Trial results for the LinkPositively intervention in HIV care were posted on ClinicalTrials.gov on 2025-07-03, with 53 participants enrolled in the pilot study.
Background
HIV/AIDS remains a significant global health challenge, requiring consistent care and antiretroviral therapy (ART) adherence to manage the condition and prevent transmission. For Black women living with HIV (WLHA) who are also affected by interpersonal violence, maintaining engagement in care and adherence can be particularly challenging due to various social and structural barriers. Digital health interventions, such as smartphone applications, offer a promising avenue to provide culturally tailored support, improve access to resources, and enhance health outcomes in this vulnerable population.
Trial design
This completed pilot study, designated as Phase NA, enrolled 53 participants with HIV/AIDS. The trial investigated the LinkPositively smartphone app, a culturally tailored, trauma-informed peer navigation and social networking intervention designed for Black women living with HIV affected by interpersonal violence. Participants were randomized to either the intervention arm or a control arm receiving Ryan White standard of care, with follow-up assessments conducted at 3 and 6 months.
Key results
The trial reported several key measurements comparing the LinkPositively intervention to standard of care:
- Number of HIV Care Visits:
- At 3 months, the median number of HIV care visits was 1.00 for the standard of care group and 3.00 for the LinkPositively intervention group.
- At 6 months, the median number of HIV care visits was 2.00 for the standard of care group and 3.00 for the LinkPositively intervention group.
- Number of Participants With ART Adherence:
- At 3 months, 8 participants in the standard of care group showed ART adherence compared to 7 in the LinkPositively intervention group.
- At 6 months, 3 participants in the standard of care group showed ART adherence compared to 7 in the LinkPositively intervention group.
- HIV Adherence Self-Efficacy (score on a scale):
- At 3 months, the median self-efficacy score was 8.17 for the standard of care group and 8.33 for the LinkPositively intervention group.
- At 6 months, the median self-efficacy score was 8.21 for the standard of care group and 9.18 for the LinkPositively intervention group.
What this means
The pilot results suggest that the LinkPositively app may improve engagement in HIV care and enhance ART adherence and self-efficacy among Black women living with HIV, particularly those affected by interpersonal violence. The observed increase in median HIV care visits and sustained ART adherence at 6 months in the intervention group compared to standard of care indicates a potential benefit. The improvement in HIV adherence self-efficacy scores also points to the intervention's positive impact on participants' confidence in managing their treatment. These preliminary findings support the potential of technology-delivered peer navigation and social networking interventions to address complex barriers to HIV care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04199052, titled "LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care", were posted on 2025-07-03 on clinicaltrials.gov.