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The TENDAI study: Task shifting to treat depression and HIV medication nonadherence in low resource settings by KING’S COLLEGE LONDON (The Research University TRU)



Background. HIV care has been rapidly decentralized in high-prevalence countries like Zimbabwe, in thedrive to expand access to antiretroviral therapy (ART) and to achieve viral suppression in people living withHIV/AIDS (PLWH).1,2 Optimising adherence to simple affordable regimens is especially critical in settingswhere third-line ART is barely available. Depression in Zimbabwe, like elsewhere, is common in PLWH3and a key barrier to ART adherence.4 There is a dearth of interventions for depression and poor ARTadherence which are feasible for non-specialists to deliver. These facts underscore the public healthsignificance of focusing on those with depression and a detectable viral load receiving ART regimens.Preliminary work. We have conducted extensive preliminary work to evaluate the cultural appropriatenessand feasibility of a stepped care, task-shifted intervention for treating depression and non-adherence inZimbabwe. Using available lay adherence counselors, this intervention links with the existing ZimbabweanHIV care pathway. We 1) culturally adapted the Life-Steps adherence intervention through qualitativestudies and tested it in 100 PLWH,5 2) developed a combined depression-adherence intervention calledTENDAI (meaning ?thankful? in the Shona language) through integrating the adapted adherenceintervention with Problem-Solving Therapy for depression (a simple culturally-acceptable treatment fordepression used in Zimbabwe)6 and 3) successfully completed an open trial and then a pilot randomizedtrial of TENDAI.7 Together, these studies show feasibility, acceptability and potential beneficial effects ondepression, adherence, and HIV viral suppression. Our combined US, UK and Zimbabwean consortiumbring together a history of successful trials in HIV and depression.8-10 Our proposal is strongly endorsed bythe Ministry of Health AIDS and TB Unit. Design: we propose a two-arm effectiveness RCT of the TENDAIintervention in HIV clinics in rural Zimbabwe in 290 people on ART (first, second or third line treatment) witha detectable viral load (=> 1000 viral RNA copies) and clinically significant depression. The TENDAIintervention will be compared to Enhanced Usual Care (EUC). Primary outcomes at 12 months (Aim 1)include proportion of HIV viral suppression in each condition, adherence to ART (assessed electronicallyand by ART detection in Dried Blood Spot), and depression (assessed via a locally validated questionnaireby an independent evaluator). We will also test (Aim 2) moderators (sex, depression severity) of thetreatment effect, and examine changes in adherence and depression as mediators of the effect on viralsuppression. Through collecting resource utilization and cost data we will examine the cost-effectiveness ofour novel treatment compared to EUC on reduced depression and, potentially, on better HIV outcomes(Aim 3). If successful, the RCT results will enable us to recommend a strategy for adherence counselingand depression care locally and in the east and southern African region.



CAPRISA Clinical Trials Unit for AIDS/Tuberculosis Prevention and Treatment by CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA (The Research University TRU)



DESCRIPTION (provided by the applicant): The CAPRISA Clinical Trials Unit for AIDS/Tuberculosis Prevention and Treatment (CAPRISA CTU), strategically located in KwaZulu-Natal, South Africa, at the epicenter of one of the world’s most severe HIV and tuberculosis (TB) epidemics, has recently made significant scientific contributions on tenofovir gel and pre-exposure prophylaxis, HIV-TB treatment, prevention of breastfeeding transmission, and immunity with broadly neutralizing antibodies. The scientific team includes investigators who have served at the highest levels in Network leadership. During the current funding cycle, 2,854 participants have been enrolled in 25 protocols to date, with retention rates usually exceeding 90% and data quality scores exceeding 95%. The CAPRISA CTU comprises 4 components; firstly, experienced leadership, senior investigators and CTU coordinator; secondly, an administrative and governance component; thirdly, 10 research support cores; and fourthly, 4 Clinical Research Sites (CRSs). The eThekwini CRS for vaccine, microbicide and adult HIV treatment studies, is located in central Durban adjoining a local clinic that annually treats 40,000 patients with sexually transmitted infections (HIV prevalence of 59.3% (CI: 56.5-62.0) and HIV incidence rate of 6.4 per 100 person-years (CI: 2.6-13.2)) as well as 3,500 new TB cases, two thirds of whom are co-infected with HIV. At the rural Vulindlela CRS for integrated prevention, vaccine and microbicide studies, the HIV prevalence among young women is 35.7% (CI: 32.7-38.8) and the HIV incidence rate is 6.5 per 100 personyears (CI: 4.4-9.2). In this community, HIV incidence is 10.2 per 100 person-years (CI: 4.1-20.9) in women under 20 years. The Springfield CRS for adult HIV/TB treatment studies is located at a regional referral hospital that treated 2,359 MDR-TB and 206 XDR-TB patients (71% co-infected with HIV) in 2010. The Umlazi CRS for maternal/pediatric HIV studies is at a 1,200 bed hospital that provides pre-natal services to about 12,000 women annually (HIV prevalence: 39% (CI: 36.7-41.5)). The vertical transmission rate is 2.4% (CI 1.1-4.5) at birth but increases to 6.6% (CI 5.3-8.2) at 6-8 weeks post-partum due to breastfeeding. The CAPRISA CTU headquarters is located at the Nelson R Mandela School of Medicine and houses the Administration as well as the laboratory, pharmacy, data management and IT, community engagement, evaluation and quality assurance, financial management, bioethics, communication, regulatory compliance, and training Cores. The CTU’s organizational structures (Leadership Group, Executive Committee and Community Advisory Board) and communication tools (regular meetings, video conferences, monthly newsletters and website) enable effective communication, management and governance in the unit. Overall, the CAPRISA CTU has diverse well-characterized high-risk populations, well established clinical facilities, accredited laboratories, pharmacies, and data management systems, strong community linkages, and extensive experience in conducting clinical trials, together with a track record of scientific innovation available to support the 5 Networks in developing new approaches to HIV and TB prevention and treatment. RELEVANCE: The overall goal of the Centre for the AIDS Program of Research in South Africa (CAPRISA) Clinical Trials Unit for AIDS/Tuberculosis Prevention and Treatment (CAPRISA CTU) is to advance the scientific agendas and research contributions of each of the five NIAID Clinical Research Networks (CRNs) focused on 1) adult HIV therapeutic strategies, 2) strategies to address HIV in pediatric and maternal populations, 3) integrated HIV prevention strategies, 4) microbicides. and 5) vaccines



Novel non-invasive antigen detection assay for the diagnosis of active visceral leishmaniasis and to monitor the therapy efficacy of this disease by DETECTOGEN, INC. (The Research University TRU)



ABSTRACT The overall goal of this Phase II project is to validate novel leishmanial protein biomarkers fordevelopment of a non-invasive urine-based assay to diagnose active visceral leishmaniasis (VL) and tomonitor the therapeutic efficacy of this serious disease. VL is endemic in 47 countries, affects 500,000people a year and kills more than 50,000, 70% of them children under age 15. VL, also known as kala-azar, iscaused by parasites of the Leishmania donovani complex: L. donovani and L. archibaldi in the Old World(primarily India and South Eastern Africa), and L. infantum in the New World (Southern Europe and SouthAmerica). Global VL morbidity and mortality in many parts of the world are increasing due to co-infection withhuman immunodeficiency virus. Although VL is usually fatal if not treated promptly, the effective drugs aretoxic, expensive and difficult to administer, and untreated people with VL are reservoirs of infection who putothers in their communities at risk. The gold standard for diagnosis is observation of the parasites (ordetection of parasite DNA) in spleen, liver, lymph node or bone marrow aspirates; serum tests measure anti-parasite antibodies, which cannot distinguish between active VL from either prior exposure to the parasite orsubsequent to successful treatment of the disease. There is no vaccine for human VL. The WHO has definedthat a key requirement for effective control of this serious worldwide disease is a sensitive non-invasive testthat can rapidly and reliably diagnose active VL and identify people who need immediate treatment. Our former published work and the Phase I component of this Phase II application have established thefoundation for the development of a simple non-invasive urine test to both diagnose active VL and to monitorthe therapy efficacy of this disease. We used mass spectroscopy to initially identify three L. infantum and morerecently four new L. donovani proteins excreted in the urine of VL patients. We characterized these antigens,raised polyclonal antibodies against them and developed an antigen detection capture ELISA to diagnose VL.A pilot clinical study defined that the three proteins of L. infantum were present in the urines 19/20 wellcharacterized New World VL patients and in none of more than 60 control urines samples from healthysubjects as well as from non VL patients like suffering from cutaneous leishmaniasis, Chagas? disease,schistosomiasis and tuberculosis. We are currently validating the recently discovered L. donovani markers. For this Phase II proposal we will use a large panel of urine samples from different areas of the worldwhere VL is endemic to validate all seven discovered L. infantum and L. donovani biomarkers as reliable toolsfor the accurate diagnosis of active VL and to monitor the therapy of this disease. In addition to a solidpreliminary data, a strength of this proposal is our access to a unique resource of urine samples fromconfirmed VL patients from VL endemic regions around the world.



Institute of Human Virology H3Africa Biorepository (I-HAB) by INSTITUTE OF HUMAN VIROLOGY (The Research University TRU)



PI: Abimiku, Alash’le G.Title: IHVN H3Africa Biorepository (I-HAB) InitiativeInstitution: Institute of Human Virology, Nigeria (IHVN)Project Summary: The Institute of Human Virology Nigeria (IHVN) H3Africa biorepository (I-HAB) inAbuja Nigeria is directed by Dr. Alash?le Abimiku, with consultation from Dr. Christine Beiswanger,retired from the Coriell Institute for Biomedical Research in the US. During the last seven years, thebiorepository has successfully upgraded its practices to be ISBER compliant through an iterative qualityassessment-based interaction involving capacity building drawing upon Coriel?sl proven models. Havinggraduated to be the W/Africa H3Africa regional biorepository, it has successfully supported clinical sitesand hubs of three U54 multiple center H3Africa projects and two U01 single research H3Africa projectsto deposit over 13,474 DNA samples of high quality; and has just picked up an additional three newH3Africa U54s and four U01s to support starting in 2017. The goal of this submission is to continueto expand the capacity of the I-HAB to support multiple H3Africa investigators and the widerscientific community to conduct high quality genomics and translational research in Africausing well processed, preserved and quality controlled and redundantly protected humanbiological samples. To achieve this, I-HAB builds on its past successes to address six specific aims.1) Implement a high-quality biorepository of primary human biologic samples and genetic materials incompliance with GLP and ISBER guidelines; and H3Africa policies and guidelines. 2) Establishadministrative processes and Quality Assurance/Quality Control procedures to ensure the integrity ofscientific process and biorepository sustainably. 3) Implement a robust cloud computing-basedbioinformatics tool which automates management of samples and chain of custody information to meetGLP and ISBER guidelines. 4) Pilot processes for efficient distribution of high-quality biological samplesto the wider scientific community based on Data and Biological samples Access Committee approvaland according to H3Africa policies and guidelines. 5) Integrate best practices in biorepository ethics intoI-HAB functions and engage the local community through awareness and educational programs todevelop a better understanding and support for the biorepository as a trustworthy partner. 6) Establisha business model as part of a long-term sustainability strategy. Working collaboratively with the othertwo sister H3Africa biorepositories and the H3Africa Bionet, I-HAB continues to advocate for hostgovernment and community support and pilot processes to make the regulatory and ethical process ofsharing samples and data easier. The strong institutional support through the expansion of thebiorepository to over 3times its size when the project started in IHVN?s new facility and the expansion ofits clientele to investigators outside of H3Africa signals a sustainable future for I-HAB.



Characterizing intact proviral HIV-1 reservoir size and determinants of reservoir dynamics in African populations by UNIVERSITY OF CAPE TOWN (The Research University TRU)



Project SummaryAntiretroviral treatment is unable to clear HIV-1 infection because a highly stable latent viral reservoirpersists in the host. Key areas of interest with respect to HIV-1 eradication strategies include latentreservoir establishment, size and make-up. A considerable amount is now known about these key areas insubtype B-infected American men, yet there remains limited knowledge in the most affected population,subtype C-infected South African women, or in African populations in general. Population differences mayexist with respect to reservoir characteristics, and eradication strategies would need to take suchdifferences into account. Characterization of the HIV-1 reservoir in the African context therefore representsa much needed area of attention.This project proposes to firstly address the need for implementation of a high-throughput, accurate reservoirsizing method in South Africa through optimization of the newly developed intact proviral DNA assay (IPDA)for subtype C HIV-1. This method will be applied to more than 200 women from KwaZulu Natal. Reservoirsize in these women will be compared to that of individuals from Ugandan and American cohorts using thesame assay to evaulate reservoir differences across populations. This project will also investigate a role forthe viral factors Nef and the long terminal repeat, which are drivers of immune evasion and genetranscription respectively, in reservoir size and make-up in a subset of these women. Finally, we will explorethe contribution of viral variants from the blood and cervix to the long-lived reservoir in these women usingBayesian evolutionary analyses.We hypothesize that Nef-mediated MHC-I downregulation and LTR activity have independent effects onreservoir size and distribution, and these effects differ according to infecting subtype and study population.This project will allow for comparison of reservoir size across populations using a standardized assay andwill evaluate determinants of size and kinetics of establishment.



CombinADO: a combination intervention strategy to improve health outcomes for adolescents living with HIV by COLUMBIA UNIVERSITY HEALTH SCIENCES (The Research University TRU)



UPROJECT ABSTRACT/ SUMMARYAdolescents are at the core of the global HIV epidemic. They are highly vulnerable to HIV acquisitionand?for adolescents living with HIV (ALHIV)?at disproportionate risk for poor health outcomesacross the HIV care continuum. Retention rates, adherence to antiretroviral treatment (ART), and viralsuppression (VS) are alarmingly low among ALHIV, warranting urgent attention. Adolescence is atime of rapid physical and psychological development, when youth move from childhood to adulthoodand experience multiple challenges as well as opportunities for growth, creativity, and learning. Youthwho enter this period under adverse conditions are ill prepared to cope with the impact of living with apotentially fatal, stigmatized, transmissible infection and the need to adopt positive, health-seekingbehaviors, engage with health services, and adhere to daily ART regimens. In high prevalencecountries like Mozambique, the burden of living with HIV during this vulnerable developmental stageis further exacerbated by fragile health systems and nascent ALHIV-specific differentiated servicedelivery (DSD) models. At the same time, few specific interventions have been developed and testedthat address the needs of ALHIV. In response, we propose to develop and test a culturally-appropriate, contextually-relevant, and theoretically-grounded adolescent-focused multicomponentintervention strategy, CombinADO, among ALHIV in Zambézia, Mozambique. Using a human-centered design approach, we will work with ALHIV, caregivers, health care providers, and local andnational stakeholders to develop and pilot this CombinADO intervention strategy consisting of fourcomponents: 1) ALHIV peer navigation and support, 2) adolescent-friendly services, 3) mHealthtechnologies, and 4) health communication messaging (Phase 1). In Phase 2, we propose to evaluatethe effectiveness of the CombinADO strategy on three milestones along the HIV care continuum: (a)retention in HIV care, (b) ART adherence, and (c) VS among ALHIV using a cluster randomizedcontrolled trial design. The study builds on longstanding partnerships between ICAP at ColumbiaUniversity, the Mozambique Ministry of Health and other local stakeholders, all aiming to improve thedisease course as well as outcomes along the continuum of care for this highly vulnerable population,adolescents living with HIV.



Clinical-Trans-Valid Core by NORTHWESTERN UNIVERSITY (The Research University TRU)



SUMMARY ? CLINICAL TRANSLATION AND VALIDATION COREThe C-THAN Clinical Translation and Validation Core (Clinical Trans Valid Core) will be robust and achievabledue to many years of HIV-focused clinical research and research training with local partners in Nigeria, SouthAfrica, Mali, and Tanzania. In addition to our key academic partners, we will integrate many other international,national, regional and community stakeholders involved in POC development, validation, and implementationacross the partner institutions. Our overarching objective is to develop a pipeline of POC products that meetthe clinical needs of HIV-infected individuals in low and middle-income countries. Investigators will be requiredto demonstrate analytical and clinical performance of technologies as well as suitability and feasibility of use inlow resource settings. The Clinical Trans Valid Core specific aims are: 1. validate and establish best practicesfor innovative POC technologies developed for the diagnosis and management of HIV and HIV related co-morbidities in ?real-world? clinical or public health settings, 2. assess outcomes of implementation processes ofinnovative POC technologies developed for the diagnosis and management of HIV and HIV related co-morbidities in ?real-world? clinical or public health settings, and 3. support translation of innovative POCtechnologies from the Technology Development (Technology Dev) Core into clinical practice though pilotfunding, expertise in validation and implementation science, and providing resources including support todevelop needed trainings, manuals and other tools to ensure effective uptake. Our Clinical Trans Valid Corewill provide a ?clinical laboratory? for innovators that will focus on validation, adoption, and assessment offeasibility and implementation of POC technologies. Depending on the status of a developing POCtechnology, we will work across Cores to select projects to participate in either the Clinical Trans Valid Core orTechnology Dev Core. We will also review projects in the Technology Dev Core in later stages for potentialtransition into the Clinical Trans Valid Core. The primary goal of the Clinical Trans Valid Core is to provideinfrastructure and services dedicated to clinical validation of POC technologies and to evaluate implementationoutcomes including adoption, fidelity, feasibility and acceptability to ensure that POC technology prototypessupported under C-THAN will have a high rate of success for clinical uptake and maximal public health impact.



Dartmouth-Boston University HIV-TB Research Training for the Infectious Disease Institute at Muhimbili University of Health and Allied Sciences by DARTMOUTH COLLEGE (The Research University TRU)



PROJECT SUMMARY/ABSTRACT  The previous three cycles of the Dartmouth-­Boston University-­Muhimbili (DBM) Fogarty HIV training program have resulted in a multi-­faceted research and training collaboration between Dartmouth, BU and Muhimbili University of Health and Allied Sciences (MUHAS). It has produced landmark studies on the epidemiology of HIV, tuberculosis (TB) and HIV-­related TB (HIV-­TB), clinical features of adult and pediatric HIV-­TB, vaccine trials to prevent HIV-­TB, and nutritional supplementation for women with HIV-­TB.     Our current 5-­year award culminated in MUHAS? approval of a TB Research Institute (TRIM-­TB), which is an HIV-­TB research collaboration between the DBM Fogarty program, MUHAS and the Tanzanian National Programme on Tuberculosis and Leprosy (NTLP). Recognizing the benefits of TRIM-­TB, MUHAS leadership endorsed the concept of a broader initiative, designated as the Infectious Disease Institute (IDI). The newly approved IDI will support research and training in all infectious diseases of importance in Tanzania, with an initial focus on HIV and TB. MUHAS, the NTLP and the National AIDS Control Program (NACP) have solicited the DBM Fogarty Program to provide the training needed to achieve the IDI?s goals. To that end, we propose: 1) Train IDI research faculty to conduct HIV and HIV/TB epidemiologic research and clinical trials 2) Establish a mentoring program through IDI to ensure junior faculty are supported and successful in performing research and obtaining independent research funding. 3) Expand the portfolio of funded collaborative HIV and HIV/TB research for MUHAS faculty/trainees. 4) Develop a program of research training for Tanzanian field scientists led by IDI faculty To develop the present proposal, we conducted a comprehensive needs assessment including: 1) discussions with key stakeholders/leadership at MUHAS, NTLP and NACP, 2) interviews with key MUHAS faculty, and 3) a survey of DBM Fogarty alumni. In response, we focused our program on training in epidemiology, biostatistics and clinical trials, developing strong Tanzanian mentors, expanding the research portfolio using NTLP and NACP data, and supporting the IDI to develop its permanent research training program.  At the end of this proposed training program, 5 Tanzanian researchers will have graduated with PhD degrees in epidemiology and/or biostatistics, 1 with a Masters degree in Epidemiology, and 4 with Masters of Public Health degrees;? 18 will have completed short course training outside of Tanzania in epidemiology, biostatistics, TB/HIV/STD research methods;? and over 150 will have attended interactive, hands-­on workshops in Dar es Salaam on HIV-­TB clinical research, monitoring & evaluation, data analysis, and grant and manuscript writing. This training program will provide the expertise to establish IDI as the premiere self-­sustaining research and training institute for HIV and TB in East Africa.






African Female Breast Cancer Epidemiology (AFBRECANE) StudyProject summaryBreast cancer is the commonest cancer in women globally and it is increasingly overtaking cervical cancer asthe commonest female cancer in low and middle income countries (LMIC). The incidence of breast cancerNigeria was 54.3 per 100,000 per year (24,750 new cases per year) in 2014 representing a rise from 20 per100,000 in the 1970s (3,000 new cases per year). It is now a major cancer burden in Nigerian women. Thereare controversies about the epidemiology and molecular subtypes of breast cancer in African women includinglimited knowledge about the incidence of breast cancer and determinants of this incidence such as the role ofdifferent risk factors; incidence and prevalence of molecular subtypes of breast cancer and the contributions ofindigenous African diets to breast cancer incidence. In the absence of prospective cohort studies, we engageinnovative research design and analytic techniques to use data from population based cancer registries(PBCR) to study the epidemiological factors associated with incident breast cancer and molecular subtypes.There has also never been a genome wide association study (GWAS) of breast cancer in general and ofmolecular subtypes of breast cancer in indigenous African women.While many researchers suggest that African diets are associated with reduced risks of breast cancer, therehave been very few systematic studies. We use the nutrition epidemiology tools that we previously developedand validated to study dietary intakes and breast cancer risk in African women. We focus in particular on therole of vitamin D and explore potential associations with breast cancer using nutrition epidemiology andgenomics epidemiology tools.






West African Sustainable Leadership and Innovation Training inBioinformatics Research (WASLITBRe)Training Program Summary. It is evidently clear that NIH has audaciously stimulatedand is supporting research in human health and heredity in Africa, which is further, enhancedwith informatics tools development and short-term training in bioinformatics. However, thelong-term sustainability of the initiatives remain a doubt if effort is not directed to AfricanUniversities to develop innovative, future-looking- oriented data science academic education toperpetuity maintain the scientific research leadership in data science. We therefore proposed hereto develop a West African Sustainable Leadership and Innovation Training in BioinformaticsResearch (WASLITBRe) to support the H3Africa consortium. The proposed WASLITBRe is acollaborative program between Covenant University (CU), Nigeria, University of Bamako (UB),Mali and the University of Ghana/KNUST. The program will have two tracks – a training leadingto award of MSc./ PhD, junior faculty (post doctorate) fellowships, and networking andmentorship training in advanced bioinformatics and data science research. Trainees for theMSc/PhD will be selected from pool of graduates with diverse background (clinician,information Science, computer science, mathematics, data Science, statistics/biostatistics,biology, physics and engineering), junior faculty fellowship will be selected from a pool ofhighly motivated graduates with less than 5 years of research experience post PhD training. Theunifying theme of both tracks is that trainee must express and demonstrate interest inbioinformatics and data science research. Our long-term goal is to produce a sustainable networkof individuals who are well trained in various aspects of advanced bioinformatics and datascience research, ready to assume leadership roles at academic, health care and researchinstitutions in West Africa.


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