Health Improvement Project - Providence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Mindfulness Training (MT)
* Behavioral: Health Coaching (HC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness training (MT)<br>Eight, 30-minute phone delivered MT sessions once a week for 8 weeks | Behavioral: Mindfulness Training (MT)<br>* 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.<br>|
| Active Comparator: Health Coaching (HC)<br>Eight, 30-minute phone delivered HC sessions once a week for 8 weeks | Behavioral: Health Coaching (HC)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Intervention | Feasibility - as indicated by the number of patients attending at least 50% of sessions | post-intervention, 9 to 10 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the Intervention | Number of patients reporting very satisfied or mostly satisfied with their intervention | post-intervention, 9 to 10 weeks after baseline | 
| Antiretroviral Medication Adherence | Self-reported number of missed days of medication | 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 | 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 | 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 | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline | 
| 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 | 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 | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Mindfulness, Adherence behaviors, Stress, Depression