Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings

Kanombe Military Hospital, Kigali, Rwanda.
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.39). 09/2011; 58(5):e127-34. DOI: 10.1097/QAI.0b013e3182354e65
Source: PubMed

ABSTRACT To assess the safety and efficacy of the PrePex device for nonsurgical circumcision in adult males as part of a comprehensive HIV prevention program in Rwanda.
Single-center 6-week noncontrolled study in which healthy men underwent circumcision using the PrePex device, which employs fitted rings to clamp the foreskin, leading to distal necrosis. In the first phase of the study, the feasibility of the procedure was tested on 5 subjects in a sterile environment; in the main phase, an additional 50 subjects were circumcised in a nonsterile setting by physicians or a nurse. Outcome measures included the rate of successful circumcision, time to complete healing, pain, and adverse events.
In the feasibility phase, all 5 subjects achieved complete circumcision without adverse events. In the main phase, all 50 subjects achieved circumcision with 1 case of diffuse edema after device removal, which resolved with minimal intervention. Pain was minimal except briefly during device removal (day 7 after placement in most cases). The entire procedure was bloodless, requiring no anesthesia, no suturing, and no sterile settings. Subjects had no sick/absent days associated with the procedure. Median time for complete healing was 21 days after device removal. There were no instances of erroneous placement and no mechanical problems with the device.
The PrePex device was safe and effective for nonsurgical adult male circumcision without anesthesia or sterile settings and may be useful in mass circumcision programs to reduce the risk of HIV infection, particularly in resource-limited settings.

1 Follower
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Scaling up voluntary medical male circumcision (VMMC) for HIV prevention is cost saving and creates fiscal space in the future that otherwise would have been encumbered by antiretroviral treatment costs. An investment of US$1,500,000,000 between 2011 and 2015 to achieve 80% coverage in 13 priority countries in southern and eastern Africa will result in net savings of US$16,500,000,000. Strong political leadership, country ownership, and stakeholder engagement, along with effective demand creation, community mobilisation, and human resource deployment, are essential. This collection of articles on determining the cost and impact of VMMC for HIV prevention signposts the way forward to scaling up VMMC service delivery safely and efficiently to reap individual- and population-level benefits.
    PLoS Medicine 11/2011; 8(11):e1001127. DOI:10.1371/journal.pmed.1001127 · 14.00 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: To assess healing with Shang Ring removal at different prespecified times; whether spontaneous detachment occurs with delayed removal; problems, complaints, and acceptability of wearing the device; satisfaction among participants; and acceptability of the procedure among providers. Fifty HIV-negative men underwent a Shang Ring circumcision in Kenya. Men were randomly assigned for device removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28, and 42 days after circumcision and 2 days after removal. Circumcision and device removal were conducted without significant problems. Mean times for circumcision and device removal were 6.5 (SD = 2.4) and 2.5 (SD = 0.8) minutes, respectively. Complete detachment of the device occurred in 22 (66.7%) men who wore it more than 7 days. Seven men (14.0%) with partial detachments requested removal 8-14 days postcircumcision due to pain/discomfort. Healing progressed normally in all participants; cumulative probabilities of complete healing were similar across groups. No severe or serious adverse events occurred. Acceptability among participants was high. Providers reported that Shang Ring circumcision was "very easy" compared with the forceps-guided procedure. The Shang Ring is safe and easy to use according to label instructions (7 day removal). Detachments occurred without significant problems, although some men requested removal of partially detached rings. Removal time had little effect on healing. These data help allay concerns about men not returning for ring removal and expand the evidence base suggesting the Shang Ring could facilitate rapid male circumcision rollout in sub-Saharan Africa.
    JAIDS Journal of Acquired Immune Deficiency Syndromes 02/2012; 60(3):e82-9. DOI:10.1097/QAI.0b013e31824ea1f2 · 4.39 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Human immunodeficiency virus (HIV) infection increases the risk of tuberculosis (TB) 21-34 fold, and has fuelled the resurgence of TB in sub-Saharan Africa. The World Health Organization (WHO) recommends the Three I's for HIV/TB (infection control, intensified case finding [ICF] and isoniazid preventive therapy) and earlier initiation of antiretroviral therapy for preventing TB in persons with HIV. Current service delivery frameworks do not identify people early enough to maximally harness the preventive benefits of these interventions. Community-based campaigns were essential components of global efforts to control major public health threats such as polio, measles, guinea worm disease and smallpox. They were also successful in helping to control TB in resource-rich settings. There have been recent community-based efforts to identify persons who have TB and/or HIV. Multi-disease community-based frameworks have been rare. Based on findings from a WHO meta-analysis and a Cochrane review, integrating ICF into the recent multi-disease prevention campaign in Kenya may have had implications in controlling TB. Community-based multi-disease prevention campaigns represent a potentially powerful strategy to deliver prevention interventions, identify people with HIV and/or TB, and link those eligible to care and treatment.
    The International Journal of Tuberculosis and Lung Disease 04/2012; 16(4):430-6. DOI:10.5588/ijtld.11.0480 · 2.76 Impact Factor
Show more