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This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. The investigators will observe how varying ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD) in medical cannabis impact neuropathic pain, inflammation and adverse events.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-11-13
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
This study will examine how medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. The investigators will enroll adults with HIV who have a) neuropathic pain, b) are actively certified for medical cannabis, and c) intend to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary). The investigators will observe how pain and inflammation change in participants after they are randomized to receive high THC:low CBD product, an equal THC:CBD product, a low THC:high CBD product, or placebo by our collaborator in a separate study. Over 14 weeks, data sources will include questionnaires, blood samples, urine samples; medical, pharmacy, and Prescription Monitoring Program (PMP) records. The primary independent variable will be type of medical cannabis product dispensed at dispensary, and the primary outcome will be self-reported pain.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
The investigators will follow participants who were randomized to receive a coupon for placebo soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study Placebo (0:0) Softgel, 0mg THC and 0mg CBD per cap, Bottle of 30 caps
The investigators will follow participants who were randomized to receive a coupon for high THC soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study Vireo Yellow (6:1) Softgel, 4.29mg THC and 0.72mg CBD per cap, Bottle of 30 caps
The investigators will follow participants who were randomized to receive a coupon for equal THC and CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study Vireo Green (1:1) Softgel, 2.5mg THC and 2.5mg CBD per cap, Bottle of 30 caps
The investigators will follow participants who were randomized to receive a coupon for high CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study Vireo Indigo (1:19) Softgel, 0.25mg THC and 4.75mg CBD per cap, Bottle of 30 caps
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Change in self-reported Pain Severity was measured at weekly intervals from baseline through 14 weeks using the Brief Pain Inventory (BPI) pain severity subscale. The BPI Pain Severity subscale uses a 0-10 numerical rating scale where 0 = "No pain at all" and 10 = "Pain as bad as you can imagine; completely interferes" such that higher scores were associated with increased Pain Severity. Participants were asked to assign a score to their pain, on average, over the prior week. Scores were summarized by study arm. For purposes of this study change in Pain Severity scores from baseline to 14 weeks following intervention were summarized and reported with positive values being indicative of increased pain severity compared to baseline and negative values being indicative of decreased pain severity compared to baseline.
Population: Number of participants analyzed is summarized for each arm/group at each week in the table below. Reasons for variability in the number of participants analyzed is attributable to missed virtual visits or incomplete data collection during specific timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | 9 | 6.44 | 2.07 |
| Coupon for a Discounted High THC Product | 8 | 6.86 | 2.27 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 8 | 2.38 |
| Coupon for a Discounted High CBD Product | 8 | 7.37 | 2.5 |
Eligibility
primary outcomes
Time frame: At weekly intervals from Baseline to 14 weeks
Change in self-reported Pain Severity was measured at weekly intervals from baseline through 14 weeks using the Brief Pain Inventory (BPI) pain severity subscale. The BPI Pain Severity subscale uses a 0-10 numerical rating scale where 0 = "No pain at all" and 10 = "Pain as bad as you can imagine; completely interferes" such that higher scores were associated with increased Pain Severity. Participants were asked to assign a score to their pain, on average, over the prior week. Scores were summarized by study arm. For purposes of this study change in Pain Severity scores from baseline to 14 weeks following intervention were summarized and reported with positive values being indicative of increased pain severity compared to baseline and negative values being indicative of decreased pain severity compared to baseline.
secondary outcomes
Time frame: From Baseline to 14 weeks
Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-10 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-10 from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Time frame: From Baseline to 14 weeks
Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-4 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-4 from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Time frame: From Baseline to 14 weeks
Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for TNFa are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of TNFa from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Publications
| Coupon for a Discounted Placebo Product |
| 9 |
| 5.87 |
| 3.09 |
| Coupon for a Discounted High THC Product | 8 | 6.67 | 2.58 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 7.37 | 1.76 |
| Coupon for a Discounted High CBD Product | 8 | 6.75 | 2.43 |
| Coupon for a Discounted Placebo Product | 9 | 5.22 | 3.15 |
| Coupon for a Discounted High THC Product | 8 | 5.86 | 2.23 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 7.57 | 2.25 |
| Coupon for a Discounted High CBD Product | 8 | 6.37 | 2.92 |
| Coupon for a Discounted Placebo Product | 9 | 3.87 | 2.64 |
| Coupon for a Discounted High THC Product | 8 | 6.28 | 2.63 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 7.14 | 2.73 |
| Coupon for a Discounted High CBD Product | 8 | 6.375 | 2.92 |
| Coupon for a Discounted Placebo Product | 9 | 4 | 2.87 |
| Coupon for a Discounted High THC Product | 8 | 3 | 2.34 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 7 | 2.23 |
| Coupon for a Discounted High CBD Product | 8 | 6.17 | 2.71 |
| Coupon for a Discounted Placebo Product | 9 | 4.37 | 2.72 |
| Coupon for a Discounted High THC Product | 8 | 5.14 | 3.43 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 6.25 | 2.37 |
| Coupon for a Discounted High CBD Product | 8 | 5.37 | 2.77 |
| Coupon for a Discounted Placebo Product | 9 | 4.11 | 3.62 |
| Coupon for a Discounted High THC Product | 8 | 5.57 | 2.29 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 6 | 2.2 |
| Coupon for a Discounted High CBD Product | 8 | 5.5 | 3.07 |
| Coupon for a Discounted Placebo Product | 9 | 4.25 | 3.11 |
| Coupon for a Discounted High THC Product | 8 | 4.86 | 3.67 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 6 | 2.56 |
| Coupon for a Discounted High CBD Product | 8 | 6.57 | 2.69 |
| Coupon for a Discounted Placebo Product | 9 | 3.44 | 2.92 |
| Coupon for a Discounted High THC Product | 8 | 5.5 | 4.63 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 5.28 | 3.03 |
| Coupon for a Discounted High CBD Product | 8 | 4.14 | 2.97 |
| Coupon for a Discounted Placebo Product | 9 | 4.22 | 3.73 |
| Coupon for a Discounted High THC Product | 8 | 5 | 3.16 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 7.6 | 2.07 |
| Coupon for a Discounted High CBD Product | 8 | 5.33 | 2.8 |
| Coupon for a Discounted Placebo Product | 9 | 3.88 | 3.72 |
| Coupon for a Discounted High THC Product | 8 | 4.75 | 2.96 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 6.83 | 3.37 |
| Coupon for a Discounted High CBD Product | 8 | 5.37 | 2.97 |
| Coupon for a Discounted Placebo Product | 9 | 3.78 | 3.67 |
| Coupon for a Discounted High THC Product | 8 | 6.37 | 3.89 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 5.87 | 3.18 |
| Coupon for a Discounted High CBD Product | 8 | 6.14 | 2.61 |
| Coupon for a Discounted Placebo Product | 9 | 3.55 | 3.21 |
| Coupon for a Discounted High THC Product | 8 | 5 | 3.21 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | 5.43 | 3.15 |
| Coupon for a Discounted High CBD Product | 8 | 5.63 | 2.5 |
| Coupon for a Discounted Placebo Product | 9 | -3 | 2.39 |
| Coupon for a Discounted High THC Product | 8 | -2.625 | 2.77 |
| Coupon for a Discounted Equal THC and CBD Product | 9 | -3.28 | 2.36 |
| Coupon for a Discounted High CBD Product | 8 | -1.88 | 2.1 |
Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-10 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-10 from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Population: Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the samples. Accordingly, no change from baseline results data are available for these patients.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | 5 | 0.15 | 1.12 |
| Coupon for a Discounted High THC Product | 7 | 0.41 | 0.83 |
| Coupon for a Discounted Equal THC and CBD Product | 8 | 0.11 | 0.44 |
| Coupon for a Discounted High CBD Product | 6 | 0.65 | 0.85 |
Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-4 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-4 from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Population: Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the samples. Accordingly, no change from baseline results data are available for these patients.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | 5 | -0.33 | 0.57 |
| Coupon for a Discounted High THC Product | 7 | -0.21 | 0.48 |
| Coupon for a Discounted Equal THC and CBD Product | 8 | 0.02 | 0.5 |
| Coupon for a Discounted High CBD Product | 6 | 0.07 | 0.54 |
Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for TNFa are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of TNFa from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Population: Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the samples. Accordingly, no change from baseline results data are available for these patients.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | 5 | -0.02 | 0.64 |
| Coupon for a Discounted High THC Product | 7 | 0.03 | 0.37 |
| Coupon for a Discounted Equal THC and CBD Product | 8 | 0.05 | 0.18 |
| Coupon for a Discounted High CBD Product | 6 | -0.18 | 0.24 |
Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-6 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-6 from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Population: Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the samples. Accordingly, no change from baseline results data are available for these patients.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | 5 | 0.24 | 0.73 |
| Coupon for a Discounted High THC Product | 7 | 0.11 | 1.58 |
| Coupon for a Discounted Equal THC and CBD Product | 8 | -0.18 | 0.83 |
| Coupon for a Discounted High CBD Product | 6 | -0.09 | 0.33 |
Change in Antiretroviral medication adherence from baseline to 14 weeks was assessed using the Visual Analog Scale (VAS) of antiretroviral therapy (ART) adherence. This is an ordinal scale representing the percentage of medication taken to that which had been administered. Participants were presented with a visual ranging from 0% to 100% scaled at 10% increments and asked to provide a best guess as to how much medicine was taken over the prior 30 days with 0% signifying no medication, 50% signifying half of administered medication taken, and 100% signifying that every single dose of medication was taken. Higher scores were indicative of increased medication adherence. Scores were summarized by study arm. For purposes of this study change in antiretroviral adherence score from baseline to 14 weeks following intervention was summarized and reported. Positive values are indicative of increased medication adherence from baseline and negative values are indicative of decreased adherence.
Population: A number of participants bypassed this question stating that they did not want to answer and skipped over it in the baseline questionnaire. No change from baseline results data was able to be reported from these participants.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | 4 | -1 | 2.708 |
| Coupon for a Discounted High THC Product | 4 | 0 | 0 |
| Coupon for a Discounted Equal THC and CBD Product | 3 | 2 | 3.46 |
| Coupon for a Discounted High CBD Product | 4 | 1 | 2 |
Change in HIV viral load suppression from baseline was measured and assessed at 14 weeks. Blood draws were obtained at baseline and 14 weeks following intervention and samples were processed, analyzed, and quantified using the Abbott RealTime HIV-1 Viral Load assay. Results were summarized and HIV viral load values were reported in copies/milliliter (copies/mL). For purposes of this study change in HIV viral load from baseline to 14 weeks following intervention were summarized and reported. Positive values are indicative of increased HIV viral load levels compared to baseline and negative values are indicative of decreased/suppressed HIV viral load levels compared to baseline. A high HIV viral load in the blood is associated with increased risk of disease progression and HIV transmission.
Population: Samples were unable to be obtained from several participants at baseline. No change from baseline results data was able to be reported from these participants.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | 7 | -12270.43 | 32267.19 |
| Coupon for a Discounted High THC Product | 7 | 7.7 | 20.4 |
| Coupon for a Discounted Equal THC and CBD Product | 8 | -5 | 14.9 |
| Coupon for a Discounted High CBD Product | 7 | 3737 | 9891.17 |
Change in Depression score was measured at baseline and 14 weeks using the Center for Epidemiologic Studies Depression (CES-D) questionnaire. The CES-D questionnaire is a 20-item screening tool used to assess the severity and frequency of depressive symptoms. Participants were asked to rate each of the 20 items using a 4-point Likert scale ranging from 0 ("Rarely/none of the time") to 3 ("Most/all of the time") to describe symptoms over the prior week (Questions, 4, 8, 12, and 16 were reverse-scored). Scores were summed to yield an overall possible scoring range of 0-60 with higher scores being indicative of increased severity/frequency of depressive symptoms. For purposes of this study change in depression score from baseline to 14 weeks following intervention was summarized. Positive values are indicative of increased depressive symptom severity/frequency compared to baseline and negative values are indicative of decreased depressive symptom severity/frequency compared to baseline.
Population: 4 participants did not complete the Depression questionnaire during baseline visit. No change from baseline results data was able to be reported from these participants.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | 7 | -9.71 | 6.6 |
| Coupon for a Discounted High THC Product | 7 | -9 | 9.39 |
| Coupon for a Discounted Equal THC and CBD Product | 8 | -3.56 | 7.07 |
| Coupon for a Discounted High CBD Product | 8 | -2.25 | 5.52 |
Change in Anxiety score was measured and assessed at baseline and 14 weeks using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item screening tool used to assess the severity of anxiety-related symptoms. Participants were asked to rate each of the 7 items using a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day") to indicate how long they have been bothered by the problems listed over the prior 2-week period, yielding an overall possible score of 0-21, with higher scores being indicative of worsening anxiety. Scores were summarized by study arm. For purposes of this study change in anxiety score from baseline to 14 weeks following intervention was summarized and reported. Positive values are indicative of increased anxiety symptoms compared to baseline and negative values are indicative of decreased anxiety symptoms compared to baseline.
Population: 4 participants did not complete the Anxiety questionnaire during baseline visit. No change from baseline results data was able to be reported from these participants.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | 7 | -5.71 | 4.07 |
| Coupon for a Discounted High THC Product | 7 | -1.43 | 2.57 |
| Coupon for a Discounted Equal THC and CBD Product | 8 | -1.75 | 4.68 |
| Coupon for a Discounted High CBD Product | 8 | -1.12 | 6.03 |
Thirty-five (35) participants were consented and enrolled into the study. One participant completed screening, consent and enrollment, but then did not want to be randomized into one of the coupon categories (study arms). As such, 34 patients were randomized into the study.
| Milestone | Coupon for a Discounted Placebo Product | Coupon for a Discounted High Tetrahydrocannabinol (THC) Product | Coupon for a Discounted Equal THC and Cannabidiol (CBD) Product | Coupon for a Discounted High CBD Product |
|---|---|---|---|---|
| STARTED | 9 | 8 | 9 | 8 |
| COMPLETED | 8 | 6 | 8 | 8 |
| NOT COMPLETED | 1 | 2 | 1 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Bradycardia | Cardiac disorders | Coupon for a Discounted Placebo Product: 0 / 9 · Coupon for a Discounted High THC Product: 1 / 8 · Coupon for a Discounted Equal THC and CBD Product: 0 / 9 · Coupon for a Discounted High CBD Product: 0 / 8 |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Coupon for a Discounted Placebo Product: 0 / 9 · Coupon for a Discounted High THC Product: 1 / 8 · Coupon for a Discounted Equal THC and CBD Product: 0 / 9 · Coupon for a Discounted High CBD Product: 0 / 8 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Coupon for a Discounted Placebo Product: 1 / 9 · Coupon for a Discounted High THC Product: 0 / 8 · Coupon for a Discounted Equal THC and CBD Product: 0 / 9 · Coupon for a Discounted High CBD Product: 0 / 8 |
| Influenza | Infections and infestations | Coupon for a Discounted Placebo Product: 1 / 9 · Coupon for a Discounted High THC Product: 0 / 8 · Coupon for a Discounted Equal THC and CBD Product: 0 / 9 · Coupon for a Discounted High CBD Product: 0 / 8 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Peripheral Neuropathy | Nervous system disorders | Coupon for a Discounted Placebo Product: 0 / 9 · Coupon for a Discounted High THC Product: 1 / 8 · Coupon for a Discounted Equal THC and CBD Product: 0 / 9 · Coupon for a Discounted High CBD Product: 0 / 8 |
| Knee Pain | Musculoskeletal and connective tissue disorders | Coupon for a Discounted Placebo Product: 1 / 9 · Coupon for a Discounted High THC Product: 0 / 8 · Coupon for a Discounted Equal THC and CBD Product: 0 / 9 · Coupon for a Discounted High CBD Product: 0 / 8 |
Time frame: From Baseline to 14 weeks
Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-6 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-6 from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Time frame: From Baseline to 14 weeks
Change in Antiretroviral medication adherence from baseline to 14 weeks was assessed using the Visual Analog Scale (VAS) of antiretroviral therapy (ART) adherence. This is an ordinal scale representing the percentage of medication taken to that which had been administered. Participants were presented with a visual ranging from 0% to 100% scaled at 10% increments and asked to provide a best guess as to how much medicine was taken over the prior 30 days with 0% signifying no medication, 50% signifying half of administered medication taken, and 100% signifying that every single dose of medication was taken. Higher scores were indicative of increased medication adherence. Scores were summarized by study arm. For purposes of this study change in antiretroviral adherence score from baseline to 14 weeks following intervention was summarized and reported. Positive values are indicative of increased medication adherence from baseline and negative values are indicative of decreased adherence.
Time frame: From Baseline to 14 weeks
Change in HIV viral load suppression from baseline was measured and assessed at 14 weeks. Blood draws were obtained at baseline and 14 weeks following intervention and samples were processed, analyzed, and quantified using the Abbott RealTime HIV-1 Viral Load assay. Results were summarized and HIV viral load values were reported in copies/milliliter (copies/mL). For purposes of this study change in HIV viral load from baseline to 14 weeks following intervention were summarized and reported. Positive values are indicative of increased HIV viral load levels compared to baseline and negative values are indicative of decreased/suppressed HIV viral load levels compared to baseline. A high HIV viral load in the blood is associated with increased risk of disease progression and HIV transmission.
Time frame: From Baseline to 14 weeks
Change in Depression score was measured at baseline and 14 weeks using the Center for Epidemiologic Studies Depression (CES-D) questionnaire. The CES-D questionnaire is a 20-item screening tool used to assess the severity and frequency of depressive symptoms. Participants were asked to rate each of the 20 items using a 4-point Likert scale ranging from 0 ("Rarely/none of the time") to 3 ("Most/all of the time") to describe symptoms over the prior week (Questions, 4, 8, 12, and 16 were reverse-scored). Scores were summed to yield an overall possible scoring range of 0-60 with higher scores being indicative of increased severity/frequency of depressive symptoms. For purposes of this study change in depression score from baseline to 14 weeks following intervention was summarized. Positive values are indicative of increased depressive symptom severity/frequency compared to baseline and negative values are indicative of decreased depressive symptom severity/frequency compared to baseline.
Time frame: From Baseline to 14 weeks
Change in Anxiety score was measured and assessed at baseline and 14 weeks using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item screening tool used to assess the severity of anxiety-related symptoms. Participants were asked to rate each of the 7 items using a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day") to indicate how long they have been bothered by the problems listed over the prior 2-week period, yielding an overall possible score of 0-21, with higher scores being indicative of worsening anxiety. Scores were summarized by study arm. For purposes of this study change in anxiety score from baseline to 14 weeks following intervention was summarized and reported. Positive values are indicative of increased anxiety symptoms compared to baseline and negative values are indicative of decreased anxiety symptoms compared to baseline.