- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01350544
Treatment Advocacy Intervention for HIV-Positive African Americans (TA)
7. april 2017 opdateret af: Laura Bogart, Boston Children's Hospital
The investigators hypothesize that participants in the treatment advocacy intervention will show significantly better HIV treatment adherence than will participants in the no-treatment (wait-list) control group.
Studieoversigt
Detaljeret beskrivelse
Compared to other races/ethnicities, African Americans with HIV have lower levels of engagement in care, are less likely to be on antiretroviral treatment (ART), and are more likely to delay care and ART initiation; those on ART are less likely to be adherent at high enough levels for the treatment to be effective.
We propose to test an innovative, culturally relevant treatment advocacy (TA) intervention for African Americans with HIV that targets social, cultural, and structural issues contributing to poor HIV treatment behaviors.
TA, which has been sustained in many community organizations throughout the HIV epidemic, has never been systematically evaluated.
TA facilitates patient navigation through the medical system and provides tailored HIV treatment education and client-centered counseling to improve adherence and engagement in care.
TA targets structural issues in healthcare and patients' lives by advocating to providers to improve patient-provider relationships, recommending changes in treatment and/or providers (if needed), and referring patients to mental health and social services.
TA is particularly appropriate for African Americans with HIV, who may be mistrustful of providers: it can be conducted outside of the medical system in a safe, neutral community setting by individuals not associated with patients' healthcare.
We developed a culturally relevant TA program that additionally discusses factors such as racism that undermine healthcare in Black communities, by acknowledging and directly addressing patients' medical mistrust and stigma as coping strategies that arise in response to oppression.
The specific aims are to (1) conduct a randomized controlled trial to examine the effects of a culturally relevant TA program on adherence among African Americans with HIV; (2) identify culturally relevant mediators that explain the effects of treatment advocacy on antiretroviral treatment adherence among African Americans with HIV (e.g., improved behavioral adherence skills, coping with stress/discrimination, mental health, and patient satisfaction; lower levels of HIV misconceptions, internalized HIV stigma/homophobia, medical mistrust, and substance use); and (3) explore culturally relevant moderators of the effects of treatment advocacy on antiretroviral treatment adherence among African Americans with HIV (e.g., access to care, discrimination, incarceration, poverty, social support, spirituality, and trauma).
A sample of 200 African Americans with HIV will be randomly assigned to a TA intervention or wait-list control group.
Participants will complete surveys at screening, and at 3- and 6-months post-baseline, to assess pre-, intra-, and post-intervention effects on adherence.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
216
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90005
- AIDS Project Los Angeles
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 18 years of age or older;
- self-identify as African American or Black
- client of APLA
- they are on ART and missed at least 1 dose in the past month
- they have a currently detectable or unknown HIV viral load (or have not had a viral load test within the last six months).
Exclusion Criteria:
- received treatment advocacy in last 6 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
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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Ingen indgriben: Wait-list control
Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
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Eksperimentel: treatment advocacy
Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period.
In the first 4 weeks, all participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session.
In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers.
Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24.
Clients receive additional linkage with AIDS Project Los Angeles' (APLA) social service programs, as necessary.
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Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period.
In the first 4 weeks, all participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session.
In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers.
Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24.
Clients receive additional linkage with APLA's social service programs, as necessary.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Medication Adherence
Tidsramme: Baseline, 1.5 months, 3 months, 4.5 months, and 6 months
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We used a repeated measures linear regression modeling continuous adherence with intervention, linear time, and their interaction, and demographic covariates.
Continuous adherence is measured as average percentages of doses taken.
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Baseline, 1.5 months, 3 months, 4.5 months, and 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Laura M Bogart, PhD, RAND
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bogart LM, Mutchler MG, McDavitt B, Klein DJ, Cunningham WE, Goggin KJ, Ghosh-Dastidar B, Rachal N, Nogg KA, Wagner GJ. A Randomized Controlled Trial of Rise, a Community-Based Culturally Congruent Adherence Intervention for Black Americans Living with HIV. Ann Behav Med. 2017 Dec;51(6):868-878. doi: 10.1007/s12160-017-9910-4.
- Wagner GJ, Bogart LM, Mutchler MG, McDavitt B, Mutepfa KD, Risley B. Increasing Antiretroviral Adherence for HIV-Positive African Americans (Project Rise): A Treatment Education Intervention Protocol. JMIR Res Protoc. 2016 Mar 29;5(1):e45. doi: 10.2196/resprot.5245.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2013
Primær færdiggørelse (Faktiske)
1. juli 2015
Studieafslutning (Faktiske)
1. december 2015
Datoer for studieregistrering
Først indsendt
6. maj 2011
Først indsendt, der opfyldte QC-kriterier
6. maj 2011
Først opslået (Skøn)
9. maj 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MD006058 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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