Improving Self-management of Diabetes in Persons Living with HIV
| ISRCTN | ISRCTN11201765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11201765 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 100 |
| Sponsor | The University of Texas at Austin |
| Funder | The Center for Transdisciplinary Collaborative Research in Self-Management Science, University of Austin, Texas |
- 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
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
Public
1710 Red River
School of Nursing
Austin
78712
United States of America
 ORCID ID |
0000-0003-3778-8148 |
|---|---|
| Phone | +15124714696 |
| jzuniga@nursing.utexas.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | One group pre-post-test |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A Pilot Study to improve Self-management of Diabetes in Persons Living with HIV |
| Study objectives | A 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) studied | 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 |
| Primary outcome measure(s) |
All measures were taken twice: baseline and 4 months. |
| Key secondary outcome measure(s) |
All measures were taken twice: baseline and 4 months. |
| Completion date | 12/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Adult aged > 18 years 2. Diagnosed with HIV and diabetes for over 6 months |
| Key exclusion criteria | 1. Diagnosis of gestational diabetes |
| Date of first enrolment | 10/01/2015 |
| Date of final enrolment | 06/01/2016 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Austin
78712
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/03/2022: Publication reference added.
29/08/2019: Internal review.
