Health Improvement Project - Providence (HIP)

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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Mindfulness Training (MT); Behavioral: Health Coaching (HC)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: MIchael P Carey, PhD, Centers for Behavioral and Preventive Medicine, The Miriam Hospital; Principal Investigator: Elena Salmoirago-Blotcher, MD, PhD, Centers for Behavioral and Preventive Medicine, The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Depression; HIV; Stress; Mindfulness; Adherence behaviors
• Other Study ID Numbers: R34AT008930 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO