An interventional study of Rise - Treatment Education in HIV/AIDS, sponsored by RAND. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by RAND · Not applicable, Interventional, and Supportive care
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Among 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States — 111 open to participants now, 153 under way, 9 of them phase 3. Acquired Immunodeficiency Syndrome · United States.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, this one is the 223rd largest by enrollment of the 1,290 interventional ones that give a count, is one of 68 that started in 2018, is one of 642 with no phase, and was the 1,219th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →111 of the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States are open now. Recruiting first, the newest first:
Nicky Mehtani, MD, MPH · Sites in United States
Ages 25–64
Columbia University · Sites in United States
Ages 18+ · Healthy volunteers
BioNTech SE · Sites in United States, South Africa
Ages 18–50 · Healthy volunteers
CAN Community Health · Sites in United States
Ages 18+
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,670 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 384 · Phase 2 258 · Phase 3 156 · Phase 4 81
First in 1981; this study’s year is marked. 68 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 306 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 60 across the 1,290 interventional studies, 154 across the 195 observational. Of the 1,449 that completed or were terminated, 355 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
510 of 1,670 have an industry lead sponsor. The 10 most frequent:
RAND is the lead sponsor of 115 studies on the registry; 7 are open to participants now.
RAND has 9 studies filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
56 of the studies in Acquired Immunodeficiency Syndrome with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT04958122Phase 3University of Southern CaliforniaCefixime Clinical Trial | 2027-01-01 |
| NCT07044297Phase 3Merck Sharp & Dohme LLCA Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) | 2027-07-22 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT05159466Tulane UniversityTulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors | 2026-11 |
Add all 56 to your calendar (.ics) → With an account.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Rise - Treatment Education
The Usual Care control group will only receive standard of care through their HIV clinics.
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.
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
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
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
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
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
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.
| Milestone | Rise - Treatment Education | Control - No Treatment Education |
|---|---|---|
| Started | 122 | 123 |
| Completed | 85 | 81 |
| Not completed | 37 | 42 |
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.
| percentage of doses taken | Rise - Treatment Education | Control - No Treatment Education |
|---|---|---|
| 7 months post-baseline | 68.80 ± 29.63 | 70.95 ± 27.24 |
| 8 months post-baseline | 72.76 ± 26.16 | 70.02 ± 26.11 |
| 9 months post-baseline | 72.09 ± 25.39 | 64.62 ± 31.41 |
| 10 months post-baseline | 71.27 ± 27.59 | 71.08 ± 25.24 |
| 11 months post-baseline | 69.87 ± 28.26 | 63.76 ± 31.44 |
| 12 months post-baseline | 70.32 ± 26.77 | 70.46 ± 23.55 |
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.
| Participants | Rise - Treatment Education | Control - No Treatment Education |
|---|---|---|
| 7 months post-baseline | 45 | 43 |
| 8 months post-baseline | 44 | 40 |
| 9 months post-baseline | 43 | 38 |
| 10 months post-baseline | 42 | 32 |
| 11 months post-baseline | 40 | 29 |
| 12 months post-baseline | 37 | 28 |
Viral load undetectable per venipuncture or medical records
| Participants | Rise - Treatment Education | Control - No Treatment Education |
|---|---|---|
| 7 month post-baseline | 45 | 60 |
| 12 month post-baseline | 50 | 56 |
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."
| Participants | Rise - Treatment Education | Control - No Treatment Education |
|---|---|---|
| 7 months post-baseline | 25 | 29 |
| 12 months post-baseline | 15 | 26 |
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.
| score on a scale | Rise - Treatment Education | Control - No Treatment Education |
|---|---|---|
| 7 months post-baseline | 2.62 ± 1.04 | 2.65 ± 0.92 |
| 12 months post-baseline | 2.41 ± 0.94 | 2.56 ± 1.07 |
Collected over 12 months (the timeframe that each participant was in the study). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rise - Treatment Education | 0/122 (0%) | 0/122 (0%) | 3/122 (2.5%) |
| Control - No Treatment Education | 2/123 (1.6%) | 0/123 (0%) | 3/123 (2.4%) |
| Event | Rise - Treatment Education | Control - No Treatment Education |
|---|---|---|
| Other Adverse EventGeneral disorders | 3/122 | 3/123 |
| Age, Categorical(Participants) | Rise - Treatment Education | Control - No Treatment Education | Total |
|---|---|---|---|
| <=18 years | 1 | 0 | 1 |
| Between 18 and 65 years | 111 | 114 | 225 |
| >=65 years | 10 | 9 | 19 |
| Age, Continuous(years) | Rise - Treatment Education | Control - No Treatment Education | Total |
|---|---|---|---|
| Mean | 49.09 ± 12.38 | 48.85 ± 11.99 | 48.97 ± 12.16 |
| Sex: Female, Male(Participants) | Rise - Treatment Education | Control - No Treatment Education | Total |
|---|---|---|---|
| Female | 25 | 23 | 48 |
| Male | 97 | 100 | 197 |
| Ethnicity (NIH/OMB)(Participants) | Rise - Treatment Education | Control - No Treatment Education | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 11 | 22 |
| Not Hispanic or Latino | 111 | 112 | 223 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Rise - Treatment Education | Control - No Treatment Education | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 112 | 110 | 222 |
| White | 0 | 0 | 0 |
| More than one race | 10 | 13 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Rise - Treatment Education | Control - No Treatment Education | Total |
|---|---|---|---|
| United States | 122 | 123 | 245 |
| Continuous Adherence(percentage of doses taken) | Rise - Treatment Education | Control - No Treatment Education | Total |
|---|---|---|---|
| Mean | 74.7 ± 22.0 | 75.7 ± 24.8 | 75.2 ± 23.4 |
| Dichotomous Adherence(Participants) | Rise - Treatment Education | Control - No Treatment Education | Total |
|---|---|---|---|
| Count of participants | 64 | 76 | 140 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Nov 2021, 45 months.
Results were first posted in Jan 2023, 1 year 2 months after primary completion.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 45 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →