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

February 2, 2014
February 3, 2014
December 2010
December 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT02055417 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention
Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
HIV
  • Behavioral: PATCH
  • Behavioral: SRS
  • 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.
    Intervention: Behavioral: PATCH
  • Active Comparator: SRS
    SRS includes training in stress reduction skills such as relaxation, problem solving, and expressing negative feelings.
    Intervention: Behavioral: SRS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years to 60 Years
No
Contact: Melanie E Bennett, Ph.D. 410-706-0722 mbenentt@psych.umaryland.edu
Contact: Seth Himelhoch, MD, MPH shimelho@psych.umaryland.edu
United States
 
NCT02055417
5 R34 MH092208-03
No
Melanie Bennett, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Melanie E Bennett, Ph.D. University of Maryland, Baltimore County
Principal Investigator: Seth Himelhoch, Md, MPH University of Maryland, Baltimore County
University of Maryland
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP