Health Improvement Project - Providence

HIV Clinical Trial

— HIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886234
• Other study ID #: R34AT008930
• Secondary ID: R34AT008930
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: December 2019
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptability of the Intervention	Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention	post-intervention, 9 to 10 weeks after baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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