Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Melanie Bennett, University of Maryland
ClinicalTrials.gov Identifier:
NCT02055417
First received: February 2, 2014
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

In this 3-year study, the investigators will develop and pilot test an intervention called Personal Approaches to Treatment Choices for HIV (PATCH). PATCH is a brief intervention designed to support participants' decision-making processes and enhance intrinsic motivation to initiate ART, using motivational interviewing (MI) techniques. The intervention will be targeted at HIV-positive African-American adults in inner-city Baltimore, Maryland who are suboptimally engaged in care and who endorse conspiracy beliefs about HIV or low readiness to begin ART. The specific aims are: (1) Develop and refine a manual for a brief MI intervention to support ART decision-making and reduce the likelihood of ART refusal: (2) Evaluate the feasibility and acceptability of implementing the PATCH intervention in a small sample of individuals who are African-American, recommended for ART but who are not current taking it, and who experience multiple barriers to ART adherence; and (3) Conduct a small randomized controlled pilot to test the potential efficacy of the PATCH intervention in producing positive attitudinal changes, including a reduction in conspiracy beliefs and perceived barriers to ART and stated readiness to begin ART.


Condition Intervention
HIV
Behavioral: PATCH
Behavioral: SRS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • positive attitudinal changes [ Time Frame: baseline, week 6 ] [ Designated as safety issue: No ]
    Positive attitudinal changes includes a reduction in conspiracy beliefs and perceived barriers to ART. Attitudes will be assessed via questionnaires completed at the baseline, post treatment, and follow-up assessments.

  • Stated readiness to begin ART [ Time Frame: baseline, week 6 ] [ Designated as safety issue: No ]
    Stated readiness to begin ART will be assessed via questionnaires and interviews completed at the post treatment assessment.


Secondary Outcome Measures:
  • Beginning ART [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    Beginning ART will be assessed via questionnaires and interviews completed at the follow-up assessment, as well as by review of the medical record.


Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PATCH
PATCH is a brief intervention designed to support participants' decision-making processes and enhance intrinsic motivation to initiate ART, using motivational interviewing (MI) techniques.
Behavioral: PATCH
Active Comparator: SRS
SRS includes training in stress reduction skills such as relaxation, problem solving, and expressing negative feelings.
Behavioral: SRS

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known to the recruitment site to be HIV-positive
  • African-American or multiracial with African-American heritage.
  • Able to speak and understand English.
  • At least one of the following:

    1. Sub-optimally involved in HIV care (defined as no regular source of HIV primary care, clinically eligible for ART but not taking it, or received an offer of ART in the last year but not currently taking it.
    2. Non-adherent to ART (defined as being offered ART but not taking it or not appropriately adhering to it (as reflected by a score of 10 or less on screening questionnaire) at the time of enrollment.
    3. Conspiracy beliefs (defined as a score of 10 or more on screening questionnaire or states that would not be ready to take ART if recommended).

Exclusion Criteria:

  • Known diagnosis of mental retardation or dementia.
  • Active psychosis or suicidality evident in initial interview.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055417

Contacts
Contact: Melanie E Bennett, Ph.D. 410-706-0722 mbenentt@psych.umaryland.edu
Contact: Seth Himelhoch, MD, MPH shimelho@psych.umaryland.edu

Locations
United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: Melanie E Bennett, Ph.D.    410-706-0722    mbennett@psych.umaryland.edu   
Contact: Seth Himelhoch, MD, MPH       shimelho@psych.umaryland.edu   
Principal Investigator: Melanie E Bennett, Ph.D.         
Principal Investigator: Seth Himelhoch, MD, MPH         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Melanie E Bennett, Ph.D. University of Maryland, Baltimore County
Principal Investigator: Seth Himelhoch, Md, MPH University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Melanie Bennett, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT02055417     History of Changes
Other Study ID Numbers: 5 R34 MH092208-03
Study First Received: February 2, 2014
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014