Engaging HIV Patients in Primary Care by Promoting Acceptance

NCT ID: NCT02004457

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-01-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

ABBT

Intervention Type: BEHAVIORAL

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.

Group Type: PLACEBO_COMPARATOR

TAU

Intervention Type: OTHER

Interventions

ABBT

Intervention Type: BEHAVIORAL

TAU

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28451891 (View on PubMed)

Other Identifiers

R34MH098694-02

Identifier Type: NIH

Identifier Source: org_study_id

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