prior to circumcision (baseline) and upon returning for their scheduled 7-day appointment (“passively” followed). Participants who did not return were called and encouraged to return (“actively-contacted”); others were provided reimbursement and/or transport (“actively-assisted”). All clients received the same review examination by clinical staff. Any AE discovered were classified, mild, moderate or severe.

Results
Thirty-six percent of clients “passively” returned for scheduled 7-day reviews, 23% returned when called by study personnel (“actively-contacted”), and 23% returned after reimbursement/transport (“actively-assisted”). Thus, 501 participants completed the follow-up survey and clinical review. This suggests that reminding MC clients by phone can significantly increase 7-day review adherence (36% vs. 58%; p< 0.01). The passive AE rate in the study population was significantly greater than the equivalent passive rate from MIS data collected during the study period. This suggests the program reported AE rate may be an underestimate of the true AE rate though more careful reporting of AEs for clients participating in the study may contribute to this difference. While study data indicated that AEs were not equally distributed among the “passively” and “actively” followed clients, the assumption that clients not returning for follow-up do not have AEs was rejected as AEs were found actively followed clients. Preliminary multivariate modeling indicates that clients who return for 2-day exam are less likely to experience AEs (OR=0.16, 0.03-0.83), while those who reported symptoms of STDs are more likely to experience AEs (OR=3.0, 1.05-8.43); an array of other factors were not found to be significant.

Conclusions and Recommendations
Preliminary results suggest the current passive follow-up system may underestimate the prevalence of AEs. Adopting active methods to encourage clients to attend scheduled reviews should be considered. While AEs are less common in those who would otherwise not return to the clinic for review, the data suggests that a percentage of AEs may not be observed. Future studies must take into account the possible subjective nature of AE classification. Finally, as the scale of MC services increase, so must the effort and sophistication of MIS reporting and quality control systems to ensure all AEs are captured and properly managed.

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Offsite link: ICASA 2011 Web site

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