Clinical trial NCT01350544: Treatment Advocacy Intervention for HIV-Positive African Americans
Official title: Treatment Advocacy Intervention for HIV-Positive African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Adherence
African American/Black
Disparities
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2011-05-09
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Medication Adherence
timeFrame: Baseline, 1.5 months, 3 months, 4.5 months, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Project Los Angeles
state: California
Study officials:
affiliation: RAND
name: Laura M Bogart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.