N/A
N=60
Adherence Connection for Counseling, Education, and Support (ACCESS) II
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT04499781 ↗Enrolled (actual)
60
Serious AEs
21.7%
Results posted
Sep 2025
Primary outcome: Primary: Self-Reported ART Adherence — 56.67; 58.7 Percentage of successful doses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACCESS II mHealth Intervention (Behavioral); ACCESS II control condition (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Reported ART Adherence |
76.77; 80.33 | — |
| PRIMARY Self-Reported ART Adherence |
76.77; 80.33 | — |
| PRIMARY Self-Reported ART Adherence |
76.77; 80.33 | — |
| PRIMARY Log10 Viral Load |
3.50; 3.40 | — |
| PRIMARY Annualized Change in Log10 Viral Load (Copies/mL) |
-0.43; -0.53 | — |
| PRIMARY Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES) |
7.7; 7.4 | — |
| PRIMARY Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES) |
7.7; 7.4 | — |
| PRIMARY Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES) |
7.7; 7.4 | — |
| SECONDARY Knowledge About ART Measured With the HIV Treatment Knowledge Scale |
15.5; 15.8 | — |
| SECONDARY Knowledge About ART Measured With the HIV Treatment Knowledge Scale |
15.5; 15.8 | — |
| SECONDARY Knowledge About ART Measured With the HIV Treatment Knowledge Scale |
15.5; 15.8 | — |
| SECONDARY HIV Stigma Measured With the HIV Stigma Scale |
96.9; 101.4 | — |
| SECONDARY HIV Stigma Measured With the HIV Stigma Scale |
96.9; 101.4 | — |
| SECONDARY HIV Stigma Measured With the HIV Stigma Scale |
96.9; 101.4 | — |
| SECONDARY Depression Measured With the Patient Health Questionnaire-9 (PHQ-9) |
4.7; 5.7 | — |
| SECONDARY Depression Measured With the Patient Health Questionnaire-9 (PHQ-9) |
4.7; 5.7 | — |
| SECONDARY Depression Measured With the Patient Health Questionnaire-9 (PHQ-9) |
4.7; 5.7 | — |
| SECONDARY Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7) |
5.0; 5.8 | — |
| SECONDARY Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7) |
5.0; 5.8 | — |
| SECONDARY Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7) |
5.0; 5.8 | — |
| SECONDARY Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD) |
4; 4 | — |
| SECONDARY Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD) |
4; 4 | — |
| SECONDARY Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD) |
4; 4 | — |
| SECONDARY 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; 48.0 | — |
| SECONDARY 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; 48.0 | — |
| SECONDARY 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; 48.0 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score |
47.9; 46.7 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score |
47.9; 46.7 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score |
47.9; 46.7 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score |
51.3; 49.3 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score |
51.3; 49.3 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score |
51.3; 49.3 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score |
49.6; 48.8 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score |
49.6; 48.8 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score |
49.6; 48.8 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score |
52.5; 52.7 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score |
52.5; 52.7 | — |
| SECONDARY Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score |
52.5; 52.7 | — |
| SECONDARY Tobacco - Lifetime Use |
20; 20 | — |
| SECONDARY Marijuana - Lifetime Use |
23; 25 | — |
| SECONDARY Alcohol - Lifetime Use |
25; 27 | — |
Summary
The primary objective of the proposed clinical trial, Adherence Connection for Counseling, Education, and Support (ACCESS)-II, is to test the efficacy of ACCESS-II on antiretroviral treatment (ART) adherence and HIV-viral load in Black and Hispanic HIV-infected (HIV+) adolescents and young adults (AYA), ages 18-29 years (N=120) using a longitudinal (12 and 24 week outcomes), two-group, randomized control trial (RCT). 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. Participants in the control will connect asynchronously to a web-based HIV ART adherence education condition.
Eligibility Criteria
Inclusion criteria for participation in this study are:
- HIV seropositive status (perinatally and behaviorally infected youth)
- Ages 18-29 years
- English speaking
- Currently being prescribed an antiretroviral treatment regimen
- Evidence of virologic failure or (detectable quantitative HIV serum viral load>200 copies/ml)
- No neuro-cognitive deficits which would impede participation in videoconferencing sessions or completion of study measures
Data sourced from ClinicalTrials.gov (NCT04499781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.