Study of Neurological Aging Among People Living With HIV

NCT05678660 | Suspended

• 2 other identifiers: RSRB_STUDY00007234R35NS122265
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective, exposure-control cohort study of older adults living with HIV comparing the neurological status of those who have had HIV infection for a longer period of time (long HIV group) to age, gender, and community-matched comparison group who have had HIV infection for a shorter period of time (short HIV group).

Conditions

Aging, Premature

Keywords

frailty; cognitive impairment; neuropathy; mental health; antiretroviral toxicity

Outcome Measures

Primary Outcomes (85)

• Cognition - Zambian Mini-Mental Status Examination (zMMSE) - During enrollment

  The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points

  baseline/during enrollment

• Cognition - Zambian Mini-Mental Status Examination (zMMSE) - on Year 1 of evaluation

  The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points

  Year 1 evaluation

• Cognition - Zambian Mini-Mental Status Examination (zMMSE) - on Year 2 of evaluation

  The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points

  Year 2 evaluation

• Cognition - International HIV Dementia Scale (I-HDS) - on Year 3 of evaluation

  The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points

  Year 3 evaluation

• Cognition - International HIV Dementia Scale (I-HDS)- on Year 4 of evaluation

  The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points

  Year 4 evaluations

• Cognition - International HIV Dementia Scale (I-HDS) - on Year 5 of evaluation

  The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points

  Year 5 evaluation

• Cognition - International HIV Dementia Scale (I-HDS)- on Year 6 of evaluation

  The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points

  Year 6 evaluation

• Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) -Baseline/during enrollment

  The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.

  Baseline/during enrollment

• Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) - on Year 1 of enrollment

  The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.

  Year 1 evaluation

• Mental Health - The Alcohol Use Disorders Identification Test (AUDIT)- on year 2 of evaluation

  The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.

  Year 2 evaluation

• Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) - on year 3 of evaluation

  The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.

  Year 3 evaluation

• Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 4 of evaluation

  is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.

  Year 4 evaluation

• Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 5 of evaluation

  is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.

  Year 5 evaluation

• Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 6 of evaluation

  is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.

  Year 6 evaluation

• Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- baseline/during enrollment

  General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.

  Baseline

• Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- baseline/during enrollment

  General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.

  Baseline/during enrollment

• Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 1 of evaluation

  General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.

  Year 1 evaluation

• Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 2 of evaluation

  General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.

  Year 2 evaluation

• Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 3 of evaluation

  General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.

  Year 3 evaluation

• Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 4 of evaluation

  General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.

  Year 4 evaluation

• Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 5 of evaluation

  General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.

  Year 5 evaluation

• Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 6 of evaluation

  General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.

  Year 6 evaluation

• Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)-baseline/during enrolment

  Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.

  Baseline/during enrollment

• Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 1 of enrolment

  Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.

  Year 1 evaluation

• Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 1 of evaluation

  Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.

  Year 2 evaluation

• Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 3 of evaluation

  Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.

  Year 3 evaluation

• Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 4 of evaluation

  Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.

  Year 4 evaluation

• Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 5 of evaluation

  Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.

  Year 5 evaluation

• Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ) - on year 6 of evaluation

  Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.

  Year 6 evaluation

• Frailty assessment - Body weight - baseline/during enrollment

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurement: Body weight in kilograms (kg).

  Baseline/during enrollment

• Frailty assessment - Body weight - on year 1 of evaluation.

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms (kg)

  Year 1 evaluation

• Frailty assessment - Body weight- on year 2 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms (kg)

  Year 2 evaluation

• Frailty assessment - Body weight - on year 3 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight, Body Fat, Body Muscle, and the Body Mass Index (BMI).

  Year 3 evaluation

• Frailty assessment - Body weight on year 4 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms(kg)

  Year 4 evaluation

• Frailty assessment - Body weight - on year 5

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight, Body Fat, Body Muscle, and the Body Mass Index (BMI).

  Year 5 evaluation

• Frailty assessment - Body weight - on year 6 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms(kg).

  Year 6 evaluation

• Frailty assessment - Body height- baseline/during enrollment

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).

  Baseline/during enrollment

• Frailty assessment - Body height- on year 1 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).

  Year 1 of evaluation

• Frailty assessment - Body height- on year 2 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).

  Year 2 of evaluation

• Frailty assessment - Body height- on year 3 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).

  Year 3 of evaluation

• Frailty assessment - Body height- on year 4 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).

  Year 4 of evaluation

• Frailty assessment - Body height- on year 5 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).

  Year 5 of evaluation

• Frailty assessment - Body height- on year 6 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).

  Year 6 of evaluation

• Frailty assessment - Body mass index-baseline/during enrollment

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.

  Baseline/during enrollment

• Frailty assessment - Body mass index- on year 1 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.

  Year 1 of evaluation

• Frailty assessment - on year 2 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.

  Year 2 of evaluation

• Frailty assessment - Body mass index- on year 3 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.

  Year 3 of evaluation

• Frailty assessment - Body mass index- on year 4 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.

  Year 4 of evaluation

• Frailty assessment - Body mass index- on year 5 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.

  Year 5 of evaluation

• Frailty assessment - Body mass index- on year 6 of evaluation

  Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.

  Year 6 of evaluation

• Frailty assessments - Grip strength- baseline/during enrollment

  Grip strength will be assessed by dynamometry against international norms for age and SNAP\_Protocol\_V2.3\_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.

  Baseline

• Frailty assessments - Grip strength - on year 1 of evaluation

  Grip strength will be assessed by dynamometry against international norms for age and SNAP\_Protocol\_V2.3\_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.

  Year 1 evaluation

• Frailty assessments - Grip strength- on year 2 of evaluation

  Grip strength will be assessed by dynamometry against international norms for age and SNAP\_Protocol\_V2.3\_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.

  Year 2 evaluation

• Frailty assessments - Grip strength- on year 3 of evaluation

  Grip strength will be assessed by dynamometry against international norms for age and SNAP\_Protocol\_V2.3\_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.

  Year 3 evaluation

• Frailty assessments - Grip strength- on year 4 of evaluation

  Grip strength will be assessed by dynamometry against international norms for age and SNAP\_Protocol\_V2.3\_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.

  Year 4 evaluation

• Frailty assessments - Grip strength-on year 5 of evaluation

  Grip strength will be assessed by dynamometry against international norms for age and SNAP\_Protocol\_V2.3\_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.

  Year 5 evaluation

• Frailty assessments - Grip strength- on year 6 of evaluation

  Grip strength will be assessed by dynamometry against international norms for age and SNAP\_Protocol\_V2.3\_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.

  Year 6 evaluation

• Frail assessment - Physical Activity- baseline/during enrollment

  Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

  Baseline

• Frail assessment - Physical Activity- on year 1 of evaluation

  Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

  Year 1 evaluation

• Frail assessment - Physical Activity- on year 2 of evaluation

  Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

  Year 2 evaluation

• Frail assessment - Physical Activity- on year 3 of evaluation

  Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

  Year 3 evaluation

• Frail assessment - Physical Activity- on year 4 of evaluation

  Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

  Year 4 evaluation

• Frail assessment - Physical Activity- on year 5 of evaluation

  Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

  Year 5 evaluation

• Frail assessment - Physical Activity- on year 6 of evaluation

  Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

  Year 6 evaluation

• Frail assessment - Time Gait- baseline/during enrollment

  Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.

  baseline

• Frail assessment - Time Gait- on year 1 of evaluation

  Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.

  Year 1 evaluation

• Frail assessment - Time Gait- on year 2 of evaluation

  Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.

  Year 2 evaluation

• Frail assessment - Time Gaiton year 3 of evaluation

  Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.

  Year 3 evaluation

• Frail assessment - Time Gait- on year 4 of evaluation

  Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.

  Year 4 evaluation

• Frail assessment - Time Gait- on year 5 of evaluation

  Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.

  Year 5 evaluation

• Frail assessment - Time Gait- on year 6 of evaluation

  Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.

  Year 6 evaluation

• Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- baseline/during enrollment

  The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).

  baseline/ during enrollment

• Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 1 of evaluation

  The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).

  Year 1 of evaluation

• Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 2 of evaluation

  The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).

  Year 2 evaluation

• Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 3 of evaluation

  The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).

  Year 3 evaluation

• Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 4 of evaluation

  The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).

  Year 4 evaluation

• Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 5 of evaluation

  The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).

  Year 5 evaluation

• Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 6 of evaluation

  The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).

  Year 6 evaluation

• Peripheral nerve health - Heart Rate Variability(HRV)- baseline/during enrollment

  Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.

  Baseline/during enrollment

• Peripheral nerve health - Heart Rate Variability(HRV)- on year 1 of evaluation

  Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.

  Year 1 evaluation

• Peripheral nerve health - Heart Rate Variability(HRV) - on year 2 of evaluation

  Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.

  Year 2 evaluation

• Peripheral nerve health - Heart Rate Variability(HRV)- on year 3 of evaluation

  Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.

  Year 3 evaluation

• Peripheral nerve health - Heart Rate Variability(HRV)- on year 4 of enrollment

  Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.

  Year 4 evaluation

• Peripheral nerve health - Heart Rate Variability(HRV)- on year 5 of evaluation

  Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.

  Year 5 evaluation

• Peripheral nerve health - Heart Rate Variability(HRV)- on year 6 of evaluation

  Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.

  Year 6 evaluation

Study Arms (2)

Long Group

Older adults individuals with longstanding HIV, stable and on antiretroviral therapy for at least 7 years

Short Group

Older adults living with HIV, on stable antiretroviral treatment for at least 1 but not more than 2 years,

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified through the antiretroviral clinics associated with Chikankata Hospital and Monze Mission Hospital in Zambia's Southern Province. Individuals will first be identified in the long group and will then be matched to a PLWH in the short group matching based upon gender, age and community of residents

You may qualify if:

• For the short group, stable on ART for 1 year, but no more than 2 years.
• For long group, on ART for 7 or more years

You may not qualify if:

• Acute medical illness.
• Decisional impairment precluding informed consent as noted by clinicians providing care to the patient or by the research staff team members.
• Communication impairments-unable to hear or unable to speak.
• Being unable to communicate in English or in the dominant language at the study site (Tonga).

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Centre for Infectious Disease Research in Zambia: collaborator

Study Sites (3)

Chilenje Level 1 Hospital

Lusaka, Lusaka Province, Zambia

Location

Chikankata Hospital

Mazabuka, Southern Province, Zambia

Location

Monze Mission Hospital

Monze, Southern Province, Zambia

Location

Related Publications (49)

• Mbewe EG, Kabundula PP, Mwanza-Kabaghe S, Buda A, Adams HR, Schneider C, Potchen MJ, Mweemba M, Mathews M, Menon JA, Wang B, Baseler T, Paciorkowski A, Birbeck GL, Bearden DR. Socioeconomic Status and Cognitive Function in Children With HIV: Evidence From the HIV-Associated Neurocognitive Disorders in Zambia (HANDZ) Study. J Acquir Immune Defic Syndr. 2022 Jan 1;89(1):56-63. doi: 10.1097/QAI.0000000000002825.

  PMID: 34878435 BACKGROUND

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Biospecimen

Retention: NONE RETAINED

Blood sample taken for CD4 count, plasma viral load, and HIV genotyping (about 8mls).

MeSH Terms

Conditions

Aging, Premature; Frailty; Cognitive Dysfunction; Psychological Well-Being

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Gretchen L. Birbeck, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: January 10, 2023
• Study Start: July 6, 2022
• Primary Completion (Estimated): June 5, 2028
• Study Completion (Estimated): June 5, 2028
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 2 years after study completion
• Access Criteria: Written request

Locations

ZA (3)