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

May 6, 2011
April 16, 2013
April 2013
July 2015   (final data collection date for primary outcome measure)
medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Electronically monitored, percentage of doses taken, of those prescribed.
Same as current
Complete list of historical versions of study NCT01350544 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment Advocacy Intervention for HIV-Positive African Americans
Treatment Advocacy Intervention for HIV-Positive African Americans

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
HIV
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
  • 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.
    Intervention: Behavioral: Treatment Advocacy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Laura M Bogart, PhD 857-218-4073 laura.bogart@childrens.harvard.edu
Contact: Matt Mutchler, PhD mmutchler@csudh.edu
United States
 
NCT01350544
R01 MD006058
No
Laura Bogart, Children's Hospital Boston
Children's Hospital Boston
National Institute of Mental Health (NIMH)
Principal Investigator: Laura M Bogart, PhD Children's Hospital Boston/Harvard Medical School
Children's Hospital Boston
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP