HIV/AIDS
Conditions
Keywords
HIV Care Continuum, Mobile Apps
Brief summary
Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. The goal is to determine preliminary effects of the intervention on HIV care (i.e., retention in HIV care, ART adherence) and mental health outcomes (e.g., PTSD, depression, anxiety). Through a randomized control trial (RCT), participants will be randomly assigned to either the intervention arm (n=40) or control arm (Ryan White standard of care, n=40), with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking-all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.
Detailed description
In the US, Black women living with HIV/AIDS (WLHA) are less likely to be engaged in care, adherent to antiretroviral therapy (ART), and virally suppressed compared to White WLHA. Black women are also disproportionately affected by interpersonal violence - physical, sexual, and/or psychological abuse by a current or former intimate partner or non-intimate partner - which may co-occur with poor mental health and/or substance use, further contributing to ART non-adherence, lower CD4 counts, and reduced viral suppression. Peer Navigation, while highlighted as a successful model of care in improving HIV care outcomes, requires resources that HIV service agencies often lack. A scalable and sustainable solution is the use of mobile health (mHealth) smartphone applications (apps). Although there has been an increase in mHealth interventions developed for HIV prevention and care among at-risk and HIV-positive men who have sex with men (MSM) and youth, investigators are unaware of any to improve retention in care, ART adherence, and viral suppression among Black WLHA, nor any mHealth interventions that are responsive to Black women's experiences with interpersonal violence. To address this gap, investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) global positioning system-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system. Guided by the Theory of Triadic Influences and Syndemic Theory, investigators will pilot test LinkPositively to assess preliminary effects of the intervention on HIV care (i.e., retention in care and ART adherence) and mental health outcomes (e.g., PTSD, depression, anxiety). Participants will be randomly assigned to either the intervention (n=40) or control (Ryan White standard of care, n=40) arm, with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking - all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.
Interventions
BEHAVIORALLinkPositively
LinkPositively is a culturally tailored, trauma-informed smartphone app for Black women living with HIV/AIDS affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system.
Sponsors
San Diego State University
National Institute of Mental Health (NIMH)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
The investigators were blinded to participant study group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female Gender * Black or African-American racial/ethnic background * Aged 18 years or older * HIV-positive status * Ever experienced physical, sexual, and/or psychological abuse by a current or former partner or non-partner (e.g., relative, friend, stranger) * Owner of a smartphone with internet browsing capabilities * English speaking
Exclusion criteria
* Male Gender * Aged 17 or younger * HIV-negative status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of HIV Care Visits | 3 Months Post-Baseline | Median number of HIV care visits |
| Number of Participants With ART Adherence | 3 Months Post-Baseline | Dichotomized into two groups (Greater than or equal to 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items vs. Less than 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items) |
| HIV Adherence Self-Efficacy | 3 Months Post-Baseline | HIV Adherence Self-Efficacy measured using the HIV Adherence Self-Efficacy Scale, minimum=0, maximum=10; higher scores mean greater self-efficacy to adhere to HIV medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Stressful Events Survey PTSD Short Scale Score | 3 Months Post-Baseline | PTSD is measured using the National Stressful Events Survey PTSD Short Scale, minimum value=0, maximum value=36; higher scores indicate a worse outcome (greater PTSD symptomatology). |
| Patient Health Questionnaire for Depression Score | 3 Months Post-Baseline | Measured using the Patient Health Questionnaire-9, minimum value=0, maximum value=27; higher scores indicate more depression. |
| Generalized Anxiety Disorder Score | 3 Months Post-Baseline | Anxiety measured using the Generalized Anxiety Disorder Scale-7, minimum value=0, maximum value=21; higher scores mean a worse outcome. |
Countries
United States
Participant flow
Pre-assignment details
Although 53 participants were eligible and enrolled into the study, 10 elected not to participate following the informed consent process, resulting in a total of 43 participants continuing on in the study.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Women assigned to the control arm will receive self-directed (non-Virtual Peer Navigator (PN) supported) treatment as usual at the HIV care service provider of choice following the Ryan White standard of care (i.e., referrals to physical, dental and mental health services; case management; and ancillary services. Annual assessments (e.g., updates on insurance, housing, referrals needed, behavioral assessment \[e.g., depression, substance use\]) are conducted by a case manager. For women who have fallen out of care and re-engage care, case management begins with an interview and assessment of current needs. Goals are set to create an individual care plan related to medical care, housing, and other resources, as needed. Referrals are made to appropriate services (e.g., primary care, housing, benefits counseling, food, support services) based on the intake assessment. It is important to note that the case management approach is self-guided versus intensive virtual PN assistance. | 17 |
| LinkPositively Intervention Women assigned to the LinkPositively intervention arm will have access to all four components of the LinkPositively app. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system. Within the first week of LP app use, virtual PNs will complete a one-on-one, in-person or phone intake session with the participant, based on the participant's preference. During this intake session, the PN will conduct a participant needs assessment to connect her to HIV medical care via local health clinics and identify other areas of need, services of need, and assisted referrals (domestic violence services, mental health care, substance abuse treatment, housing and legal support, etc.). Weekly, PNs will provide trauma-informed emotional and informational support, including guidance on accessing information about referred services. | 26 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 18 |
Baseline characteristics
| Characteristic | Total | Standard of Care | LinkPositively Intervention |
|---|---|---|---|
| Age, Continuous | 49.00 years | 49.50 years | 48.00 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 17 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Generalized Anxiety Disorder | 7.00 units on a scale | 7.00 units on a scale | 7.00 units on a scale |
| HIV Adherence Self-Efficacy | 8.25 units on a scale | 8.67 units on a scale | 8.17 units on a scale |
| National Stress Events Survey PTSD Short Scale | 11.00 units on a scale | 13.00 units on a scale | 10.00 units on a scale |
| Number of HIV Care Visits in Past Year | 2.00 HIV care visits | 3.00 HIV care visits | 2 HIV care visits |
| Number of participants who have ever experienced attempts to control you | 35 Participants | 13 Participants | 22 Participants |
| Number of participants who have ever experienced emotional abuse | 42 Participants | 17 Participants | 25 Participants |
| Number of participants who have ever experienced forced sexual activity | 34 Participants | 14 Participants | 20 Participants |
| Number of participants who have ever experienced physical violence | 31 Participants | 12 Participants | 19 Participants |
| Number of participants who have ever experienced sexual assault | 34 Participants | 15 Participants | 19 Participants |
| Number of participants who have experienced threats of physical violence | 31 Participants | 13 Participants | 18 Participants |
| Patient Health Questionnaire for Depression | 9.00 units on a scale | 9.00 units on a scale | 9.00 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 15 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 43 Participants | 17 Participants | 26 Participants |
| Sex: Female, Male Female | 43 Participants | 17 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 26 |
| other Total, other adverse events | 0 / 17 | 0 / 26 |
| serious Total, serious adverse events | 0 / 17 | 0 / 26 |
Outcome results
Primary
HIV Adherence Self-Efficacy
HIV Adherence Self-Efficacy measured using the HIV Adherence Self-Efficacy Scale, minimum=0, maximum=10; higher scores mean greater self-efficacy to adhere to HIV medication.
Time frame: 3 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | HIV Adherence Self-Efficacy | 8.17 units on a scale |
| LinkPositively Intervention | HIV Adherence Self-Efficacy | 8.33 units on a scale |
Primary
HIV Adherence Self-Efficacy
HIV Adherence Self-Efficacy measured using the HIV Adherence Self-Efficacy Scale, minimum=0, maximum=10; higher scores mean greater self-efficacy to adhere to HIV medication.
Time frame: 6 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | HIV Adherence Self-Efficacy | 8.21 score on a scale |
| LinkPositively Intervention | HIV Adherence Self-Efficacy | 9.18 score on a scale |
Primary
Number of HIV Care Visits
Median number of HIV care visits
Time frame: 3 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Number of HIV Care Visits | 1.00 HIV Care Visits |
| LinkPositively Intervention | Number of HIV Care Visits | 3.00 HIV Care Visits |
Primary
Number of HIV Care Visits
Median number of HIV care visits in past 6 months
Time frame: 6 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Number of HIV Care Visits | 2.00 HIV Care Visits |
| LinkPositively Intervention | Number of HIV Care Visits | 3.00 HIV Care Visits |
Primary
Number of Participants With ART Adherence
Dichotomized into two groups (Greater than or equal to 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items vs. Less than 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items)
Time frame: 6 Months Post-Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants With ART Adherence | 3 Participants |
| LinkPositively Intervention | Number of Participants With ART Adherence | 7 Participants |
Primary
Number of Participants With ART Adherence
Dichotomized into two groups (Greater than or equal to 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items vs. Less than 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items)
Time frame: 3 Months Post-Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants With ART Adherence | 8 Participants |
| LinkPositively Intervention | Number of Participants With ART Adherence | 7 Participants |
Secondary
Generalized Anxiety Disorder Score
Anxiety was measured using the Generalized Anxiety Disorder Scale-7, minimum value=0, maximum value=21; higher scores mean a worse outcome.
Time frame: 6 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Generalized Anxiety Disorder Score | 8.00 score on a scale |
| LinkPositively Intervention | Generalized Anxiety Disorder Score | 5.00 score on a scale |
Secondary
Generalized Anxiety Disorder Score
Anxiety measured using the Generalized Anxiety Disorder Scale-7, minimum value=0, maximum value=21; higher scores mean a worse outcome.
Time frame: 3 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Generalized Anxiety Disorder Score | 6.00 score on a scale |
| LinkPositively Intervention | Generalized Anxiety Disorder Score | 6.00 score on a scale |
Secondary
National Stressful Events Survey PTSD Short Scale Score
PTSD is measured using the National Stressful Events Survey PTSD Short Scale, minimum value=0, maximum value=36; higher scores indicate a worse outcome (greater PTSD symptomatology).
Time frame: 3 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | National Stressful Events Survey PTSD Short Scale Score | 12.00 score on a scale |
| LinkPositively Intervention | National Stressful Events Survey PTSD Short Scale Score | 8.00 score on a scale |
Secondary
National Stressful Events Survey PTSD Short Scale Score
PTSD is measured using the National Stressful Events Survey PTSD Short Scale, minimum value=0, maximum value=36; higher scores indicate a worse outcome (greater PTSD symptomatology).
Time frame: 6 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | National Stressful Events Survey PTSD Short Scale Score | 10.00 score on a scale |
| LinkPositively Intervention | National Stressful Events Survey PTSD Short Scale Score | 7.50 score on a scale |
Secondary
Patient Health Questionnaire for Depression Score
Measured using the Patient Health Questionnaire-9, minimum value=0, maximum value=27; higher scores indicate more depression.
Time frame: 3 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Patient Health Questionnaire for Depression Score | 7.00 score on a scale |
| LinkPositively Intervention | Patient Health Questionnaire for Depression Score | 6.00 score on a scale |
Secondary
Patient Health Questionnaire for Depression Score
Measured using Patient Health Questionnaire-9, minimum value=0, maximum value=27; higher scores indicate more depression.
Time frame: 6 Months Post-Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Patient Health Questionnaire for Depression Score | 8.50 score on a scale |
| LinkPositively Intervention | Patient Health Questionnaire for Depression Score | 6.00 score on a scale |