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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH122014-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| San Diego State University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | 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. | |
| LinkPositively Intervention | Experimental | Women assigned to the LinkPositively intervention arm will have access to all four components of the LinkPositively app. Women will be scheduled for a session with staff to inform them of their assigned virtual Peer Navigator (PN). Staff will train participants on how to download the app, explain the five components, using each component, and contacting their PN. Within the first week after, 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.). PNs will provide trauma-informed emotional and informational support, including guidance on accessing information about referred services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LinkPositively | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of HIV Care Visits | Median number of HIV care visits | 3 Months Post-Baseline |
| Number of HIV Care Visits | Median number of HIV care visits in past 6 months | 6 Months Post-Baseline |
| 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) | 3 Months Post-Baseline |
| 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) | 6 Months Post-Baseline |
| 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. | 3 Months Post-Baseline |
| 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. | 6 Months Post-Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 Months Post-Baseline |
| National Stressful Events Survey PTSD Short Scale Score |
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Inclusion Criteria:
Exclusion Criteria:
Female gender identifying
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| Name | Affiliation | Role |
|---|---|---|
| Jamila K. Stockman, PhD, MPH | University of California, San Diego | Principal Investigator |
| Keith J. Horvath, PhD | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD AntiViral Research Center | San Diego | California | 92103 | United States |
No current plan
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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) global positioning system-enabled Resource Locator for HIV care and ancillary support service agencies; and e) HIV medication self-monitoring and reminder system. Within the first week of the LinkPositively 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of HIV Care Visits | Median number of HIV care visits | Posted | Median | Inter-Quartile Range | HIV Care Visits | 3 Months Post-Baseline |
|
Adverse event data were collected over a 6 month period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jamila K. Stockman, Professor | University of California San Diego | (858) 822-4652 | jstockman@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2025 | May 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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The investigators were blinded to participant study group assignment.
|
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). |
| 6 Months Post-Baseline |
| Patient Health Questionnaire for Depression Score | Measured using the Patient Health Questionnaire-9, minimum value=0, maximum value=27; higher scores indicate more depression. | 3 Months Post-Baseline |
| Patient Health Questionnaire for Depression Score | Measured using Patient Health Questionnaire-9, minimum value=0, maximum value=27; higher scores indicate more depression. | 6 Months Post-Baseline |
| 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. | 3 Months Post-Baseline |
| 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. | 6 Months Post-Baseline |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of participants who have ever experienced physical violence | Count of Participants | Participants |
|
| Number of participants who have ever experienced sexual assault | Count of Participants | Participants |
|
| Number of participants who have ever experienced forced sexual activity | Count of Participants | Participants |
|
| Number of participants who have ever experienced emotional abuse | Count of Participants | Participants |
|
| Number of participants who have ever experienced attempts to control you | Count of Participants | Participants |
|
| Number of participants who have experienced threats of physical violence | Count of Participants | Participants |
|
| Number of HIV Care Visits in Past Year | Median | Inter-Quartile Range | HIV care visits |
|
| 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. | Median | Inter-Quartile Range | units on a scale |
|
| National Stress Events Survey PTSD Short Scale | 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). | Median | Inter-Quartile Range | units on a scale |
|
| Patient Health Questionnaire for Depression | Patient Health Questionnaire (PHQ-9) for depression symptoms. Score range minimum = 0, maximum = 27, with higher scores indicating more depressive symptoms | Median | Inter-Quartile Range | units on a scale |
|
| Generalized Anxiety Disorder | Generalized Anxiety Disorder (GAD-7) for anxiety symptoms. Score ranges from minimum = 0, maximum = 21, with higher scores indicating more anxiety symptoms | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | 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. |
|
|
| Primary | Number of HIV Care Visits | Median number of HIV care visits in past 6 months | Posted | Median | Inter-Quartile Range | HIV Care Visits | 6 Months Post-Baseline |
|
|
|
| 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) | Posted | Count of Participants | Participants | 3 Months Post-Baseline |
|
|
|
| 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) | Posted | Count of Participants | Participants | 6 Months Post-Baseline |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 3 Months Post-Baseline |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 6 Months Post-Baseline |
|
|
|
| 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). | Posted | Median | Inter-Quartile Range | score on a scale | 3 Months Post-Baseline |
|
|
|
| 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). | Posted | Median | Inter-Quartile Range | score on a scale | 6 Months Post-Baseline |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 3 Months Post-Baseline |
|
|
|
| Secondary | Patient Health Questionnaire for Depression Score | Measured using Patient Health Questionnaire-9, minimum value=0, maximum value=27; higher scores indicate more depression. | Posted | Median | Inter-Quartile Range | score on a scale | 6 Months Post-Baseline |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 3 Months Post-Baseline |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 6 Months Post-Baseline |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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. | 0 | 26 | 0 | 26 | 0 | 26 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |