Health Improvement Project - Providence

NCT ID: NCT02886234

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-08-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mindfulness training (MT)

Eight, 30-minute phone delivered MT sessions once a week for 8 weeks

Group Type: EXPERIMENTAL

Mindfulness Training (MT)

Intervention Type: BEHAVIORAL

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.

Health Coaching (HC)

Eight, 30-minute phone delivered HC sessions once a week for 8 weeks

Group Type: ACTIVE_COMPARATOR

Health Coaching (HC)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael P. Carey

Professor and Director, Centers for Preventive and Behavioral Medicine, The Miriam Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MIchael P Carey, PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Behavioral and Preventive Medicine, The Miriam Hospital

Elena Salmoirago-Blotcher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Behavioral and Preventive Medicine, The Miriam Hospital

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34AT008930

Identifier Type: NIH

Identifier Source: secondary_id

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R34AT008930

Identifier Type: NIH

Identifier Source: org_study_id

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