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 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|
- 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.
- 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.
|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)|
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02004457
|Contact: Ethan Moitra, PhDfirstname.lastname@example.org|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Contact: Ethan Moitra, PhD 401-444-1949 email@example.com|
|Principal Investigator: Ethan Moitra, PhD|
|Principal Investigator: Michael D Stein, MD|