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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02004457
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : March 9, 2017
Brown University
Information provided by (Responsible Party):
Butler Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: ABBT Other: TAU Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Engaging HIV Patients in Primary Care by Promoting Acceptance
Study Start Date : March 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Primary Outcome Measures :
  1. Frequency of attended primary care medical appointments [ Time Frame: 9 months ]
    The number of primary care medical appointments a participant attends over the course of 9 months.

  2. Acceptance and Action Questionnaire-2 [ Time Frame: 9 months ]
    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.

  3. HIV Disclosure Scale [ Time Frame: 9 months ]
    The HIV Disclosure Scale will be used to quantify how willing participants are to disclose their HIV status to others.

Secondary Outcome Measures :
  1. Berger HIV Stigma Scale [ Time Frame: 9 months ]
    The Berger HIV Stigma Scale will used to measure the degree to which participants experience HIV-related stigma.

  2. Disclosure to others [ Time Frame: 9 months ]
    The number of individuals to whom the participant discloses his/her HIV status to.

  3. Social Support Questionnaire [ Time Frame: 9 months ]
    The Social Support Questionnaire will be used to measure participants' perceived social support.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02004457

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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Brown University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Butler Hospital Identifier: NCT02004457    
Other Study ID Numbers: R34MH098694-02 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Butler Hospital:
Primary care