The role of management on costs and efficiency in HIV prevention interventions for female sex workers in Nigeria: a cluster-randomized control trial.

BACKGROUND: While the world has made much global progress toward the reduction of new HIV infections, HIV continues to be an important public health problem. In the face of constantly constrained resources, donors and grantees alike must seek to optimize resources and deliver HIV services as efficiently as possible. While there is evidence that management practices can affect efficiency, this has yet to be rigorously tested in the context of HIV service delivery. METHODS: The present protocol describes the design of a cluster-randomized control trial to estimate the effect of management practices on efficiency. Specifically, we will evaluate the impact of an intervention focused on improving management practices among community-based organizations (CBOs), on the costs of HIV prevention services for female sex workers (FSW) in Nigeria. To design the intervention, we used a qualitative, design thinking-informed methodology that allowed us to understand management in its organizational context better and to develop a user-centered solution. After designing the suite of management tools, we randomly assigned 16 CBOs to the intervention group, and 15 CBOs to the control group. The intervention consisted of a comprehensive management training and a management "toolkit" to support better planning and organization of their work and better communication between CBOs and community volunteers. Both treatment and control groups received training to record data on efficiency-inputs used, and outputs produced. Both groups will be prospectively followed through to the end of the study, at which point we will compare the average unit cost per FSW served between the two groups using a quasi-experimental "difference-in-differences" (DiD) strategy. This approach identifies the effect of the intervention by examining differences between treatment and control groups, before and after the intervention thus accounting for time-constant differences between groups. Despite the rigorous randomization procedure, the small sample size and diversity in the country may still cause unobservable characteristics linked to efficiency to unbalanced between treatment and control groups at baseline. In anticipation of this possibility, using the quasi-experimental DiD approach allows any baseline differences to be "differenced out" when measuring the effect. DISCUSSION: This study design will uniquely add to the literature around management practices by building rigorous evidence on the relationship between management skills and practices and service delivery efficiency. We expect that management will positively affect efficiency. This study will produce valuable evidence that we will disseminate to key stakeholders, including those integral to the Nigerian HIV response.Trial registration This trial has been registered in Clinical Trials (NCT03371914). Registered 13 December 2018.

Terapia gênica com fator de crescimento endotelial vascular 165 para pacientes com angina refratária: mobilização de células progenitoras endoteliais / VEGF 165 gene therapy for patients with refractory angina: mobilization of endothelial progenitor cells

FUNDAMENTO: O fator de crescimento endotelial vascular (VEGF - vascular endothelial growth factor) induz a mobilização de células progenitoras endoteliais (CPEs) com capacidade de proliferação e diferenciação em células endoteliais, contribuindo, dessa forma, para o processo angiogênico. OBJETIVO: Buscamos avaliar o comportamento de CPEs em pacientes com doença cardíaca isquêmica e angina refratária que receberam injeções intramiocardicas de 2000 µg de VEGF165 como terapia única. MÉTODOS: O estudo foi uma subanálise de um ensaio clínico. Pacientes com doença cardíaca isquêmica avançada e angina refratária foram avaliados para inclusão no estudo. Os critérios de inclusão foram: sinais e sintomas de angina e/ou insuficiência cardíaca apesar de tratamento medicamentoso máximo e área de isquemia miocárdica de, no mínimo, 5% conforme avaliado por uma tomografia computadorizada por emissão de fóton único (TCEFU). Os critérios de exclusão foram: idade > 65 anos, fração de ejeção do ventrículo esquerdo < 25% e cancer diagnosticado. Os pacientes cujos níveis de CPE foram avaliados foram incluídos. A intervenção consistiu na administração de 2000 µg de VEGF 165 de plasmídeo injetado no miocárdio isquêmico. A frequência de células CD34+/KDR+ foi analisada por citometria de fluxo antes e 3, 9, e 27 dias após a intervenção. RESULTADOS: Um total de 9 pacientes foram incluídos, 8 homens, média de idade de 59,4 anos, fração de ejeção ventricular esquerda de 59,3%, e classe de angina predominante III. Observou-se um aumento significativo dos níveis de CPEs no terceiro dia após a intervenção. Todavia, 9 e 27 dias após a intervenção, os níveis de CPEs foram similares aos basais. CONCLUSÃO: Identificamos uma mobilização transitória de CPE, com pico no terceiro dia após a intervenção com VEGF 165 em pacientes com angina refratária. Todavia, os níveis de CPEs apresentaram-se semelhantes aos basais 9 e 27 dias após a intervenção.

BACKGROUND: Vascular endothelial growth factor (VEGF) induces mobilization of endothelial progenitor cells (EPCs) with the capacity for proliferation and differentiation into mature endothelial cells, thus contributing to the angiogenic process. OBJECTIVE: We sought to assess the behavior of EPCs in patients with ischemic heart disease and refractory angina who received an intramyocardial injections of 2000 µg of VEGF 165 as the sole therapy. METHODS: The study was a subanalysis of a clinical trial. Patients with advanced ischemic heart disease and refractory angina were assessed for eligibility. Inclusion criteria were as follows: signs and symptoms of angina and/or heart failure despite maximum medical treatment and a myocardial ischemic area of at least 5% as assessed by single-photon emission computed tomography (SPECT). Exclusion criteria were as follows: age > 65 years, left ventricular ejection fraction < 25%, and a diagnosis of cancer. Patients whose EPC levels were assessed were included. The intervention was 2000 µg of VEGF 165 plasmid injected into the ischemic myocardium. The frequency of CD34+/KDR+ cells was analyzed by flow cytometry before and 3, 9, and 27 days after the intervention. RESULTS: A total of 9 patients were included, 8 males, mean age 59.4 years, mean left ventricular ejection fraction of 59.3% and predominant class III angina. The number of EPCs on day 3 was significantly higher than that at baseline (p = 0.03); however, that on days 9 and 27 was comparable to that at baseline. CONCLUSION: We identified a transient mobilization of EPCs, which peaked on the 3th day after VEGF 165 gene therapy in patients with refractory angina and returned to near baseline levels on days 9 and 27.

VEGF 165 gene therapy for patients with refractory angina: mobilization of endothelial progenitor cells.

BACKGROUND: Vascular endothelial growth factor (VEGF) induces mobilization of endothelial progenitor cells (EPCs) with the capacity for proliferation and differentiation into mature endothelial cells, thus contributing to the angiogenic process. OBJECTIVE: We sought to assess the behavior of EPCs in patients with ischemic heart disease and refractory angina who received an intramyocardial injections of 2000 µg of VEGF 165 as the sole therapy. METHODS: The study was a subanalysis of a clinical trial. Patients with advanced ischemic heart disease and refractory angina were assessed for eligibility. Inclusion criteria were as follows: signs and symptoms of angina and/or heart failure despite maximum medical treatment and a myocardial ischemic area of at least 5% as assessed by single-photon emission computed tomography (SPECT). Exclusion criteria were as follows: age > 65 years, left ventricular ejection fraction < 25%, and a diagnosis of cancer. Patients whose EPC levels were assessed were included. The intervention was 2000 µg of VEGF 165 plasmid injected into the ischemic myocardium. The frequency of CD34+/KDR+ cells was analyzed by flow cytometry before and 3, 9, and 27 days after the intervention. RESULTS: A total of 9 patients were included, 8 males, mean age 59.4 years, mean left ventricular ejection fraction of 59.3% and predominant class III angina. The number of EPCs on day 3 was significantly higher than that at baseline (p = 0.03); however, that on days 9 and 27 was comparable to that at baseline. CONCLUSION: We identified a transient mobilization of EPCs, which peaked on the 3th day after VEGF 165 gene therapy in patients with refractory angina and returned to near baseline levels on days 9 and 27.

Is age irrelevant? Perceptions of young and old adult eyewitnesses.

In Experiment 1, we videotaped elderly and younger adults (n = 69) reporting their memories of a crime video. The seniors were significantly less accurate than the younger adults. In Experiment 2, participants viewed the "testimony" videotapes and rated the elderly as less credible than the younger adults. In Experiment 3, participant-jurors (n = 302) evaluated transcribed testimonies provided by Experiment 1 participants. The ostensible age of the witnesses was manipulated. Thus, some participants read a senior's testimony believing it was provided by a younger adult and vice versa. Participants were apparently not biased by negative stereotypes of seniors' eyewitness capabilities.

A randomized trial of nurse-midwifery prenatal care to reduce low birth weight.

In a randomized, controlled trial in five regional centers with state health department clinics, 1458 women at high risk for low birth weight (LBW) outcome received either prenatal interventions provided by nurse-midwives and nurses under their supervision or the standard high-risk prenatal care provided by obstetricians. The intervention administered by the nurse-midwives included patient education to identify the signs and symptoms of preterm labor, activity counseling in response to monitoring of the cervix by frequent examinations, stress reduction by enhancing social support, nutrition counseling with emphasis on weight gain, and substance-abuse counseling. For women in the control group, care was provided by obstetricians according to local standards for the management of high-risk pregnancies. We hypothesized that the LBW rate among live births to women who had received care from nurse-midwives would be lower than that in the control group. Although the LBW rate was lower in the intervention group than in the control group, the observed difference was not statistically significant. Race was not prespecified as a possible effect modifier, but examination of the data post hoc suggested that black women at high statistical risk of giving birth to an LBW infant may have derived benefit from the program. Although the results do not suggest any striking advantage of the nurse-midwifery intervention over standard obstetric care for women at high statistical risk of having an LBW infant, neither do they suggest any disadvantage. Nurse-midwives could provide care to certain populations of high-risk women and facilitate future coverage of these presently underserved populations.

Social support in improving perinatal outcome: the Resource Mothers Program.

This report studies the Resource Mothers Program, an organization that improves perinatal outcome through social support. Resource Mothers are nonprofessional women who combine warmth, parenting experience, and knowledge of their local community services to reduce the hazards associated with rural adolescent pregnancy. Each Resource Mother is assigned to a pregnant teenage primigravida and serves as part of her support system throughout pregnancy and until the infant's first birthday. We studied 565 matched pairs (case/control) of rural teenage primigravidas with single pregnancies with and without the social support of the Resource Mother. There were significantly more patients with adequate prenatal care in the program group (P less than .000001). The frequency of low birth weight infants was significantly less (P = .006), as was the small-for-gestational-age rate (P = .002).