Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes.

OBJECTIVES: To assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia. METHODS: We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing. RESULTS: Four hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends. CONCLUSIONS: The moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics and inventory.

Safety and Efficacy of the PrePex Male Circumcision Device: Results From Pilot Implementation Studies in Mozambique, South Africa, and Zambia.

BACKGROUND: Fourteen countries in East and Southern Africa have engaged in national programs to accelerate the provision of voluntary medical male circumcision (VMMC) since 2007. Devices have the potential to accelerate VMMC programs by making the procedure easier, quicker, more efficient, and widely accessible. METHODS: Pilot Implementation studies were conducted in Mozambique, South Africa, and Zambia. The primary objective of the studies was to assess the safety of PrePex device procedures when conducted by nurses and clinical officers in adults and adolescent males (13-17 years, South Africa only) with the following end points: number and grade of adverse events (AEs); pain-related AEs measured using visual analog score; device displacements/self-removals; time to complete wound healing; and procedure times for device placement and removal. RESULTS: A total of 1401 participants (1318 adult and 83 adolescent males) were circumcised using the PrePex device across the 3 studies. Rates of moderate/severe AEs were low (1.0%; 2.0%; and 2.8%) in the studies in Mozambique, Zambia, and South Africa, respectively. Eight early self-removals of 1401 (0.6%) were observed, all required corrective surgery. High rates of moderate/severe pain-related AEs were recorded especially at device removal in South Africa (34.9%) and Mozambique (59.5%). Ninety percent of participants were healed at day 56 postplacement. DISCUSSION: The study results from the 3 countries suggest that the implementation of the PrePex device using nonphysician health care workers is both safe and feasible, but better pain control at device removal needs to be put in place to increase the comfort of VMMC clients using the PrePex device.

Unexpected Complications Following Adult Medical Male Circumcision Using the PrePex Device.

INTRODUCTION: In this study, we describe and depict unexpected sequelae of adult medical male circumcision (MMC) using the PrePex device. MATERIALS AND METHODS: The PrePex system is an elastic compression device for adult MMC. The device is well studied, has been pre-qualified by the World Health Organization (WHO), and its use is being scaled-up in African countries targeted by WHO. We conducted a PrePex implementation study in routine service delivery among 427 men in the age range of 18-49 in western Kenya. We captured penile photographs to create a record of adverse events (AEs) and to monitor healing. Several unexpected AEs ensued, including some that have not been reported in other PrePex studies. We describe and depict those unexpected complications and resulting treatments to alert circumcision providers in the relevant areas. RESULTS: We observed 5 device displacements (1.2%); 3 cases of early sloughing of foreskin tissue (0.7%) among men with long foreskins; 2 cases of a long foreskin obstructing urine flow, as it became dry and necrotic (0.5%); and 2 cases of insufficient foreskin removal caused by invagination for which surgical completion was necessary (0.5%). All of the participants healed completely by day 42 post-circumcision or shortly thereafter. CONCLUSION: The potential for these complications should be incorporated into PrePex training programs. Integration of devices into MMC programs in medically underserved areas requires the availability of prompt surgical intervention for some sequelae, particularly displacement events.

Prospective Observational Study of the ShangRing Device for Adult Medical Male Circumcision in a Routine Clinical Setting in Malawi.

We evaluated the safety and acceptability of the ShangRing device for male circumcision during routine clinical service delivery in Namitete, Malawi. We conducted a prospective observational study enrolling 500 HIV-negative men ages 18 to 49 years at St. Gabriel's Hospital. Participants returned for two follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement). We assessed pain, adverse events (AEs), acceptability, and healing. 500 men were screened; 498 were circumcised using the ShangRing and comprised the analysis population. Seven participants (1.4%) experienced moderate AEs related to circumcision. 93% were judged to be completely healed at or before the day 42 visit; 6% were judged to be healed later than the day 42 visit; 5 participants (1.0%) were lost to follow-up. 98% of men stated they were very satisfied with the appearance of their circumcised penis, and 99.6% would recommend ShangRing circumcision to family/friends. Adult male circumcision using the ShangRing was safe with a low AE rate at this service delivery site. Acceptability factors were also favorable. Addition of the ShangRing device could be beneficial to achieving the goals of the circumcision program in Malawi.

Longer-Term Follow-Up of Kenyan Men Circumcised Using the ShangRing Device.

OBJECTIVES: To ascertain clinical sequelae, client satisfaction and sexual behavior 2+ years after male circumcision using the ShangRing device. METHODS: We enrolled 199 men from the Kenya sites (Homa Bay district) participating in a 2012 study of the ShangRing device used in routine male circumcision services (N = 552). We enrolled men who had had the ShangRing placed successfully, and over-sampled men who had had an adverse event and/or were HIV-positive during the field study. In the present study, each participant was examined and interviewed by a study clinician, and penile photographs were taken to document longer-term cosmetic results and any abnormal findings. RESULTS: 194 men were included in the analysis. The mean and median times between circumcision and the longer-term follow-up visit in this study were 31.8 and 32 months, respectively. Four men (2.1%) had signs/symptoms of a sexually transmitted infection (STI). Virtually all (99.5%) of the men were very satisfied with the appearance of their circumcised penis, and all would recommend a ShangRing circumcision to friends or family members. The most prevalent reported advantage of the circumcision was the ease of bathing and enhanced cleanliness of the penis (75.8%). 94.3% of the men did not cite a single negative feature of their circumcision. 87.5% of men reported more sexual pleasure post-MC, the most common reason being more prolonged intercourse. The majority of men (52.6%) reported one sexual partner post-MC, but more than a quarter of the men (28.1%) reported an increased number of partners post-MC. Less than half of the men (44.3%) reported using condoms half of the time or more, but the great majority of condom users stated that condom use was much easier post-MC, and 76.9% of users said they used condoms more after circumcision than before. CONCLUSIONS: This study supports the safety and acceptability of ShangRing male circumcision during 2-3 years of follow-up. It should allay worries that the ShangRing procedure could lead to delayed complications later than the observation period of most clinical studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT01567436.

The levonorgestrel intrauterine system: cohort study to assess satisfaction in a postpartum population in Kenya.

BACKGROUND: The levonorgestrel intrauterine system (LNG IUS) may become the next long-acting contraceptive to be introduced in public sector programs of resource-poor countries. Whereas service provision for subdermal implants and intrauterine devices is growing, little is known about how the LNG IUS might fit in. STUDY DESIGN: We conducted a cohort study of 313 women in Kenya who were 6-12 weeks postpartum when they started using these methods: subdermal implant (205), LNG IUS (93), and copper intrauterine device (15). Participants returned for visits at 6 and 12 months to share information on bleeding patterns, side effects, satisfaction, and continued use of the products. We used Kaplan-Meier techniques to estimate method continuation rates and chi-square tests of association to identify differences in experiences with the methods. RESULTS: The 12-month continuation rate for the LNG IUS was 89.1 (95% confidence interval [CI] = 86.9-94.9) and statistically equivalent to that of the subdermal implant (91.8: 95% CI = 80.6-94.0). Nearly 87% of LNG IUS users were very satisfied with the method at 6 months compared to 75% of implant users; this gap closed somewhat at 12 months as satisfaction levels of implant users rose. At 12 months 78% of LNG IUS users felt that their bleeding pattern was highly acceptable compared with about 66% of implant users. CONCLUSIONS: This study found that the LNG IUS compared favorably to the subdermal implant in terms of satisfaction levels and continued use. The LNG IUS will provide another long-acting option for postpartum women. IMPLICATIONS: The LNG IUS may soon be purchased by international donor agencies for use in public sector programs in sub-Saharan Africa and other resource-poor countries. The results of this study suggest that the product will be successful in future introduction activities.

Introduction of the levonorgestrel intrauterine system in Kenya through mobile outreach: review of service statistics and provider perspectives.

BACKGROUND: The levonorgestrel intrauterine system (LNG IUS) was developed over 30 years ago, but the product is currently too expensive for widespread use in many developing countries. In Kenya, one organization has received donated commodities for 5 years, providing an opportunity to assess impact and potential future role of the product. METHODS: We reviewed service statistics on insertions of the LNG IUS, copper intrauterine device (IUD), and subdermal implant from 15 mobile outreach teams during the 2011 calendar year. To determine the impact of the LNG IUS introduction, we analyzed changes in uptake and distribution of the copper IUD and subdermal implant by comparing periods of time when the LNG IUS was available with periods when it was not available. In addition, we interviewed 27 clinicians to assess their views of the product and of its future role. RESULTS: When the LNG IUS was not available, intrauterine contraception accounted for 39% of long-acting method provision. The addition of the LNG IUS created a slight rise in intrauterine contraception uptake (to 44%) at the expense of the subdermal implant, but the change was only marginally significant (P = .08) and was largely attributable to the copper IUD. All interviewed providers felt that the LNG IUS would increase uptake of long-acting methods, and 70% felt that the noncontraceptive benefits of the product are important to clients. CONCLUSIONS: The LNG IUS was well-received among providers and family planning clients in this population in Kenya. Although important changes in service statistics were not apparent from this analysis (perhaps due to the small quantity of LNG IUS that was available), provider enthusiasm for the product was high. This finding, above all, suggests that a larger-scale introduction effort would have strong support from providers and thus increase the chances of success. Adding another proven and highly acceptable long-acting contraceptive technology to the method mix could have important reproductive health impact.

Uptake of the levonorgestrel intrauterine system among recent postpartum women in Kenya: factors associated with decision-making.

BACKGROUND: The levonorgestrel intrauterine system (LNG IUS) may become more available in the public sector of resource-poor countries, but it is unclear what product features might be attractive to users and what factors will influence uptake. STUDY DESIGN: We recruited 671 women in Kenya who were seeking contraception at 6-12 weeks postpartum and gave them an opportunity to try the LNG IUS. We asked why they did or did not choose it, relative to the alternative options. χ² tests of association were done to examine participant characteristics and decision-making associated with choice. RESULTS: Participants chose the following methods: LNG IUS (16%), injectable (36%), subdermal implant (30%), progestin-only pills (15%) and copper intrauterine device (IUD) (3%). Reasons for not choosing the LNG IUS included fear of pain/injury/discomfort (34%), modesty issues regarding insertion (33%) and fear of hormonal/health side effects (31%). Nearly a third of LNG IUS acceptors said they would have chosen a short-acting method if the LNG IUS were not available, and only 21% would have chosen the copper IUD. CONCLUSIONS: The LNG IUS could be an ideal method for increasing uptake of long-acting methods among recent postpartum women. Product attributes and comparisons to other contraceptive options are important factors in decision-making. Even among women comfortable with intrauterine contraception, great distinctions and preferences are apparent. Addressing specific misconceptions and fears with better information can help women make the best personal choices.