Trial Outcomes & Findings for Developing a Trauma-focused Intervention for Older Adults Living With HIV (NCT NCT05287230)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Baseline

Results posted on

2025-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
Overall Study STARTED	17	11
Overall Study COMPLETED	13	6
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Developing a Trauma-focused Intervention for Older Adults Living With HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=17 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=11 Participants Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	10 Participants n=7 Participants	27 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	0 Participants n=7 Participants	0 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	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=17 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=11 Participants Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
ART Adherence	79.0 score on a scale Standard Deviation 25.9	92.7 score on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=7 Participants Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
ART Adherence	92.4 score on a scale Standard Deviation 11.3	96.4 score on a scale Standard Deviation 4.8

PRIMARY outcome

Timeframe: 3 months

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)

Outcome measures

Outcome measures
Measure	Intervention n=12 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=6 Participants Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
ART Adherence	79.1 score on a scale Standard Deviation 29.1	96.3 score on a scale Standard Deviation 4.3

PRIMARY outcome

Timeframe: 6 months

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)

Outcome measures

Outcome measures
Measure	Intervention n=12 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=7 Participants Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
ART Adherence	83.7 score on a scale Standard Deviation 22.0	91.1 score on a scale Standard Deviation 22.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=17 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=11 Participants Control: 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	2.59 score on a scale Standard Deviation 0.80	2.36 score on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=14 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=6 Participants Control: 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	2.64 score on a scale Standard Deviation 1.08	3.50 score on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=7 Participants Control: 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	2.69 score on a scale Standard Deviation 0.75	3.29 score on a scale Standard Deviation 1.11

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=7 Participants Control: 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	2.85 score on a scale Standard Deviation 0.80	3.14 score on a scale Standard Deviation 1.21

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=16 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=11 Participants Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
Depressive Symptoms	21.6 score on a scale Standard Deviation 7.7	22.8 score on a scale Standard Deviation 7.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=14 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=7 Participants Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
Depressive Symptoms	19.3 score on a scale Standard Deviation 7.7	18.0 score on a scale Standard Deviation 6.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 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.

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=7 Participants Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
Depressive Symptoms	19.5 score on a scale Standard Deviation 8.7	18.6 score on a scale Standard Deviation 6.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging): Investigators will use concepts from the LIFT and REFLECT interventions.	Control n=7 Participants Control: Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
Depressive Symptoms	14.5 score on a scale Standard Deviation 5.0	18.1 score on a scale Standard Deviation 4.3

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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. Monique Brown

University of South Carolina

Phone: 8037775057

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place