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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH115794 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging) | Behavioral | Investigators will use concepts from the LIFT and REFLECT interventions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 6 weeks |
| 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) | 3 months |
| 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Depressive Symptoms |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monique J Brown, PhD, MPH | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
Data will be made available to other researchers.
Data will be made available to other researchers after investigators have submitted the related primary paper.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions. |
| FG001 | Control | Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions. |
| BG001 | Control | Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
6 months
Participants were not at risk for serious adverse events, mortality or other adverse events.
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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 | Intervention | CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions. |
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Small sample size as this is a pilot trial. Therefore, results should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Monique Brown | University of South Carolina | 8037775057 | brownm68@mailbox.sc.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 | Oct 13, 2021 | Jul 11, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 13, 2021 | Jul 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000097813 | Coping Skills |
| D000069078 | Seroconversion |
| D000375 | Aging |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D055633 | Immune System Phenomena |
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| Control | Behavioral | Participants will watch HIV and health related videos and discuss how it is related to aging with HIV. |
|
| 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. | 6 weeks |
| 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. | 3 months |
| 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. | 6 months |
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.
| 6 weeks |
| 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. | 3 months |
| 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. | 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Control | Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV. | 0 | 11 | 0 | 11 | 0 | 11 |
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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 |
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |