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Completed

NCT Number: NCT05287230

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

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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Key information

Conditions

Trauma Acquired Immunodeficiency Syndrome Aging Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases Wounds and Injuries

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging)

Behavioral

Investigators will use concepts from the LIFT and REFLECT interventions.

Control

Behavioral

Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.

Primary outcomes

  1. ART Adherence

    Time frame: 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.

  2. ART Adherence

    Time frame: 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.

  3. ART Adherence

    Time frame: 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)

  4. ART Adherence

    Time frame: 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)

Secondary outcomes

  1. Health-related Quality of Life - General Health

    Time frame: 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.

  2. Health-related Quality of Life - General Health

    Time frame: 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.

  3. Health-related Quality of Life - General Health

    Time frame: 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.

  4. Health-related Quality of Life - General Health

    Time frame: 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.

Other outcomes

  1. Depressive Symptoms

    Time frame: 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.

  2. Depressive Symptoms

    Time frame: 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.

  3. Depressive Symptoms

    Time frame: 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.

  4. Depressive Symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2022
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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