246254S
THE PROPOSAL DESCRIBES A STUDY TO MEASURE THE EPIDEMIOLOGY OF COGNITIVE IMPAIRMENT AND DEMENTIA AMONG PEOPLE LIVING WITH HIV IN RURAL, SOUTHWESTERN UGANDA. PARTICIPANTS WILL INCLUDE BOTH PEOPLE WITH HIV WHO HAVE RECEIVED TREATMENT AT THE IMMUNE SUPPRESSION SYNDROME CLINIC AT THE MBARARA REGIONAL REFERRAL HOSPITAL, THE ACADEMIC TEACHING HOSPITAL OF THE MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY (MUST) OR THE KABWOHE HIV CLINIC, AND A CONTROL GROUP OF HIV-UNINFECTED PERSONS WHO RESIDE IN THE NYAKABARE OR KABWOHE REGIONS. DRS. MARK SIEDNER OF MGH AND STEPHEN ASIIMWE, OF MUST AND KCRC, ARE THE PRINCIPAL INVESTIGATORS OF THE STUDY. STUDY STAFF WILL BE RESPONSIBLE FOR IDENTIFYING AND RECRUITING PARTICIPANTS, PERFORMING INFORMED CONSENT, ENROLLING PARTICIPANTS, PERFORMING STUDY SURVEYS AND INTERVIEWS, THE PERFORMANCE OF NON-INVASIVE TESTS SUCH AS NEUROCOGNITIVE ASSESSMENTS, THE PERFORMANCE OF BRAIN IMAGING, COLLECTION, STORAGE AND SHIPMENT OF BLOOD SAMPLES, ENTERING STUDY DATA, TRANSLATING AND BACK-TRANSLATING STUDY SURVEYS, AND PERFORMING QUALITY ASSURANCE FOR STUDY PROTOCOLS. KCRC SHALL PROVIDE THE FOLLOWING SERVICES TO MASSACHUSETTS GENERAL HOSPITAL, BOSTON, USA: 1. WORK WITH BOTH THE US AND UGANDA-BASED PROJECT DIRECTORS, TO DEVELOP STUDY RECRUITMENT, PROCEDURES, AND THE DEVELOPMENT AND THE IMPLEMENTATION OF STUDY QUESTIONNAIRES AND OUTCOME MEASURES. 2. PROVIDE HUMAN RESOURCES STAFF AND RESOURCES TO ASSIST IN RECRUITMENT, CONTRACT PREPARATION, AND HIRING OF STUDY STAFF. 3. REPORT TO LOCAL ETHICAL REVIEW BOARD REVIEW AND CONDUCT OF STUDY PROCEDURES IN ACCORDANCE WITH GUIDELINES. 4. IDENTIFY STUDY CANDIDATES AND ENROLL THEM IN THE STUDY. 5. FOLLOW A CASELOAD OF APPROXIMATELY 350 SUBJECTS. CARRY OUT SUBJECT RECRUITMENT, INFORMED CONSENT, TRANSLATION TO ENGLISH AND BACK TRANSLATION OF ALL SURVEYS, STRUCTURED INTERVIEWING, PHLEBOTOMY, NONINVASIVE TESTING (E.G. BLOOD PRESSURE AND ANKLE-BRANCHIAL INDEX), LABORATORY RESULT MONITORING, COHORT RETENTION INCLUDING CALLING AND/OR TRACKING MISSING PATIENTS, AND DATA ENTRY AND QUALITY CONTROL. 6. CONDUCT BRAIN IMAGING PER STUDY PROTOCOLS FOR UP TO 350 STUDY PARTICIPANTS AND HELP MANAGE DATA STORAGE AND TRANSFER AS WELL AS CLINICAL REFERRAL FOR THOSE WITH ABNORMALITIES IDENTIFIED. 7. MAINTAIN CONFIDENTIAL SUBJECT RECORDS. 8. CORRESPOND WEEKLY WITH DR. SIEDNER (MGH) FOR STUDY UPDATES AND PROGRESS, AS WELL AS TO TROUBLESHOOT ISSUES AS THEY ARISE. 9. CREATE AND MAINTAIN ONLINE PROTECTED DATABASES AS WELL AS TRAIN RESEARCH ASSISTANTS TO ENTER SURVEY DATA. 10. SECURE AND MAINTAIN ADEQUATE SPACE FOR ALL PROJECT OPERATIONS.
None
Project Grant R56AG087790
$39.1k 12/19/24 GR0246254S
THE PROPOSAL DESCRIBES A STUDY TO MEASURE THE EPIDEMIOLOGY OF COGNITIVE IMPAIRMENT AND DEMENTIA AMONG PEOPLE LIVING WITH HIV IN RURAL, SOUTHWESTERN UGANDA. PARTICIPANTS WILL INCLUDE BOTH PEOPLE WITH HIV WHO HAVE RECEIVED TREATMENT AT THE IMMUNE SUPPRESSION SYNDROME CLINIC AT THE MBARARA REGIONAL REFERRAL HOSPITAL, THE ACADEMIC TEACHING HOSPITAL OF THE MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY (MUST) OR THE KABWOHE HIV CLINIC, AND A CONTROL GROUP OF HIV-UNINFECTED PERSONS WHO RESIDE IN THE NYAKABARE OR KABWOHE REGIONS. DRS. MARK SIEDNER OF MGH AND STEPHEN ASIIMWE, OF MUST AND KCRC, ARE THE PRINCIPAL INVESTIGATORS OF THE STUDY. STUDY STAFF WILL BE RESPONSIBLE FOR IDENTIFYING AND RECRUITING PARTICIPANTS, PERFORMING INFORMED CONSENT, ENROLLING PARTICIPANTS, PERFORMING STUDY SURVEYS AND INTERVIEWS, THE PERFORMANCE OF NON-INVASIVE TESTS SUCH AS NEUROCOGNITIVE ASSESSMENTS, THE PERFORMANCE OF BRAIN IMAGING, COLLECTION, STORAGE AND SHIPMENT OF BLOOD SAMPLES, ENTERING STUDY DATA, TRANSLATING AND BACK-TRANSLATING STUDY SURVEYS, AND PERFORMING QUALITY ASSURANCE FOR STUDY PROTOCOLS. KCRC SHALL PROVIDE THE FOLLOWING SERVICES TO MASSACHUSETTS GENERAL HOSPITAL, BOSTON, USA: 1. WORK WITH BOTH THE US AND UGANDA-BASED PROJECT DIRECTORS, TO DEVELOP STUDY RECRUITMENT, PROCEDURES, AND THE DEVELOPMENT AND THE IMPLEMENTATION OF STUDY QUESTIONNAIRES AND OUTCOME MEASURES. 2. PROVIDE HUMAN RESOURCES STAFF AND RESOURCES TO ASSIST IN RECRUITMENT, CONTRACT PREPARATION, AND HIRING OF STUDY STAFF. 3. REPORT TO LOCAL ETHICAL REVIEW BOARD REVIEW AND CONDUCT OF STUDY PROCEDURES IN ACCORDANCE WITH GUIDELINES. 4. IDENTIFY STUDY CANDIDATES AND ENROLL THEM IN THE STUDY. 5. FOLLOW A CASELOAD OF APPROXIMATELY 350 SUBJECTS. CARRY OUT SUBJECT RECRUITMENT, INFORMED CONSENT, TRANSLATION TO ENGLISH AND BACK TRANSLATION OF ALL SURVEYS, STRUCTURED INTERVIEWING, PHLEBOTOMY, NONINVASIVE TESTING (E.G. BLOOD PRESSURE AND ANKLE-BRANCHIAL INDEX), LABORATORY RESULT MONITORING, COHORT RETENTION INCLUDING CALLING AND/OR TRACKING MISSING PATIENTS, AND DATA ENTRY AND QUALITY CONTROL. 6. CONDUCT BRAIN IMAGING PER STUDY PROTOCOLS FOR UP TO 350 STUDY PARTICIPANTS AND HELP MANAGE DATA STORAGE AND TRANSFER AS WELL AS CLINICAL REFERRAL FOR THOSE WITH ABNORMALITIES IDENTIFIED. 7. MAINTAIN CONFIDENTIAL SUBJECT RECORDS. 8. CORRESPOND WEEKLY WITH DR. SIEDNER (MGH) FOR STUDY UPDATES AND PROGRESS, AS WELL AS TO TROUBLESHOOT ISSUES AS THEY ARISE. 9. CREATE AND MAINTAIN ONLINE PROTECTED DATABASES AS WELL AS TRAIN RESEARCH ASSISTANTS TO ENTER SURVEY DATA. 10. SECURE AND MAINTAIN ADEQUATE SPACE FOR ALL PROJECT OPERATIONS.
None
Project Grant R56AG087790
$39.1k 12/19/24 246254S
THE PROPOSAL DESCRIBES A STUDY TO MEASURE THE EPIDEMIOLOGY OF COGNITIVE IMPAIRMENT AND DEMENTIA AMONG PEOPLE LIVING WITH HIV IN RURAL, SOUTHWESTERN UGANDA. PARTICIPANTS WILL INCLUDE BOTH PEOPLE WITH HIV WHO HAVE RECEIVED TREATMENT AT THE IMMUNE SUPPRESSION SYNDROME CLINIC AT THE MBARARA REGIONAL REFERRAL HOSPITAL, THE ACADEMIC TEACHING HOSPITAL OF THE MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY (MUST) OR THE KABWOHE HIV CLINIC, AND A CONTROL GROUP OF HIV-UNINFECTED PERSONS WHO RESIDE IN THE NYAKABARE OR KABWOHE REGIONS. STUDY STAFF WILL BE RESPONSIBLE FOR IDENTIFYING AND RECRUITING PARTICIPANTS, PERFORMING INFORMED CONSENT, ENROLLING PARTICIPANTS, PERFORMING STUDY SURVEYS AND INTERVIEWS, THE PERFORMANCE OF NON-INVASIVE TESTS SUCH AS NEUROCOGNITIVE ASSESSMENTS, THE PERFORMANCE OF BRAIN IMAGING, COLLECTION, STORAGE AND SHIPMENT OF BLOOD SAMPLES, ENTERING STUDY DATA, TRANSLATING AND BACK-TRANSLATING STUDY SURVEYS, AND PERFORMING QUALITY ASSURANCE FOR STUDY PROTOCOLS. THE COHORT SHALL LARGER COMPRISE INDIVIDUALS CURRENTLY INVOLVED IN OUR AGING STUDY. MUSTCGO SHALL PROVIDE THE FOLLOWING SERVICES TO MASSACHUSETTS GENERAL HOSPITAL, BOSTON, USA: 1. WORK WITH BOTH THE US AND UGANDA-BASED PROJECT DIRECTORS, TO DEVELOP STUDY RECRUITMENT, PROCEDURES, AND THE DEVELOPMENT AND THE IMPLEMENTATION OF STUDY QUESTIONNAIRES AND OUTCOME MEASURES. 2. PROVIDE HUMAN RESOURCES STAFF AND RESOURCES TO ASSIST IN RECRUITMENT, CONTRACT PREPARATION, AND HIRING OF STUDY STAFF. 3. OVERSEE LOCAL ETHICAL REVIEW BOARD REVIEW AND CONDUCT OF STUDY PROCEDURES IN ACCORDANCE WITH GUIDELINES. 4. IDENTIFY STUDY CANDIDATES AND ENROLL THEM IN THE STUDY. 5. FOLLOW A CASELOAD OF APPROXIMATELY 600 SUBJECTS. CARRY OUT SUBJECT RECRUITMENT, INFORMED CONSENT, TRANSLATION TO ENGLISH AND BACK TRANSLATION OF ALL SURVEYS, STRUCTURED INTERVIEWING, PHLEBOTOMY, NON-INVASIVE TESTING (E.G. BLOOD PRESSURE AND ANKLE-BRANCHIAL INDEX), LABORATORY RESULT MONITORING, COHORT RETENTION INCLUDING CALLING AND/OR TRACKING MISSING PATIENTS, AND DATA ENTRY AND QUALITY CONTROL. 6. CONDUCT BRAIN IMAGING PER STUDY PROTOCOLS FOR UP TO 600 STUDY PARTICIPANTS AND HELP MANAGE DATA STORAGE AND TRANSFER AS WELL AS CLINICAL REFERRAL FOR THOSE WITH ABNORMALITIES IDENTIFIED. 7. MAINTAIN CONFIDENTIAL SUBJECT RECORDS. 8. CORRESPOND WEEKLY WITH DR. SIEDNER (MGH) FOR STUDY UPDATES AND PROGRESS, AS WELL AS TO TROUBLESHOOT ISSUES AS THEY ARISE 8. CREATE AND MAINTAIN ONLINE PROTECTED DATABASES AS WELL AS TRAIN RESEARCH ASSISTANTS TO ENTER SURVEY DATA. 9. SECURE AND MAINTAIN ADEQUATE SPACE FOR ALL PROJECT OPERATIONS.
Mbarara University Of Science And Technology
Project Grant R56AG087790
$87.8k 12/19/24 246254S
DR. JEREMY TANNER WILL SERVE AS A CO-INVESTIGATOR ON THE PROJECT. HE WILL DEDICATE HIS EFFORT TO ELEMENTS OF STUDY DESIGN, BIOMARKER SELECTION AND TESTING, DATA ANALYSIS AND INTERPRETATION. SPECIFICALLY, HE WILL COLLABORATE WITH THE OVERALL PRINCIPAL INVESTIGATOR, DR. MARK SIEDNER, AND COLLABORATORS (DRS. NOELINE NAKASUJJA, DEANNA SAYLOR, ROBERT PAUL AND MOSES ACAN) TO SELECT OPTIMAL NEUROCOGNITIVE TEST MODALITIES AND BIOMARKERS FOR TESTING, AND LEAD ON ELEMENTS OF DIAGNOSTIC VALIDITY EVALUATION. HE WILL ALSO PARTICIPATE IN THE INTERPRETATION OF NEUROCOGNITIVE ASSESSMENTS, INCLUDING CLINICAL CASE CONSENSUS DIAGNOSIS FOR PARTICIPANTS IN YEARS 1. THE PROJECT WILL PROVIDE SUPPORT FOR HIM AND FUNDING FOR TRAVEL TO THE STUDY SITES FOR TRAINING AND QUALITY CONTROL PURPOSES.
The University Of Texas Health Science Center At San Antonio
Project Grant R56AG087790
$51.3k 12/18/24