NCT02004457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

3.2 years

First QC Date

November 26, 2013

Last Update Submit

March 8, 2017

Conditions

HIV

Keywords

HIVPrimary careEngagementAcceptanceDisclosureStigma

Outcome Measures

Primary Outcomes (3)

  • Frequency of attended primary care medical appointments

    The number of primary care medical appointments a participant attends over the course of 9 months.

    9 months

  • Acceptance and Action Questionnaire-2

    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.

    9 months

  • HIV Disclosure Scale

    The HIV Disclosure Scale will be used to quantify how willing participants are to disclose their HIV status to others.

    9 months

Secondary Outcomes (3)

  • Berger HIV Stigma Scale

    9 months

  • Disclosure to others

    9 months

  • Social Support Questionnaire

    9 months

Study Arms (2)

Acceptance-based behavior therapy (ABBT)

EXPERIMENTAL

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

Treatment-as-usual (TAU)

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.

Other: TAU

Interventions

ABBTBEHAVIORAL
Acceptance-based behavior therapy (ABBT)
TAUOTHER
Treatment-as-usual (TAU)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • psychiatrically or cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • 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.

    PMID: 28451891DERIVED

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 9, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2016

Study Completion

January 1, 2017

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

US(1)