Trial Outcomes & Findings for LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care (NCT NCT04199052)
NCT ID: NCT04199052
Last Updated: 2025-07-03
Results Overview
Median number of HIV care visits
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
3 Months Post-Baseline
Results posted on
2025-07-03
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
26
|
|
Overall Study
Completed Intervention Period
|
17
|
26
|
|
Overall Study
Completed 3-month Follow-up
|
11
|
9
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
18
|
Baseline Characteristics
LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care
Baseline characteristics by cohort
| Measure |
Standard of Care
n=17 Participants
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
n=26 Participants
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.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.50 years
n=5 Participants
|
48.00 years
n=7 Participants
|
49.00 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Number of participants who have ever experienced physical violence
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Number of participants who have ever experienced sexual assault
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Number of participants who have ever experienced forced sexual activity
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Number of participants who have ever experienced emotional abuse
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Number of participants who have ever experienced attempts to control you
|
13 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Number of participants who have experienced threats of physical violence
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Number of HIV Care Visits in Past Year
|
3.00 HIV care visits
n=5 Participants
|
2 HIV care visits
n=7 Participants
|
2.00 HIV care visits
n=5 Participants
|
|
HIV Adherence Self-Efficacy
|
8.67 units on a scale
n=5 Participants
|
8.17 units on a scale
n=7 Participants
|
8.25 units on a scale
n=5 Participants
|
|
National Stress Events Survey PTSD Short Scale
|
13.00 units on a scale
n=5 Participants
|
10.00 units on a scale
n=7 Participants
|
11.00 units on a scale
n=5 Participants
|
|
Patient Health Questionnaire for Depression
|
9.00 units on a scale
n=5 Participants
|
9.00 units on a scale
n=7 Participants
|
9.00 units on a scale
n=5 Participants
|
|
Generalized Anxiety Disorder
|
7.00 units on a scale
n=5 Participants
|
7.00 units on a scale
n=7 Participants
|
7.00 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Months Post-BaselineMedian number of HIV care visits
Outcome measures
| Measure |
Standard of Care
n=11 Participants
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
n=9 Participants
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.
|
|---|---|---|
|
Number of HIV Care Visits
|
1.00 HIV Care Visits
Interval 1.0 to 2.0
|
3.00 HIV Care Visits
Interval 0.5 to 3.0
|
PRIMARY outcome
Timeframe: 6 Months Post-BaselineMedian number of HIV care visits in past 6 months
Outcome measures
| Measure |
Standard of Care
n=6 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
Number of HIV Care Visits
|
2.00 HIV Care Visits
Interval 1.0 to 3.5
|
3.00 HIV Care Visits
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: 3 Months Post-BaselineDichotomized 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)
Outcome measures
| Measure |
Standard of Care
n=11 Participants
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
n=9 Participants
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.
|
|---|---|---|
|
Number of Participants With ART Adherence
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 6 Months Post-BaselineDichotomized 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)
Outcome measures
| Measure |
Standard of Care
n=6 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
Number of Participants With ART Adherence
|
3 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 3 Months Post-BaselineHIV 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.
Outcome measures
| Measure |
Standard of Care
n=11 Participants
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
n=9 Participants
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.
|
|---|---|---|
|
HIV Adherence Self-Efficacy
|
8.17 units on a scale
Interval 6.58 to 9.67
|
8.33 units on a scale
Interval 6.96 to 9.79
|
PRIMARY outcome
Timeframe: 6 Months Post-BaselineHIV 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.
Outcome measures
| Measure |
Standard of Care
n=6 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
HIV Adherence Self-Efficacy
|
8.21 score on a scale
Interval 6.79 to 9.31
|
9.18 score on a scale
Interval 6.79 to 9.42
|
SECONDARY outcome
Timeframe: 3 Months Post-BaselinePTSD 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).
Outcome measures
| Measure |
Standard of Care
n=11 Participants
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
n=9 Participants
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.
|
|---|---|---|
|
National Stressful Events Survey PTSD Short Scale Score
|
12.00 score on a scale
Interval 2.0 to 20.0
|
8.00 score on a scale
Interval 5.5 to 16.5
|
SECONDARY outcome
Timeframe: 6 Months Post-BaselinePTSD 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).
Outcome measures
| Measure |
Standard of Care
n=6 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
National Stressful Events Survey PTSD Short Scale Score
|
10.00 score on a scale
Interval 3.75 to 18.75
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7.50 score on a scale
Interval 5.25 to 12.75
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SECONDARY outcome
Timeframe: 3 Months Post-BaselineMeasured using the Patient Health Questionnaire-9, minimum value=0, maximum value=27; higher scores indicate more depression.
Outcome measures
| Measure |
Standard of Care
n=11 Participants
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
n=9 Participants
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.
|
|---|---|---|
|
Patient Health Questionnaire for Depression Score
|
7.00 score on a scale
Interval 4.0 to 12.0
|
6.00 score on a scale
Interval 4.0 to 7.5
|
SECONDARY outcome
Timeframe: 6 Months Post-BaselineMeasured using Patient Health Questionnaire-9, minimum value=0, maximum value=27; higher scores indicate more depression.
Outcome measures
| Measure |
Standard of Care
n=17 Participants
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
n=26 Participants
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.
|
|---|---|---|
|
Patient Health Questionnaire for Depression Score
|
8.50 score on a scale
Interval 6.75 to 11.25
|
6.00 score on a scale
Interval 1.5 to 8.75
|
SECONDARY outcome
Timeframe: 3 Months Post-BaselineAnxiety measured using the Generalized Anxiety Disorder Scale-7, minimum value=0, maximum value=21; higher scores mean a worse outcome.
Outcome measures
| Measure |
Standard of Care
n=11 Participants
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
n=9 Participants
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.
|
|---|---|---|
|
Generalized Anxiety Disorder Score
|
6.00 score on a scale
Interval 2.0 to 11.0
|
6.00 score on a scale
Interval 4.5 to 8.0
|
SECONDARY outcome
Timeframe: 6 Months Post-BaselineAnxiety was measured using the Generalized Anxiety Disorder Scale-7, minimum value=0, maximum value=21; higher scores mean a worse outcome.
Outcome measures
| Measure |
Standard of Care
n=6 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
Generalized Anxiety Disorder Score
|
8.00 score on a scale
Interval 2.75 to 11.0
|
5.00 score on a scale
Interval 3.25 to 7.75
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LinkPositively Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jamila K. Stockman, Professor
University of California San Diego
Phone: (858) 822-4652
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place