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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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.
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
The Miriam Hospital
Providence, Rhode Island, United States
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
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
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
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
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
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
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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
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