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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rise - Treatment Education | Experimental | 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. |
|
| Control - No Treatment Education | No Intervention | The Usual Care control group will only receive standard of care through their HIV clinics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rise - Treatment Education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline |
| 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. | baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline |
| Viral Suppression | Viral load undetectable per venipuncture or medical records | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDS Project Los Angeles | Los Angeles | California | 90016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22595873 | Background | Simoni JM, Huh D, Wilson IB, Shen J, Goggin K, Reynolds NR, Remien RH, Rosen MI, Bangsberg DR, Liu H. Racial/Ethnic disparities in ART adherence in the United States: findings from the MACH14 study. J Acquir Immune Defic Syndr. 2012 Aug 15;60(5):466-72. doi: 10.1097/QAI.0b013e31825db0bd. | |
| 20438378 | Background | Giordano TP, Bartsch G, Zhang Y, Tedaldi E, Absalon J, Mannheimer S, Thomas A, MacArthur RD. Disparities in outcomes for African American and Latino subjects in the Flexible Initial Retrovirus Suppressive Therapies (FIRST) trial. AIDS Patient Care STDS. 2010 May;24(5):287-95. doi: 10.1089/apc.2009.0332. |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control - No Treatment Education | The Usual Care control group will only receive standard of care through their HIV clinics. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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) | Posted | Mean | Standard Deviation | percentage of doses taken | baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline |
|
12 months (the timeframe that each participant was in the study)
The definition did not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Adverse Event | General disorders | Systematic Assessment | Includes hospitalizations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Bogart | RAND Corporation | 3103930411 | 7281 | lbogart@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2022 | Nov 10, 2022 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2017 | Nov 10, 2022 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2020 | Nov 10, 2022 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| 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. | baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline |
| 14723901 | Background | Bogart LM, Bird ST, Walt LC, Delahanty DL, Figler JL. Association of stereotypes about physicians to health care satisfaction, help-seeking behavior, and adherence to treatment. Soc Sci Med. 2004 Mar;58(6):1049-58. doi: 10.1016/s0277-9536(03)00277-6. |
| 19952767 | Background | Bogart LM, Wagner G, Galvan FH, Banks D. Conspiracy beliefs about HIV are related to antiretroviral treatment nonadherence among african american men with HIV. J Acquir Immune Defic Syndr. 2010 Apr;53(5):648-55. doi: 10.1097/QAI.0b013e3181c57dbc. |
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| 23688090 | Background | Earnshaw VA, Bogart LM, Dovidio JF, Williams DR. Stigma and racial/ethnic HIV disparities: moving toward resilience. Am Psychol. 2013 May-Jun;68(4):225-36. doi: 10.1037/a0032705. |
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| BG001 | Control - No Treatment Education | The Usual Care control group will only receive standard of care through their HIV clinics. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Continuous Adherence | Percentage of prescribed doses that were taken during the month between baseline and the start of the intervention period | Adherence data, collected when participants brought in electronically monitored pill bottle caps (MEMS), was missing for some participants and some time points. Here we present all adherence data collected at baseline. Note that analysis for intervention efficacy was restricted to participants with adherence data at (a) baseline and (b) at least one of the 6 post-intervention months | Mean | Standard Deviation | percentage of doses taken |
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| Dichotomous Adherence | Count of participants for whom the electronically monitored percentage of prescribed dosages taken exceeded 75% during the month between baseline and the start of the intervention period | Adherence data, collected when participants brought in electronically monitored pill bottle caps (MEMS), was missing for some participants and some time points. Here we present all adherence data collected at baseline. Note that analysis for intervention efficacy was restricted to participants with adherence data at (a) baseline and (b) at least one of the 6 post-intervention months | Count of Participants | Participants |
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| Viral Suppression | Viral load undetectable per venipuncture or medical records | Data are missing for participants who could not get venipuncture and for whom we were unable to acquire medical records (mainly b/c of COVID-19 pandemic). Here we present all data among participants with data within 6 months before baseline to 3 months after baseline (for controls) or start of intervention. | Count of Participants | Participants |
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| Internalized HIV Stigma | 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" | Some responses to these questions are missing, either due to item or unit nonresponse. Here we present all collected baseline data. Note that analysis of intervention efficacy was restricted to participants with data at (a) baseline and (b) at either of the two follow-up surveys. | Count of Participants | Participants |
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| Medical Mistrust (HIV conspiracy beliefs) | Mean agreement with 9 HIV-related conspiracy beliefs. Agreement is measured on a 5-point scale from 1=Strongly Disagree to 5=Strongly Agree | Some responses to these questions are missing, either due to item or unit nonresponse. Here we present all collected baseline data. Note that analysis of intervention efficacy was restricted to participants with data at (a) baseline and (b) at either of the two follow-up surveys. | Mean | Standard Deviation | units on a scale |
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| 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. |
| OG001 | Control - No Treatment Education | The Usual Care control group will only receive standard of care through their HIV clinics. |
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| 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. | 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) | Posted | Count of Participants | Participants | baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline |
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| Primary | Viral Suppression | Viral load undetectable per venipuncture or medical records | 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). | Posted | Count of Participants | Participants | 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 |
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| 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." | 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) | Posted | Count of Participants | Participants | baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline |
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| 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline |
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| 0 |
| 122 |
| 0 |
| 122 |
| 3 |
| 122 |
| EG001 | Control - No Treatment Education | The Usual Care control group will only receive standard of care through their HIV clinics. | 2 | 123 | 0 | 123 | 3 | 123 |
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 8 months post-baseline |
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| 9 months post-baseline |
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| 10 months post-baseline |
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| 11 months post-baseline |
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| 12 months post-baseline |
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| Superiority |
| 12 month post-baseline |
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| Superiority |
| 12 months post-baseline |
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| Superiority |
| 12 months post-baseline |
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| Superiority |