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.

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.

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.

Factors Associated With Delayed Healing in a Study of the PrePex Device for Adult Male Circumcision in Kenya.

Objectives: To explore factors associated with healing requiring more than 6 weeks after placement of the PrePex device for adult medical male circumcision.

Methods: We enrolled 427 men ages 18-49 years in an observational study of PrePex at 1 urban and 2 peripheral clinics in western Kenya. Participants were scheduled for device removal at day 7 and a follow-up visit at day 42 (allowable range, 40-44) at which the provider recorded wound status, with complete healing defined as a dry wound without any scab, later confirmed by site investigator review of digital penile photographs.

Men's Understanding of and Experiences During the Postcircumcision Abstinence Period: Results From a Field Study of ShangRing Circumcision During Routine Clinical Services in Kenya and Zambia.

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.

Surgical Outcomes of Newly Trained ShangRing Circumcision Providers.

Background: Devices can potentially accelerate scale-up of voluntary medical male circumcision in sub-Saharan Africa. Studies have demonstrated advantages of the ShangRing device over conventional circumcision. With the need to train providers rapidly for scale-up, concerns arise about the transferability of techniques and the expertise of new trainees.

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.

Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input.

Objective: To estimate contraceptive efficacy, safety, acceptability, and fit of a single-size diaphragm used with contraceptive gel.

Methods: We conducted a multicenter trial in which 450 couples used the single-size diaphragm, 300 randomized to acid-buffering gel and 150 to nonoxynol-9, for at least 190 days and six menstrual cycles. Visits were at enrollment and after menstrual cycles 1, 3, and 6.

Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.

Objective: To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya.

Methods: We enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses.

Toward early safety alert endpoints: exploring biomarkers suggestive of microbicide failure.

Several microbicides, including nonoxynol-9 (N-9) and cellulose sulfate (CS), looked promising during early trials but failed in efficacy trials. We aimed to identify Phase I mucosal safety endpoints that might explain that failure. In a blinded, randomized, parallel trial, 60 healthy premenopausal sexually abstinent women applied Universal HEC placebo, 6% CS or 4% N-9 gel twice daily for 13½ days.

Colposcopy: still useful in microbicide safety trials?

Background: Colposcopy is used to evaluate vaginal microbicides, but its link to risk of HIV is unknown. This reanalysis of 9 safety studies determined the impact of omitting colposcopy on the number of findings detected and assessed whether colposcopy was useful in identifying nonoxynol-9 (N-9) as an unsafe product in one study.

Methods: Product-related findings seen with naked eye and colposcopy or by colposcopy alone were evaluated.

Baseline variation and associations between subject characteristics and five cytokine biomarkers of vaginal safety among healthy non-pregnant women in microbicide trials.

Interleukins (IL)-8, IL-1α, IL-1β, and IL-1 receptor antagonist (IL-1RA) have emerged as indicators of vaginal inflammation and HIV-1 transmission risk. We provide values and factors of normal variation of these immune mediators in premenopausal women to allow their wider clinical application as biomarkers of vaginal health. Cross-sectional analyzes (Kruskal-Wallis and Wilcoxon exact tests) of cytokine concentrations in relation to sociodemographic variables and Nugent score were performed on baseline (prior to product) cervicovaginal lavage from two Phase I randomized microbicide trials.

A randomized six-day safety study of an antiretroviral microbicide candidate UC781, a non-nucleoside reverse transcriptase inhibitor.

Goal: This study evaluated the effect of a single dose and 5 additional consecutive daily doses of UC781 gel at concentrations of 0.1%, 0.25%, 1.

Safety and acceptability of 6% cellulose sulfate vaginal gel applied four times per day for 14 days.

Background: Six percent cellulose sulfate (CS) is a vaginal gel that has been in development as a microbicide.

Study Design: This was a single-center, multi-dose, Phase I, placebo-controlled, randomized, fully masked study conducted in Yaoundé, Cameroon, and involving sexually active women at low risk for sexually transmitted infections (STIs).

Methods: The study assessed the effect of CS and K-Y Jelly applied vaginally four times per day, for 14 consecutive days, on genital epithelial disruption, candidiasis and bacterial vaginosis (BV).

Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study.

Background: Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirritating to the female genital epithelium are urgently needed to slow the heterosexual spread of HIV infection. Products that are also effective contraceptives provide additional benefits. Cellulose sulfate (CS) is a noncytotoxic antifertility agent that exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV.

Single and multiple exposure tolerance study of polystyrene sulfonate gel: a phase I safety and colposcopy study.

Objectives: To evaluate symptoms and signs of genital irritation, vaginal leakage and acceptability of polystyrene sulfonate (PSS), which is being studied as a vaginal contraceptive and microbicide.

Methods: Forty-nine women applied 2.5 mL of either 5% PSS, 10% PSS, PSS vehicle, or Conceptrol (a marketed spermicidal product containing 4% nonoxynol-9) for 6 consecutive days.

Diaphragms in clinical trials: is clinician fitting necessary?

Background: The need for fitting a contraceptive diaphragm has recently been questioned in the context of upcoming trials in which the ability of the diaphragm to prevent sexually transmitted infections will be tested. Being able to provide the same size device to all women would greatly simplify supplying the device and training the clinicians, provided that it does not compromise effectiveness.

Methods: Data from studies of Lea's Shield and FemCap, in which all women were sized for a standard diaphragm and half were randomized to use it during the studies, were reanalyzed to determine if it was feasible to give all women in a barrier study the same size diaphragm or, alternatively, to determine if diaphragm size could be predicted using an algorithm of one or more parameters.