TA: Treatment Advocacy Intervention for HIV-Positive African Americans

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01350544
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
• Enrollment: 216
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 6.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Behavioral: Treatment Advocacy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Treatment Advocacy Intervention for HIV-Positive African Americans
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 AIDS Project Los Angeles' (APLA) social service programs, as necessary.	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.; Other Names: treatment education

Outcome Measures

Primary Outcome Measures

1. Medication Adherence [Baseline, 1.5 months, 3 months, 4.5 months, and 6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	AIDS Project Los Angeles	Los Angeles	California	United States	90005

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Laura M Bogart, PhD, RAND

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Bogart, Senior Behavioral Scientist, RAND
• ClinicalTrials.gov Identifier: NCT01350544
• Other Study ID Numbers: R01MD006058; R01MD006058
• First Posted: May 9, 2011
• Last Update Posted: Apr 11, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Laura Bogart, Senior Behavioral Scientist, RAND: HIV; Adherence; African American/Black; Disparities
• Additional relevant MeSH terms: HIV Seropositivity

Study Results

Participant Flow

Arm/Group Title	Wait-list Control	Treatment Advocacy
Arm/Group 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, 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.
Period Title: Overall Study
STARTED	108	108
COMPLETED	85	86
NOT COMPLETED	23	22

Baseline Characteristics

Arm/Group Title	Wait-list Control	Treatment Advocacy	Total
Arm/Group 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, 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.	Total of all reporting groups
Overall Participants	108	107	215
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.0 (10.2)	50.1 (10.0)	48.6 (10.2)
Sex/Gender, Customized (Count of Participants)
Male	79 73.1%	78 72.9%	157 73%
Female	24 22.2%	27 25.2%	51 23.7%
Transgender	5 4.6%	2 1.9%	7 3.3%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	7 6.5%	6 5.6%	13 6%
Not Hispanic or Latino	101 93.5%	101 94.4%	202 94%
Unknown or Not Reported	0 0%	0 0%	0 0%
Income (Count of Participants)
None	11 10.2%	10 9.3%	21 9.8%
>$0 - <$10K	66 61.1%	53 49.5%	119 55.3%
$10K - $20K	18 16.7%	35 32.7%	53 24.7%
>$20K - $30K	10 9.3%	8 7.5%	18 8.4%
>$30K - $40K	2 1.9%	0.0 0%	2 0.9%
Unknown	1 0.9%	1 0.9%	2 0.9%
Education (Count of Participants)
7th to 11th Grade	17 15.7%	23 21.5%	40 18.6%
High School diploma or GED	37 34.3%	33 30.8%	70 32.6%
Some college	41 38%	40 37.4%	81 37.7%
College degree	6 5.6%	7 6.5%	13 6%
Some graduate school	3 2.8%	4 3.7%	7 3.3%
Graduate degree	4 3.7%	0.0 0%	4 1.9%
Housing Status (Count of Participants)
Rent/Own	65 60.2%	69 64.5%	134 62.3%
Treatment facility	9 8.3%	2 1.9%	11 5.1%
Subsidized / Sect. 8	8 7.4%	8 7.5%	16 7.4%
Friend / relative	11 10.2%	8 7.5%	19 8.8%
Temporary or transitional	9 8.3%	13 12.1%	22 10.2%
Homeless	5 4.6%	6 5.6%	11 5.1%
Other	1 0.9%	1 0.9%	2 0.9%
Employment Status (Count of Participants)
Full time	4 3.7%	1 0.9%	5 2.3%
Part time	4 3.7%	5 4.7%	9 4.2%
Unemployed	63 58.3%	71 66.4%	134 62.3%
Retired	19 17.6%	14 13.1%	33 15.3%
Other	18 16.7%	17 15.9%	35 16.3%
Length of Time Diagnosed (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.3 (8.8)	15.5 (7.9)	15.5 (8.3)
Viral Load (Count of Participants)
Detectable	41 38%	30 28%	71 33%
Undetectable (<200 copies)	41 38%	54 50.5%	95 44.2%
Unknown	26 24.1%	23 21.5%	49 22.8%
CD4 Cell Count (cells per microliter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells per microliter]	534 (316)	650 (343)	593 (334)
Received HIV care in last 6 months (Count of Participants)
received HIV care	103 95.4%	102 95.3%	205 95.3%
did not receive HIV care	5 4.6%	5 4.7%	10 4.7%
Sexual Orientation (Count of Participants)
Straight	36 33.3%	43 40.2%	79 36.7%
Gay man	50 46.3%	42 39.3%	92 42.8%
Gay woman	1 0.9%	3 2.8%	4 1.9%
Bisexual	16 14.8%	16 15%	32 14.9%
Not Sure	1 0.9%	2 1.9%	3 1.4%
Other	4 3.7%	2 1.9%	6 2.8%
Ever Incarcerated (Count of Participants)
ever incarcerated	58 53.7%	59 55.1%	117 54.4%
never incarcerated	49 45.4%	48 44.9%	97 45.1%
Unknow	1 0.9%	0 0%	1 0.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control	Treatment Advocacy
Arm/Group Description	Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.	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.
Measure Participants	85	86
Baseline	77.96 (23.15)	80.13 (21.74)
1.5 month follow-up	64.87 (33.88)	76.13 (25.55)
3 month follow-up	63.44 (33.01)	76.76 (24.60)
4.5 month follow-up	63.69 (32.08)	79.17 (25.31)
6 month follow-up	56.50 (33.97)	78.76 (22.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Wait-list Control, Treatment Advocacy
	Comments	We used generalized linear mixed models predicting adherence at baseline and 1.5-, 3-, 4.5-, and 6-months post-baseline, with intervention , time, interaction between intervention and time, medical and socio-demographic covariates, and baseline viral load. Sample size was determined with a power analysis assuming .80 power and an alpha level of .05 that would allow for detection of a small-to-medium effect size in adherence between arms.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.005
	Comments	a priori threshold for significance for p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.69 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Wait-list Control		Treatment Advocacy
Arm/Group 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, 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.
All Cause Mortality
	Wait-list Control		Treatment Advocacy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Wait-list Control		Treatment Advocacy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/108 (0%)		0/107 (0%)
Other (Not Including Serious) Adverse Events
	Wait-list Control		Treatment Advocacy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/108 (0%)		0/107 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.