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Importance: The ways in which we access, acquire, and use data in clinical trials have evolved very little over time, resulting in a fragmented and inefficient system that limits the amount and quality of evidence that can be generated. Observations: Clinical trial design has advanced steadily over several decades. Yet the infrastructure for clinical trial data collection remains expensive and labor intensive and limits the amount of evidence that can be collected to inform whether and how interventions work for different patient populations. Meanwhile, there is increasing demand for evidence from randomized clinical trials to inform regulatory decisions, payment decisions, and clinical care. Although substantial public and industry investment in advancing electronic health record interoperability, data standardization, and the technology systems used for data capture have resulted in significant progress on various aspects of data generation, there is now a need to combine the results of these efforts and apply them more directly to the clinical trial data infrastructure. Conclusions and Relevance: We describe a vision for a modernized infrastructure that is centered around 2 related concepts. First, allowing the collection and rigorous evaluation of multiple data sources and types and, second, enabling the possibility to reuse health data for multiple purposes. We address the need for multidisciplinary collaboration and suggest ways to measure progress toward this goal.
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BACKGROUND: The impact of multiple sclerosis (MS) disease-modifying therapies (DMTs) on SARS-CoV-2 vaccination response is uncertain. METHODS: Post-SARS-CoV-2 vaccination blood samples across multiple DMTs were tested for SARS-CoV-2 immunoglobulin G (IgG) response. RESULTS: Three hundred twenty-two people with MS were included; 91.9% received an mRNA vaccine. Post-vaccination reactive IgG rates (IgG index > 1) were 40% for anti-CD20 (32/80 patients); 41% for sphingosine 1-phosphate receptor modulators (S1PRM, 16/39); and 100% for all other classes, including the no DMT group. CONCLUSION: Anti-CD20 therapies and S1PRMs reduce IgG response to SARS-CoV-2 vaccination; IgG response is preserved with other DMTs.
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COVID-19 , Esclerosis Múltiple , Anticuerpos Antivirales , COVID-19/prevención & control , Vacunas contra la COVID-19 , Humanos , Inmunidad , Inmunoglobulina G , Esclerosis Múltiple/tratamiento farmacológico , SARS-CoV-2 , Tecnología , Vacunación , Vacunas Sintéticas , Vacunas de ARNmRESUMEN
BACKGROUND: Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection. METHODS: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe. RESULTS: Among the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0.046) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P=0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P<0.001) but not among those 21 years of age or younger (-27%; 95% CI, -133 to 31; P=0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups. CONCLUSIONS: A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01617096 .).
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Infecciones por VIH/prevención & control , VIH-1 , Pirimidinas/administración & dosificación , Inhibidores de la Transcriptasa Inversa/administración & dosificación , Adolescente , Adulto , África Austral/epidemiología , Factores de Edad , Método Doble Ciego , Farmacorresistencia Viral , Femenino , Infecciones por VIH/epidemiología , Humanos , Incidencia , Persona de Mediana Edad , Cooperación del Paciente , Pirimidinas/efectos adversos , Inhibidores de la Transcriptasa Inversa/efectos adversos , Vagina , Adulto JovenRESUMEN
BACKGROUND: Reproductive-age women need effective interventions to prevent the acquisition of human immunodeficiency virus type 1 (HIV-1) infection. METHODS: We conducted a randomized, placebo-controlled trial to assess daily treatment with oral tenofovir disoproxil fumarate (TDF), oral tenofovir-emtricitabine (TDF-FTC), or 1% tenofovir (TFV) vaginal gel as preexposure prophylaxis against HIV-1 infection in women in South Africa, Uganda, and Zimbabwe. HIV-1 testing was performed monthly, and plasma TFV levels were assessed quarterly. RESULTS: Of 12,320 women who were screened, 5029 were enrolled in the study. The rate of retention in the study was 91% during 5509 person-years of follow-up. A total of 312 HIV-1 infections occurred; the incidence of HIV-1 infection was 5.7 per 100 person-years. In the modified intention-to-treat analysis, the effectiveness was -49.0% with TDF (hazard ratio for infection, 1.49; 95% confidence interval [CI], 0.97 to 2.29), -4.4% with TDF-FTC (hazard ratio, 1.04; 95% CI, 0.73 to 1.49), and 14.5% with TFV gel (hazard ratio, 0.85; 95% CI, 0.61 to 1.21). In a random sample, TFV was detected in 30%, 29%, and 25% of available plasma samples from participants randomly assigned to receive TDF, TDF-FTC, and TFV gel, respectively. Independent predictors of TFV detection included being married, being older than 25 years of age, and being multiparous. Detection of TFV in plasma was negatively associated with characteristics predictive of HIV-1 acquisition. Elevations of serum creatinine levels were seen more frequently among participants randomly assigned to receive oral TDF-FTC than among those assigned to receive oral placebo (1.3% vs. 0.2%, P=0.004). We observed no significant differences in the frequencies of other adverse events. CONCLUSIONS: None of the drug regimens we evaluated reduced the rates of HIV-1 acquisition in an intention-to-treat analysis. Adherence to study drugs was low. (Funded by the National Institutes of Health; VOICE ClinicalTrials.gov number, NCT00705679.).
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Adenina/análogos & derivados , Antirretrovirales/administración & dosificación , Desoxicitidina/análogos & derivados , Infecciones por VIH/prevención & control , VIH-1 , Organofosfonatos/administración & dosificación , Profilaxis Pre-Exposición , Adenina/administración & dosificación , Adenina/efectos adversos , Adenina/sangre , Administración Intravaginal , Administración Oral , Adolescente , Adulto , África del Sur del Sahara , Antirretrovirales/efectos adversos , Antirretrovirales/sangre , Desoxicitidina/administración & dosificación , Desoxicitidina/efectos adversos , Desoxicitidina/sangre , Farmacorresistencia Viral , Quimioterapia Combinada , Emtricitabina , Femenino , Infecciones por VIH/complicaciones , Seropositividad para VIH , VIH-1/efectos de los fármacos , Humanos , Cumplimiento de la Medicación , Persona de Mediana Edad , Organofosfonatos/efectos adversos , Organofosfonatos/sangre , Encuestas y Cuestionarios , Tenofovir , Adulto JovenRESUMEN
Accurate estimates of study product use are critical to understanding and addressing adherence challenges in HIV prevention trials. The VOICE trial exposed a significant gap between self-reported adherence and drug detection. The VOICE-D qualitative study was designed to better understand non-adherence during VOICE, and was conducted in 2 stages: before (stage 1) and after (stage 2) drug detection results were provided to participants. Transcripts from 44 women who participated in both stages were analysed to understand the effect of presenting drug detection data on narratives of product use. Thirty-six women reported high adherence in stage 1, yet admitted non-use in stage 2, three reported high adherence in both stages (contrary to their drug detection results) and five had consistent responses across both stages and drug results. Presenting objective measures of use may facilitate more accurate product use reporting and should be evaluated in future prevention trials.
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Fármacos Anti-VIH/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/psicología , Cumplimiento de la Medicación , Profilaxis Pre-Exposición , Adulto , Femenino , Infecciones por VIH/epidemiología , Humanos , Investigación Cualitativa , Autoinforme , Sudáfrica/epidemiología , Uganda/epidemiología , Zimbabwe/epidemiologíaRESUMEN
We sought to integrate a brief computer and counseling support intervention into the routine practices of HIV clinics and evaluate effects on patients' viral loads. The project targeted HIV patients in care whose viral loads exceeded 1000 copies/ml at the time of recruitment. Three HIV clinics initiated the intervention immediately, and three other HIV clinics delayed onset for 16 months and served as concurrent controls for evaluating outcomes. The intervention components included a brief computer-based intervention (CBI) focused on antiretroviral therapy adherence; health coaching from project counselors for participants whose viral loads did not improve after doing the CBI; and behavioral screening and palm cards with empowering messages available to all patients at intervention clinics regardless of viral load level. The analytic cohort included 982 patients at intervention clinics and 946 patients at control clinics. Viral loads were assessed at 270 days before recruitment, at time of recruitment, and +270 days later. Results indicated that both the control and intervention groups had significant reductions in viral load, ending with approximately the same viral level at +270 days. There was no evidence that the CBI or the targeted health coaching was responsible for the viral reduction in the intervention group. Results may stem partially from statistical regression to the mean in both groups. Also, clinical providers at control and intervention clinics may have taken action (e.g., conversations with patients, referrals to case managers, adherence counselors, mental health, substance use specialists) to help their patients reduce their viral loads. In conclusion, neither a brief computer-based nor targeted health coaching intervention reduced patients' viral loads beyond levels achieved with standard of care services available to patients at well-resourced HIV clinics.
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Consejo , Infecciones por VIH/virología , Carga Viral , Adulto , Fármacos Anti-VIH/uso terapéutico , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/psicología , Humanos , Masculino , Cumplimiento de la Medicación , Persona de Mediana EdadRESUMEN
Background: Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. Methods: MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. Results: MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in ≥grade 2 adverse event rates between daily gel (incidence rate ratio [IRR], 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (≥80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio [OR], 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001). Conclusions: Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen. Clinical Trials Registration: NCT01687218.
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Infecciones por VIH/tratamiento farmacológico , Recto/efectos de los fármacos , Recto/virología , Inhibidores de la Transcriptasa Inversa/administración & dosificación , Tenofovir/administración & dosificación , Adolescente , Adulto , Terapia Antirretroviral Altamente Activa , Femenino , Geles , Glicerol , Infecciones por VIH/virología , VIH-1 , Homosexualidad Masculina , Humanos , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Inhibidores de la Transcriptasa Inversa/efectos adversos , Tenofovir/efectos adversos , Resultado del Tratamiento , Adulto JovenRESUMEN
Treatment as prevention is expected to have a major role in reducing HIV incidence, but other prevention interventions will also be required to bring the epidemic under control, particularly among key populations. One or more forms of pre-exposure prophylaxis (PrEP) will likely play a critical role. Oral PrEP with emtricitabine-tenofovir (Truvada®) is currently available in the US and some other countries, but uptake has been slow. We review the concerns that have contributed to this slow uptake and discuss current and future research in this critical area of HIV prevention research.
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Antirretrovirales/administración & dosificación , Desoxicitidina/análogos & derivados , Infecciones por VIH/prevención & control , Compuestos Organofosforados/administración & dosificación , Profilaxis Pre-Exposición/tendencias , Administración Oral , Desoxicitidina/administración & dosificación , Combinación de Medicamentos , Combinación Emtricitabina y Fumarato de Tenofovir Disoproxil , Femenino , Humanos , Masculino , Profilaxis Pre-Exposición/economíaRESUMEN
Depression is one of the most common co-morbidities of HIV infection. It negatively impacts self-care, quality of life, and biomedical outcomes among people living with HIV (PLWH) and may interfere with their ability to benefit from health promotion interventions. State-of-the-science research among PLWH, therefore, must address depression. To guide researchers, we describe the main diagnostic, screening, and symptom-rating measures of depression, offering suggestions for selecting the most appropriate instrument. We also address cultural considerations in the assessment of depression among PLWH, emphasizing the need to consider measurement equivalence and offering strategies for developing measures that are valid cross-culturally. Finally, acknowledging the high prevalence of depression among PLWH, we provide guidance to researchers on incorporating depression into the theoretical framework of their studies and employing procedures that account for participants with depression.
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Depresión/psicología , Infecciones por VIH/psicología , Investigación sobre Servicios de Salud , Cultura , Depresión/complicaciones , Depresión/diagnóstico , Infecciones por VIH/diagnóstico , Necesidades y Demandas de Servicios de Salud , Humanos , Escalas de Valoración Psiquiátrica , Psicometría/instrumentaciónRESUMEN
HIV continues to exact an enormous toll on society and to disproportionately affect gay and bisexual men and other men who have sex with men (MSM). Innovative prevention interventions are needed to reverse this trend. In August 2009, the U.S. National Institute of Mental Health and the Centers for Disease Control and Prevention convened a meeting of scientists, community representatives, advocates, and federal partners to discuss innovative prevention-intervention science. The meeting was structured to maximize discussion of (1) healthy sex interventions, (2) community and structural interventions, (3) integrated biomedical and behavioral interventions, and (4) interventions to improve uptake of HIV testing. Presentations and discussion focused on research gaps in designing risk-reducing and sexual health-promoting interventions for MSM, including interventions to address mental health, substance use, disclosure, and stigma. This article summarizes the meeting proceedings, highlights key points, and outlines future directions.
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Infecciones por VIH/prevención & control , Investigación sobre Servicios de Salud/organización & administración , Homosexualidad Masculina , Práctica de Salud Pública , Infecciones por VIH/complicaciones , Infecciones por VIH/diagnóstico , Conocimientos, Actitudes y Práctica en Salud , Política de Salud , Humanos , Masculino , Salud Mental , Prejuicio , Conducta Sexual , Trastornos Relacionados con Sustancias/complicacionesRESUMEN
[This corrects the article DOI: 10.2196/23011.].
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Sharing clinical trial data can provide value to research participants and communities by accelerating the development of new knowledge and therapies as investigators merge data sets to conduct new analyses, reproduce published findings to raise standards for original research, and learn from the work of others to generate new research questions. Nonprofit funders, including disease advocacy and patient-focused organizations, play a pivotal role in the promotion and implementation of data sharing policies. Funders are uniquely positioned to promote and support a culture of data sharing by serving as trusted liaisons between potential research participants and investigators who wish to access these participants' networks for clinical trial recruitment. In short, nonprofit funders can drive policies and influence research culture. The purpose of this paper is to detail a set of aspirational goals and forward thinking, collaborative data sharing solutions for nonprofit funders to fold into existing funding policies. The goals of this paper convey the complexity of the opportunities and challenges facing nonprofit funders and the appropriate prioritization of data sharing within their organizations and may serve as a starting point for a data sharing toolkit for nonprofit funders of clinical trials to provide the clarity of mission and mechanisms to enforce the data sharing practices their communities already expect are happening.
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Despite substantial attention in the past decade to the co-morbidity of mental health problems among people living with HIV/AIDS (PLWHA), these problems remain a significant barrier to maintaining health and secondary prevention. To address these issues, program staff from the Center for Mental Health Research on AIDS at the NIMH convened a meeting on 19th and 20th July 2007 to discuss the intersection of mental health and HIV. The conveners brought together leaders in the fields of mental illness and HIV to discuss current gaps in the research related to the prevention, diagnosis, and treatment of mental disorders among PLWHA, and how attention to mental health can affect a variety of health outcomes. Attendees were asked to discuss key questions that, if addressed through empirical investigation, could move the field toward the aim of reducing or alleviating the burden of mental illness for those living with HIV disease. The purpose of this brief report is to summarize this meeting's proceedings, overview key points of discussion, and outline areas that may be useful to consider for clinical researchers in the field.
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Infecciones por VIH/complicaciones , Infecciones por VIH/prevención & control , Trastornos Mentales , Prevención Secundaria/métodos , Infecciones por VIH/epidemiología , Infecciones por VIH/transmisión , Humanos , Trastornos Mentales/complicaciones , Trastornos Mentales/tratamiento farmacológico , Trastornos Mentales/epidemiología , Trastornos Mentales/prevención & control , Salud Mental , Proyectos de Investigación , Factores de RiesgoRESUMEN
This study examined factors associated with high-risk adolescents' movement toward or away from adopting consistent condom use behavior using the Transtheoretical Model Stages of Change. Participants drawn from the inactive comparison condition of a randomized HIV prevention trial (Project SHIELD) responded to items assessing pros and cons of condom use, peer norms, condom communication, and perceived invulnerability to HIV. Participants were categorized based on their condom use behavior using the Transtheoretical Model. Multiple logistic regressions found that progression to consistent condom use was predicted by continuing to perceive more advantages to condom use, reporting greater condom use communication with partners, and less perceived invulnerability to HIV. Movement away from adopting consistent condom use was predicted by a decrease in perceived advantages to condom use, increased perceived condom disadvantages, and fewer condom discussions. Future interventions may be tailored to enhance these factors that were found to change over time.
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Conducta del Adolescente , Condones/estadística & datos numéricos , Infecciones por VIH/prevención & control , Conocimientos, Actitudes y Práctica en Salud , Conducta Sexual/psicología , Adolescente , Actitud Frente a la Salud , Femenino , Conductas Relacionadas con la Salud , Humanos , Masculino , Modelos Psicológicos , Valor Predictivo de las Pruebas , Asunción de Riesgos , Sexo Seguro/psicología , Sexo Seguro/estadística & datos numéricos , Conducta Sexual/estadística & datos numéricos , Resultado del Tratamiento , Sexo Inseguro/psicología , Sexo Inseguro/estadística & datos numéricos , Adulto JovenRESUMEN
OBJECTIVE: A wide range exists in the frequency of adolescent self-cutting behavior; however, the implications of this variability are relatively unexplored. Although evidence suggesting a relationship between self-harm and sexual risk behaviors has been identified, little is known regarding the relationship between frequency of self-cutting and sexual risk. The present study aimed to test the hypothesis that adolescents who repeatedly self-cut would report more HIV risk behaviors and riskier attitudes than those who had engaged in infrequent self-injury. METHOD: Adolescents (11-18 years; mean age, 15 years) from intensive psychiatric treatment programs with a history of self-cutting (N = 105, 53% female) completed measures of self-cutting, sexual risk behaviors, and risk attitudes. RESULTS: Frequent self-cutting (more than three times, lifetime) was associated with being sexually active, using condoms inconsistently, and sharing cutting instruments. Frequent self-cutters were significantly more likely to be female and nonwhite, and report low self-restraint. They also showed a trend toward being more likely to have a history of sexual abuse. CONCLUSIONS: This study found important differences in self-cutters based on frequency of cutting. Adolescent self-cutting may be a spectrum of behavior that ranges from habitual, repeated behavior contrasted with infrequent, experimental, socially motivated cutting. The associations between frequent cutting, sexual risk, and low self-restraint suggest that common underlying mechanisms may determine these patterns.
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Infecciones por VIH/epidemiología , Conducta Autodestructiva/epidemiología , Sexo Inseguro , Adolescente , Niño , Abuso Sexual Infantil/psicología , Abuso Sexual Infantil/estadística & datos numéricos , Comorbilidad , Condones/estadística & datos numéricos , Estudios Transversales , Trastornos Disruptivos, del Control de Impulso y de la Conducta/diagnóstico , Trastornos Disruptivos, del Control de Impulso y de la Conducta/epidemiología , Trastornos Disruptivos, del Control de Impulso y de la Conducta/psicología , Femenino , Infecciones por VIH/prevención & control , Infecciones por VIH/transmisión , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Trastornos del Humor/diagnóstico , Trastornos del Humor/epidemiología , Trastornos del Humor/psicología , Enfermedades de Transmisión Sexual/epidemiología , Enfermedades de Transmisión Sexual/prevención & control , Enfermedades de Transmisión Sexual/transmisión , Estados UnidosRESUMEN
BACKGROUND: The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection among African women. A nested qualitative component was conducted at six of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa to evaluate acceptability of and adherence to the ring. METHOD: Qualitative study participants (nâ=â214) were interviewed with one of three modalities: single in-depth interview, up to three serial interviews or an exit Focus Group Discussion. Using semistructured guides administered in local languages, 280 interviews were audio-recorded, transcribed, translated, coded and analyzed. RESULTS: We identified three key findings: first, despite initial fears about the ring's appearance and potential side effects, participants grew to like it and developed a sense of ownership of the ring once they had used it. Second, uptake and sustained adherence challenges were generally overcome with staff and peer support. Participants developed gradual familiarity with ring use through trial progression, and most reported that it was easy to use and integrate into their lives. Using the ring in ASPIRE was akin to joining a team and contributing to a broader, communal good. Third, the actual or perceived dynamics of participants' male partner relationship(s) were the most consistently described influence (which ranged from positive to negative) on participants' acceptability and use of the ring. CONCLUSION: It is critical that demonstration projects address challenges during the early adoption stages of ring diffusion to help achieve its potential public health impact as an effective, long-acting, female-initiated HIV prevention option addressing women's disproportionate HIV burden.
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Fármacos Anti-VIH/administración & dosificación , Quimioprevención/métodos , Dispositivos Anticonceptivos Femeninos/estadística & datos numéricos , Infecciones por VIH/prevención & control , Aceptación de la Atención de Salud , Pirimidinas/administración & dosificación , Adolescente , Adulto , África , Fármacos Anti-VIH/efectos adversos , Dispositivos Anticonceptivos Femeninos/efectos adversos , Femenino , Humanos , Entrevistas como Asunto , Persona de Mediana Edad , Pirimidinas/efectos adversos , Adulto JovenRESUMEN
Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)-if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18-64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ≥80% adherence to daily tablet, 41% having perfect adherence; 83% had ≥80% adherence to daily gel, 29% having perfect adherence; and 93% had ≥80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ≥80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP.
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Fármacos Anti-VIH/administración & dosificación , Emtricitabina/administración & dosificación , Infecciones por VIH/prevención & control , Tenofovir/administración & dosificación , Administración Oral , Administración Rectal , Adolescente , Adulto , Estudios Cruzados , Femenino , Geles , Homosexualidad Masculina , Humanos , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Profilaxis Pre-Exposición , Personas Transgénero , Adulto JovenRESUMEN
The quest for a cure for HIV remains a timely and key challenge for the HIV research community. Despite significant scientific advances, current HIV therapy regimens do not completely eliminate the negative impact of HIV on the immune system; and the economic impact of treating all people infected with HIV globally, for the duration of their lifetimes, presents significant challenges. This article discusses, from a multidisciplinary approach, critical social, behavioral, ethical, and economic issues permeating the HIV-cure research agenda. As part of a search for an HIV cure, both the perspective of patients/participants and clinical researchers should be taken into account. In addition, continued efforts should be made to involve and educate the broader community.
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Investigación Biomédica/métodos , Infecciones por VIH/terapia , Ciencias Sociales/métodos , Síndrome de Inmunodeficiencia Adquirida/terapia , Investigación Biomédica/economía , Investigación Biomédica/ética , Investigación Biomédica/tendencias , Ensayos Clínicos como Asunto/economía , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/métodos , Conducta Cooperativa , Análisis Costo-Beneficio , Humanos , Comunicación Interdisciplinaria , Inducción de Remisión , Ciencias Sociales/economía , Ciencias Sociales/ética , Ciencias Sociales/tendenciasRESUMEN
Adolescent boys and girls are disproportionately affected in the current HIV epidemic. Numerous sociobehavioral studies have addressed the indirect drivers surrounding this vulnerability-for example, socioeconomic, geographical locale, and all forms of violence. However, the direct factors that may influence infection, such as the anatomical and physiological maturation of the anogenital tracts of adolescents or the trauma and wound-healing processes of injured mucosal tissue, are understudied and represent a gap within the HIV prevention field. This article reviews the epidemiology of HIV infection and violence in adolescents and the available basic science knowledge attending this research area. More importantly, this review highlights the most critical gaps that need to be addressed to design preventive interventions that are safe and effective for this population, which is key to ending the HIV pandemic.
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Factores de Edad , Susceptibilidad a Enfermedades , Infecciones por VIH/inmunología , Membrana Mucosa/lesiones , Cicatrización de Heridas , Adolescente , Femenino , Infecciones por VIH/epidemiología , Humanos , Masculino , Delitos Sexuales , Adulto JovenRESUMEN
BACKGROUND: The HIV continuum of care paradigm uses a single viral load test per patient to estimate the prevalence of viral suppression. We compared this single-value approach with approaches that used multiple viral load tests to examine the stability of suppression. METHODS: The retrospective analysis included HIV patients who had at least 2 viral load tests during a 12-month observation period. We assessed the (1) percent with suppressed viral load (<200 copies/mL) based on a single test during observation, (2) percent with suppressed viral loads on all tests during observation, (3) percent who maintained viral suppression among patients whose first observed viral load was suppressed, and (4) change in viral suppression status comparing first with last measurement occasions. Prevalence ratios compared demographic and clinical subgroups. RESULTS: Of 10,942 patients, 78.5% had a suppressed viral load based on a single test, whereas 65.9% were virally suppressed on all tests during observation. Of patients whose first observed viral load was suppressed, 87.5% were suppressed on all subsequent tests in the next 12 months. More patients exhibited improving status (13.3% went from unsuppressed to suppressed) than worsening status (5.6% went from suppressed to unsuppressed). Stable suppression was less likely among women, younger patients, black patients, those recently diagnosed with HIV, and those who missed ≥1 scheduled clinic visits. CONCLUSIONS: Using single viral load measurements overestimated the percent of HIV patients with stable suppressed viral load by 16% (relative difference). Targeted clinical interventions are needed to increase the percent of patients with stable suppression.