Aging, Hiv, Trauma
Conditions
Brief summary
Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.
Interventions
BEHAVIORALCoSHA (Coping with childhood Sexual Abuse, HIV, and Aging)
Investigators will use concepts from the LIFT and REFLECT interventions.
BEHAVIORALControl
Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
Sponsors
National Institute of Mental Health (NIMH)
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Living with HIV * 50 years old or older * \<100 % ART adherence * depressive symptoms
Exclusion criteria
* Not living with HIV * \<50 years * 100% ART Adherence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ART Adherence | Baseline | Investigators will measure number of participants who report improved adherence to antiretroviral therapy in the past month using the 30-day visual analogue scale (VAS). Minimum is 0, Maximum is 100%. Higher scores mean better ART adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life - General Health | Baseline | Investigators will measure health-related quality of life of participants, specifically, general health, using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Minimum value is 1. Maximum value is 5. Values were recoded so that higher scores mean better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | Baseline | Investigators will measure depressive symptoms as measured by the Patient Health Questionnaire-9 which ranges from 0 to 24 with higher values representing greater depressive symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions. | 17 |
| Control Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV. | 11 |
| Total | 28 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 11 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 10 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 6 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 6 Participants |
| Region of Enrollment United States | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 11 |
| other Total, other adverse events | 0 / 17 | 0 / 11 |
| serious Total, serious adverse events | 0 / 17 | 0 / 11 |
Outcome results
Primary
ART Adherence
Investigators will measure number of participants who report improved adherence to antiretroviral therapy in the past month using the 30-day visual analogue scale (VAS)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ART Adherence | 83.7 score on a scale | Standard Deviation 22 |
| Control | ART Adherence | 91.1 score on a scale | Standard Deviation 22.6 |
Primary
ART Adherence
Investigators will measure number of participants who report improved adherence to antiretroviral therapy in the past month using the 30-day visual analogue scale (VAS). Minimum is 0, Maximum is 100%. Higher scores mean better ART adherence.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ART Adherence | 79.0 score on a scale | Standard Deviation 25.9 |
| Control | ART Adherence | 92.7 score on a scale | Standard Deviation 2.5 |
p-value: 0.061ANOVA
Primary
ART Adherence
Investigators will measure number of participants who report improved adherence to antiretroviral therapy in the past month using the 30-day visual analogue scale (VAS). Minimum is 0, Maximum is 100%. Higher scores mean better ART adherence.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ART Adherence | 92.4 score on a scale | Standard Deviation 11.3 |
| Control | ART Adherence | 96.4 score on a scale | Standard Deviation 4.8 |
Primary
ART Adherence
Investigators will measure number of participants who report improved adherence to antiretroviral therapy in the past month using the 30-day visual analogue scale (VAS)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ART Adherence | 79.1 score on a scale | Standard Deviation 29.1 |
| Control | ART Adherence | 96.3 score on a scale | Standard Deviation 4.3 |
Secondary
Health-related Quality of Life - General Health
Investigators will measure health-related quality of life of participants, specifically, general health, using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Minimum value is 1. Maximum value is 5. Values were recoded so that higher scores mean better outcome.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Health-related Quality of Life - General Health | 2.59 score on a scale | Standard Deviation 0.8 |
| Control | Health-related Quality of Life - General Health | 2.36 score on a scale | Standard Deviation 1.21 |
Secondary
Health-related Quality of Life - General Health
Investigators will measure health-related quality of life of participants, specifically, general health, using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Minimum value is 1. Maximum value is 5. Values were recoded so that higher scores mean better outcome.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Health-related Quality of Life - General Health | 2.64 score on a scale | Standard Deviation 1.08 |
| Control | Health-related Quality of Life - General Health | 3.50 score on a scale | Standard Deviation 1.05 |
Secondary
Health-related Quality of Life - General Health
Investigators will measure health-related quality of life of participants, specifically, general health, using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Minimum value is 1. Maximum value is 5. Values were recoded so that higher scores mean better outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Health-related Quality of Life - General Health | 2.69 score on a scale | Standard Deviation 0.75 |
| Control | Health-related Quality of Life - General Health | 3.29 score on a scale | Standard Deviation 1.11 |
Secondary
Health-related Quality of Life - General Health
Investigators will measure health-related quality of life of participants, specifically, general health, using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Minimum value is 1. Maximum value is 5. Values were recoded so that higher scores mean better outcome.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Health-related Quality of Life - General Health | 2.85 score on a scale | Standard Deviation 0.8 |
| Control | Health-related Quality of Life - General Health | 3.14 score on a scale | Standard Deviation 1.21 |
Other Pre-specified
Depressive Symptoms
Investigators will measure depressive symptoms as measured by the Patient Health Questionnaire-9 which ranges from 0 to 24 with higher values representing greater depressive symptoms.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Depressive Symptoms | 21.6 score on a scale | Standard Deviation 7.7 |
| Control | Depressive Symptoms | 22.8 score on a scale | Standard Deviation 7.4 |
Other Pre-specified
Depressive Symptoms
Investigators will measure depressive symptoms as measured by the Patient Health Questionnaire-9 which ranges from 0 to 24 with higher values representing greater depressive symptoms.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Depressive Symptoms | 19.3 score on a scale | Standard Deviation 7.7 |
| Control | Depressive Symptoms | 18.0 score on a scale | Standard Deviation 6.4 |
Other Pre-specified
Depressive Symptoms
Investigators will measure depressive symptoms as measured by the Patient Health Questionnaire-9 which ranges from 0 to 24 with higher values representing greater depressive symptoms.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Depressive Symptoms | 19.5 score on a scale | Standard Deviation 8.7 |
| Control | Depressive Symptoms | 18.6 score on a scale | Standard Deviation 6.9 |
Other Pre-specified
Depressive Symptoms
Investigators will measure depressive symptoms as measured by the Patient Health Questionnaire-9 which ranges from 0 to 24 with higher values representing greater depressive symptoms.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Depressive Symptoms | 14.5 score on a scale | Standard Deviation 5 |
| Control | Depressive Symptoms | 18.1 score on a scale | Standard Deviation 4.3 |