Health Improvement Project - Providence (HIP)

Lifespan

Status: Completed

Conditions: HIV

Treatments: Behavioral: Health Coaching (HC); Behavioral: Mindfulness Training (MT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02886234

R34AT008930 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Mindfulness training (MT)

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Training (MT)

Health Coaching (HC)

Active Comparator group

Description:

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

Treatment:

Behavioral: Health Coaching (HC)