NCT05287230

Brief Summary

Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 31, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2.9 years

First QC Date

February 18, 2022

Results QC Date

April 18, 2025

Last Update Submit

July 11, 2025

Conditions

TraumaHivAging

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (4)

  • Health-related Quality of Life - General Health

    Baseline

  • Health-related Quality of Life - General Health

    6 weeks

  • Health-related Quality of Life - General Health

    3 months

  • Health-related Quality of Life - General Health

    6 months

Other Outcomes (4)

  • Depressive Symptoms

    Baseline

  • Depressive Symptoms

    6 weeks

  • Depressive Symptoms

    3 months

  • +1 more other outcomes

Study Arms (2)

Intervention

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

Control

OTHER
Behavioral: Control

Interventions

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

Investigators will use concepts from the LIFT and REFLECT interventions.

Intervention
ControlBEHAVIORAL

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

Control

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living with HIV
  • years old or older
  • \<100 % ART adherence
  • depressive symptoms

You may not qualify if:

  • Not living with HIV
  • \<50 years
  • % ART Adherence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesAcquired Immunodeficiency Syndrome

Interventions

Coping SkillsSeroconversionAging

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesImmune System PhenomenaGrowth and DevelopmentPhysiological Phenomena

Limitations and Caveats

Small sample size as this is a pilot trial. Therefore, results should be interpreted with caution.

Results Point of Contact

Title
Dr. Monique Brown
Organization
University of South Carolina
brownm68@mailbox.sc.edu
8037775057

Study Officials

  • Monique J Brown, PhD, MPH

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 18, 2022

Study Start

January 18, 2022

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

July 31, 2025

Results First Posted

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Data will be made available to other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be made available to other researchers after investigators have submitted the related primary paper.

Locations

US(1)