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Treatment Advocacy Intervention for HIV-Positive African Americans (TA)

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment Advocacy
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, Adherence, African American/Black, Disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AIDS Project Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Wait-list control

treatment advocacy

Arm Description

Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.

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.

Outcomes

Primary Outcome Measures

Medication Adherence
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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2011
Last Updated
April 7, 2017
Sponsor
Boston Children's Hospital
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01350544
Brief Title
Treatment Advocacy Intervention for HIV-Positive African Americans
Acronym
TA
Official Title
Treatment Advocacy Intervention for HIV-Positive African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, Adherence, African American/Black, Disparities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
Arm Title
treatment advocacy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Advocacy
Other Intervention Name(s)
treatment education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
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.
Time Frame
Baseline, 1.5 months, 3 months, 4.5 months, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura M Bogart, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDS Project Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90005
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28432578
Citation
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.
Results Reference
derived
PubMed Identifier
27025399
Citation
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.
Results Reference
derived

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Treatment Advocacy Intervention for HIV-Positive African Americans

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