- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02055417
Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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:
- 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).
Exclusion Criteria:
- Known diagnosis of mental retardation or dementia.
- Active psychosis or suicidality evident in initial interview.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
Andre navne:
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Aktiv komparator: Stress Reduction Skills Program
SRSP includes training in stress reduction skills such as relaxation, problem solving, and expressing negative feelings.
|
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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positive attitudinal changes
Tidsramme: baseline, week 6
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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.
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baseline, week 6
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Stated readiness to begin ART
Tidsramme: baseline, week 6
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Stated readiness to begin ART will be assessed via questionnaires and interviews completed at the post treatment assessment.
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baseline, week 6
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Beginning ART
Tidsramme: baseline, week 16
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Beginning ART will be assessed via questionnaires and interviews completed at the follow-up assessment, as well as by review of the medical record.
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baseline, week 16
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Melanie E Bennett, Ph.D., University of Maryland, Baltimore
- Ledende efterforsker: Seth Himelhoch, MD, MPH, University of Maryland, Baltimore
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HP-00047473
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