Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention

NCT02055417 | Completed

• 1 other identifier: HP-00047473
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• positive attitudinal changes

  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.

  baseline, week 6

• Stated readiness to begin ART

  Stated readiness to begin ART will be assessed via questionnaires and interviews completed at the post treatment assessment.

  baseline, week 6

Secondary Outcomes (1)

• Beginning ART

  baseline, week 16

Study Arms (2)

Personal Approaches to Treatment Choices for HIV

EXPERIMENTAL

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

Stress Reduction Skills Program

ACTIVE COMPARATOR

SRSP includes training in stress reduction skills such as relaxation, problem solving, and expressing negative feelings.

Behavioral: Stress Reduction Skills Program

Interventions

Personal Approaches to Treatment Choices for HIV BEHAVIORAL

Also known as: PATCH

Personal Approaches to Treatment Choices for HIV

Stress Reduction Skills Program BEHAVIORAL

Also known as: SRSP

Stress Reduction Skills Program

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.
• 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.
• 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).

You may not qualify if:

• Known diagnosis of mental retardation or dementia.
• Active psychosis or suicidality evident in initial interview.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Seroconversion

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Melanie E Bennett, Ph.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Seth Himelhoch, Md, MPH

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2014
• First Posted: February 5, 2014
• Study Start: December 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: November 4, 2019

Record last verified: 2019-11

Locations

US (1)