Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial

IntroductionMost women face multiple and co-occurring risks from unwanted pregnancy, human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) at some point during their lifetime. While a range of contraceptive methods exist and options for HIV prevention are increasing, to date, only male and female condoms provide multipurpose protection from both pregnancy and disease.MethodsFrom September 2017 to December 2018, 60 women from the United States and the Dominican Republic, randomized 1:1 to continuous or interrupted use and 4:1 to active vs. placebo ring, participated in a Phase I trial to assess the safety and tolerability of a three-month multipurpose intravaginal ring (IVR) containing the antiviral tenofovir and the contraceptive levonorgestrel. This study examines survey responses from all participants and qualitative data from a subset of 17 women to assess acceptability of and preferences for IVR characteristics.ResultsOverall, women liked the concept of a multipurpose IVR and found it easy to insert and remove. Initial concerns about the size or thickness of the ring generally disappeared with use experience. Women weighed trade-offs between the ease of continuous use for a longer duration against concerns about hygiene and discoloration of the ring when left in place during menses. Whether randomized to continuous or interrupted use, most women found ring attributes (size, thickness, flexibility) very acceptable. They provided recommendations via survey and qualitative interviews for ring modifications that would further increase acceptability. Insights into women's use experiences also suggest the need for clear counseling messages and introduction strategies that can facilitate women's choice and use of prevention methods.DiscussionStudy findings suggest that a multipurpose IVR would make a valuable contribution to women's sexual and reproductive health options, and that both continuous and interrupted use strategies may be preferred

A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir

BackgroundNew multi-purpose prevention technology (MPT) products are needed to prevent human immunodeficiency virus (HIV) and herpes simplex virus type 2 (HSV2). In this study, we evaluated a fast-dissolve insert that may be used vaginally or rectally for prevention of infection.ObjectiveTo describe the safety, acceptability, multi-compartment pharmacokinetics (PK), and in vitro modeled pharmacodynamics (PD) after a single vaginal dose of an insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG) in healthy women.MethodsThis was a Phase I, open-label, study. Women (n=16) applied one TAF (20mg)/EVG (16mg) vaginal insert and were randomized (1:1) to sample collection time groups for up to 7 days post dosing. Safety was assessed by treatment-emergent adverse events (TEAEs). EVG, TAF and tenofovir (TFV) concentrations were measured in plasma, vaginal fluid and tissue, and TFV-diphosphate (TFV-DP) concentration in vaginal tissue. PD was modeled in vitro by quantifying the change in inhibitory activity of vaginal fluid and vaginal tissue against HIV and HSV2 from baseline to after treatment. Acceptability data was collected by a quantitative survey at baseline and post treatment.ResultsThe TAF/EVG insert was safe, with all TEAEs graded as mild, and acceptable to participants. Systemic plasma exposure was low, consistent with topical delivery, while high mucosal levels were detected, with median TFV vaginal fluid concentrations exceeding 200,000 ng/mL and 1,000 ng/mL for up to 24 hours and 7 days post dosing, respectively. All participants had vaginal tissue EVG concentrations of > 1 ng/mg at 4 and 24 hours post dosing. The majority had tissue TFV-DP concentrations exceeding 1000 fmol/mg by 24 – 72 hours post dosing. Vaginal fluid inhibition of HIV-1 and HSV-2 in vitro significantly increased from baseline and was similarly high at 4 and 24 hours post dosing. Consistent with high tissue TFV-DP concentrations, p24 HIV antigen production from ectocervical tissues infected ex vivo with HIV-1 significantly decreased from baseline at 4 hours post dosing. HSV-2 production from tissue also decreased post treatment.ConclusionsA single dose of TAF/EVG inserts met PK benchmarks, with PK data supporting an extended window of high mucosal protection. PD modeling supports mucosal protection against both HIV-1 and HSV-2. The inserts were safe and highly acceptable.Clinical trial registrationClinicalTrials.gov, identifier NCT03762772

Individual and contextual factors of influence on adherence to antiretrovirals among people attending public clinics in Rio de Janeiro, Brazil.

PMC3710472BACKGROUND: There are inconsistencies in the determinants of adherence to antiretrovirals (ARVs) across settings as well as a lack of studies that take into consideration factors beyond the individual level. This makes it necessary to examine factors holistically in multiple settings and populations while taking into consideration the particularities of each context, in order to understand the patterns of ARV adherence. This research explored ARV adherence and individual, relational and environmental-structural factors. METHODS: A cross-sectional survey was conducted from August 2008 through July 2009 among participants currently on ARVs recruited from 6 public health clinics, selected to maximize diversity in terms of caseload and location, representing the range of clinics within Rio de Janeiro city, Brazil. Multivariate logistic regression analysis was used to assess the association between our multilevel factors with ARV adherence among participants with complete cases (n = 632). RESULTS: Eighty-four percent of respondents reported adherence to all of their ARV doses in the last 4 days. Of the socio-demographic variables, those who had one child were positively associated with adherence (AOR 2.29 CI [1.33-3.94]). On the relational level, those with high social support (AOR 2.85 CI [1.50-5.41]) were positively associated with adherence to ARVs. On the environmental-structural level, we found gender was significant with women negatively associated with adherence to ARVs (AOR 0.58 CI [0.38-0.88]) while those with a high asset index (AOR 2.47 CI [1.79-3.40]) were positively associated with adherence to ARVs. CONCLUSIONS: This research highlights the importance of examining the multiple levels of influence on ARV adherence. Intervention research in lower and middle-income settings should address and evaluate the impact of attending to both gender and economic inequalities to improve ARV adherence, as well as relational areas such as the provision of social support.JH Libraries Open Access Fun

The public health system in Afghanistan : current issues / Ronald Waldman; Homaira Hanif

Parallel als Buch-Ausg. erschiene

The public health system in Afghanistan : current issues

Ronald Waldman; Homaira HanifParallel als Buch-Ausg. erschiene

HIV+ Men Need Reproductive Counseling Too: Assessing Childbearing Goals and Provider Communication Among HIV+ Male Patients in Rio de Janeiro, Brazil

Submitted by Anderson Silva ([email protected]) on 2014-12-08T16:12:46Z No. of bitstreams: 1 HIV+ Men Need Reproductive Counseling Too Assessing Childbearing Goals and Provider Communication Among HIV+ Male Patients in Rio de Janeiro, Brazil.pdf: 136730 bytes, checksum: 2f29aaeb078b19f92083fdae0d82aed5 (MD5)Approved for entry into archive by Anderson Silva ([email protected]) on 2014-12-08T16:12:56Z (GMT) No. of bitstreams: 1 HIV+ Men Need Reproductive Counseling Too Assessing Childbearing Goals and Provider Communication Among HIV+ Male Patients in Rio de Janeiro, Brazil.pdf: 136730 bytes, checksum: 2f29aaeb078b19f92083fdae0d82aed5 (MD5)Made available in DSpace on 2014-12-08T17:24:31Z (GMT). No. of bitstreams: 1 HIV+ Men Need Reproductive Counseling Too Assessing Childbearing Goals and Provider Communication Among HIV+ Male Patients in Rio de Janeiro, Brazil.pdf: 136730 bytes, checksum: 2f29aaeb078b19f92083fdae0d82aed5 (MD5) Previous issue date: 2014University of Kansas Medical Center. Department of Family Medicine. Kansas, KS, United States of AmericaFundação Oswaldo Cruz. Instituto de Comunicação e Informação Cientifica e Tecnológica em Saúde. Rio de Janeiro, RJ, BrasilFundação Oswaldo Cruz. Instituto de Comunicação e Informação Cientifica e Tecnológica em Saúde. Rio de Janeiro, RJ, BrasilFundação Oswaldo Cruz. Instituto de Comunicação e Informação Cientifica e Tecnológica em Saúde. Rio de Janeiro, RJ, BrasilJohns Hopkins Bloomberg School of Public Health. Department of International Health. Baltimore, MD, United States of AmericaWe assessed reported communication with HIV providers about reproductive plans among HIV+ men in Rio de Janeiro, Brazil, and factors associated with having had such communication. A total of N=311 HIV+ men (18–50 years) receiving HIV care at one of six public primary care clinics in Rio de Janeiro between 2008–2009 were surveyed. We used descriptive statistics, and multivariate logistic regression to identify factors associated with communication about childbearing with an HIV provider. HIV+ male patients (mean age=42.7 years, 57% mixed race; 23% bisexual, 51% married/committed partner, 61% with at least one biological child, 77% on ART) reported accepting attitudes of HIV and childbearing (51%), the desire (39%), and/or intention (19%) to have a future child, and reported communication with the HIV provider (14%) or their primary partner (28%) about having children. There were no significant differences between the responses of HIV+ heterosexual and bisexual men on the above outcomes. Men who discussed childbearing with their HIV provider were more likely to have accepting attitudes about HIV and childbearing [AOR 2.8, 95%CI (1.2–6.4), p=0.014], and intend to have a child [AOR 2.6, 95% CI (1.2–5.6), p=0.018], but less likely to have discussed this topic with their partner [AOR 0.32 (0.15–0.68), p=0.003]. Among men reporting communication, 40% (17/42) reported advice against having a child. An unmet need for collaborative, nonjudgmental, and provider-initiated communication about childbearing goals exists for HIV+ men in clinical car

Where does treatment optimism fit in? Examining factors associated with consistent condom use among people receiving antiretroviral treatment in Rio de Janeiro, Brazil

Made available in DSpace on 2014-12-10T11:48:56Z (GMT). No. of bitstreams: 1 license.txt: 1914 bytes, checksum: 7d48279ffeed55da8dfe2f8e81f3b81f (MD5) Previous issue date: 2014Made available in DSpace on 2015-01-05T15:49:42Z (GMT). No. of bitstreams: 2 HANIF_ETAL_ICICT_2014.pdf: 208175 bytes, checksum: cd422336f31c0640b31a0cce98290de3 (MD5) license.txt: 1914 bytes, checksum: 7d48279ffeed55da8dfe2f8e81f3b81f (MD5) Previous issue date: 2014Johns Hopkins Bloomberg School of Public Health. Department of International Health. Social and Behavioral Interventions Program. Baltimore, MD, USA.Johns Hopkins Bloomberg School of Public Health. Department of Health, Behavior and Society. Baltimore, MD, USA.Fundação Oswaldo Cruz. Instituto de Comunicação e Informação Científica e Tecnológica em Saúde. Departamento de Informação em Saúde. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Departamento de Ciências da Saúde. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Comunicação e Informação Científica e Tecnológica em Saúde. Departamento de Informação em Saúde. Rio de Janeiro, RJ, Brasil.Johns Hopkins Bloomberg School of Public Health. Department of International Health. Social and Behavioral Interventions Program. Baltimore, MD, USA.In the era of highly active antiretrovirals, people living with HIV (PLWH) have resumed sexual activity in the context of longer and healthier lives, and thus the chances of transmitting the HIV virus, as well as the potential to be re-infected also increase. HIV treatment optimism has been found to be associated with sexual risk behaviors among PLWH in different settings. A cross sectional survey was conducted to examine the relationship between treatment optimism, safer sex burnout and consistent condom use as well as variables associated with treatment optimism in a sample of PLWH on antiretrovirals (ARVs) in Rio de Janeiro, Brazil (n = 604). Seventy-two percent of participants always used a condom in the last 6 months. Homosexual, bisexual, transexual persons were less likely to use condoms consistently than heterosexuals (AOR .58 CI .42–.78). Those who were treatment optimistic (AOR .46 CI .25–.88) were more likely not use a condom consistently in the past 6 months, as were participants who reported safer sex burnout (AOR .58 CI .36– .90). Sexual orientation, safer sex burnout, and lower education levels were significantly associated with higher treatment optimism in multivariate analysis. Study findings highlight the need to address psychosocial factors such as treatment optimism and safer sex burnout associated with lower consistent condom use among PLWH in Rio de Janeiro, Brazil