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Completed

NCT Number: NCT02004457

Engaging HIV Patients in Primary Care by Promoting Acceptance

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABBT

Behavioral

TAU

Other

Primary outcomes

  1. Frequency of attended primary care medical appointments

    Time frame: 9 months

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

  2. Acceptance and Action Questionnaire-2

    Time frame: 9 months

    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.

  3. HIV Disclosure Scale

    Time frame: 9 months

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

Secondary outcomes

  1. Berger HIV Stigma Scale

    Time frame: 9 months

    The Berger HIV Stigma Scale will used to measure the degree to which participants experience HIV-related stigma.

  2. Disclosure to others

    Time frame: 9 months

    The number of individuals to whom the participant discloses his/her HIV status to.

  3. Social Support Questionnaire

    Time frame: 9 months

    The Social Support Questionnaire will be used to measure participants' perceived social support.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Brown University

Registry information

Acronym: HIV Engage

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 9, 2013
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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