HIV
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Withdrawal | 0 | 1 |
| Overall Study | Death | 1 | 2 |
| Overall Study | Incarceration | 1 | 0 |
| Overall Study | Lost to Follow-up | 18 | 15 |
| Overall Study | Medical Issues | 1 | 1 |
| Overall Study | Moved out of LA County | 2 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Wait-list Control | Treatment Advocacy | Total |
|---|---|---|---|
| Age, Continuous | 47.0 years STANDARD_DEVIATION 10.2 | 50.1 years STANDARD_DEVIATION 10 | 48.6 years STANDARD_DEVIATION 10.2 |
| CD4 Cell Count | 534 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 Participants | 23 Participants | 40 Participants |
| Education College degree | 6 Participants | 7 Participants | 13 Participants |
| Education Graduate degree | 4 Participants | 0.0 Participants | 4 Participants |
| Education High School diploma or GED | 37 Participants | 33 Participants | 70 Participants |
| Education Some college | 41 Participants | 40 Participants | 81 Participants |
| Education Some graduate school | 3 Participants | 4 Participants | 7 Participants |
| Employment Status Full time | 4 Participants | 1 Participants | 5 Participants |
| Employment Status Other | 18 Participants | 17 Participants | 35 Participants |
| Employment Status Part time | 4 Participants | 5 Participants | 9 Participants |
| Employment Status Retired | 19 Participants | 14 Participants | 33 Participants |
| Employment Status Unemployed | 63 Participants | 71 Participants | 134 Participants |
| Ever Incarcerated ever incarcerated | 58 Participants | 59 Participants | 117 Participants |
| Ever Incarcerated never incarcerated | 49 Participants | 48 Participants | 97 Participants |
| Ever Incarcerated Unknow | 1 Participants | 0 Participants | 1 Participants |
| Housing Status Friend / relative | 11 Participants | 8 Participants | 19 Participants |
| Housing Status Homeless | 5 Participants | 6 Participants | 11 Participants |
| Housing Status Other | 1 Participants | 1 Participants | 2 Participants |
| Housing Status Rent/Own | 65 Participants | 69 Participants | 134 Participants |
| Housing Status Subsidized / Sect. 8 | 8 Participants | 8 Participants | 16 Participants |
| Housing Status Temporary or transitional | 9 Participants | 13 Participants | 22 Participants |
| Housing Status Treatment facility | 9 Participants | 2 Participants | 11 Participants |
| Income >$0 - <$10K | 66 Participants | 53 Participants | 119 Participants |
| Income $10K - $20K | 18 Participants | 35 Participants | 53 Participants |
| Income >$20K - $30K | 10 Participants | 8 Participants | 18 Participants |
| Income >$30K - $40K | 2 Participants | 0.0 Participants | 2 Participants |
| Income None | 11 Participants | 10 Participants | 21 Participants |
| Income Unknown | 1 Participants | 1 Participants | 2 Participants |
| Length of Time Diagnosed | 15.3 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 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 101 Participants | 101 Participants | 202 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Received HIV care in last 6 months did not receive HIV care | 5 Participants | 5 Participants | 10 Participants |
| Received HIV care in last 6 months received HIV care | 103 Participants | 102 Participants | 205 Participants |
| Sex/Gender, Customized Female | 24 Participants | 27 Participants | 51 Participants |
| Sex/Gender, Customized Male | 79 Participants | 78 Participants | 157 Participants |
| Sex/Gender, Customized Transgender | 5 Participants | 2 Participants | 7 Participants |
| Sexual Orientation Bisexual | 16 Participants | 16 Participants | 32 Participants |
| Sexual Orientation Gay man | 50 Participants | 42 Participants | 92 Participants |
| Sexual Orientation Gay woman | 1 Participants | 3 Participants | 4 Participants |
| Sexual Orientation Not Sure | 1 Participants | 2 Participants | 3 Participants |
| Sexual Orientation Other | 4 Participants | 2 Participants | 6 Participants |
| Sexual Orientation Straight | 36 Participants | 43 Participants | 79 Participants |
| Viral Load Detectable | 41 Participants | 30 Participants | 71 Participants |
| Viral Load Undetectable (<200 copies) | 41 Participants | 54 Participants | 95 Participants |
| Viral Load Unknown | 26 Participants | 23 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 108 | 0 / 107 |
| serious Total, serious adverse events | 0 / 108 | 0 / 107 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wait-list Control | Medication Adherence | Baseline | 77.96 Percentage of doses taken | Standard Deviation 23.15 |
| Wait-list Control | Medication Adherence | 3 month follow-up | 63.44 Percentage of doses taken | Standard Deviation 33.01 |
| Wait-list Control | Medication Adherence | 4.5 month follow-up | 63.69 Percentage of doses taken | Standard Deviation 32.08 |
| Wait-list Control | Medication Adherence | 1.5 month follow-up | 64.87 Percentage of doses taken | Standard Deviation 33.88 |
| Wait-list Control | Medication Adherence | 6 month follow-up | 56.50 Percentage of doses taken | Standard Deviation 33.97 |
| Treatment Advocacy | Medication Adherence | 6 month follow-up | 78.76 Percentage of doses taken | Standard Deviation 22.46 |
| Treatment Advocacy | Medication Adherence | Baseline | 80.13 Percentage of doses taken | Standard Deviation 21.74 |
| Treatment Advocacy | Medication Adherence | 1.5 month follow-up | 76.13 Percentage of doses taken | Standard Deviation 25.55 |
| Treatment Advocacy | Medication Adherence | 3 month follow-up | 76.76 Percentage of doses taken | Standard Deviation 24.6 |
| Treatment Advocacy | Medication Adherence | 4.5 month follow-up | 79.17 Percentage of doses taken | Standard Deviation 25.31 |