Clinical trial NCT02055417: Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention
Official title: Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: positive attitudinal changes
timeFrame: baseline, week 6
measure: Stated readiness to begin ART
timeFrame: baseline, week 6
Secondary outcomes:
measure: Beginning ART
timeFrame: baseline, week 16
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Melanie E Bennett, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: Seth Himelhoch, Md, MPH
role: PRINCIPAL_INVESTIGATOR
References: