Treatment Advocacy Intervention for HIV-Positive African Americans

NCT01350544 | Completed Results

• 1 other identifier: R01MD006058
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Adherence; African American/Black; Disparities

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1.5 months, 3 months, 4.5 months, and 6 months

Study Arms (2)

Wait-list control

NO INTERVENTION

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

treatment advocacy

EXPERIMENTAL

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.

Behavioral: Treatment Advocacy

Interventions

Treatment Advocacy BEHAVIORAL

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.

Also known as: treatment education

treatment advocacy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• received treatment advocacy in last 6 months

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

AIDS Project Los Angeles

Los Angeles, California, 90005, United States

Location

Related Publications (2)

• 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.

  PMID: 28432578 DERIVED

• 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.

  PMID: 27025399 DERIVED

Limitations and Caveats

We did not assess long-term effects, as the 6-month follow-up assessment occurred immediately after the last booster session. In addition, we did not assess the effects of the intervention on viral suppression.

Results Point of Contact

• Title: Laura M. Bogart, PhD
• Organization: RAND Corporation

lbogart@rand.org

(310) 393-0411

Study Officials

• Laura M Bogart, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Behavioral Scientist

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 9, 2011
• Study Start: April 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)