Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention
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|ClinicalTrials.gov Identifier: NCT02055417|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : May 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Personal Approaches to Treatment Choices for HIV Behavioral: Stress Reduction Skills Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
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
- positive attitudinal changes [ Time Frame: baseline, week 6 ]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 ]Stated readiness to begin ART will be assessed via questionnaires and interviews completed at the post treatment assessment.
- Beginning ART [ Time Frame: baseline, week 16 ]Beginning ART will be assessed via questionnaires and interviews completed at the follow-up assessment, as well as by review of the medical record.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055417
|United States, Maryland|
|University of Maryland School of Medicine|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Melanie E Bennett, Ph.D.||University of Maryland|
|Principal Investigator:||Seth Himelhoch, Md, MPH||University of Maryland|