Plain English Summary
Background and study aims
Persons living with HIV have an increased risk of developing diabetes which has been attributed to factors including advancing age, abnormal immune function, minority race/ethnicity, and the use of HIV medication. Concomitant self-management of HIV and diabetes can be difficult because of the complexity of these two different medical regimens, sometimes conflicting input from multiple health care providers, and overlapping treatment side effects and symptoms. This study aims to address the unique challenges of the dual diagnosis of HIV and diabetes. We will (1) adapt an evidence-based type 2 diabetes mellitus (T2DM) intervention (content and format) and study protocol based on a focus group of persons with HIV-T2DM and (2) test the feasibility of the HIV-T2DM intervention.
Who can participate?
Adults diagnosed with HIV+T2DM
What does the study involve?
The intervention is a small group intervention for a total of 6 hours of educational instructions, then six follow up phone calls. Data collection was done at baseline and after completion of the phone calls, estimated to be 4 months from baseline to follow up.
What are the possible benefits and risks of participating?
Participants in the feasibility may not receive direct benefit from participating in this study; however, the possible benefits of participation are helping to contribute to the understanding of self-management of diabetes for persons with HIV. They may improve health information on HIV and diabetes, as well as improve self-management skills. There are no foreseeable risks for participating in the educational sessions of the intervention. Participants will be providing a blood sample as part of data collection. There is a small risk that the patients would develop a hematoma at the blood draw site.
Where is the study run from?
The University of Texas at Austin
When is the study starting and how long is it expected to run for?
January 2015 to January 2016
Who is funding the study?
The University of Texas at Austin Office of Research Support and Compliance
Who is the main contact?
Julie Zuniga, jzuniga@nursing.utexas.edu
Trial website
Contact information
Type
Public
Primary contact
Dr Julie Zuniga
ORCID ID
http://orcid.org/0000-0003-3778-8148
Contact details
1710 Red River
School of Nursing
Austin
78712
United States of America
+15124714696
jzuniga@nursing.utexas.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
100
Study information
Scientific title
A Pilot Study to improve Self-management of Diabetes in Persons Living with HIV
Acronym
Study hypothesis
A six hour group intervention will improve diabetes self-management in persons living with HIV
Ethics approval
Approved 02/09/2015, The University of Texas at Austin (Office of Research Support and Compliance, P.O. Box 7426, Austin, TX; 78713512-232-1543; irb@austin.utexas.edu), ref: 2015-05-0104
Study design
One group pre-post-test
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Community
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
HIV and diabetes
Intervention
The intervention provided 6 hours of educational sessions for groups of approximately six to eight participants followed by six follow-up telephone calls. The topics included pathophysiology of HIV and T2DM; medications; diet; depression; and relevant lab tests for HIV+T2DM. Each topic was introduced interactively using case studies, role-play, games, and group discussions. The intervention sessions concluded with an unfolding case study that contained information about all the topics covered. A registered nurse or licensed social worker led the groups and made six follow-up telephone calls to participants, in which they solicited participants’ questions about each of the intervention topics and re-explained or reinforced the intervention content. Telephone calls lasted about 10 minutes each.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
All measures were taken twice: baseline and 4 months.
1. Blood draws to measure HgA1c
2. Summary of Diabetes Self-Care Activities (SDSCA)
3. Diabetes Knowledge Test (DKT)
4. HIV Knowledge Questionnaire (HIV-KQ-18)
Secondary outcome measures
All measures were taken twice: baseline and 4 months.
1. Blood draws to measure CD4 count, and viral load.
2. NIH Toolbox Instrumental Support Survey
3. NIH Toolbox Neuro-QOL Depression
4. Adherence Visual Analog Scale
5. Drug and Alcohol Involvement Scale
Overall trial start date
08/01/2015
Overall trial end date
12/01/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult aged > 18 years
2. Diagnosed with HIV and diabetes for over 6 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Diagnosis of gestational diabetes
Recruitment start date
10/01/2015
Recruitment end date
06/01/2016
Locations
Countries of recruitment
United States of America
Trial participating centre
The University of Texas at Austin
1710 Red River
Austin
78712
United States of America
Sponsor information
Organisation
The University of Texas at Austin
Sponsor details
1710 Red River
School of Nursing
Austin
78712
United States of America
5124714696
jzuniga@nursing.utexas.edu
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The Center for Transdisciplinary Collaborative Research in Self-Management Science, University of Austin, Texas
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We will present at conferences then write a paper to be published in a high-impact peer-reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
15/04/2019
Participant level data
Available on request
Basic results (scientific)
Publication list