This trial is active, not recruiting.

Condition hiv
Treatments abbt, tau
Sponsor Butler Hospital
Collaborator Brown University
Start date March 2013
End date January 2016
Trial size 50 participants
Trial identifier NCT02004457, R34MH098694-02


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
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).
(Placebo Comparator)
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.

Primary Outcomes

Frequency of attended primary care medical appointments
time frame: 9 months
Acceptance and Action Questionnaire-2
time frame: 9 months
HIV Disclosure Scale
time frame: 9 months

Secondary Outcomes

Berger HIV Stigma Scale
time frame: 9 months
Disclosure to others
time frame: 9 months
Social Support Questionnaire
time frame: 9 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Engaging HIV Patients in Primary Care by Promoting Acceptance
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Butler Hospital.