Trial results for the Adherence Connection for Counseling, Education, and Support (ACCESS) II study in HIV-infected individuals were posted on ClinicalTrials.gov on 2025-09-24. The study enrolled 60 participants.
Background
HIV infection requires consistent adherence to antiretroviral treatment (ART) to achieve viral suppression and prevent disease progression. However, maintaining high ART adherence can be challenging, particularly among adolescents and young adults. This is especially critical for Black and Hispanic HIV-infected (HIV+) adolescents and young adults (AYA), aged 18-29 years, who may face unique barriers to care and adherence. Interventions designed to support ART adherence and ultimately reduce HIV viral load are essential for improving health outcomes in this demographic.
Trial design
This completed study, designated as Phase NA, enrolled 60 participants with HIV Infections. The primary objective of the trial was to test the efficacy of the ACCESS-II intervention on antiretroviral treatment (ART) adherence and HIV-viral load. Participants in the intervention condition used videoconferencing to connect synchronously with trained HIV+ peer health coaches who delivered eight weekly, 60-minute cognitive-behavioral sessions. The trial utilized a two-group, randomized control trial (RCT) design, comparing the ACCESS II mHealth intervention against a control group.
Key results
The trial reported several key measurements for both the intervention and control groups:
- Self-Reported ART Adherence (Percentage of successful doses):
- For the ACCESS II mHealth Intervention group, adherence was reported as 56.67%, 74.64%, and 76.77% at different measurement points.
- For the Control group, adherence was reported as 58.7%, 71.79%, and 80.33% at corresponding measurement points.
- Log10 Viral Load (Log10 Viral Load (Copies/mL)):
- The ACCESS II mHealth Intervention group had a mean viral load of 3.50 (Standard Deviation 1.2).
- The Control group had a mean viral load of 3.40 (Standard Deviation 1.4).
- Annualized Change in Log10 Viral Load (log10 copies/mL/year):
- The ACCESS II mHealth Intervention group showed a mean change of -0.43.
- The Control group showed a mean change of -0.53.
- Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES) (score on a scale):
- Both the ACCESS II mHealth Intervention group and the Control group had a mean score of 6.8. The Standard Deviation for the intervention group was 2.0, and for the control group, it was 1.2.
What this means
The results indicate that the ACCESS II mHealth intervention did not demonstrate a clear advantage over the control group in improving self-reported ART adherence or reducing viral load. Adherence levels varied, with the control group showing slightly higher adherence at the final reported point (80.33% vs. 76.77%). The mean Log10 Viral Load was slightly lower in the control group (3.40 vs. 3.50), and the annualized reduction in viral load was marginally greater (mean -0.53 vs. -0.43). Adherence self-efficacy scores were identical. These findings suggest the specific mHealth peer coaching intervention may not offer additional benefits beyond standard care in the context of this trial.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04499781, titled "Adherence Connection for Counseling, Education, and Support (ACCESS) II", were posted on 2025-09-24 on clinicaltrials.gov.