Trial Outcomes & Findings for A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans (NCT NCT03331978)

NCT ID: NCT03331978

Last Updated: 2023-01-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

306 participants

Primary outcome timeframe

baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline

Results posted on

2023-01-18

Participant Flow

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.

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of the study: 51 were lost to follow-up (could not be re-contacted for randomization visit), 6 were administratively withdrawn (2 relocated out of Los Angeles, 2 died, 2 misrepresented themselves and were not Black/African American) and 4 self-withdrew (3 due to COVID-19, 1 for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).

Participant milestones

Participant milestones
Measure	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.	Control - No Treatment Education The Usual Care control group will only receive standard of care through their HIV clinics.
Overall Study STARTED	122	123
Overall Study COMPLETED	85	81
Overall Study NOT COMPLETED	37	42

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rise - Treatment Education n=122 Participants 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.	Control - No Treatment Education n=123 Participants The Usual Care control group will only receive standard of care through their HIV clinics.	Total n=245 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=122 Participants	0 Participants n=123 Participants	1 Participants n=245 Participants
Age, Categorical Between 18 and 65 years	111 Participants n=122 Participants	114 Participants n=123 Participants	225 Participants n=245 Participants
Age, Categorical >=65 years	10 Participants n=122 Participants	9 Participants n=123 Participants	19 Participants n=245 Participants
Age, Continuous	49.09 years STANDARD_DEVIATION 12.38 • n=122 Participants	48.85 years STANDARD_DEVIATION 11.99 • n=123 Participants	48.97 years STANDARD_DEVIATION 12.16 • n=245 Participants
Sex: Female, Male Female	25 Participants n=122 Participants	23 Participants n=123 Participants	48 Participants n=245 Participants
Sex: Female, Male Male	97 Participants n=122 Participants	100 Participants n=123 Participants	197 Participants n=245 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=122 Participants	11 Participants n=123 Participants	22 Participants n=245 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=122 Participants	112 Participants n=123 Participants	223 Participants n=245 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) Asian	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) Black or African American	112 Participants n=122 Participants	110 Participants n=123 Participants	222 Participants n=245 Participants
Race (NIH/OMB) White	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) More than one race	10 Participants n=122 Participants	13 Participants n=123 Participants	23 Participants n=245 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Region of Enrollment United States	122 participants n=122 Participants	123 participants n=123 Participants	245 participants n=245 Participants
Continuous Adherence	74.7 percentage of doses taken STANDARD_DEVIATION 22.0 • n=114 Participants • 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	75.7 percentage of doses taken STANDARD_DEVIATION 24.8 • n=116 Participants • 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	75.2 percentage of doses taken STANDARD_DEVIATION 23.4 • n=230 Participants • 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
Dichotomous Adherence	64 Participants n=114 Participants • 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	76 Participants n=116 Participants • 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	140 Participants n=230 Participants • 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
Viral Suppression	82 Participants n=101 Participants • 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.	91 Participants n=110 Participants • 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.	173 Participants n=211 Participants • 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.
Internalized HIV Stigma	33 Participants n=119 Participants • 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.	32 Participants n=123 Participants • 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.	65 Participants n=242 Participants • 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.
Medical Mistrust (HIV conspiracy beliefs)	2.75 units on a scale STANDARD_DEVIATION 0.92 • n=119 Participants • 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.	2.59 units on a scale STANDARD_DEVIATION 0.92 • n=123 Participants • 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.	2.67 units on a scale STANDARD_DEVIATION 0.92 • n=242 Participants • 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.

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Rise - Treatment Education n=83 Participants 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.	Control - No Treatment Education n=81 Participants The Usual Care control group will only receive standard of care through their HIV clinics.
Continuous Adherence 7 months post-baseline	68.80 percentage of doses taken Standard Deviation 29.63	70.95 percentage of doses taken Standard Deviation 27.24
Continuous Adherence 8 months post-baseline	72.76 percentage of doses taken Standard Deviation 26.16	70.02 percentage of doses taken Standard Deviation 26.11
Continuous Adherence 9 months post-baseline	72.09 percentage of doses taken Standard Deviation 25.39	64.62 percentage of doses taken Standard Deviation 31.41
Continuous Adherence 10 months post-baseline	71.27 percentage of doses taken Standard Deviation 27.59	71.08 percentage of doses taken Standard Deviation 25.24
Continuous Adherence 11 months post-baseline	69.87 percentage of doses taken Standard Deviation 28.26	63.76 percentage of doses taken Standard Deviation 31.44
Continuous Adherence 12 months post-baseline	70.32 percentage of doses taken Standard Deviation 26.77	70.46 percentage of doses taken Standard Deviation 23.55

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rise - Treatment Education n=83 Participants 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.	Control - No Treatment Education n=81 Participants The Usual Care control group will only receive standard of care through their HIV clinics.
Dichotomous Adherence 9 months post-baseline	43 Participants	38 Participants
Dichotomous Adherence 10 months post-baseline	42 Participants	32 Participants
Dichotomous Adherence 12 months post-baseline	37 Participants	28 Participants
Dichotomous Adherence 7 months post-baseline	45 Participants	43 Participants
Dichotomous Adherence 8 months post-baseline	44 Participants	40 Participants
Dichotomous Adherence 11 months post-baseline	40 Participants	29 Participants

PRIMARY outcome

Timeframe: 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).

Viral load undetectable per venipuncture or medical records

Outcome measures

Outcome measures
Measure	Rise - Treatment Education n=68 Participants 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.	Control - No Treatment Education n=83 Participants The Usual Care control group will only receive standard of care through their HIV clinics.
Viral Suppression 7 month post-baseline	45 Participants	60 Participants
Viral Suppression 12 month post-baseline	50 Participants	56 Participants

SECONDARY outcome

Timeframe: 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)

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."

Outcome measures

Outcome measures
Measure	Rise - Treatment Education n=94 Participants 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.	Control - No Treatment Education n=96 Participants The Usual Care control group will only receive standard of care through their HIV clinics.
Internalized HIV Stigma 7 months post-baseline	25 Participants	29 Participants
Internalized HIV Stigma 12 months post-baseline	15 Participants	26 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rise - Treatment Education n=94 Participants 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.	Control - No Treatment Education n=97 Participants The Usual Care control group will only receive standard of care through their HIV clinics.
Medical Mistrust 7 months post-baseline	2.62 score on a scale Standard Deviation 1.04	2.65 score on a scale Standard Deviation 0.92
Medical Mistrust 12 months post-baseline	2.41 score on a scale Standard Deviation 0.94	2.56 score on a scale Standard Deviation 1.07

Adverse Events

Rise - Treatment Education

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Control - No Treatment Education

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rise - Treatment Education n=122 participants at risk 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.	Control - No Treatment Education n=123 participants at risk The Usual Care control group will only receive standard of care through their HIV clinics.
General disorders Other Adverse Event	2.5% 3/122 • Number of events 3 • 12 months (the timeframe that each participant was in the study) The definition did not differ	2.4% 3/123 • Number of events 3 • 12 months (the timeframe that each participant was in the study) The definition did not differ

Additional Information

Laura Bogart

RAND Corporation

Phone: 3103930411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place