Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/03/2019
Date assigned
21/03/2019
Last edited
29/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

29/08/2019: Internal review.