Clinical trial NCT02886234: Health Improvement Project - Providence
Official title: Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Mindfulness
Adherence behaviors
Stress
Depression
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: post-intervention, 9 to 10 weeks after baseline
Secondary outcomes:
measure: Acceptability of the Intervention
timeFrame: post-intervention, 9 to 10 weeks after baseline
measure: Antiretroviral Medication Adherence
timeFrame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
measure: Self-reported Sexual Risk Behavior
timeFrame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
measure: Perceived Stress Scale
timeFrame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
measure: Barratt Impulsiveness Scale
timeFrame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
measure: Patient Health Questionnaire
timeFrame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Centers for Behavioral and Preventive Medicine, The Miriam Hospital
name: MIchael P Carey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Behavioral and Preventive Medicine, The Miriam Hospital
name: Elena Salmoirago-Blotcher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: