Evaluating SMS to promote retention in and adherence to ART programs
| ISRCTN | ISRCTN16558614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16558614 |
| Secondary identifying numbers | QW4/1218 |
- Submission date
- 07/03/2016
- Registration date
- 09/03/2016
- Last edited
- 24/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The rapid uptake of mobile phones across the developing world in recent years has inspired a host of innovative concepts for how they may be used to promote public health, including encouraging people to adopt healthy behaviours and help with delivering health services. Yet, to date, few rigorous evaluations have been done to see how good these “mobile health” (mHealth) programmes (or interventions) really are. This study will look at whether a short message service (SMS) reminder system can be used to support HIV/AIDS patients in Burkina Faso. In the midst of the country’s push to escalate access to antiretroviral therapy (ART), the fact that many people do not continue with their treatment program long term has been identified as a concern. This is a two year study using SMS texts to follow-up on patients and encourage them to stick with their treatment programme. Testing how well the SMS intervention works will be tested as part of the study.
Who can participate?
Patients with HIV and currently being treated with antiretroviral. They should be at least 15 years old and have reliable access to a mobile phone.
What does the study involve?
Participants are randomly allocated to one of five different groups. Those in group 1 are placed in the control group and do not receive any SMS texts. Those in group 2 are placed in the “treatment 1” group, and receive one SMS text a week. Those in group 3 are placed in the “treatment 2” group, and receive two SMS text a week. Those in group 4 are placed in the “treatment 3” group, and receive one SMS text and one ASCII image a week. Those in group 5 are placed in the “treatment 4” group, and receive one ASCII image a week. The messages received by all participants remind them to take their antiretroviral medications and refill their prescriptions and their content varies every week. All participants receive their usual standard of care throughout the study period. Support to help them stick with the treatment and additional counselling sessions may also be offered in the community. They are assessed using surveys and via their medical records at the start of the study, after 2 months, after 6 months and finally, after 1 year.
What are the possible benefits and risks of participating?
Benefits of participating include the patients being reminded of taking treatment and being provided with a form of long-distance psycho-social support. Possible risks include the patient stopping their treatment as soon as they stop receiving the reminder messages. There is also the risk of other people being able to take a participants mobile phone and scroll through it, revealing their HIV+ status.
Where is the study run from?
A number of hospitals in Burkina Faso.
When is the study starting and how long is it expected to run for?
November 2014 to November 2017
Who is funding the study?
The 3ie-International Impact Evaluation Initiative and Institute of Social Studies, Erasmus University Rotterdam.
Who is the main contact?
1. Professor Arjun Bedi (public)
2. Dr Natascha Wagner (scientific)
Contact information
Public
Institute of Social Studies
Erasmus University Rotterdam
Kortenaerkade 12
The Hague
2518AX
Netherlands
Scientific
Institute of Social Studies
Erasmus University Rotterdam
Kortenaerkade 12
The Hague
2518AX
Netherlands
| Phone | +31-70-4260574 |
|---|---|
| natascha.wagner@ru.nl |
Study information
| Study design | Multi-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | http://www.iss.nl/fileadmin/ASSETS/iss/Documents/Research_and_projects/EDEM/Burkina_Faso/SMS_to_support_HIVAIDS_patients.pdf |
| Scientific title | Evaluating SMS to promote retention in and adherence to ART programs: a multi-center randomized controlled trial |
| Study acronym | sms-hiv-bf |
| Study objectives | 1. Do SMS reminders promote retention in HIV treatment programs and encourage adherence to antiretroviral regimens? 2. Are health outcomes improved as patients receive SMS reminders? 3. Are subjective health outcomes improved as patients receive SMS reminders? 4. Can message fatigue be observed in the medium to long-term? 5. Do the type (text versus picture) and the frequency (once a week versus twice a week) of the SMS have a differential impact? 6. Are patients receiving the SMS messages more likely to work? 7. Have patients receiving the messages a better nutritional status? |
| Ethics approval(s) | Ministry of Health, Ministry of Scientific Research and Innovation, Ethics Committee for Health-Related Research, 03/12/2014, ref: 2014-12-141 |
| Health condition(s) or problem(s) studied | HIV (human immunodeficiency virus) |
| Intervention | Participants are randomly allocated to one of five treatments: Treatment 0: Control group Treatment 1: SMS text with varying content, low frequency, one message per week Treatment 2: SMS text with varying content, high frequency, two messages per week Treatment 3: SMS text with varying content and ASCII image, two messages per week Treatment 4: ASCII image, low frequency, one message per week All groups will receive the standard of care. Along with periodic clinical check-ups and treatment counseling, this includes routine monitoring of patient CD4 cells and viral load as measures of disease progression. Adherence support and/or additional treatment counseling may also be provided at the community level. This will be assessed during follow-up surveys. For groups 1-4, messages will be sent on a weekly basis. A total of 4-8 monthly text messages will thus be sent to each participant assigned to groups 1-4. |
| Intervention type | Other |
| Primary outcome measure | 1. CD4 count, BMI: Retrieved from patient medical records and measured by the health personnel, measured at baseline (February-April 2015) and in all three follow-up surveys (April-May 2016, October-December 2016, October-December 2017) 2. Subjective wellbeing: Survey responses from patients (1-5 Likert scale), recorded by enumerators, who are part of HIV support associations; measured at baseline (February-April 2015) and in all three follow-up surveys (April-May 2016, October-December 2016, October-December 2017) 3. Pill taking: Survey responses from patients, recorded by enumerators, who are part of HIV support associations; measured at baseline (February-April 2015) and in all three follow-up surveys (April-May 2016, October-December 2016, October-December 2017) 4. For patients that are lost to follow up we identify the reason based on administrative data. This happens at any point in time and will be used to assess retention |
| Secondary outcome measures | 1. Weekly monitoring data from the SMS platform is collected electronically staring from October 2015. This information allows us to assess whether all patients received the SMS messages 2. Whether a patient worked during the last month, how many days and the amount of pay : Survey responses from patients, recorded by enumerators, who are part of HIV support associations; measured at baseline (February-April 2015) and in all three follow-up surveys (April-May 2016, October-December 2016, October-December 2017) 3. Consumption module with detailed list of foods consumed in Burkina: Survey responses from patients, recorded by enumerators, who are part of HIV support associations; measured at baseline (February-April 2015) and in the second follow-up survey (October-December 2016) |
| Overall study start date | 25/11/2014 |
| Completion date | 30/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 3800 |
| Key inclusion criteria | 1. The patient must provide his/her informed consent to participate in the study 2. The patient must be at least 15 years 3. The patient must have reliable access to a mobile phone |
| Key exclusion criteria | 1. No informed consent provided 2. Patient only makes use of the services of the health center once |
| Date of first enrolment | 01/02/2015 |
| Date of final enrolment | 26/05/2015 |
Locations
Countries of recruitment
- Burkina Faso
Study participating centres
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Sponsor information
University/education
Institute of Social Studies
Kortenaerkade 12
The Hague
2518AX
Netherlands
| Phone | +31-70-4260493 |
|---|---|
| bedi@iss.nl | |
| Website | http://www.iss.nl |
"ROR" |
https://ror.org/057w15z03 |
University/education
01 BP 1091 Bobo-Dioulasso 01
Bobo-Dioulasso
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Burkina Faso
Funders
Funder type
Research organisation
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- Erasmus University Rotterdam, Erasmus Universiteit, EUR
- Location
- Netherlands
Results and Publications
| Intention to publish date | 31/08/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We plan to publish a paper about the determinants of "good" health and wellbeing making use of the baseline information. We hope to have a working paper by August 2016. We further plan to prepare a paper on the impact of the study in the short-run (after 6 months of the intervention) on retention, adherence, health, work capacity. We plan to have this done by November 2016. We plan to have another impact paper on the same outcomes after the second follow up and one after the third follow up. These papers should be available in March 2017 and February 2018. All these paper are intended to be published as scientific publications. In addition, we plan a policy brief accompanying each paper. This one will be shared locally with the partnering hospitals and associations and internationally with practitioners. |
| IPD sharing plan | - |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 17/08/2016 | 24/08/2022 | Yes | No | |
| Results article | 23/05/2022 | 24/08/2022 | Yes | No | |
| Results article | 09/01/2020 | 24/08/2022 | Yes | No |
Editorial Notes
24/08/2022: Publication references added. Contact details updated.
