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Treatment Advocacy Intervention for HIV-Positive African Americans

Treatment Advocacy Intervention for HIV-Positive African Americans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01350544
Acronym
TA
Enrollment
216
Registered
2011-05-09
Start date
2013-04-30
Completion date
2015-12-31
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, Adherence, African American/Black, Disparities

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.

Interventions

BEHAVIORALTreatment 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.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Medication AdherenceBaseline, 1.5 months, 3 months, 4.5 months, and 6 monthsWe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Wait-list Control
Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
108
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, 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.
107
Total215

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdministrative Withdrawal01
Overall StudyDeath12
Overall StudyIncarceration10
Overall StudyLost to Follow-up1815
Overall StudyMedical Issues11
Overall StudyMoved out of LA County22
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicWait-list ControlTreatment AdvocacyTotal
Age, Continuous47.0 years
STANDARD_DEVIATION 10.2
50.1 years
STANDARD_DEVIATION 10
48.6 years
STANDARD_DEVIATION 10.2
CD4 Cell Count534 cells per microliter
STANDARD_DEVIATION 316
650 cells per microliter
STANDARD_DEVIATION 343
593 cells per microliter
STANDARD_DEVIATION 334
Education
7th to 11th Grade
17 Participants23 Participants40 Participants
Education
College degree
6 Participants7 Participants13 Participants
Education
Graduate degree
4 Participants0.0 Participants4 Participants
Education
High School diploma or GED
37 Participants33 Participants70 Participants
Education
Some college
41 Participants40 Participants81 Participants
Education
Some graduate school
3 Participants4 Participants7 Participants
Employment Status
Full time
4 Participants1 Participants5 Participants
Employment Status
Other
18 Participants17 Participants35 Participants
Employment Status
Part time
4 Participants5 Participants9 Participants
Employment Status
Retired
19 Participants14 Participants33 Participants
Employment Status
Unemployed
63 Participants71 Participants134 Participants
Ever Incarcerated
ever incarcerated
58 Participants59 Participants117 Participants
Ever Incarcerated
never incarcerated
49 Participants48 Participants97 Participants
Ever Incarcerated
Unknow
1 Participants0 Participants1 Participants
Housing Status
Friend / relative
11 Participants8 Participants19 Participants
Housing Status
Homeless
5 Participants6 Participants11 Participants
Housing Status
Other
1 Participants1 Participants2 Participants
Housing Status
Rent/Own
65 Participants69 Participants134 Participants
Housing Status
Subsidized / Sect. 8
8 Participants8 Participants16 Participants
Housing Status
Temporary or transitional
9 Participants13 Participants22 Participants
Housing Status
Treatment facility
9 Participants2 Participants11 Participants
Income
>$0 - <$10K
66 Participants53 Participants119 Participants
Income
$10K - $20K
18 Participants35 Participants53 Participants
Income
>$20K - $30K
10 Participants8 Participants18 Participants
Income
>$30K - $40K
2 Participants0.0 Participants2 Participants
Income
None
11 Participants10 Participants21 Participants
Income
Unknown
1 Participants1 Participants2 Participants
Length of Time Diagnosed15.3 years
STANDARD_DEVIATION 8.8
15.5 years
STANDARD_DEVIATION 7.9
15.5 years
STANDARD_DEVIATION 8.3
Race/Ethnicity, Customized
Hispanic or Latino
7 Participants6 Participants13 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
101 Participants101 Participants202 Participants
Race/Ethnicity, Customized
Unknown or Not Reported
0 Participants0 Participants0 Participants
Received HIV care in last 6 months
did not receive HIV care
5 Participants5 Participants10 Participants
Received HIV care in last 6 months
received HIV care
103 Participants102 Participants205 Participants
Sex/Gender, Customized
Female
24 Participants27 Participants51 Participants
Sex/Gender, Customized
Male
79 Participants78 Participants157 Participants
Sex/Gender, Customized
Transgender
5 Participants2 Participants7 Participants
Sexual Orientation
Bisexual
16 Participants16 Participants32 Participants
Sexual Orientation
Gay man
50 Participants42 Participants92 Participants
Sexual Orientation
Gay woman
1 Participants3 Participants4 Participants
Sexual Orientation
Not Sure
1 Participants2 Participants3 Participants
Sexual Orientation
Other
4 Participants2 Participants6 Participants
Sexual Orientation
Straight
36 Participants43 Participants79 Participants
Viral Load
Detectable
41 Participants30 Participants71 Participants
Viral Load
Undetectable (<200 copies)
41 Participants54 Participants95 Participants
Viral Load
Unknown
26 Participants23 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1080 / 107
serious
Total, serious adverse events
0 / 1080 / 107

Outcome results

Primary

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.

Time frame: Baseline, 1.5 months, 3 months, 4.5 months, and 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Wait-list ControlMedication AdherenceBaseline77.96 Percentage of doses takenStandard Deviation 23.15
Wait-list ControlMedication Adherence3 month follow-up63.44 Percentage of doses takenStandard Deviation 33.01
Wait-list ControlMedication Adherence4.5 month follow-up63.69 Percentage of doses takenStandard Deviation 32.08
Wait-list ControlMedication Adherence1.5 month follow-up64.87 Percentage of doses takenStandard Deviation 33.88
Wait-list ControlMedication Adherence6 month follow-up56.50 Percentage of doses takenStandard Deviation 33.97
Treatment AdvocacyMedication Adherence6 month follow-up78.76 Percentage of doses takenStandard Deviation 22.46
Treatment AdvocacyMedication AdherenceBaseline80.13 Percentage of doses takenStandard Deviation 21.74
Treatment AdvocacyMedication Adherence1.5 month follow-up76.13 Percentage of doses takenStandard Deviation 25.55
Treatment AdvocacyMedication Adherence3 month follow-up76.76 Percentage of doses takenStandard Deviation 24.6
Treatment AdvocacyMedication Adherence4.5 month follow-up79.17 Percentage of doses takenStandard Deviation 25.31
Comparison: 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.p-value: 0.00595% CI: [0.69, 0.91]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026