RESUMO
INTRODUCTION: A better understanding of pain treatment satisfaction in patients with chronic noncancer pain (CNCP) and substance use is needed, especially as opioid prescribing policies are changing. We sought to identify factors associated with pain treatment satisfaction in individuals with CNCP on recent opioid therapy and prior or active substance use. METHODS: An exploratory cross-sectional analysis using baseline data from a cohort study of 300 adults with CNCP receiving >20 morphine milligram equivalents of opioids for ≥3 of the preceding 12 months and prior or active substance use. Participants completed interviews, clinical assessments, urine drug screening, and medical chart review. RESULTS: Participants were predominantly middle-aged (mean age 57.5 years), Black (44%), and cisgender men (60%). One-third (33%) had high, 28% moderate, and 39% low pain treatment satisfaction. Post-traumatic stress disorder (PTSD), tobacco use, past-year opioid discontinuation, and higher average pain scores were associated with lower satisfaction. HIV and prescription cannabis use were associated with higher satisfaction. CONCLUSIONS: The relationship between PTSD and tobacco use with lower satisfaction should be explored to augment pain outcomes. Higher satisfaction among individuals with HIV and prescription cannabis use presents potential research areas to guide CNCP management and reduce reliance on opioid therapies.
Assuntos
Dor Crônica , Transtornos Relacionados ao Uso de Substâncias , Adulto , Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Dor Crônica/epidemiologia , Estudos de Coortes , Estudos Transversais , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Satisfação Pessoal , Padrões de Prática Médica , Transtornos Relacionados ao Uso de Substâncias/epidemiologiaRESUMO
HIV pre-exposure prophyalxis (PrEP) might lead individuals to view serodisclosure as unnecessary. We examined the prevalence of non-disclosure and lack of knowledge of partner status in a global cohort of men who have sex with men (MSM) and transgender women (TW) enrolled in the iPrEx Open Label Extension (OLE). We calculated prevalence ratios by fitting a logistic model and estimating predicted probabilities using marginal standardization. Prevalence of non-disclosure and lack of knowledge of partner status were highest in Thailand (73% and 74%, respectively) and lowest in the USA (23% and 37%, respectively). In adjusted analyses, PrEP use was not significantly associated with non-disclosure or lack of knowledge of partner status (p-values>0.05). We found that relationship characteristics were significantly associated with both outcomes. Non-disclosure was higher among casual (adjusted prevalence ratio [aPR] 1.54, [95% confidence interval 1.24-1.84]) and transactional sex partners (aPR 2.03, [1.44-2.62]), and among partners whom participants have known only minutes or hours before their first sexual encounter (aPR 1.62, [1.33-1.92]). Similarly, participants were less likely to know the HIV status of casual partners (aPR 1.50, [1.30-1.71]), transactional sex partners (aPR 1.62, [1.30-1.95]), and those they have known for only days or weeks (aPR 1.13, [0.99-1.27]) or minutes or hours (aPR 1.27, [1.11-1.42]). Our findings underscore the role of dyadic factors in influencing serodisclosure. Comprehensive risk reduction counseling provided in conjunction with PrEP that address relationship characteristics are needed to help patients navigate discussions around HIV status.
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Infecções por HIV/prevenção & controle , Profilaxia Pré-Exposição/estatística & dados numéricos , Autorrevelação , Adulto , Idoso , Feminino , Infecções por HIV/diagnóstico , Homossexualidade Masculina , Humanos , Relações Interpessoais , Masculino , Pessoa de Meia-Idade , Parceiros Sexuais , África do Sul , América do Sul , Tailândia , Pessoas Transgênero , Estados Unidos , Adulto JovemRESUMO
BACKGROUND: Pre-exposure prophylaxis (PrEP) with oral emtricitabine and tenofovir disoproxil fumarate is used to prevent the sexual acquisition of HIV in groups at high risk such as transgender women. We used data from the iPrEx study to assess PrEP efficacy, effectiveness, and adherence in transgender women. METHODS: The iPrEx trial was a randomised controlled trial of PrEP with oral emtricitabine plus tenofovir disoproxil fumarate compared with placebo in men who have sex with men (MSM) and transgender women, followed by an open-label extension. Drug concentrations were measured in blood by liquid chromatography and tandem mass spectroscopy. We did unplanned exploratory analyses to investigate differences in PrEP outcomes among transgender women and between transgender women and MSM. FINDINGS: Of the 2499 participants enrolled in the randomised controlled trial, 29 (1%) identified as women, 296 (12%) identified as trans, 14 (1%) identified as men but reported use of feminising hormones, such that 339 (14%) reported one or more characteristics and are classified as transgender women for the purpose of this study. Compared with MSM, transgender women more frequently reported transactional sex, receptive anal intercourse without a condom, or more than five partners in the past 3 months. Among transgender women, there were 11 HIV infections in the PrEP group and ten in the placebo group (hazard ratio 1·1, 95% CI 0·5-2·7). In the PrEP group, drug was detected in none of the transgender women at the seroconversion visit, six (18%) of 33 seronegative transgender women (p=0·31), and 58 (52%) of 111 seronegative MSM (p<0·0001). PrEP use was not linked to behavioural indicators of HIV risk among transgender women, whereas MSM at highest risk were more adherent. INTERPRETATION: PrEP seems to be effective in preventing HIV acquisition in transgender women when taken, but there seem to be barriers to adherence, particularly among those at the most risk. Studies of PrEP use in transgender women populations should be designed and tailored specifically for this population, rather than adapted from or subsumed into studies of MSM. FUNDING: US National Institutes of Health and the Bill & Melinda Gates Foundation.
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Fármacos Anti-HIV/administração & dosagem , Preservativos/estatística & dados numéricos , Emtricitabina/administração & dosagem , Infecções por HIV/prevenção & controle , Adesão à Medicação/psicologia , Profilaxia Pré-Exposição , Tenofovir/administração & dosagem , Pessoas Transgênero , Adulto , Brasil/epidemiologia , Ensaios Clínicos Fase III como Assunto , Prestação Integrada de Cuidados de Saúde , Aconselhamento Diretivo/métodos , Equador/epidemiologia , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Homossexualidade Masculina , Humanos , Masculino , Adesão à Medicação/estatística & dados numéricos , Peru/epidemiologia , Parceiros Sexuais/psicologia , África do Sul/epidemiologia , Tailândia/epidemiologia , Pessoas Transgênero/psicologia , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: To evaluate the concordance between adherence estimated by self-report (in-person interview or computer-assisted self-interview), in-clinic pill counts, and pharmacy dispensation records and drug detection among participants in a placebo-controlled pre-exposure prophylaxis HIV prevention trial (iPrEx). DESIGN: Cross-sectional evaluation of 510 participants who had drug concentration data and matched adherence assessments from their week-24 study visit. METHODS: Self-reported adherence collected through (1) interview and (2) computer-assisted self-interview surveys, (3) adherence estimated by pill count, and (4) medication possession ratio was contrasted to having a detectable level of drug concentrations [either tenofovir diphosphate (TFV-DP) or emtricitabine triphosphate (FTC-TP)], as well as to having evidence of consistent dosing (tenofovir diphosphate ≥ 16 fmol/106 cells), focusing on positive predictive values, overall and by research site. RESULTS: Overall, self-report and pharmacy records suggested high rates of product use (over 90% adherence); however, large discrepancies between these measures and drug detection were noted, which varied considerably between sites (positive predictive values from 34% to 62%). Measures of adherence performed generally well in the US sites but had poor accuracy in other research locations. Medication possession ratio outperformed other measures but still had relatively low discrimination. CONCLUSIONS: The sizable discrepancy between adherence measures and drug detection in certain regions highlights the potential contribution of factors that may have incentivized efforts to seem adherent. Understanding the processes driving adherence reporting in some settings, but not others, is essential for finding effective ways to increase accuracy in measurement of product use and may generalize to promotion efforts for open-label pre-exposure prophylaxis.
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Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/prevenção & controle , Adesão à Medicação , Adulto , Fármacos Anti-HIV/sangue , Feminino , Saúde Global , Infecções por HIV/sangue , Humanos , Masculino , Pessoas Transgênero , Adulto JovemRESUMO
BACKGROUND: For maximum effect pre-exposure prophylaxis should be targeted to the subpopulations that account for the largest proportion of infections (population-attributable fraction [PAF]) and for whom the number needed to treat (NNT) to prevent infection is lowest. We aimed to estimate the PAF and NNT of participants in the iPrEx (Pre-Exposure Prophylaxis Initiative) trial. METHODS: The iPrEx study was a randomised controlled efficacy trial of pre-exposure prophylaxis with coformulated tenofovir disoproxil fumarate and emtricitabine in 2499 men who have sex with men (MSM) and transgender women. Participants aged 18 years or older who were male at birth were enrolled from 11 trial sites in Brazil, Ecuador, Peru, South Africa, Thailand, and the USA. Participants were randomly assigned (1:1) to receive either a pill with active pre-exposure prophylaxis or placebo, taken daily. We calculated the association between demographic and risk behaviour during screening and subsequent seroconversion among placebo recipients using a Poisson model, and we calculated the PAF and NNT for risk behaviour subgroups. The iPrEx trial is registered with ClinicalTrials.gov, NCT00458393. FINDINGS: Patients were enrolled between July 10, 2007, and Dec 17, 2009, and were followed up until Nov 21, 2010. Of the 2499 MSM and transgender women in the iPrEx trial, 1251 were assigned to pre-exposure prophylaxis and 1248 to placebo. 83 of 1248 patients in the placebo group became infected with HIV during follow-up. Participants reporting receptive anal intercourse without a condom seroconverted significantly more often than those reporting no anal sex without a condom (adjusted hazard ratio [AHR] 5·11, 95% CI 1·55-16·79). The overall PAF for MSM and transgender women reporting receptive anal intercourse without a condom was 64% (prevalence 60%). Most of this risk came from receptive anal intercourse without a condom with partners with unknown serostatus (PAF 53%, prevalence 54%, AHR 4·76, 95% CI 1·44-15·71); by contrast, the PAF for receptive anal intercourse without a condom with an HIV-positive partner was 1% (prevalence 1%, AHR 7·11, 95% CI 0·70-72·75). The overall NNT per year for the cohort was 62 (95% CI 44-147). NNTs were lowest for MSM and transgender women self-reporting receptive anal intercourse without a condom (NNT 36), cocaine use (12), or a sexually transmitted infection (41). Having one partner and insertive anal sex without a condom had the highest NNTs (100 and 77, respectively). INTERPRETATION: Pre-exposure prophylaxis may be most effective at a population level if targeted toward MSM and transgender women who report receptive anal intercourse without a condom, even if they perceive their partners to be HIV negative. Substance use history and testing for STIs should also inform individual decisions to start pre-exposure prophylaxis. Consideration of the PAF and NNT can aid in discussion of the benefits and risks of pre-exposure prophylaxis with MSM and transgender women. FUNDING: National Institute of Allergy and Infectious Diseases and the Bill & Melinda Gates Foundation.