A Behavioral mHealth Intervention for People With HIV With Anxiety and Depression
Purpose
This study will adapt and assess the preliminary effectiveness of a community health worker-delivered mental health counselling intervention delivered remotely to reduce anxiety and depression among people with HIV in Florida.
Conditions
- HIV
- Depression
- Anxiety
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- HIV diagnosis - GAD-7 score of 5 or greater - PHQ-8 score of 5 or greater
Exclusion Criteria
- Active psychosis - Suicidal ideation
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Modified PositiveLinks app with CHW-delivered counseling |
This arm includes a modified version of the PositiveLinks app which includes access to community health worker-delivered positive affect counseling via a video call feature on the app |
|
|
Active Comparator Unmodified PositiveLinks with no counseling |
This arm includes the standard of care which includes the standard version of the PositiveLinks app and feedback on self-reported anxiety and depression symptoms and a list of local mental health resources |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Florida
Detailed Description
The investigators will conduct a pilot randomized controlled trial to evaluate the preliminary effectiveness of an adapted community health worker (CWH)-delivered positive affect counselling intervention delivered remotely via mHealth. The adapted intervention will include CHW-delivered positive affect skill-based counseling accessible through video call that will be accessible through the mHealth app. The CHW will conduct approximately 5 weekly individual 60-minute counseling sessions via a secure video call feature. If the participant does not have symptomatic improvement, the CHW will refer the participant to a licensed mental health professional. Participants will be randomized to receive access to the counselling intervention that also includes modified features of the mHealth app with increased mental health resources (intervention arm) or to current standard of mental health care that includes the unmodified version of the app (control arm). Participants allocated to the intervention arm will receive the counseling intervention approximately weekly for 5 weeks. The study will continue to abstract data from participants' EMR and mHealth app for approximately 6 months after enrollment. To assess preliminary effectiveness, the investigators will analyze differences by condition in anxiety and depression (primary outcome). Informed consent will be obtained prior to study participation.
