HIV
Conditions
Keywords
HIV, Mindfulness, Adherence behaviors, Stress, Depression
Brief summary
This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors.
Detailed description
Two-thirds of people living with HIV show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. In this trial, the investigators will examine the utility of phone-delivered mindfulness training (MT) for people living with HIV. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents. Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to health coaching intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.
Interventions
BEHAVIORALMindfulness Training (MT)
Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
BEHAVIORALHealth Coaching (HC)
The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* HIV infection * Sub-optimal adherence to ART (Less than always taking ART medication and/or viral load \> 20 copies/mL); * Psychological distress (PHQ-4 score ≥ 2); * Recent risky sexual behavior (any unprotected sex OR \> 1 sexual partner over the past 6 months) * Access to a telephone or cell phone
Exclusion criteria
* Unwilling or unable to provide informed consent * Cognitive impairment * Non-English speaking * Low literacy (i.e., reporting they often or always need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them * Enrolled in another behavioral trials * Prior formal mindfulness training or have practiced of mindfulness or related mind-body techniques in the previous year * Severe hearing impairment not allowing phone delivery * Suicidal ideation * Planning to move out of the area within the study period * Clinic provider advising against recruitment in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention | post-intervention, 9 to 10 weeks after baseline | Feasibility - as indicated by the number of patients attending at least 50% of sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral Medication Adherence | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline | Self-reported number of missed days of medication |
| Self-reported Sexual Risk Behavior | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline | Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome |
| Five Facet Mindfulness Questionnaire | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline | Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome |
| Acceptability of the Intervention | post-intervention, 9 to 10 weeks after baseline | Number of patients reporting very satisfied or mostly satisfied with their intervention |
| Barratt Impulsiveness Scale | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline | Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome |
| Patient Health Questionnaire | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline | Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome |
| Perceived Stress Scale | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline | Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome |
Countries
United States
Participant flow
Pre-assignment details
Prior to being randomized, patients had to complete all baseline activities, which included two months of counting to establish a baseline adherence measure. During this interval, 6 patients withdrew from the study. Thus, 44 patients were randomized (24 to health coaching arm, and 20 to the mindfulness training arm).
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Training (MT) Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. | 20 |
| Health Coaching (HC) Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics | 22 |
| Total | 42 |
Baseline characteristics
| Characteristic | Mindfulness Training (MT) | Total | Health Coaching (HC) |
|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 11.7 | 47.5 years STANDARD_DEVIATION 11.2 | 48.5 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 31 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 18 Participants | 8 Participants |
| Region of Enrollment United States | 20 participants | 42 participants | 22 participants |
| Sex: Female, Male Female | 9 Participants | 20 Participants | 11 Participants |
| Sex: Female, Male Male | 11 Participants | 22 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 22 |
| other Total, other adverse events | 0 / 20 | 0 / 22 |
| serious Total, serious adverse events | 0 / 20 | 0 / 22 |
Outcome results
Primary
Feasibility of Intervention
Feasibility - as indicated by the number of patients attending at least 50% of sessions
Time frame: post-intervention, 9 to 10 weeks after baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness Training (MT) | Feasibility of Intervention | 11 Participants |
| Health Coaching (HC) | Feasibility of Intervention | 19 Participants |
Secondary
Acceptability of the Intervention
Number of patients reporting very satisfied or mostly satisfied with their intervention
Time frame: post-intervention, 9 to 10 weeks after baseline
Population: 3 participants in the MT arm did not complete the acceptability rating at the post-intervention assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness Training (MT) | Acceptability of the Intervention | 15 Participants |
| Health Coaching (HC) | Acceptability of the Intervention | 19 Participants |
Secondary
Antiretroviral Medication Adherence
Self-reported number of missed days of medication
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Antiretroviral Medication Adherence | Baseline | 4.20 days | Standard Deviation 7.02 |
| Mindfulness Training (MT) | Antiretroviral Medication Adherence | Post-Intervention | 3.41 days | Standard Deviation 6.57 |
| Mindfulness Training (MT) | Antiretroviral Medication Adherence | 3-month Follow-up | 2.70 days | Standard Deviation 3.53 |
| Health Coaching (HC) | Antiretroviral Medication Adherence | Baseline | 1.95 days | Standard Deviation 3.15 |
| Health Coaching (HC) | Antiretroviral Medication Adherence | Post-Intervention | 1.64 days | Standard Deviation 3.3 |
| Health Coaching (HC) | Antiretroviral Medication Adherence | 3-month Follow-up | 1.45 days | Standard Deviation 1.99 |
Secondary
Barratt Impulsiveness Scale
Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Barratt Impulsiveness Scale | baseline | 18.15 score on a scale | Standard Deviation 3.76 |
| Mindfulness Training (MT) | Barratt Impulsiveness Scale | post-intervention | 17.76 score on a scale | Standard Deviation 4.31 |
| Mindfulness Training (MT) | Barratt Impulsiveness Scale | 3-month Follow-up | 16.05 score on a scale | Standard Deviation 4.07 |
| Health Coaching (HC) | Barratt Impulsiveness Scale | baseline | 17.50 score on a scale | Standard Deviation 4.36 |
| Health Coaching (HC) | Barratt Impulsiveness Scale | post-intervention | 15.68 score on a scale | Standard Deviation 3.4 |
| Health Coaching (HC) | Barratt Impulsiveness Scale | 3-month Follow-up | 16.50 score on a scale | Standard Deviation 4.42 |
Secondary
Five Facet Mindfulness Questionnaire
Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Five Facet Mindfulness Questionnaire | Post-Intervention | 53.06 score on a scale | Standard Deviation 10.32 |
| Mindfulness Training (MT) | Five Facet Mindfulness Questionnaire | Baseline | 47.70 score on a scale | Standard Deviation 7.09 |
| Mindfulness Training (MT) | Five Facet Mindfulness Questionnaire | 3-month Follow-up | 53.05 score on a scale | Standard Deviation 7.49 |
| Health Coaching (HC) | Five Facet Mindfulness Questionnaire | Post-Intervention | 52.73 score on a scale | Standard Deviation 8.98 |
| Health Coaching (HC) | Five Facet Mindfulness Questionnaire | Baseline | 49.09 score on a scale | Standard Deviation 8.09 |
| Health Coaching (HC) | Five Facet Mindfulness Questionnaire | 3-month Follow-up | 52.18 score on a scale | Standard Deviation 7.84 |
Secondary
Patient Health Questionnaire
Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Patient Health Questionnaire | Baseline | 9.80 score on a scale | Standard Deviation 6.58 |
| Mindfulness Training (MT) | Patient Health Questionnaire | Post-Intervention | 8.82 score on a scale | Standard Deviation 6.66 |
| Mindfulness Training (MT) | Patient Health Questionnaire | 3-month Follow-up | 6.90 score on a scale | Standard Deviation 5.23 |
| Health Coaching (HC) | Patient Health Questionnaire | Baseline | 8.55 score on a scale | Standard Deviation 5.54 |
| Health Coaching (HC) | Patient Health Questionnaire | Post-Intervention | 5.68 score on a scale | Standard Deviation 4.82 |
| Health Coaching (HC) | Patient Health Questionnaire | 3-month Follow-up | 5.18 score on a scale | Standard Deviation 3.72 |
Secondary
Perceived Stress Scale
Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Perceived Stress Scale | Baseline | 6.90 score on a scale | Standard Deviation 4.09 |
| Mindfulness Training (MT) | Perceived Stress Scale | post-Intervention | 6.06 score on a scale | Standard Deviation 3.58 |
| Mindfulness Training (MT) | Perceived Stress Scale | 3-month Follow-up | 5.80 score on a scale | Standard Deviation 3.71 |
| Health Coaching (HC) | Perceived Stress Scale | Baseline | 5.86 score on a scale | Standard Deviation 3.01 |
| Health Coaching (HC) | Perceived Stress Scale | post-Intervention | 5.64 score on a scale | Standard Deviation 2.75 |
| Health Coaching (HC) | Perceived Stress Scale | 3-month Follow-up | 5.73 score on a scale | Standard Deviation 3.28 |
Secondary
Self-reported Sexual Risk Behavior
Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Self-reported Sexual Risk Behavior | Baseline | 57 percentage of sexual events condom used | Standard Deviation 44 |
| Mindfulness Training (MT) | Self-reported Sexual Risk Behavior | post-intervention | 100 percentage of sexual events condom used | Standard Deviation 236 |
| Mindfulness Training (MT) | Self-reported Sexual Risk Behavior | 3-month Follow-up | 71 percentage of sexual events condom used | Standard Deviation 49 |
| Health Coaching (HC) | Self-reported Sexual Risk Behavior | Baseline | 32 percentage of sexual events condom used | Standard Deviation 44 |
| Health Coaching (HC) | Self-reported Sexual Risk Behavior | post-intervention | 49 percentage of sexual events condom used | Standard Deviation 71 |
| Health Coaching (HC) | Self-reported Sexual Risk Behavior | 3-month Follow-up | 43 percentage of sexual events condom used | Standard Deviation 48 |