Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia.

BACKGROUND: Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. METHODS: We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall and by HIV status. We enrolled men aged 18-54 years and scheduled them for 2 post-circumcision follow-up visits at day 7 for device removal and days 35-42. Men were examined to document AEs and healing and to ascertain client acceptability. Provider preferences were also assessed. RESULTS: We enrolled 1163 men (557 in Kenya and 606 in Zambia); the as-treated analysis population comprised 1149 men, including 84 HIV-positive men. There were no serious AEs and 2 severe AEs: 1 severe wound dehiscence and 1 severe pain, both of which resolved with treatment. There were 18 moderate/severe AEs among 16 men (1.4% of men; 95% confidence interval: 0.8% to 2.3%). The most common AE was wound dehiscence (9 men, 0.8%). Healing was similar between HIV-infected and uninfected men, with 85.7% and 87.3% completely healed at days 35-42. Most men (94.8%) were very satisfied with post-circumcision appearance of the penis, and almost all would recommend a ShangRing procedure. Nineteen of 21 providers preferred the ShangRing over conventional surgery. CONCLUSIONS: The ShangRing has an excellent safety profile with few hemorrhagic and infectious complications. The ShangRing is well accepted by clients and preferred by providers, making it a potential boon to the scale-up of adult voluntary medical male circumcision in African countries.

Implant removal experience with Sino-implant (II) at four Chinese sites.

OBJECTIVES: Complications during contraceptive implant removal are important for users and programs. We describe breakage rates during Sino-implant (II) removals at four Chinese family planning clinics. STUDY DESIGN: We collected data by observation of consecutive removal cases and subsequent data transcription onto a standardized case report form. Three sites used the "pull out" removal technique, and one site used the "U" technique. RESULTS: Sino-implant (II) rods were removed from 318 women. There were 16 implant breaks (5.0%), with the breakage rate varying by site from 0% to 7.4%. All 16 breaks occurred at the three sites that used the standard "pull out" technique. Six implants were cut by the scalpel, five were snapped by the clamp, and five were unspecified. Other contributing factors included deeper or wider positioning of the implants (n=6) and implants that were enveloped by thick fibrous tissue (n=3). There was no relationship between breakage rate and duration of implant use. Less than 1% of removals took more than 10 min. CONCLUSIONS: Both the standard "pull out" technique as well as the "U" technique can be used to remove Sino-implant (II). Breakage during implant removal may not be problematic if all fragments of the rod are readily removable. Breakage occurs with predictable low frequency, and training is needed to assure that providers can deal with breakage events. IMPLICATIONS: Contraceptive implant removal complications are important for users and programs. These are some of the first data on breakage during removal of Sino-implant (II). More than one removal technique can be used, but training is required to ensure that providers can deal with the infrequent implant breaks.

Pelvic surgery and hospitalization among Chilean women after nonsurgical sterilization with quinacrine pellets between 1977 and 1989.

BACKGROUND: Concern about quinacrine lingers because of its carcinogenic effects in rats. We describe results of long-term follow-up of women who underwent quinacrine pellet sterilization in Chile between 1977 and 1989 (N=1492). METHODS: We interviewed the women or relatives in five rounds of data collection between 1991-1993 and 2006-2007, and reviewed hospital records. Median follow-up was 18.5 years; total person-time was 23,894 woman-years. This analysis focuses on pelvic and abdominal surgeries and conditions. We used survival analysis to estimate the 15-year cumulative probability of hysterectomy, other pelvic surgical procedures and relevant adverse events. RESULTS: Uterine fibroids were by far the most common gynecologic condition, reported by 11% of the cohort. Surgical procedures were recorded for 15% of the cohort; hysterectomy was the most frequent procedure (10%), followed by salpingectomy (2%). The 15-year probability of any pelvic or abdominal procedure was 14.7 per 100 women (95% confidence interval 12.4-16.9). The probability of hysterectomy was 9.3 per 100 women (95% confidence interval 7.4-11.1). Number of quinacrine insertions had little impact on the probabilities. CONCLUSION: During long-term follow-up of women who received quinacrine pellets for nonsurgical sterilization, the incidence of noncancer adverse outcomes was not unusually high, and no alarming patterns emerged.

What predicts non-retention in microbicide trials?

BACKGROUND: Poor retention can reduce study power and thwart randomization, possibly resulting in biased estimates of effect. Some HIV prevention trials conducted in developing countries have been challenged by high loss to follow-up. Identifying factors associated with non-retention could lead to recruitment of women more likely to remain in the trial, potentially yielding greater efficiency and validity. METHODS: We summarized retention rates and, using Cox regression, evaluated factors associated with non-retention in four trials of two candidate vaginal microbicides (1% C31G or SAVVY® and 6% cellulose sulfate or CS) conducted in multiple sub-Saharan African countries. We defined retention as completion of the trial, including those with an HIV outcome. Non-retention comprised participants randomized to a study arm who were either lost to follow-up or discontinued prior to infection with HIV. RESULTS: 7,367 women were enrolled and randomized in the four trials; 7,086 are included in this analysis. 1,514 (21.4%) participants were either lost to follow-up or had early discontinuation. In the final Cox model, the following baseline factors were associated with non-retention: younger age (hazard ratio [HR] = 0.95); less education (HR = 0.97); condom use at last sex (HR = 1.18); larger number of sex acts in a typical week (HR = 1.01); and baseline candidiasis or bacterial vaginosis (HR = 1.12). CONCLUSIONS: Younger and less educated women were more difficult to retain in these microbicide trials. But these same traits may be associated with higher HIV infection rates. Enhanced retention methods focused on those at highest risk of non-retention and possibly infection will optimize study efficiency and validity.

Screening young adults for prevalent chlamydial infection in community settings.

PURPOSE: Community-based testing may identify young adults in the general population with sexually transmitted chlamydial infection. To develop selective screening guidelines appropriate for community settings, the authors conducted a cross-sectional analysis of the National Longitudinal Study of Adolescent Health Wave III (April 2, 2001, to May 9, 2002). METHODS: Separately for women and men, we developed three predictive models by using unconditional multiple logistic regression for survey data. To account for racial/ethnic disparity in prevalence, initial models included identical predictor characteristics plus information on 1) respondent's race/ethnicity; or 2) respondent's most recent partner's race/ethnicity; or 3) no information on race/ethnicity. RESULTS: Chlamydia trachomatis diagnosis was available for 10,928 (88.6%) of the sexually experienced respondents. A combination of five characteristics for women and six characteristics for men identified approximately 80% of infections when testing