Trial record 1 of 30 for:    " April 06, 2011":" May 06, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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Treatment Advocacy Intervention for HIV-Positive African Americans (TA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Children's Hospital Boston
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laura Bogart, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01350544
First received: May 6, 2011
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
HIV
Behavioral: Treatment Advocacy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Treatment Advocacy Intervention for HIV-Positive African Americans

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Electronically monitored, percentage of doses taken, of those prescribed.


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Wait-list control
Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
Experimental: 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 APLA's social service programs, as necessary. This description is subject to change after consideration by the community advisory board.
Behavioral: 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 APLA's social service programs, as necessary. This description is subject to change after consideration by the community advisory board.
Other Name: treatment education

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350544

Contacts
Contact: Laura M Bogart, PhD 857-218-4073 laura.bogart@childrens.harvard.edu
Contact: Matt Mutchler, PhD mmutchler@csudh.edu

Locations
United States, California
AIDS Project Los Angeles Recruiting
Los Angeles, California, United States, 90005
Principal Investigator: Laura M Bogart, PhD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Laura M Bogart, PhD Children's Hospital Boston/Harvard Medical School
  More Information

No publications provided

Responsible Party: Laura Bogart, Associate Professor of Pediatrics, Harvard Medical School; Research Director, Division of General Pediatrics, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01350544     History of Changes
Other Study ID Numbers: R01 MD006058
Study First Received: May 6, 2011
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
HIV
Adherence
African American/Black
Disparities

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014