Developing a Trauma-focused Intervention for Older Adults Living With HIV
Phase: NA
Conditions: Trauma, Hiv, Aging
Sponsor: University of South Carolina

Official Title: Developing a trauma-focused intervention for older adults living 
with HIV  
 
NCT Number: NCT05287230  
 
Date of Document: 10/13/2021 
 
 
 

Study Title:   Developing a trauma-focused intervention for older adults living with 
HIV - Phase III 
 
Principal Investigator Name:  Monique J. Brown 
 
Faculty Mentor Name (if applicable):        
 
 
A. SPECIFIC AIMS  
1) To determine the feasibility and acceptability of a pilot intervention addressing 
childhood sexual abuse among older adults living with HIV. 
 
B. BACKGROUND AND SIGNIFICANCE 
 
 
HIV/AIDS continues to be a major public health issue for older adults, locally, nationally 
and globally. In 2018, over half of people diagnosed with HIV were aged 50 and older 
(1).  Around 1 in 6 new HIV diagnoses in 2018 were among people aged 50 and older 
(1) Based on data from the South Carolina Department of Health and Environmental 
Control and the Census, the case rate among adults 50 and older living in South 
Carolina was 521.1 cases per 100,000 population in 2016 (n=9,925 cases) and this 
population accounted for half of all people living with HIV (2). The prevalence of 
childhood sexual abuse (CSA) among older adults living with HIV may range from 16-
22%. Older adults with CSA history had three to four times higher odds of reporting 
depression compared to older adults who did not experience CSA (3). Addressing CSA 
among older adults living with HIV (OALH) may help to reduce depression, which may 
help to improve ART adherence, viral suppression, and overall health-related quality of 
life (HRQoL). 
 
C. PRELIMINARY STUDIES 
 
This is Phase III of a 3-phase research project.  The research team and PI have 
completed data collection for Phases I (qualitative study) and II (quantitative study) and 
are currently analyzing the data. 
 
D. RESEARCH DESIGN AND METHODS AND DATA ANALYSIS  
 
Phase III (Pilot intervention): A baseline assessment will be used to garner data on 
these relationships. ART adherence and viral suppression will be obtained by viral load 
data via assessment of medical record copies from recruitment sites, via informed and 
HIPPA consent. The data will then be deidentified and Dr. Sharon Weissman will assist 
in the interpretation of viral load data to determine ART adherence and viral 
suppression of participants. HRQoL will be measured by the CDC Healthy Day Cores 
Module (HRQOL-4), (4) and CSA using 15 related items from the Early Trauma 
Inventory – Self Report (ETI-SR) (5). Concepts related to aging with HIV will include 
data on comorbidities using the Self-Administered Comorbidity Questionnaire (6); AIDS 
diagnosis using medical records; loneliness using the UCLA Loneliness Scale (7); HIV-

related stigma using the Berger Stigma Scale (8); and the role of caregivers in ART 
adherence. For potential mediators, coping strategies will be measured by the Brief 
Cope Scale (9); substance use using the Substance Abuse and Mental Illness Screener 
(10); and depressive symptoms using the 20-item Center for Epidemiologic Studies – 
Depression Scale (11). Data will also be collected on condomless sexual intercourse 
[vaginal, anal (receptive and/or insertive), oral] in the past 6 months (12); IPV 
victimization and/or perpetration using the Partner Violence Screen (13) and the Conflict 
Tactics Scale (14), respectively; and on sociodemographics including age, sex, 
race/ethnicity, education, income, sexual orientation, and time since diagnosis. 
 
 
This phase is proposed so as to determine the feasibility and acceptability of the 
Coping with Childhood Sexual abuse, HIV and Aging (CoSHA) intervention. The 
CoSHA one-on-one intervention will be developed by drafting a manual, and having it 
reviewed by experts and 
potential users. Findings from Phase I will be the formative phase of providing input 
from the population for which the intervention will be designed. Input will also be sought 
from stakeholders (healthcare providers and ASO staff). Facilitators will be 
systematically trained using a criterion of successful implementation based on the 
REFLECT and the LIFT interventions. Implementation of treatment will be monitored to 
determine if the facilitator follows the approaches appropriately. CoSHA will be pilot-
tested among OALH with CSA history and will use some of the main concepts from the 
REFLECT and LIFT interventions. Components to be used from REFLECT will include: 
appraisal and changeability of stressors related to aging with HIV; implementing 
adaptive problem- and emotion-focused coping skills; optimizing coping efforts by using 
interpersonal supports. Concepts from the LIFT intervention will include: identifying and 
expressing emotion related to CSA and perceptions of being a victim; identifying 
stressors and coping difficulties in relation to CSA; and developing adaptive strategies 
to reduce psychological stress. We will do theater/usability testing with 5 individuals to 
examine the preliminary intervention.  Individual usability interviews with OALH will be 
conducted with the same recruitment procedures below.  During the interviews, the 
moderator will walk the participant through each portion of the manual.  Participants will 
be asked to reflect on whether the intervention met expectations.  CoSHA will be a 5-
session intervention with each session conducted weekly for five weeks. During the first 
session, baseline data will be collected and participants (N=40) will be randomly 
assigned to the intervention or to the 5-session attention control case management 
(ACCM) control group. For ACCM, participants will be given resources and will be able 
to talk about any issue of their interest. Sessions 2 and 3 for the intervention will focus 
on improving CSA coping strategies, and sessions 4 and 5 will focus on aging with HIV. 
Assessments will be done post session 5 (6-weeks post baseline), at 3 months, and at 6 
months post baseline. A 3-month booster will be also 
given. After each session, the facilitator will complete quality assurance forms. The 
graduate research assistant or the PI will deliver the intervention. 
 
Fidelity checks will be done by recording the sessions. Selected parts of the recordings 
of sessions will be reviewed and feedback will be provided to the facilitators. An 

independent coder (undergraduate student) will estimate level of adherence to the 
CoSHA protocol. He/she/they will be trained to evaluate sessions using a checklist. 
Twenty percent (20%) of all recoded sessions will be coded to ensure the intervention is 
delivered as intended. Fidelity will be measured by calculating the percent performance 
of desired and undesirable behaviors during intervention delivery and will be done on a 
continual basis. If more focused training is required to improve fidelity, additional 
supervised sessions will be done until acceptable levels of fidelity are obtained. 
 
Location: Recruitment will occur at the University of South Carolina Immunology clinic.  
After screening, and informed consent is obtained in person, data collection will be 
conducted in-person.  Analysis will occur in the Department of Epidemiology and 
Biostatistics at the Arnold School of Public Health (ASPH).  The five sessions will occur 
at the HIV clinic or in the Discovery Building at ASPH. 
 
 
Analytic approach. Data collected will not be enough to perform advanced statistical 
analyses (N=40). Therefore, analyses will be for exploratory and informational purposes. For 
example, these data will inform on the length and burden of items asked. Evaluation of the 
intervention will occur throughout the pilot testing at each session, at post-intervention, and at 
three- and six-month follow-up. 
The pilot study will be used to test recruitment methods, willingness of participants to 
participate, feasibility of the protocols, training staff, and examining data collection and retrieval 
methods. As a result, participants will be requested to evaluate each part of the intervention on 
the following criteria: suitability, impact, enjoyment, importance, interest, innovativeness, 
uniqueness, acceptability, and clarity. Participants will be asked to rate each portion on a 5-point 
Likert-type scale (e.g., 1 = very clear and 5 = not clear at all) as well as provide open-ended 
feedback. The goal is to assess the suitability, appropriateness, and tolerability of each 
component utilized. A modified version of the 8-item Abbreviated Acceptability Rating Profile 
(AAR) will be used to assess the intervention acceptability. 
Participants will also be asked to evaluate the feasibility of recruitment methods and provide 
input on additional methods to be examined. As part of the evaluation of the study protocol and 
tasks, participants and facilitators will rate the extent to which the study protocol was presented 
in a logical, iterative, and cogent manner. Participants will also complete information about the 
facilitator and his/her training and professionalism. Having audiotapes of the sessions will also 
help to ensure the validity of protocol and serve as qualitative data for the evaluation of the 
project. Near the conclusion of the pilot, evaluation data will be analyzed and used to modify the 
intervention further for use in preparation of a R01 application to conduct a larger scale trial. 
Specifically, the outcome data will be analyzed using generalized estimating equations (GEE) in 
order to generate estimates of effect sizes for future large scale studies. It is important to note 
that once the intervention begins, no changes will be made to intervention materials for the pilot. 
Differences in feasibility and acceptability of the intervention by sex will also be noted. 
 
 
E. PROTECTION OF HUMAN SUBJECTS 
1.  TARGET POPULATION: 
Discuss the population you are targeting for the study (e.g., college students, elementary school 
students, adults with aphasia), the demographics of the population, any inclusion or  exclusion 
criteria, and your anticipated sample size including method used to determine sample 
necessary to accomplish aims.  

Inclusion/Exclusion criteria. To be eligible, participants will be 50 years or older, HIV-
positive, give informed and HIPAA consent to access medical records so as to obtain 
viral load measurements, not have significant cognitive impairment, <100% ART 
adherence in the past month, and score  
 
Sample size: N=40.  We will determine the feasibility and acceptability of the 
intervention, and preliminary efficacy. 
 
2.  RECRUITMENT  PLANS:  
 
Advertisements will be placed in the waiting room at the immunology clinic.  The clinic 
staff will inform the research staff of people who are 50 and older and then the research 
staff approaches these participants and determine their interest.  If they are interested, 
we will determine eligibility in a private room.  If eligible, we will obtain informed consent 
and HIPAA authorization.  We have already obtained approval from the immunology 
clinic. Research staff will be at the clinic for recruitment.   
 
3. EXISTING DATA/SAMPLES:  
 
N/A 
 
4.  CONSENT/ASSENT: 
Describe procedures to be used to obtain consent/assent of subjects, including means that will 
be used to minimize any risks of coercion or undue influence.  
 
Research staff will obtain informed consent and HIPAA authorization.  Potential 
participants will be informed about the study and we will garner their interest and 
eligibility before obtaining informed consent and HIPAA authorization.  Participants will 
also be informed that they are free to leave the study at any time.   
 
 
5.  POTENTIAL RISKS: 
 
Risks to participants may include breach of confidentiality and emotional distress. 
Breach of confidentiality could result in emotional consequences for the subjects in the 
study. Emotional distress for the participants could occur due to remembering childhood 
traumatic experiences. Nevertheless, research staff will be trained so as to keep data 
and information on participants confidential.  All data will be stored on a password-
protected server. 
 
A. Protection of Human Subjects 
 
A.1. Protection against breach of confidentiality. Research staff will undergo human 
subjects protection training from the Collaborative Institutional Training Initiative (CITI) 
program and will also sign a contract to maintain confidentiality of study participants. 
The graduate research assistant will also be consistently reminded and monitored to 
maintain the confidentiality of the participants. In remembering experiences with 

childhood sexual abuse, in the event a participant indicates to be an imminent threat to 
harm himself or someone specific, a clinical psychologist will be consulted, and he/she 
will advise on next steps.  
 
 
 
6.  POTENTIAL BENEFITS: 
Findings retrieved will help in the design and implementation of a coping intervention for 
older adults who may still be struggling with the effects of childhood trauma. 
 
7.  CONFIDENTIALITY 
 
B.1. Participant materials and lap-tops will be kept in a locked file cabinet. The laptop for 
data analysis will be password-protected and encrypted. Electronic materials will be 
stored on a computer network, which is also password-protected and encrypted. The 
electronic materials and files will also be stored based on USC procedures for HIPAA-
protected data. Only the PI and research staff will have access to the data. 
 
Data will be confidential.  The investigator will maintain a key linking participants to ID 
numbers. 
 
8. COMPENSATION: 
 
Participants will be compensated $230 in gift cards: $40 for Session 1; $10 each for 
Sessions 2 to 5; 6-week assessment - $50; 3-month assessment - $50; 6-month 
assessment - $50. 
 
9.  WITHDRAWAL: 
 
Participants will be able to withdraw from the study at any time. 
 
 
F. REFERENCES/LITERATURE CITATIONS 
 
1. HIV among People Aged 50 and Over. 2020. Centers for Disease Control and 
Prevention (CDC). (Accessed December 3, 2020, at 
https://www.cdc.gov/hiv/group/age/olderamericans/index.html). 
2. An Epidemiologic Profile of HIV and AIDS in South Carolina 2019. (Accessed 
December 3, 2020, at 
https://scdhec.gov/sites/default/files/media/document/2019-Epi-Profile.pdf 
3. Ege MA, Messias E, Thapa PB, Krain LP. Adverse childhood experiences and 
geriatric depression: results from the 2010 BRFSS. Am J Geriatr Psychiatry 
2015;23:110-4. 
4. Health-Related Quality of Life (HRQOL) 2016. Centers for Disease Control and 
Prevention (CDC). (Accessed March 8, 2017, at 
https://www.cdc.gov/hrqol/hrqol14_measure.htm). 

5. Bremner JD, Bolus R, Mayer EA. Psychometric properties of the Early Trauma 
Inventory-Self Report. J Nerv Ment Dis 2007;195:211-8. 
6. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying 
prognostic comorbidity in longitudinal studies: development and validation. J 
Chronic Dis 1987;40:373-83. 
7. Russell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. 
Journal of personality assessment 1978;42:290-4. 
8. Berger BE, Ferrans CE, Lashley FR. Measuring stigma in people with HIV: 
psychometric assessment of the HIV stigma scale. Res Nurs Health 
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9. Carver CS. You want to measure coping but your protocol's too long: consider 
the brief COPE. Int J Behav Med 1997;4:92-100. 
10. Whetten K, Reif S, Swartz M, et al. A brief mental health and substance abuse 
screener for persons with HIV. AIDS Patient Care STDS 2005;19:89-99. 
11. Radloff LS. The CES-D scale: a self-report depression scale for research in the 
general population. Applied Psychological Measurement 1977;1:385-401. 
12. Illa L, Brickman A, Saint-Jean G, et al. Sexual risk behaviors in late middle age 
and older HIV seropositive adults. AIDS Behav 2008;12:935-42. 
13. Davis JW, Parks SN, Kaups KL, Bennink LD, Bilello JF. Victims of domestic 
violence on the trauma service: unrecognized and underreported. J Trauma 
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14. Straus M, Gelles R. Physical violence in American families: risk factors and 
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