N/A Completed N=44 Randomized Single-blind Treatment

Health Improvement Project - Providence

HIV

Source: ClinicalTrials.gov NCT02886234 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcomePrimary: Feasibility of Intervention — 11; 19 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Intervention	11; 19	—
SECONDARY Acceptability of the Intervention	15; 19	—
SECONDARY Antiretroviral Medication Adherence	4.20; 1.95; 3.41; 1.64; 2.70; 1.45	—
SECONDARY Self-reported Sexual Risk Behavior	57; 32; 100; 49; 71; 43	—
SECONDARY Five Facet Mindfulness Questionnaire	47.70; 49.09; 53.06; 52.73; 53.05; 52.18	—
SECONDARY Perceived Stress Scale	6.90; 5.86; 6.06; 5.64; 5.80; 5.73	—
SECONDARY Barratt Impulsiveness Scale	18.15; 17.50; 17.76; 15.68; 16.05; 16.50	—
SECONDARY Patient Health Questionnaire	9.80; 8.55; 8.82; 5.68; 6.90; 5.18	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02886234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.