Improving Self-management of Diabetes in Persons Living with HIV

ISRCTN ISRCTN11201765
DOI https://doi.org/10.1186/ISRCTN11201765
Secondary identifying numbers 100
Submission date
19/03/2019
Registration date
21/03/2019
Last edited
02/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Julie Zuniga
Public

1710 Red River
School of Nursing
Austin
78712
United States of America

ORCiD logoORCID ID 0000-0003-3778-8148
Phone +15124714696
Email jzuniga@nursing.utexas.edu

Study information

Study designOne group pre-post-test
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Community
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA Pilot Study to improve Self-management of Diabetes in Persons Living with HIV
Study objectivesA six hour group intervention will improve diabetes self-management in persons living with HIV
Ethics approval(s)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
Health condition(s) or problem(s) studiedHIV and diabetes
InterventionThe 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 typeBehavioural
Primary outcome measureAll 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 measuresAll 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 study start date08/01/2015
Completion date12/01/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Key inclusion criteria1. Adult aged > 18 years
2. Diagnosed with HIV and diabetes for over 6 months
Key exclusion criteria1. Diagnosis of gestational diabetes
Date of first enrolment10/01/2015
Date of final enrolment06/01/2016

Locations

Countries of recruitment

  • United States of America

Study participating centre

The University of Texas at Austin
1710 Red River
Austin
78712
United States of America

Sponsor information

The University of Texas at Austin
University/education

1710 Red River
School of Nursing
Austin
78712
United States of America

Phone 5124714696
Email jzuniga@nursing.utexas.edu
ROR logo "ROR" https://ror.org/00hj54h04

Funders

Funder type

University/education

The Center for Transdisciplinary Collaborative Research in Self-Management Science, University of Austin, Texas

No information available

Results and Publications

Intention to publish date15/04/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe will present at conferences then write a paper to be published in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 07/11/2019 02/03/2022 Yes No

Editorial Notes

02/03/2022: Publication reference added.
29/08/2019: Internal review.