HIV/AIDSNCT03331978

A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans

A study testing Rise - Treatment Education in people with HIV/AIDS, run by RAND at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV/AIDS
What is being tested?: Rise - Treatment Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 306 participants
Where: 1 siteUnited States
Study dates: 23 Jan 2018to 7 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

AIDS Project Los Angeles
Los Angeles, California, 90016

Other trials in United States

About this study

Read the 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.

Conditions: HIV/AIDS
Being tested: Rise - Treatment Education
Keywords: Adherence, Antiretroviral treatment, Black/ AfricanAmerican
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rise - Treatment EducationBehavioural
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.

Study groups in NCT03331978
Study group	Role	What they receive
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. Receives: Behavioral: Rise - Treatment Education
Control - No Treatment Education	No intervention	The Usual Care control group will only receive standard of care through their HIV clinics.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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

Secondary outcomes (2)

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."
Measured: 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.
Measured: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 20187 Nov 2021

First posted6 Nov 2017
Study start23 Jan 2018
Primary completion7 Nov 2021
Study completion7 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (150)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03331978
Sponsor's protocol ID: R01NR017334
Status last verified: Dec 2022
First submitted: 30 Oct 2017
Last updated: 18 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 22595873
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.
PubMed 20438378
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.
PubMed 14723901
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.
PubMed 19952767
Bogart LM, Wagner GJ, Green HD Jr, Mutchler MG, Klein DJ, McDavitt B, Lawrence SJ, Hilliard CL. Medical mistrust among social network members may contribute to antiretroviral treatment nonadherence in African Americans living with HIV. Soc Sci Med. 2016 Sep;164:133-140. doi: 10.1016/j.socscimed.2016.03.028. Epub 2016 Mar 19.
PubMed 27046475
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.
PubMed 23688090
Bogart LM, Wagner GJ, Green HD Jr, Mutchler MG, Klein DJ, McDavitt B. Social Network Characteristics Moderate the Association Between Stigmatizing Attributions About HIV and Non-adherence Among Black Americans Living with HIV: a Longitudinal Assessment. Ann Behav Med. 2015 Dec;49(6):865-72. doi: 10.1007/s12160-015-9724-1.
PubMed 26296702
Dale SK, Bogart LM, Wagner GJ, Galvan FH, Klein DJ. Medical mistrust is related to lower longitudinal medication adherence among African-American males with HIV. J Health Psychol. 2016 Jul;21(7):1311-21. doi: 10.1177/1359105314551950. Epub 2014 Oct 7.
PubMed 25293970
Wagner GJ, Bogart LM, Galvan FH, Banks D, Klein DJ. Discrimination as a key mediator of the relationship between posttraumatic stress and HIV treatment adherence among African American men. J Behav Med. 2012 Feb;35(1):8-18. doi: 10.1007/s10865-011-9320-1. Epub 2011 Feb 12.
PubMed 21318411
Bogart LM, Landrine H, Galvan FH, Wagner GJ, Klein DJ. Perceived discrimination and physical health among HIV-positive Black and Latino men who have sex with men. AIDS Behav. 2013 May;17(4):1431-41. doi: 10.1007/s10461-012-0397-5.
PubMed 23297084
Fields EL, Bogart LM, Smith KC, Malebranche DJ, Ellen J, Schuster MA. HIV risk and perceptions of masculinity among young black men who have sex with men. J Adolesc Health. 2012 Mar;50(3):296-303. doi: 10.1016/j.jadohealth.2011.07.007. Epub 2011 Oct 2.
PubMed 22325136
Fields EL, Bogart LM, Galvan FH, Wagner GJ, Klein DJ, Schuster MA. Association of discrimination-related trauma with sexual risk among HIV-positive African American men who have sex with men. Am J Public Health. 2013 May;103(5):875-80. doi: 10.2105/AJPH.2012.300951. Epub 2013 Mar 14.
PubMed 23488499
Fields EL, Bogart LM, Smith KC, Malebranche DJ, Ellen J, Schuster MA. "I Always Felt I Had to Prove My Manhood": Homosexuality, Masculinity, Gender Role Strain, and HIV Risk Among Young Black Men Who Have Sex With Men. Am J Public Health. 2015 Jan;105(1):122-131. doi: 10.2105/AJPH.2013.301866.
PubMed 24832150
Bogart LM, Galvan FH, Wagner GJ, Klein DJ. Longitudinal association of HIV conspiracy beliefs with sexual risk among black males living with HIV. AIDS Behav. 2011 Aug;15(6):1180-6. doi: 10.1007/s10461-010-9796-7.
PubMed 20734227
McGuire TG, Miranda J. New evidence regarding racial and ethnic disparities in mental health: policy implications. Health Aff (Millwood). 2008 Mar-Apr;27(2):393-403. doi: 10.1377/hlthaff.27.2.393.
PubMed 18332495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV/AIDS trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
ClinicalTrials.gov ID: NCT03331978
Acronym / sponsor ID: R01NR017334
Conditions: HIV/AIDS
Keywords: Adherence, Antiretroviral treatment, Black/ AfricanAmerican
Study type: Interventional
Recruitment status: Completed
Enrolment: 306 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Study start: 23 Jan 2018 (actual)
Primary completion: 7 Nov 2021 (actual)
Study completion: 7 Nov 2021 (actual)
First posted: 6 Nov 2017 (actual)
Results: Posted 18 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Rise - Treatment Education	Experimental	Behavioral: Rise - Treatment EducationRise 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rise - Treatment EducationRise 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.	Behavioural	Rise - Treatment Education

Primary outcome

Continuous Adherence
Time frame: 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
Time frame: 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
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
Viral load undetectable per venipuncture or medical records

2 secondary outcomes

Internalized HIV Stigma
Time frame: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline
Medical Mistrust
Time frame: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline

Results and safety

Results posted to the registry on 18 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rise - Treatment Education	122	85
Control - No Treatment Education	123	81

Primary outcome: Continuous Adherence

Time frame: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline. Mean (Standard Deviation). Unit: percentage of doses taken

Measure	Rise - Treatment Education n = 83	Control - No Treatment Education n = 81
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)

Rise - Treatment Education vs Control - No Treatment Education: Mean Difference (Net): 6.89 (95% CI -0.82 to 14.61), p = .08, Regression, Linear

Population analysed: 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)

Primary outcome: Dichotomous Adherence

Time frame: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline. Count of participants. Unit: Participants

Measure	Rise - Treatment Education n = 83	Control - No Treatment Education n = 81
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

Rise - Treatment Education vs Control - No Treatment Education: Odds Ratio (OR): 1.98 (95% CI 1.09 to 3.60), p = .0257, Regression, Logistic

Primary outcome: Viral Suppression

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. Count of participants. Unit: Participants

Measure	Rise - Treatment Education n = 68	Control - No Treatment Education n = 83
7 month post-baseline	45	60
12 month post-baseline	50	56

Rise - Treatment Education vs Control - No Treatment Education: Odds Ratio (OR): 1.82 (95% CI 0.64 to 5.18), p = .26, Regression, Logistic

Population analysed: 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).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months (the timeframe that each participant was in the study). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rise - Treatment Education	0 of 122 (0%)	3 of 122 (2.5%)	0 of 122
Control - No Treatment Education	0 of 123 (0%)	3 of 123 (2.4%)	2 of 123

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22595873Simoni 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.
Background: PubMed 20438378Giordano 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.
Background: PubMed 14723901Bogart 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.
Background: PubMed 19952767Bogart 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.
Background: PubMed 27046475Bogart LM, Wagner GJ, Green HD Jr, Mutchler MG, Klein DJ, McDavitt B, Lawrence SJ, Hilliard CL. Medical mistrust among social network members may contribute to antiretroviral treatment nonadherence in African Americans living with HIV. Soc Sci Med. 2016 Sep;164:133-140. doi: 10.1016/j.socscimed.2016.03.028. Epub 2016 Mar 19.
Background: PubMed 23688090Earnshaw 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.
Background: PubMed 26296702Bogart LM, Wagner GJ, Green HD Jr, Mutchler MG, Klein DJ, McDavitt B. Social Network Characteristics Moderate the Association Between Stigmatizing Attributions About HIV and Non-adherence Among Black Americans Living with HIV: a Longitudinal Assessment. Ann Behav Med. 2015 Dec;49(6):865-72. doi: 10.1007/s12160-015-9724-1.
Background: PubMed 25293970Dale SK, Bogart LM, Wagner GJ, Galvan FH, Klein DJ. Medical mistrust is related to lower longitudinal medication adherence among African-American males with HIV. J Health Psychol. 2016 Jul;21(7):1311-21. doi: 10.1177/1359105314551950. Epub 2014 Oct 7.
Background: PubMed 21318411Wagner GJ, Bogart LM, Galvan FH, Banks D, Klein DJ. Discrimination as a key mediator of the relationship between posttraumatic stress and HIV treatment adherence among African American men. J Behav Med. 2012 Feb;35(1):8-18. doi: 10.1007/s10865-011-9320-1. Epub 2011 Feb 12.
Background: PubMed 23297084Bogart LM, Landrine H, Galvan FH, Wagner GJ, Klein DJ. Perceived discrimination and physical health among HIV-positive Black and Latino men who have sex with men. AIDS Behav. 2013 May;17(4):1431-41. doi: 10.1007/s10461-012-0397-5.
Background: PubMed 22325136Fields EL, Bogart LM, Smith KC, Malebranche DJ, Ellen J, Schuster MA. HIV risk and perceptions of masculinity among young black men who have sex with men. J Adolesc Health. 2012 Mar;50(3):296-303. doi: 10.1016/j.jadohealth.2011.07.007. Epub 2011 Oct 2.
Background: PubMed 23488499Fields EL, Bogart LM, Galvan FH, Wagner GJ, Klein DJ, Schuster MA. Association of discrimination-related trauma with sexual risk among HIV-positive African American men who have sex with men. Am J Public Health. 2013 May;103(5):875-80. doi: 10.2105/AJPH.2012.300951. Epub 2013 Mar 14.
Individual participant dataSharing planned: No

Related trials for HIV/AIDS

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rise - Treatment Education in people with HIV/AIDS, run by RAND at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous Adherence (time frame: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03331978, which also lists 150 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.