Trial Outcomes & Findings for Adherence Connection for Counseling, Education, and Support (ACCESS) II (NCT NCT04499781)

NCT ID: NCT04499781

Last Updated: 2025-09-24

Results Overview

3-day self-report of ART adherence was collected to describe subjective adherence behavior. Investigators will compute an cumulative average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline

Results posted on

2025-09-24

Participant Flow

Participant milestones

Participant milestones
Measure
ACCESS II mHealth Intervention
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Overall Study
STARTED
30
30
Overall Study
COMPLETED
26
27
Overall Study
NOT COMPLETED
4
3

Reasons for withdrawal

Reasons for withdrawal
Measure
ACCESS II mHealth Intervention
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Overall Study
Lost to Follow-up
2
3
Overall Study
Withdrawal by Subject
2
0

Baseline Characteristics

Adherence Connection for Counseling, Education, and Support (ACCESS) II

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Total
n=60 Participants
Total of all reporting groups
Age, Continuous
25 years
STANDARD_DEVIATION 3.51 • n=5 Participants
24.9 years
STANDARD_DEVIATION 2.9 • n=7 Participants
24.95 years
STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
15 Participants
n=7 Participants
31 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
15 Participants
n=7 Participants
29 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants
n=5 Participants
13 Participants
n=7 Participants
26 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=5 Participants
17 Participants
n=7 Participants
34 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
19 Participants
n=5 Participants
18 Participants
n=7 Participants
37 Participants
n=5 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
Region of Enrollment
United States
30 participants
n=5 Participants
30 participants
n=7 Participants
60 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline

3-day self-report of ART adherence was collected to describe subjective adherence behavior. Investigators will compute an cumulative average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence)

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=90 Doses
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=90 Doses
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Self-Reported ART Adherence
56.67 Percentage of successful doses
58.7 Percentage of successful doses

PRIMARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-12 study activities and 2 were lost to follow-up.

3-day self-report of ART adherence was collected to describe subjective adherence behavior. Investigators will compute an cumulative average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence)

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=72 Doses
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=90 Doses
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Self-Reported ART Adherence
74.64 Percentage of successful doses
71.79 Percentage of successful doses

PRIMARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

3-day self-report of ART adherence will be collected to describe subjective adherence behavior. Investigators will compute an average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence )

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=78 Doses
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=81 Doses
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Self-Reported ART Adherence
76.77 Percentage of successful doses
80.33 Percentage of successful doses

PRIMARY outcome

Timeframe: Baseline

Measured to eliminate the potential for social desirability bias associated with self-reported adherence. Viral load data was extracted from the medical records of participants.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Log10 Viral Load
3.50 Log10 Viral Load (Copies/mL)
Standard Deviation 1.2
3.40 Log10 Viral Load (Copies/mL)
Standard Deviation 1.4

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

Annualized change in log10 viral load is a useful metric for conveying change over time while accounting for varying time points and number of viral load data measurements. All available viral load data for study participants was included and some participants had more than 3 viral loads included.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Annualized Change in Log10 Viral Load (Copies/mL)
-0.43 log10 copies/mL/year
Interval -1.15 to 0.28
-0.53 log10 copies/mL/year
Interval -1.14 to 0.08

PRIMARY outcome

Timeframe: Baseline

Assessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)
6.8 score on a scale
Standard Deviation 2.0
6.8 score on a scale
Standard Deviation 1.2

PRIMARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

Assessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)
8.0 score on a scale
Standard Deviation 1.4
7.6 score on a scale
Standard Deviation 1.2

PRIMARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

Assessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)
7.7 score on a scale
Standard Deviation 1.6
7.4 score on a scale
Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline

The HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Knowledge About ART Measured With the HIV Treatment Knowledge Scale
14.8 score on a scale
Standard Deviation 3.1
14.5 score on a scale
Standard Deviation 3.2

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

The HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Knowledge About ART Measured With the HIV Treatment Knowledge Scale
14.4 score on a scale
Standard Deviation 3.8
14.8 score on a scale
Standard Deviation 3.3

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

The HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Knowledge About ART Measured With the HIV Treatment Knowledge Scale
15.5 score on a scale
Standard Deviation 3.4
15.8 score on a scale
Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline

The HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
HIV Stigma Measured With the HIV Stigma Scale
100.1 score on a scale
Standard Deviation 21.1
105.9 score on a scale
Standard Deviation 17.5

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

The HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
HIV Stigma Measured With the HIV Stigma Scale
97.9 score on a scale
Standard Deviation 18.9
103.3 score on a scale
Standard Deviation 17.8

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

The HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
HIV Stigma Measured With the HIV Stigma Scale
96.9 score on a scale
Standard Deviation 21.4
101.4 score on a scale
Standard Deviation 15.6

SECONDARY outcome

Timeframe: Baseline

Depression was measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)
5.6 score on a scale
Standard Deviation 6.3
7.7 score on a scale
Standard Deviation 6.2

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

Depression was measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)
4.3 score on a scale
Standard Deviation 5.0
5.6 score on a scale
Standard Deviation 5.5

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

Depression was measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)
4.7 score on a scale
Standard Deviation 5.6
5.7 score on a scale
Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline

Generalized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)
6.3 score on a scale
Standard Deviation 5.8
7.3 score on a scale
Standard Deviation 5.9

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

Generalized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)
4.5 score on a scale
Standard Deviation 4.3
6.0 score on a scale
Standard Deviation 5.6

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

Generalized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)
5.0 score on a scale
Standard Deviation 5.0
5.8 score on a scale
Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline

Post-traumatic stress disorder (PTSD) was measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. The total score is the number of "Yes" responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have "trauma" if they reported 3 or more trauma symptoms in the past month.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)
11 Participants
11 Participants

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

Post-traumatic stress disorder (PTSD) was measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. The total score is the number of "Yes" responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have "trauma" if they reported 3 or more trauma symptoms in the past month.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)
5 Participants
10 Participants

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

Post-traumatic stress disorder (PTSD) was measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. The total score is the number of "Yes" responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have "trauma" if they reported 3 or more trauma symptoms in the past month.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)
4 Participants
4 Participants

SECONDARY outcome

Timeframe: Baseline

The ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score
47.0 T-score
Standard Error 2.7
46.9 T-score
Standard Error 2.5

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

The ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score
50.1 T-score
Standard Error 2.8
48.9 T-score
Standard Error 2.8

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

The ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score
49.4 T-score
Standard Error 2.8
48.0 T-score
Standard Error 2.7

SECONDARY outcome

Timeframe: Baseline

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score
47.2 T-score
Standard Error 2.8
46.7 T-score
Standard Error 2.8

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score
48.5 T-score
Standard Error 2.7
47.9 T-score
Standard Error 2.7

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score
47.9 T-score
Standard Error 2.8
46.7 T-score
Standard Error 2.6

SECONDARY outcome

Timeframe: Baseline

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score
47.1 T-score
Standard Error 2.7
47.7 T-score
Standard Error 2.7

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score
51.3 T-score
Standard Error 2.8
50.2 T-score
Standard Error 3.0

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score
51.3 T-score
Standard Error 2.8
49.3 T-score
Standard Error 2.8

SECONDARY outcome

Timeframe: Baseline

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score
45.9 T-score
Standard Error 2.8
44.0 T-score
Standard Error 2.7

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score
48.7 T-score
Standard Error 3.0
47.3 T-score
Standard Error 3.0

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score
49.6 T-score
Standard Error 3.0
48.8 T-score
Standard Error 3.0

SECONDARY outcome

Timeframe: Baseline

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score
54.6 T-score
Standard Error 2.9
56.3 T-score
Standard Error 2.8

SECONDARY outcome

Timeframe: Week 12

Population: 24 participants in the intervention arm were analyzed, as 2 withdrew from the study, 2 did not complete week-24 study activities and 2 were lost to follow-up.

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=24 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score
50.7 T-score
Standard Error 3.3
52.0 T-score
Standard Error 2.9

SECONDARY outcome

Timeframe: Week 24

Population: 26 participants in the intervention arm were analyzed, as 2 withdrew from the study and 2 were lost to follow-up. 27 participants in the control arm were analyzed, as 3 were lost to follow-up.

The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=26 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=27 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score
52.5 T-score
Standard Error 3.3
52.7 T-score
Standard Error 2.9

SECONDARY outcome

Timeframe: Baseline

Substance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime tobacco use.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Tobacco - Lifetime Use
20 Participants
20 Participants

SECONDARY outcome

Timeframe: Baseline

Substance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime marijuana use.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Marijuana - Lifetime Use
23 Participants
25 Participants

SECONDARY outcome

Timeframe: Baseline

Substance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime alcohol use.

Outcome measures

Outcome measures
Measure
ACCESS II mHealth Intervention
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 Participants
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Alcohol - Lifetime Use
25 Participants
27 Participants

Adverse Events

ACCESS II mHealth Intervention

Serious events: 8 serious events
Other events: 3 other events
Deaths: 0 deaths

Control

Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
ACCESS II mHealth Intervention
n=30 participants at risk
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 participants at risk
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Injury, poisoning and procedural complications
Self-report of injury from being stabbed
0.00%
0/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
3.3%
1/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
Infections and infestations
Pneumocystis carinii pneumonia (PCP) and esophageal candidiasis
0.00%
0/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
3.3%
1/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
Psychiatric disorders
Self-report of suicidal thoughts within the past 2 weeks
20.0%
6/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
6.7%
2/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
Infections and infestations
Pneumonia
6.7%
2/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
0.00%
0/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
Renal and urinary disorders
Self-report of hospitalization for kidney stones
0.00%
0/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
3.3%
1/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.

Other adverse events

Other adverse events
Measure
ACCESS II mHealth Intervention
n=30 participants at risk
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II mHealth Intervention: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
Control
n=30 participants at risk
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation. ACCESS II control condition: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Psychiatric disorders
Self-report of nervous breakdown, "not doing well mentally, physically, emotionally"
3.3%
1/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
0.00%
0/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
Social circumstances
Self-reported incarceration
6.7%
2/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.
0.00%
0/30 • 24 weeks
Adverse event data were collected at baseline, 12 weeks, and 24 weeks study visit through standard questionnaire, PHQ-9 question #9, "Over the last 2 weeks, how often have you been bothered by any of the following problems? Thoughts that you would be better off dead, or of hurting yourself." Additionally, self-reporting by participants were also documented.

Additional Information

Ann-Margaret Navarra, PhD, CPNP-PC

NYU Langone Health

Phone: 631-638-0859

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place