Trial record 11 of 1436 for:    HIV | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Butler Hospital
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT02004457
First received: November 26, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention
HIV
Behavioral: ABBT
Other: TAU

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Engaging HIV Patients in Primary Care by Promoting Acceptance

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Frequency of attended primary care medical appointments [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The number of primary care medical appointments a participant attends over the course of 9 months.

  • Acceptance and Action Questionnaire-2 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.

  • HIV Disclosure Scale [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The HIV Disclosure Scale will be used to quantify how willing participants are to disclose their HIV status to others.


Secondary Outcome Measures:
  • Berger HIV Stigma Scale [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The Berger HIV Stigma Scale will used to measure the degree to which participants experience HIV-related stigma.

  • Disclosure to others [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The number of individuals to whom the participant discloses his/her HIV status to.

  • Social Support Questionnaire [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The Social Support Questionnaire will be used to measure participants' perceived social support.


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02004457

Contacts
Contact: Ethan Moitra, PhD 401-444-1949 ethan_moitra@brown.edu

Locations
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Ethan Moitra, PhD    401-444-1949    ethan_moitra@brown.edu   
Principal Investigator: Ethan Moitra, PhD         
Principal Investigator: Michael D Stein, MD         
Sponsors and Collaborators
Butler Hospital
Brown University
  More Information

No publications provided

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT02004457     History of Changes
Other Study ID Numbers: R34MH098694-02
Study First Received: November 26, 2013
Last Updated: July 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:
HIV
Primary care
Engagement
Acceptance
Disclosure
Stigma

ClinicalTrials.gov processed this record on August 28, 2014