- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02055417
Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Andra namn:
|
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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.
|
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
positive attitudinal changes
Tidsram: 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.
|
baseline, week 6
|
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Stated readiness to begin ART
Tidsram: baseline, week 6
|
Stated readiness to begin ART will be assessed via questionnaires and interviews completed at the post treatment assessment.
|
baseline, week 6
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Beginning ART
Tidsram: 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.
|
baseline, week 16
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Melanie E Bennett, Ph.D., University of Maryland, Baltimore
- Huvudutredare: Seth Himelhoch, MD, MPH, University of Maryland, Baltimore
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HP-00047473
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