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)
COMPLETED
NA
60 participants
Baseline
2025-09-24
Participant Flow
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
| 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
| 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: Baseline3-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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineMeasured 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
| 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 24Population: 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
| 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: BaselineAssessment 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineThe 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineThe 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineDepression 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineGeneralized 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselinePost-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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineThe 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineThe 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineThe 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineThe 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineThe 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
| 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 12Population: 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
| 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 24Population: 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
| 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: BaselineSubstance 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
| 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: BaselineSubstance 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
| 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: BaselineSubstance 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
| 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
Control
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place