Elsevier

The Lancet HIV

Volume 2, Issue 5, May 2015, Pages e181-e189
The Lancet HIV

Articles
The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial

https://doi.org/10.1016/S2352-3018(15)00042-9Get rights and content

Summary

Background

Widespread voluntary medical male circumcision in Africa could avert an estimated 3·436 million HIV infections and 300 000 deaths over the next 10 years. Most Zambian men have expressed little interest in the procedure. We tested the effect of the Spear and Shield intervention designed to increase demand for voluntary medical male circumcision among these hard-to-reach men.

Methods

This cluster randomised controlled trial was done between Feb 1, 2012, and Oct 31, 2014, in Lusaka, Zambia, where HIV prevalence is 20·8%. 13 community health centres were stratified by HIV voluntary counselling and testing rates and patient census, and randomly assigned (5:5:3) to experimental (the intervention), control, or observation-only conditions. Community health centre health-care providers at all 13 sites received training in voluntary medical male circumcision. Eligible participants were aged at least 18 years, HIV-negative, uncircumcised, and had not proactively requested or planned for voluntary medical male circumcision at the time of enrolment. Trial statisticians did not participate in randomisation. After voluntary counselling and HIV testing, participants were recruited; female partners were invited to participate. The primary outcomes at the individual level were the likelihood of voluntary medical male circumcision by 12 months post-intervention, and condom use after voluntary medical male circumcision among participants receiving the intervention. The trial is registered with ClinicalTrials.gov, number NCT01688167.

Findings

800 uncircumcised HIV-negative men (400 in the experimental group, 400 in the control group) were enrolled. 161 participants in the experimental group and 96 in the control group had voluntary medical male circumcision (adjusted odds ratio 2·45, 95% CI 1·24–4·90; p=0·02). Condom use was examined in participants who had voluntary medical male circumcision and reported sexual activity within 1 month of a post-circumcision assessment (88 in the experimental group and 64 in the control group). Condom use over time increased in the experimental group (p=0·03) but not in the control group (p=0·2). One patient died in each group; no adverse events related to study participation were reported.

Interpretation

Comprehensive HIV prevention programmes can increase the demand for and uptake of voluntary medical male circumcision services.

Funding

US National Institutes of Health/National Institute of Mental Health (R01MH095539).

Introduction

The effectiveness of voluntary medical male circumcision in lowering the risk of HIV infection for men in southern and eastern Africa by 51–60% was so compelling that three randomised clinical trials were halted prematurely as a result of positive preliminary results.1, 2 Follow-up studies of up to 5·5 years after circumcision have reported increased levels of protection (up to 67–73%), confirming the long-term protective effect of voluntary medical male circumcision.3, 4, 5 These findings support concurrent observations that behavioural disinhibition (eg, reduction in condom use, increase in multiple partners) did not occur in newly circumcised men.6, 7 Mathematical modelling suggests that widespread voluntary medical male circumcision in Africa could avert up to 3·4 million HIV infections and 300 000 deaths over the next 10 years, and an additional 3·7 million infections and 2·7 million deaths in the 10 years after that.8

Zambia has a population of over 14 million, a high prevalence of HIV (19·7% in urban areas), high incidence of HIV (4% per year in urban areas among those aged 15–49 years), and a low rate of male circumcision (12%).9 The WHO Global Programme on AIDS public health recommendations10 were initially codified by the Zambian Ministry of Health into a 5 year plan, the Zambian National Male Circumcision Strategy and Implementation Plan 2010–15, with the goal of doing 1·9 million male circumcisions (80% of the eligible male population) by 2015, or 400 000 circumcisions per year. The plan has since been extended until 2020, with a modified goal of 1·25 million male circumcisions by the end of 2015.

The initial enthusiasm for voluntary medical male circumcision led to long waiting lines of prospective patients at hospitals and community health centres, and as of October, 2014, over 700 000 circumcisions had been reported by the Government of the Republic of Zambia Ministry of Community Development, Mother and Child Health. However, this is about 37% of the national goal and the Zambia Sexual Behaviour Survey,9 and subsequent studies11 forecast a less optimistic portrait of the acceptability and uptake of voluntary medical male circumcision among the remaining population of uncircumcised Zambian men. Whereas studies done in several sub-Saharan African countries have found at least 65% of the men surveyed expressed willingness to be circumcised,11 the Zambia survey published in 2010 showed that over 80% of uncircumcised men interviewed had no interest in voluntary medical male circumcision. Among those surveyed, major impediments to circumcision as a risk-reduction strategy included fear of pain, concerns about sexual performance and satisfaction after surgery, cultural tradition, and partner preferences. These perceptions suggest the need for a more comprehensive strategy for increasing acceptability (demand) and availability (supply) of medical circumcision services in Zambia.

Research in context

Evidence before the study

We searched Scopus and PubMed between Jan 1, 2009, and Nov 30, 2014, with the terms “male circumcision”, “Africa”, and “intervention” for studies designed to increase voluntary medical male circumcision acceptability and uptake, and prevent behavioural disinhibition. Search results identified one behavioural intervention designed to reduce sexual risk behaviour after voluntary medical male circumcision that showed a decrease in sexual risk behaviour (ie, number of partners and unprotected vaginal sex in the experimental condition), suggesting the short-term effect of a brief counselling and HIV risk reduction session. Several previous studies have found no change in sexual risk behaviour after voluntary medical male circumcision. An additional intervention, providing monetary compensation to increase voluntary medical male circumcision uptake, showed a slight increase in uptake of the procedure as the level of compensation increased. However, in our study the compensation associated with voluntary medical male circumcision was less than half that associated with increasing rates in the monetary compensation intervention. A recent text messaging intervention did not affect risk behaviour, and all other recent studies primarily addressed the acceptability of voluntary medical male circumcision and barriers to uptake but have not addressed interventions to simultaneously increase uptake and decrease sexual risk behaviours.

Added value of the study

This study confirms the added value of nesting voluntary medical male circumcision within the context of a comprehensive sexual risk reduction intervention. Our study provides the first clinical trial evidence of the potential effect of a comprehensive behavioural intervention combined with increased voluntary medical male circumcision availability on the simultaneous increase in uptake and decrease in sexual risk behaviour.

Implications of all available evidence

Availability of the procedure might be necessary but not sufficient to encourage men to have voluntary medical male circumcision. These studies support combining educational and experiential interventions with targeted voluntary medical male circumcision promotion strategies to significantly increase uptake. The increase in the procedure is not associated with an increase in sexual risk behaviours; indeed, such comprehensive interventions also might increase condom use.

To optimise the potential benefits, innovative community-level interventions are needed to convince hard-to-reach uncircumcised Zambian men (ie, men who express no interest in the procedure) that voluntary medical male circumcision is a viable means of reducing their risk of HIV infection. In this cluster randomised controlled trial, we sought to measure the effect of increasing both the availability and the acceptability of voluntary medical male circumcision in men at high risk of HIV with little interest in the procedure, with a systematic and comprehensive sexual risk reduction and circumcision promotion intervention designed to scale up both supply of, and demand for, voluntary medical male circumcision services. Because health-care providers at all 13 study sites received training in the procedure before the study, changes in the likelihood of voluntary medical male circumcision would be due to the presence (or absence) of the experimental or control conditions relative to the observation-only condition. We hypothesised that the experimental intervention would significantly increase the likelihood of circumcision with no increase in sexual risk behaviours over the 12 month follow-up period as compared with the control condition.

Section snippets

Study design and participants

This cluster randomised controlled trial was done at 13 urban community health centres in Lusaka District, Zambia. A cluster randomised design was chosen to avoid cross-contamination between conditions within clinics. Community health centres were randomly assigned (5:5:3) to one of three groups: experimental, control, or observation-only. The observation-only group controlled for the effect of media, public health campaigns, and other secular effects, and for the effect of having circumcision

Results

800 (82%) of 977 people screened were enrolled in the study. The most common reasons for non-enrolment were inability to attend study activities due to work or distance from the clinic or failure to meet study criteria (figure 1). Loss to follow-up ranged from zero to 11 participants within clinics (mean 5), and was not different between the experimental and control groups (p=0·9; figure 1). One patient died in each group; no adverse events related to study participation were reported.

Discussion

The Spear and Shield intervention significantly increased the number of Zambian men opting to undergo circumcision, with participants in the experimental group having about 2·5 times the odds of having the procedure relative to control participants.

Although there was no specific discussion of voluntary medical male circumcision in the control group, multiple questionnaires at four timepoints during the course of the study that assessed their attitudes, feelings, knowledge, and intentions

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