A sexual risk reduction intervention increased demand for male adult circumcision, according to a cluster randomized controlled trial conducted in 2012–2014 in Zambia.¹ Men who participated in a program designed to increase the supply of and demand for male medical circumcision were more likely to opt for the procedure by 12 months postintervention than were men in the control group (odds ratio, 2.5). In addition, after circumcision, condom use increased among men in the intervention group, but not among those in the control group, indicating that newly circumcised men did not start engaging in risky behavior that might have nullified the HIV-prevention benefits of the circumcision.

The study was designed to assess the effects of combining increased availability of circumcision with a comprehensive sexual risk reduction and circumcision promotion intervention among men who had little interest in circumcision but were at high risk for HIV. The intervention, called Spear and Shield, is a culturally tailored program that addresses attitudes, beliefs and preferences related to male circumcision.

The researchers recruited 13 urban community health centers in Lusaka District to take part in the trial. Centers were eligible if they had at least 50 HIV voluntary counseling and testing clients each month and had at least five health care providers and counselors available to receive circumcision training and sexual risk reduction training, but did not have trained personnel providing circumcisions on a regular basis. Five centers were randomly assigned to the experimental group, five to the control group and three to an observation-only group. Before randomization, providers at all centers received male circumcision training; after randomization, counselors at the intervention sites were trained to provide the Spear and Shield intervention to eligible clients, while those at the control sites were trained to provide a video-based endemic disease prevention program that focused on cholera, malaria, tuberculosis and waterborne diseases. No changes in services were instituted at clinics in the observation-only group, and outcomes for those centers are not reported here. Men who underwent voluntary HIV counseling and testing at the intervention or control sites were eligible to participate in the trial if they were 18 or older, uncircumcised and HIV negative; were not requesting circumcision at their current visit; and did not have diseases of the foreskin or penile abnormalities in need of repair.

The Spear and Shield intervention consisted of four weekly 90-minute group sessions that discussed strategies to prevent HIV and other STIs, with an emphasis on circumcision; participants were given opportunities to interact with peers who had undergone the procedure as well as with circumcision providers. The disease prevention program for the control group also included four weekly sessions; in both the intervention and control groups, participants’ female partners were invited to attend sessions held specifically for them. In addition, participants in both groups received a week’s supply of male condoms, female condoms or both after the first three sessions; after the fourth session, all participants received a month’s supply of condoms. At study entry, after completing their assigned program, and at follow-up evaluations six and 12 months later and (when applicable) three months after circumcision, participants completed assessments that included questions on sexual behavior. Circumcisions were verified by clinic record review, provider interviews and voluntary physical examinations. The 800 men who enrolled in the trial were recruited in 2012–2013 and completed follow-up in 2014.

The outcomes of interest were the likelihood of circumcision by 12 months post-intervention and trends in condom use after circumcision. In addition to conducting descriptive analyses, the researchers generated Kaplan-Meier curves to show the cumulative incidence of circumcision over time by study group. Multilevel logistic regression was used to compare the odds of circumcision between the experimental and control groups, and a linear mixed model was used to examine condom use over time among circumcised men.

The mean age of the participants at baseline was 27 (range, 18 to 57). About half were unemployed (51%), and a similar proportion reported an annual income equivalent to less than US$100 (53%). Sixty-six percent had 12 or more years of education, 43% were married or cohabiting, and 39% had at least one child. Most participants (88%) either had never considered circumcision, were not considering undergoing the procedure in the next six months or were considering the possibility of circumcision sometime in the next six months but had not made any decisions; the remainder were planning to undergo the procedure in the next 30 days (12%). A higher proportion of men were unemployed in the control group than in the experimental group, but no other differences in demographic characteristics were apparent by study group.

Overall, 40% of men in the intervention group underwent circumcision during the study, as did 24% of those in the control group. At six months postintervention, the proportions were 27% in the intervention group and 15% in the control group; they were 42% and 24%, respectively, among men who completed 12 months of follow-up. Multivariable regression analysis revealed that men in the intervention group were more likely to have undergone circumcision by 12 months postintervention than were men in the control group (odds ratio, 2.5). The results were similar in sensitivity analyses that included self-reported circumcisions that could not be verified, or that excluded men who had already planned to be circumcised.

Condom use was assessed among circumcised participants who reported sexual activity within 2–3 months of circumcision. At baseline, condom use was lower in the experimental group than in the control group (2.5 vs. 3.5 on a scale ranging from 1 to 5). However, during the 12 months of follow-up, condom use increased among participants in the experimental group at an estimated rate of 0.06 points per month; condom use among participants in the control group did not change.

The researchers note that their study was limited by the small number of participating clinics (which may affect external validity) and by the fact that only surgical circumcision, rather than new nonsurgical or minimally invasive options, was offered (which may have affected acceptability). Despite these limitations, the researchers suggest that their study lends support to the idea that combined approaches (i.e., behavioral interventions and environmental changes) work synergistically "to achieve outcomes that neither could accomplish by themselves." They conclude that scaling up interventions that simultaneously increase the demand for and availability of circumcision "might be one of the best and most cost-effective ways to significantly affect HIV rates in high-incidence countries."—L. Melhado

REFERENCE

1. Weiss SM et al., The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial, Lancet HIV, 2015, doi: 10.1016/S2352-3018(15)00042-9, accessed May 5, 2015.