Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02055417
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2014-02-02
Brief Title:
Increasing Motivation for Antiretroviral Therapy Initiation A Pilot Intervention
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Increasing Motivation for Antiretroviral Therapy Initiation A Pilot Intervention
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None