A strategic action framework for multipurpose prevention technologies combining contraceptive hormones and antiretroviral drugs to prevent pregnancy and HIV.

OBJECTIVE: Multipurpose prevention technologies (MPTs) are an innovative class of products that deliver varied combinations of human immunodeficiency virus (HIV) prevention, other sexually transmitted infection (STI) prevention, and contraception. Combining separate strategies for different indications into singular prevention products can reduce the stigma around HIV and STI prevention, improve acceptability of and adherence to more convenient products, and be more cost-effective by addressing overlapping risks. METHODS: This article outlines a strategic action framework developed as an outcome of a series of expert meetings held between 2014 and 2016. The meetings focused on identifying opportunities and challenges for MPTs that combine hormonal contraception (HC) with antiretroviral drugs into single products. The framework aims to present an actionable strategy, by addressing key research gaps and outlining the key areas for progress, to guide current and future HC MPT development. RESULTS: We identified eight primary action areas for the development of impactful HC MPTs, and includes aspects from epidemiology, pharmacology, clinical trial design, regulatory requirements, manufacturing and commercialisation, behavioural science, and investment needs for research and development. CONCLUSION: Overall, the challenges involved with reconciling the critical social-behavioural context that will drive MPT product use and uptake with the complexities of research and development and regulatory approval are of paramount importance. To realise the potential of MPTs given their complexity and finite resources, researchers in the MPT field must be strategic about the way forward; increased support among policy-makers, advocates, funders and the pharmaceutical industry is critical.

Nutrition Education in Internal Medicine Residency Programs and Predictors of Residents' Dietary Counseling Practices.

BACKGROUND: Although physicians are expected to provide dietary counseling for patients with cardiovascular (CV) risk factors such as hypertension, hyperlipidemia, diabetes, and obesity, nutrition education in graduate medical education remains limited. Few studies have recently examined nutrition education and dietary counseling practices in Internal Medicine (IM) residency training. OBJECTIVES: To conduct a contemporary assessment of outpatient nutrition education in IM residency programs in the United States, identify predictors of residents' dietary counseling practices for CV risk factors, and identify barriers for educators in providing nutrition education and barriers for residents in counseling patients. DESIGN: Cross-sectional anonymous surveys were completed by IM program directors (PDs) and residents throughout the United States. Linear regression was used to examine the association between the amount of nutrition education received and the number of instruction methods used by the residents and frequency of residents' dietary counseling for patients with CV risk factors. KEY RESULTS: A total of 40 educators (PDs and ambulatory/primary care PDs) and 133 residents across the United States responded to the survey. About 61% of residents reported having very little or no training in nutrition. Nutrition education in residency, both the amount of education (ß = 0.20, P = .05) and the number of instruction methods used (ß = 0.26, P = .02), predicted frequency of residents' dietary counseling practices independent of nutrition education in medical school, which was also significantly associated with counseling (ß = 0.20, P = .03). Residents' total fruit and vegetable intake likewise predicted frequency of counseling (ß = 0.24, P < .001). Low perceived faculty expertise was a major barrier for educators and was associated with lower level of provided nutrition education (r = -.33, P = .04). Low resident and low perceived clinic preceptors' interests in nutrition were also associated with lower frequency of residents' dietary counseling (r = -.19, P = .04; r = -.18, P = .05). CONCLUSIONS: The provision of nutrition education in IM residency programs and IM residents' dietary counseling for patients need to be systematically assessed nationally. This study's preliminary findings suggest that multimodal nutrition education in IM residency and better resident dietary habits are associated with higher frequency of dietary counseling for patients. Lack of faculty expertise and low faculty and resident interests in patient counseling need to be addressed perhaps by mandating nutrition education in graduate and continuing medical education.

Trypan blue staining to determine vaginal exposure in two types of plastic vaginal applicators containing two different microbicide formulations.

Dye staining of applicators has been shown to be a reliable and objective method to test vaginal insertion in clinical microbicide trials, but different plastics, dyes, and product formulations may impact the accuracy of this method. Reportedly used applicators returned from 3 clinical trials were stained with 1% trypan blue. In a phase 1 study (VivaGel), using gel-filled HTI polypropylene applicators, 1271 (97%) of applicators stained positive. In a phase 1 and a phase 2a study (LACTIN-V) using linear low-density polyethylene applicators to deliver a dry powder formulation, 57 (95%) and 135 (86%) tested positive, respectively. Dye staining of vaginal applicators is an objective low-cost measure suitable for low-resource settings.

Phase 1 dose-ranging safety trial of Lactobacillus crispatus CTV-05 for the prevention of bacterial vaginosis.

BACKGROUND: Bacterial vaginosis is a very common vaginal infection. The lack of endogenous lactobacilli and overgrowth of pathogens facilitate numerous gynecological complications. METHODS: A phase I dose-ranging safety trial tested the safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by vaginal applicator. Twelve healthy volunteers were enrolled in 3 blocks of 4 (5 x 10, 1 x 10, and 2 x 10 cfu/dose). Each block was randomized in a 3:1 ratio of active product to placebo. Participants used study product for 5 consecutive days, returned for follow-up on days 7 and 14, and had phone interviews on days 2 and 35. RESULTS: All 12 participants took 5 doses and completed study follow-up.Overall, 45 adverse events (AEs) occurred, of which 31 (69%) were genitourinary (GU) AEs. GU AEs appeared evenly distributed between the 3 treatment blocks and between LACTIN-V and placebo arms. The most common GU AEs were vaginal discharge in 5 subjects (42%), abdominal pain in 4 subjects (33%), metrorrhagia in 4 subjects (33%), vulvovaginitis in 4 subjects (33%), vaginal candidiasis in 3 subjects (25%), and vaginal odor in 3 subjects (25%). Forty-one (91%) AEs were mild (grade 1) in severity. All 4 moderate AEs (grade 2) were unrelated to product use. No grade 3 or 4 AEs or serious adverse events (SAE) occurred. Laboratory parameters and colposcopy findings were within normal limits or clinically insignificant. The product was well-tolerated and accepted. CONCLUSION: All 3 dose levels of LACTIN-V appeared to be safe and acceptable in healthy volunteers.

Lime juice as a candidate microbicide? An open-label safety trial of 10% and 20% lime juice used vaginally.

OBJECTIVE: Lime has a long history as a contraceptive and vaginal hygiene douche, and ongoing use in Africa is documented. We report on the first safety study on diluted lime juice to assess its potential as a candidate microbicide. METHODS: Twenty-five sexually abstinent women were randomly assigned to apply a 10% or 20% concentration of lime juice or 0% (water-only) through a soaked tampon once daily for 14 consecutive days. Tests for genital infections, measurement of inflammatory biomarkers, and a colposcopy were performed before and after treatment. RESULTS: No participant showed severe vaginal irritation. Two women developed a yeast infection after using lime juice. More than 70% of women in all groups reported side effects, most being singular, mild, and transient events. The users of 20% diluted lime juice experienced a significantly higher frequency of burning and dryness. Vaginal inflammatory biomarkers showed no significant change between preexposure and postexposure levels. The naturally low vaginal pH showed little change, and lactobacilli colonization did not decrease. CONCLUSIONS: Lime juice up to 20% concentration has an acceptable safety profile for vaginal use. However, as new in vitro research shows that the effectiveness of lime juice to prevent HIV transmission in concentrations lower than >or=50% is unlikely and concentrations of 50% have been shown to be toxic, women should be discouraged from commencing or continuing the vaginal use of lime juice.