Table 2.
St PETER HIV data and sample collection.
| Study Time Point (in months) |
|||||||
|---|---|---|---|---|---|---|---|
| Administered Assessment | Description | Baseline | Short Check Ins | 1 Mo. | 3 Mo. |
6 Mo. |
12 Mo. |
| Demographics [41,42] | Participant demographics and socio-economic status | X | X | ||||
| 30-day Alcohol Timeline Followback (TLFB) [43] | Estimates of participant's daily drinking over the past 30 days | X | X | X | X | X | |
| Alcohol Use Disorders Identification Test (AUDIT) [44] | Identifies persons with hazardous alcohol use | X | X | X | |||
| DSM-5 Alcohol Use Disorder [45] | Diagnosis of alcohol use disorders, with classifications of mild, moderate, and severe | X | X | ||||
| Short Inventory of Problems (SIP) for Alcohol Use [46,47] | Assessment of adverse consequences of alcohol use | X | X | X | X | X | |
| Penn Alcohol Craving Scale [48] | Instrument for assessing alcohol craving. Measures frequency, intensity, and duration of thoughts about drinking, as well as ability to resist drinking | X | X | X | X | X | |
| Readiness to Quit Alcohol [49] | Assesses readiness to quit drinking via a readiness to change ruler | X | X | X | X | X | |
| 30-day Cigarette Timeline Followback (TLFB) [50,51] | Estimates of participant's daily cigarette smoking over the past 30 days | X | X | X | X | X | |
| Tobacco Use (Fagerström) [52,53] | A measure of nicotine dependence | X | X | X | X | X | |
| Other Tobacco Use [54] | Assesses tobacco use other than cigarette use | X | X | X | X | X | |
| Tobacco Craving (QSU) [[55], [56], [57]] | Instrument for assessing craving to smoke | X | X | X | X | X | |
| Readiness to Quit Tobacco [58] | Assesses readiness to quit smoking via a readiness to change ruler | X | X | X | X | X | |
| Smoking Quit Attempts | Assesses whether participant attempted to quit smoking in past 6 months | X | X | X | |||
| HIV Risk Categories [59] | Asks about participant's potential exposure to HIV | X | |||||
| Depressive Symptoms (CES-D) [60,61] | A measure of depressive symptomology | X | X | X | X | X | |
| Anxiety (GAD-7)62 | A measure of severity of anxiety | X | X | X | X | X | |
| Trauma | Questions about traumatic experiences | X | X | ||||
| HIV Testing and HCV Diagnosis | Dates and locations of HIV/HCV testing and HIV/HCV treatment | X | X | ||||
| ART Use and Adherence [63] | Questions on ART and 30-day adherence | X | X | X | |||
| Opportunistic Infections [64] | Assesses any history of candida or yeast infection of the esophagus, TB, pneumonia, or toxoplasmosis | X | X | ||||
| Co-Morbidities [65] | Participant and family medical history | X | X | ||||
| Brief Chronic Pain Questionnaire [66,67] | Two questions about severity of body pain in the past week and duration of bodily pain | X | X | X | |||
| HIV Symptom Index [68] | A 20-item HIV symptom index includes patient-reported symptoms | X | X | ||||
| Smoking-related symptoms [[69], [70], [71]] | Assesses smoking-related respiratory symptom severity | X | X | X | X | X | |
| Reproductive Health | Questions regarding reproductive health | X | X | ||||
| Falls [72] | Questions about falls in the past 6 months | X | X | ||||
| TB testing and treatment | Questions about TB testing, diagnosis, and treatment | X | X | ||||
| Healthcare Utilization [73] | How often participants see a physician and if they receive treatment for HIV and addiction | X | X | X | |||
| Medications | Prescription and non-prescription medication taken in the past 7 days | X | X | X | X | X | |
| Brief Pain Inventory- SF [74] | Participant pain severity in the past 7 days | X | X | X | |||
| Drug Use (modified RBS) & Overdose [[75], [76], [77]] | Participant's self-reported drug use, modified to adapt to drug practices in Russia, and questions regarding history of overdose | X | X | X | X | X | |
| 24 Hour Activities | Participant past 24-h activities that may impact inflammatory biomarkers measured | X | X | X | X | X | |
| Social Support Scale [78,79] | Measures access to companionship, assistance, or other types of support | X | X | ||||
| Veterans Rand 12-Item Health Survey plus 4 cognitive questions from MOS-HIV [80,81] | Assessment of overall health and cognitive function | X | X | ||||
| Smartphones | Asks whether participant owns a smartphone and whether they would be willing to use a free app to help quit drinking or smoking | X | |||||
| Medication Adherence [63] | Adherence to study medication in the past week, as indicated by measurement on a ruler ranging from 0 to 100 and additional questions on adherence patterns | X | X | X | |||
| Medication Satisfaction [82] | Participant satisfaction with study medication | X | X | ||||
| Blinding Questions | Questions on which study medication the participant believes to be taking | X | X | ||||
| Clinical and Laboratory Values/Testing | Baseline | Short Check Ins | 1 Mo. |
3 Mo. |
6 Mo. |
12 Mo. |
|
| Height (m/cm) | X | X | X | X | X | ||
| Weight (kg) | X | X | X | X | X | ||
| Breath Alcohol Content (%) | X | X | X | X | X | ||
| Exhaled Carbon Monoxide (abstinence threshold < 10 ppm)_ | X | X | X | X | X | ||
| Urine Pregnancy Testing | X | X | X | ||||
| Blood Pressure (mmHG) | X | X | X | X | X | ||
| Urine Nicotine Metabolite Testing | X | X | |||||
| Reynolds Risk Score (Cholesterol [total and HD], hsCRP) | X | X | |||||
| VACS Index (HIV Viral Load, CD4 count, AST/ALT, Creatinine, Hemoglobin & Platelets, HCV Aba) | X | X | |||||
| Nicotine Metabolite Ratio (NMR) (Whole blood) | X | ||||||
| Available Repository Samples | Baseline | Short Check Ins | 1 Mo. |
3 Mo. |
6 Mo. |
12 Mo. |
|
| DBS Cards (PEth) | X | X | X | ||||
| Serum and Plasma | X | X | X | X | X | ||
HCV Ab will be measured at baseline, and if negative at baseline, again at 3 months.