Health Improvement Project - Providence

Not Applicable

Completed

Conditions: HIV

Interventions: Behavioral: Health Coaching (HC)
Behavioral: Mindfulness Training (MT)

Registration Number: NCT02886234

Lead Sponsor: The Miriam Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Coaching (HC)	Health Coaching (HC)	Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Mindfulness training (MT)	Mindfulness Training (MT)	Eight, 30-minute phone delivered MT sessions once a week for 8 weeks

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention	post-intervention, 9 to 10 weeks after baseline	Feasibility - as indicated by the number of patients attending at least 50% of sessions

Secondary Outcome Measures

Name	Time	Method
Self-reported Sexual Risk Behavior	Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline	Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome
Acceptability of the Intervention	post-intervention, 9 to 10 weeks after baseline	Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention
Antiretroviral Medication Adherence	Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline	Self-reported number of missed days of medication
Five Facet Mindfulness Questionnaire	Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline	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
Perceived Stress Scale	Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline	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
Barratt Impulsiveness Scale	Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline	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
Patient Health Questionnaire	Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline	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