Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Melanie Bennett, University of Maryland
ClinicalTrials.gov Identifier:
NCT02055417
First received: February 2, 2014
Last updated: December 11, 2015
Last verified: December 2015
  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: Personal Approaches to Treatment Choices for HIV
Behavioral: Stress Reduction Skills Program

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.


Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Personal Approaches to Treatment Choices for HIV
PATCH is a brief intervention designed to support participants' decision-making processes and enhance intrinsic motivation to initiate ART.
Behavioral: Personal Approaches to Treatment Choices for HIV
Other Name: PATCH
Active Comparator: Stress Reduction Skills Program
SRSP includes training in stress reduction skills such as relaxation, problem solving, and expressing negative feelings.
Behavioral: Stress Reduction Skills Program
Other Name: SRSP

Detailed Description:

Many persons with HIV refuse recommended treatment or delay initiation of antiretroviral therapy (ART). Widespread belief in conspiracy theories regarding the origin and treatment of HIV may complicate the ART decision-making process. Research has found that conspiracy beliefs and mistrust in the mainstream medical system are common among African-Americans attending an HIV primary care clinic and that conspiracy beliefs are more likely to be held by patients who are not on ART. Moreover, research shows that conspiracy beliefs and other maladaptive cognitions predict subsequent readiness to begin ART. The investigators have developed an intervention called PATCH: Personal Approaches to Treatment Choices for HIV. 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 targets 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.

In this project the investigators will conduct a small randomized controlled pilot trial to test the potential efficacy of PATCH in producing positive attitudinal changes, including a reduction in conspiracy beliefs and perceived barriers to ART and an increase in stated readiness to begin ART. The investigators will compare PATCH to an attentional control. Participants will be recruited from outpatient HIV clinics settings but will be individuals who are not taking ART. Assessments will be conducted at baseline, post-treatment (estimated 4-8 weeks post-baseline), and at 3-month post-baseline follow-up. 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.

  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

Locations
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
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: 5R34MH092208-03 
Study First Received: February 2, 2014
Last Updated: December 11, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 09, 2016