HIV Antibody Positivity
Conditions
Keywords
Positive Links, Youth, Emerging Adults
Brief summary
A small pilot study to assess feasibility and acceptability of the PL4Y intervention.
Detailed description
After completing enrollment and informed consent, participants will be randomly assigned to PL4Y in a 2:1 fashion (intervention:control) with a target enrollment of 40 receiving the intervention and 20 in the control arm for a total of 60 participants. There is no blinding in this study protocol.
Interventions
BEHAVIORALMobile health app
A mobile app provided to participants to assess effectiveness in managing HIV
Sponsors
The University of Texas Health Science Center at San Antonio
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants will be randomized in a 2:1 ratio to intervention (PL4Y use) or standard of care
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed HIV infection * Recent diagnosis of HIV (within the past 6 months) OR be virologically unsuppressed (\>1000 copies/ml) OR disengaged from HIV care (\< 2 visits/last 12 months \> 90 days apart)
Exclusion criteria
* Cannot consent * Unwilling to come to visits * Unwilling to be in San Antonio for a year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Undetectable Viral Load | 12 months | Virologic suppression is the primary goal of HIV treatment. Virologic failure is defined as a measurement over 200 copies per mL by the Department of Health and Human Services, and is the primary determinant of successful HIV control. This outcome is categorized as: Undetectable (VL \<200 at 12 months) |
| Feasibility Survey Completion | 6 and 12 month time points | Feasibility of the intervention assessed using a participant-completed survey at 6 and 12 months. Measured as number of participants that completed the survey in the arm that received the intervention only. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBarbara Taylor, MD, MS
The University of Texas Health Science Center at San Antonio
Participant flow
Recruitment details
Participants were recruited from San Antonio, Texas based HIV clinics through a combination of provider referrals, electronic health record screening, and study outreach materials (e.g., flyers, phone calls, and/or email). Individuals who met preliminary eligibility criteria were contacted by study staff and provided with information about the study. Interested participants completed a screening process to confirm eligibility prior to enrollment. Recruitment occurred January - December 2023.
Pre-assignment details
Following informed consent and completion of baseline assessments, eligible participants were randomized to the control or intervention arm per the PL4Y protocol. Assignment occurred after all pre-assignment procedures were completed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 25.65 Years STANDARD_DEVIATION 3.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 9 |
| other Total, other adverse events | 0 / 20 | 0 / 9 |
| serious Total, serious adverse events | 0 / 20 | 0 / 9 |
Outcome results
None listed