Publications by authors named "David C Sokal"

Background: Men's understanding of counseling messages after voluntary medical male circumcision (VMMC) plays an important role in whether they follow them. Data on triggers for early resumption of sex may be useful as scale-up of VMMC for HIV prevention continues in sub-Saharan Africa.

Methods: Data on understanding of post-VMMC abstinence recommendations, resumption of sex, condom use, and triggers for resuming sex were collected from participants during a follow-up interview 35-42 days after ShangRing circumcision in Kenya and Zambia.

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Background: Breastfeeding is a route of mother-to-child transmission (MTCT) of the human immunodeficiency virus (HIV). The World Health Organization recommends antiretroviral (ARV) prophylaxis as the best method to prevent mother-to-child transmission of HIV (PMTCT) during breastfeeding. The nipple shield delivery system (NSDS) is being developed as an accessible method to deliver ARVs to infants and PMTCT during breastfeeding.

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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.

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Objective: To compare clinical profiles of Shang Ring versus conventional circumcisions.

Design: Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites.

Methods: We enrolled HIV-negative men aged 18-54 years in Homa Bay, Kenya, and Lusaka, Zambia and followed them at 2, 7, 14, 21, 28, 42, and 60 days after Shang Ring versus conventional circumcision.

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Background: Early infant (1-60 days of life) male circumcision is being trialed in Africa as a human immunodeficiency virus prevention strategy. Postcircumcision bleeding is particularly concerning where most infants are breastfed, and thus these infants are at increased risk of vitamin K deficiency bleeding.

Case: During a circumcision trial, one infant bled for 90 minutes postprocedure.

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A recent article in the JLM (Boyle GJ and Hill G, "Sub-Saharan African Randomised Clinical Trials into Male Circumcision and HIV Transmission: Methodological, Ethical and Legal Concerns" (2011) 19 JLM 316) criticises the large randomised controlled trials (RCTs) that scientists, clinicians and policy-makers worldwide have concluded provide compelling evidence in support of voluntary medical male circumcision (VMMC) as an effective HIV prevention strategy. The present article addresses the claims advanced by Boyle and Hill, demonstrating their reliance on outmoded evidence, outlier studies, and flawed statistical analyses. In the current authors' view, their claims portray misunderstandings of the design, execution and interpretation of findings from RCTs in general and of the epidemiology of HIV transmission in sub-Saharan Africa in particular.

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Purpose: The purpose of this guideline is to provide guidance to clinicians who offer vasectomy services.

Materials And Methods: A systematic review of the literature using the search dates January 1949-August 2011 was conducted to identify peer-reviewed publications relevant to vasectomy. The search identified almost 2,000 titles and abstracts.

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Background: Recent developments in vasectomy research indicate that occluding the vas using cautery combined with fascial interposition (FI) significantly lowers failure rates and is an appropriate technology for low-resource settings. We report the introduction of this technique in Ministry of Health (MOH) vasectomy services in Rwanda.

Design: In February 2010, an international vasectomy expert trained three Rwandan physicians to become trainers in no-scalpel vasectomy (NSV) with thermal cautery and FI.

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Background: Tenofovir gel, used vaginally before and after coitus, reduced women's acquisition of HIV by 39%. This is a safety assessment of tenofovir gel, including renal, bone, gastrointestinal, genital and haematological parameters.

Methods: In the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, a double-blind, randomized placebo-controlled trial, 445 of the 889 eligibly enrolled women were assigned to tenofovir gel.

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A new drug delivery method for infants is presented which incorporates an active pharmaceutical ingredient (API)-loaded insert into a nipple shield delivery system (NSDS). The API is released directly into milk during breastfeeding. This study investigates the feasibility of using the NSDS to deliver the microbicide sodium dodecyl sulfate (SDS), with the goal of preventing mother-to-child transmission (MTCT) of HIV during breastfeeding in low-resource settings, when there is no safer alternative for the infant but to breastfeed.

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Background: Ovarian cancer, one of the most common cancers in women and the most serious gynecologic cancer, is known to be influenced by reproductive factors, but these factors have not previously been examined in Vietnamese women.

Study Design: We analyzed 262 ovarian cancer patients recruited from 27 hospitals in 12 provinces and Ha Noi City from April 2001 to May 2006, plus 755 controls matched by age and residential address.

Results: The risk of ovarian cancer was significantly lower in parous women than nulliparous women.

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Objectives: 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.

Methods: 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).

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Background: Studies published in the 1970s by Mostafa S. Fahim and colleagues showed that a short treatment with ultrasound caused the depletion of germ cells and infertility. The goal of the current study was to determine if a commercially available therapeutic ultrasound generator and transducer could be used as the basis for a male contraceptive.

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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.

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Purpose: We used a local anesthetic jet injection technique for adult male circumcision. This method eliminates needle use and may decrease the fear of local anesthetic injection used for male circumcision.

Materials And Methods: We recruited 60 men seeking voluntary adult male circumcision into the study from June to September 2009.

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Background: Over 100,000 women worldwide have been sterilized by insertion of quinacrine into the uterus to induce tubal scarring. Concern has been expressed about possible carcinogenicity, and specifically the risk of uterine cancer.

Methods: From 2001 through 2006, we conducted a population-based, case-control study of gynecologic cancers in 12 provinces in northern Vietnam, where relatively large numbers of women had received quinacrine.

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Background: Dating back to the 1970s, thousands of women worldwide have voluntarily been sterilized with transcervical insertion of quinacrine pellets. The safety and efficacy of the technology are still being assessed today; in particular, better estimates on the incidence of human cancers are now feasible.

Methods: We conducted a cohort study of 1492 women in Santiago and Valdivia, Chile, who received transcervical quinacrine pellets for contraceptive sterilization between 1977 and 1989.

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Background: In 1992 Liomba et al used HIV-AIDS prevalence data from 1980 to 1990 and projected the adult HIV prevalence and the impact of AIDS for the years 1991 to 2000, under high and low HIV incidence scenarios, using EpiModel, DemProj and the AIDS Impact Model. This report compares the actual outcomes of the HIV-AIDS epidemic in Malawi from 1991 to 2000 with projections made by Liomba et al.

Methods And Findings: Due to the lack of data on rural HIV prevalence in 1992, the prevalence estimates for the years 1980 to 1990 used by Liomba et al were higher than the now published prevalence.

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Objective: Standardization of and training in adult male circumcision can significantly reduce its complication rate. Currently no such program exists for its standardization and training, making it difficult to guarantee the quality of male circumcision services. We therefore established a standardized surgical protocol for adult male circumcision in China using the Shang Ring, and applied it to a clinical study examining the performance of the Shang Ring in adult male circumcision.

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The effectiveness of various vasectomy techniques is reviewed, with a focus on methods used for vas occlusion. Spontaneous recanalization of the vas is more common than generally recognized and is often transient. Simple ligation and excision has an unacceptably high risk for failure.

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This study investigated if quinacrine can induce a tumorigenic response in rats when administered in a manner similar to the intended human use for female non-surgical sterilization. Young sexually mature female rats received two doses of quinacrine (or 1% methylcellulose control) into each uterine horn approximately 21 days apart, and were observed for 23 months after the second dose administration. Dose levels were 0/0, 0/0, 10/10, 70/70, and 70/250-350 mg/kg (first dose/second dose), which represent local doses in the uterus at approximate multiples of 1x, 8x and 40x the human dose (mg quinacrine/g uterine weight) used for female non-surgical sterilization.

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Although HIV is a significant problem in Africa, HIV infection rates are rising rapidly in other regions such as Asia and South America. International health organizations have recognized the need to develop effective strategies to check the worldwide transmission of HIV. Studies have demonstrated the significant reduction of HIV, HPV, HSV-2 and other STD infection rates with male circumcision (MC).

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