Engaging HIV Patients in Primary Care by Promoting Acceptance (HIV Engage)

Engagement in primary care for People Living with HIV/AIDS (PLWHA) is a significant public health concern because reduced commitment to care puts PLWHA at risk for illness progression, death, and transmission of HIV to others. This project will develop a novel treatment, brief acceptance-based behavior therapy (ABBT), to promote self-acceptance of HIV status as a pathway to reducing engagement barriers. The clinical and public health impact of this project will be the development of a simple, low-cost, disseminable intervention that enhances longitudinal commitment to care so PLWHA can obtain effective medical treatments that will prolong survival and improve quality of life. We hypothesize that individuals randomized to brief ABBT will showed increased longitudinal attendance of primary care appointments.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: TAU; Behavioral: ABBT

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• new to the primary care clinic
• HIV+
• between 18 and 60 years old
• entering HIV care for the first time
• able to speak and read English sufficiently to be able to complete the study procedures
• have access to a telephone

Exclusion Criteria:

• psychiatrically or cognitively impaired

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance-based behavior therapy (ABBT); ABBT will consist of 2 sessions. The first session will be used to introduce the concept of acceptance and its possible benefits in the context of life values and patient-identified barriers to care engagement. Following a discussion of life values will be a discussion of which, if any, of these values are currently misaligned with the participant's HIV self-care. At the second session, acceptance-based coping skills will be practiced and a behavioral plan will be developed to targets barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage his/her HIV (e.g. when and how to disclose, what to expect at appointments).	Behavioral: ABBT
Placebo Comparator: Treatment-as-usual (TAU); TAU will consist of the standard sessions all individuals receive as they enter HIV care and attend their first follow-up visit to review lab results. TAU includes identification of environmental barriers to care, assessment of needs for additional care and corresponding referrals (i.e., for depression, substance abuse), and recommendations to attend HIV support groups.	Other: TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of attended primary care medical appointments	The number of primary care medical appointments a participant attends over the course of 9 months.	9 months
Acceptance and Action Questionnaire-2	A modified version of the Acceptance and Action Questionnaire-2 (AAQ-2) will be used to quantify the degree to which participants accept their HIV diagnosis and related stresses.	9 months
HIV Disclosure Scale	The HIV Disclosure Scale will be used to quantify how willing participants are to disclose their HIV status to others.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berger HIV Stigma Scale	The Berger HIV Stigma Scale will used to measure the degree to which participants experience HIV-related stigma.	9 months
Disclosure to others	The number of individuals to whom the participant discloses his/her HIV status to.	9 months
Social Support Questionnaire	The Social Support Questionnaire will be used to measure participants' perceived social support.	9 months

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: Brown University

Publications and helpful links

General Publications

• Moitra E, LaPlante A, Armstrong ML, Chan PA, Stein MD. Pilot Randomized Controlled Trial of Acceptance-Based Behavior Therapy to Promote HIV Acceptance, HIV Disclosure, and Retention in Medical Care. AIDS Behav. 2017 Sep;21(9):2641-2649. doi: 10.1007/s10461-017-1780-z.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: HIV; Primary care; Stigma; Engagement; Disclosure; Acceptance
• Other Study ID Numbers: R34MH098694-02 (U.S. NIH Grant/Contract)