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

February 2, 2014
December 11, 2015
December 2010
December 2015   (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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
HIV
  • Behavioral: Personal Approaches to Treatment Choices for HIV
    Other Name: PATCH
  • Behavioral: Stress Reduction Skills Program
    Other Name: SRSP
  • 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.
    Intervention: Behavioral: Personal Approaches to Treatment Choices for HIV
  • Active Comparator: Stress Reduction Skills Program
    SRSP includes training in stress reduction skills such as relaxation, problem solving, and expressing negative feelings.
    Intervention: Behavioral: Stress Reduction Skills Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2016
December 2015   (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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02055417
5R34MH092208-03
No
Not Provided
Not Provided
Melanie Bennett, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Melanie E Bennett, Ph.D. University of Maryland
Principal Investigator: Seth Himelhoch, Md, MPH University of Maryland
University of Maryland
December 2015

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