HIV/AIDS
Conditions
Keywords
Adherence, Antiretroviral treatment, Black/ AfricanAmerican
Brief summary
Project Rise is a randomized controlled trial (RCT) of an innovative, culturally congruent treatment education (TE) intervention for African Americans with HIV that targets cultural and social issues contributing to health disparities.
Detailed description
Project Rise is a randomized controlled trial (RCT) of an innovative, culturally congruent treatment education (TE) intervention for African Americans with HIV that targets cultural and social issues contributing to health disparities. TE facilitates patient navigation through the medical system and provides treatment education and client-centered counseling to improve adherence and retention in care. TE targets structural issues in healthcare and patients' lives by advocating to providers to improve patient-provider relationships, recommending changes in treatment and/or providers, and referring patients to mental health and social services. A total of 350 Black participants will be recruited through APLA Health and randomly assigned to the intervention or usual care control group (175 per group). Adherence will be electronically monitored daily (and downloaded bi-monthly) from baseline to 13-months post-baseline. Viral load will be assessed through venipuncture at baseline and 6- and 13-months post-baseline. It is hypothesized that the intervention group will show better adherence and have a greater likelihood of suppressed viral load than the control group over time.
Interventions
BEHAVIORALRise - Treatment Education
Rise consists of a one-month intensive intervention (with three core 60-minute counseling sessions at weeks 1, 2, and 4) followed by two booster sessions (at weeks 12 and 20). If participants show nonadherence during booster sessions, they are offered up to four additional booster sessions (i.e., extra booster sessions if \<85% of prescribed doses were taken in the past month). Thus, participants receive three core sessions in the first month, followed by 2-6 booster sessions over the next four months.
Sponsors
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-positive * 18 years of age or older * Self-identified as African American/Black * Been prescribed antiretroviral therapy (ART) in the past 12 months * Self-reported adherence problems (i.e. missed at least 1 ART dose in the past month) and/or detectable viral load * Willing to use Medication Events Monitoring System (MEMS) for electronic adherence monitoring.
Exclusion criteria
* HIV-negative * 17 years of age or younger * Not self-identified as African American/Black, not on antiretroviral therapy (ART) or not prescribed ART therapy in the last than 12 months * No self-reported adherence problems and/or no detectable viral load * Not willing to use Medication Events Monitoring System (MEMS) for electronic adherence monitoring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Adherence | baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline | Percentage of doses taken of those prescribed from electronic monitoring. Here we present all data collected at all time points used in analysis. Evaluation of intervention efficacy was performed with repeated measures regression using continuous adherence measurements at all 6 months post-intervention (7th through 12th month post-baseline) and was restricted to those with adherence data at baseline. |
| Dichotomous Adherence | baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline | Number of Participants who Reported Taking Greater Than or Equal to 75% of Prescribed Dosage, based on electronic monitoring. Here we present all data collected at all time points used in analysis. Evaluation of intervention efficacy was performed with repeated measures regression using adherence measurements at all 6 months post-intervention (7th through 12th month post-baseline) and was restricted to those with adherence data at baseline. |
| Viral Suppression | baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline. For 7M, medical records were used if within 90 days of survey completion; for 13 months, medical records were used if within 90 days before or 180 days after survey | Viral load undetectable per venipuncture or medical records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Internalized HIV Stigma | baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline | Measure is count of participants who slightly agree or strongly agree with either Most people with AIDS are responsible for having their illness or A person with AIDS must have done something wrong and deserves to be punished. |
| Medical Mistrust | baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline | Outcome is mean agreement with 9 HIV-related conspiracy beliefs, each measured on a 5-point scale from 1=Strongly Disagree to 5=Strongly Agree. |
Countries
United States
Participant flow
Recruitment details
Enrollment started on January 23, 2018 (and lasted until July 2020). The study setting was a large community-based HIV services organization that is connected to a Federally Qualified Health Center (FQHC) in Los Angeles County, California.
Pre-assignment details
Prior to randomization (group assignment), 61 dropped out of the study: 51 were lost to follow-up (could not be re-contacted for randomization visit), 6 were administratively withdrawn (2 relocated out of Los Angeles, 2 died, 2 misrepresented themselves and were not Black/African American) and 4 self-withdrew (3 due to COVID-19, 1 for personal reasons).
Participants by arm
| Arm | Count |
|---|---|
| Rise - Treatment Education Rise consists of a one-month intensive intervention (with three core 60-minute counseling sessions at weeks 1, 2, and 4) followed by two booster sessions (at weeks 12 and 20). If participants show nonadherence during booster sessions, they are offered up to four additional booster sessions (i.e., extra booster sessions if \<85% of prescribed doses were taken in the past month). Thus, participants receive three core sessions in the first month, followed by 2-6 booster sessions over the next four months.
Rise - Treatment Education: Rise consists of a one-month intensive intervention (with three core 60-minute counseling sessions at weeks 1, 2, and 4) followed by two booster sessions (at weeks 12 and 20). If participants show nonadherence during booster sessions, they are offered up to four additional booster sessions (i.e., extra booster sessions if \<85% of prescribed doses were taken in the past month). Thus, participants receive three core sessions in the first month, followed by 2-6 booster sessions over the next four months. | 122 |
| Control - No Treatment Education The Usual Care control group will only receive standard of care through their HIV clinics. | 123 |
| Total | 245 |
Baseline characteristics
| Characteristic | Rise - Treatment Education | Total | Control - No Treatment Education |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 19 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 111 Participants | 225 Participants | 114 Participants |
| Age, Continuous | 49.09 years STANDARD_DEVIATION 12.38 | 48.97 years STANDARD_DEVIATION 12.16 | 48.85 years STANDARD_DEVIATION 11.99 |
| Continuous Adherence | 74.7 percentage of doses taken STANDARD_DEVIATION 22 | 75.2 percentage of doses taken STANDARD_DEVIATION 23.4 | 75.7 percentage of doses taken STANDARD_DEVIATION 24.8 |
| Dichotomous Adherence | 64 Participants | 140 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 22 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 111 Participants | 223 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Internalized HIV Stigma | 33 Participants | 65 Participants | 32 Participants |
| Medical Mistrust (HIV conspiracy beliefs) | 2.75 units on a scale STANDARD_DEVIATION 0.92 | 2.67 units on a scale STANDARD_DEVIATION 0.92 | 2.59 units on a scale STANDARD_DEVIATION 0.92 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 112 Participants | 222 Participants | 110 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 23 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 122 participants | 245 participants | 123 participants |
| Sex: Female, Male Female | 25 Participants | 48 Participants | 23 Participants |
| Sex: Female, Male Male | 97 Participants | 197 Participants | 100 Participants |
| Viral Suppression | 82 Participants | 173 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 2 / 123 |
| other Total, other adverse events | 3 / 122 | 3 / 123 |
| serious Total, serious adverse events | 0 / 122 | 0 / 123 |
Outcome results
Primary
Continuous Adherence
Percentage of doses taken of those prescribed from electronic monitoring. Here we present all data collected at all time points used in analysis. Evaluation of intervention efficacy was performed with repeated measures regression using continuous adherence measurements at all 6 months post-intervention (7th through 12th month post-baseline) and was restricted to those with adherence data at baseline.
Time frame: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline
Population: Adherence data, collected when participants brought in electronically monitored pill bottle caps (MEMS), was missing for some participants and some time points. As can be seen below, the # of participants with adherence data varies by time point; the numbers above are the total number of participants included in the analysis (adherence data present at baseline and at least one follow-up time point)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rise - Treatment Education | Continuous Adherence | 7 months post-baseline | 68.80 percentage of doses taken | Standard Deviation 29.63 |
| Rise - Treatment Education | Continuous Adherence | 8 months post-baseline | 72.76 percentage of doses taken | Standard Deviation 26.16 |
| Rise - Treatment Education | Continuous Adherence | 9 months post-baseline | 72.09 percentage of doses taken | Standard Deviation 25.39 |
| Rise - Treatment Education | Continuous Adherence | 10 months post-baseline | 71.27 percentage of doses taken | Standard Deviation 27.59 |
| Rise - Treatment Education | Continuous Adherence | 11 months post-baseline | 69.87 percentage of doses taken | Standard Deviation 28.26 |
| Rise - Treatment Education | Continuous Adherence | 12 months post-baseline | 70.32 percentage of doses taken | Standard Deviation 26.77 |
| Control - No Treatment Education | Continuous Adherence | 11 months post-baseline | 63.76 percentage of doses taken | Standard Deviation 31.44 |
| Control - No Treatment Education | Continuous Adherence | 7 months post-baseline | 70.95 percentage of doses taken | Standard Deviation 27.24 |
| Control - No Treatment Education | Continuous Adherence | 10 months post-baseline | 71.08 percentage of doses taken | Standard Deviation 25.24 |
| Control - No Treatment Education | Continuous Adherence | 8 months post-baseline | 70.02 percentage of doses taken | Standard Deviation 26.11 |
| Control - No Treatment Education | Continuous Adherence | 12 months post-baseline | 70.46 percentage of doses taken | Standard Deviation 23.55 |
| Control - No Treatment Education | Continuous Adherence | 9 months post-baseline | 64.62 percentage of doses taken | Standard Deviation 31.41 |
Comparison: Tested with repeated measures linear regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and continuous adherence measured at baseline. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.p-value: 0.0895% CI: [-0.82, 14.61]Regression, Linear
Primary
Dichotomous Adherence
Number of Participants who Reported Taking Greater Than or Equal to 75% of Prescribed Dosage, based on electronic monitoring. Here we present all data collected at all time points used in analysis. Evaluation of intervention efficacy was performed with repeated measures regression using adherence measurements at all 6 months post-intervention (7th through 12th month post-baseline) and was restricted to those with adherence data at baseline.
Time frame: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline
Population: Adherence data, collected when participants brought in electronically monitored pill bottle caps (MEMS), was missing for some participants and some time points. As can be seen below, the # of participants with adherence data varies by time point; the numbers above are the total number of participants included in the analysis (adherence data present at baseline and at least one follow-up time point)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rise - Treatment Education | Dichotomous Adherence | 7 months post-baseline | 45 Participants |
| Rise - Treatment Education | Dichotomous Adherence | 8 months post-baseline | 44 Participants |
| Rise - Treatment Education | Dichotomous Adherence | 9 months post-baseline | 43 Participants |
| Rise - Treatment Education | Dichotomous Adherence | 10 months post-baseline | 42 Participants |
| Rise - Treatment Education | Dichotomous Adherence | 11 months post-baseline | 40 Participants |
| Rise - Treatment Education | Dichotomous Adherence | 12 months post-baseline | 37 Participants |
| Control - No Treatment Education | Dichotomous Adherence | 11 months post-baseline | 29 Participants |
| Control - No Treatment Education | Dichotomous Adherence | 7 months post-baseline | 43 Participants |
| Control - No Treatment Education | Dichotomous Adherence | 10 months post-baseline | 32 Participants |
| Control - No Treatment Education | Dichotomous Adherence | 8 months post-baseline | 40 Participants |
| Control - No Treatment Education | Dichotomous Adherence | 12 months post-baseline | 28 Participants |
| Control - No Treatment Education | Dichotomous Adherence | 9 months post-baseline | 38 Participants |
Comparison: Tested with repeated measures logistic regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and baseline dichotomous adherence. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.p-value: 0.025795% CI: [1.09, 3.6]Regression, Logistic
Primary
Viral Suppression
Viral load undetectable per venipuncture or medical records
Time frame: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline. For 7M, medical records were used if within 90 days of survey completion; for 13 months, medical records were used if within 90 days before or 180 days after survey
Population: Data are missing for participants who were unable to come in for venipuncture and for whom we were unable to acquire medical records within 90 days of the 7-month survey OR within 90 days before / 180 days after 13 month survey. As can be seen below, the # of participants with adherence data varies by time point; the numbers above are the total number of participants included in the analysis (data present at baseline and at either follow-up time point).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rise - Treatment Education | Viral Suppression | 7 month post-baseline | 45 Participants |
| Rise - Treatment Education | Viral Suppression | 12 month post-baseline | 50 Participants |
| Control - No Treatment Education | Viral Suppression | 7 month post-baseline | 60 Participants |
| Control - No Treatment Education | Viral Suppression | 12 month post-baseline | 56 Participants |
Comparison: Tested with repeated measures logistic regression where both post-intervention measurements were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for presence of viral suppression data were used. Fixed effects were an intervention indicator and baseline viral suppression. Model included all viral suppression data (a) at baseline and (b) close to either of the two follow-up surveys.p-value: 0.2695% CI: [0.64, 5.18]Regression, Logistic
Secondary
Internalized HIV Stigma
Measure is count of participants who slightly agree or strongly agree with either Most people with AIDS are responsible for having their illness or A person with AIDS must have done something wrong and deserves to be punished.
Time frame: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline
Population: Data may be missing due to unit or item nonresponse. As can be seen below, the # of participants with stigma data varies by time point; the numbers above are the total number of participants included in the analysis (data present at baseline and at either follow-up time point)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rise - Treatment Education | Internalized HIV Stigma | 7 months post-baseline | 25 Participants |
| Rise - Treatment Education | Internalized HIV Stigma | 12 months post-baseline | 15 Participants |
| Control - No Treatment Education | Internalized HIV Stigma | 7 months post-baseline | 29 Participants |
| Control - No Treatment Education | Internalized HIV Stigma | 12 months post-baseline | 26 Participants |
Comparison: Tested with repeated measures logistic regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.p-value: 0.0595% CI: [0.32, 1]Regression, Logistic
Secondary
Medical Mistrust
Outcome is mean agreement with 9 HIV-related conspiracy beliefs, each measured on a 5-point scale from 1=Strongly Disagree to 5=Strongly Agree.
Time frame: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline
Population: Data may be missing due to unit or item nonresponse. As can be seen below, the # of participants with stigma data varies by time point; the numbers above are the total number of participants included in the analysis (data present at baseline and at either follow-up time point)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rise - Treatment Education | Medical Mistrust | 7 months post-baseline | 2.62 score on a scale | Standard Deviation 1.04 |
| Rise - Treatment Education | Medical Mistrust | 12 months post-baseline | 2.41 score on a scale | Standard Deviation 0.94 |
| Control - No Treatment Education | Medical Mistrust | 7 months post-baseline | 2.65 score on a scale | Standard Deviation 0.92 |
| Control - No Treatment Education | Medical Mistrust | 12 months post-baseline | 2.56 score on a scale | Standard Deviation 1.07 |
Comparison: Tested with repeated measures linear regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.p-value: 0.019995% CI: [-0.395, -0.034]Regression, Linear