Plain English Summary
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)
Trial website
Contact information
Type
Public
Primary contact
Prof Arjun Bedi
ORCID ID
Contact details
Institute of Social Studies
Erasmus University Rotterdam
Kortenaerkade 12
The Hague
2518AX
Netherlands
Type
Scientific
Additional contact
Dr Natascha Wagner
ORCID ID
Contact details
Institute of Social Studies
Erasmus University Rotterdam
Kortenaerkade 12
The Hague
2518AX
Netherlands
+31-70-4260574
wagner@iss.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
QW4/1218
Study information
Scientific title
Evaluating SMS to promote retention in and adherence to ART programs: a multi-center randomized controlled trial
Acronym
sms-hiv-bf
Study hypothesis
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
Ministry of Health, Ministry of Scientific Research and Innovation, Ethics Committee for Health-Related Research, 03/12/2014, ref: 2014-12-141
Study design
Multi-center randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Drug names
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 trial start date
25/11/2014
Overall trial end date
30/11/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3800
Participant exclusion criteria
1. No informed consent provided
2. Patient only makes use of the services of the health center once
Recruitment start date
01/02/2015
Recruitment end date
26/05/2015
Locations
Countries of recruitment
Burkina Faso
Trial participating centre
Dédougou Regional Hospital (Centre Hospitalier Régional Dédougou)
Dédougou
-
Burkina Faso
Trial participating centre
Boromo Medical Center (Centre Médical Boromo)
Boromo
-
Burkina Faso
Trial participating centre
Nouna Medical Center (Centre Médical Nouna)
Nouna
-
Burkina Faso
Trial participating centre
Solenzo Medical Center (Centre Médical Solenzo)
Solenzo
-
Burkina Faso
Trial participating centre
Toma Medical Center (Centre Médical Toma)
Toma
-
Burkina Faso
Trial participating centre
Tougan Medical Center (Centre Médical Tougan)
Tougan
-
Burkina Faso
Trial participating centre
University Medical Center Banfora (Centre Médical Universitair Banfora)
Banfora
-
Burkina Faso
Trial participating centre
Banfora Regional Hospital (Centre Hospitalier Régional Banfora)
Banfora
-
Burkina Faso
Trial participating centre
Niangoloko Medical Center (Centre Médical Niangoloko)
Niangoloko
-
Burkina Faso
Trial participating centre
Samandin Medical Center (Centre Médical Samandin)
Samandin
-
Burkina Faso
Trial participating centre
Oasis Medical Center (Centre Médical Oasis)
Laye
-
Burkina Faso
Trial participating centre
Clinique OST
Kadiogo
-
Burkina Faso
Trial participating centre
Hope Medical Center and Life / Ouaga(Centre Médical Espoir et Vie/Ouaga)
Ouagadougou
-
Burkina Faso
Trial participating centre
30 Medical Center (Centre Médical 30)
Ouagadougou
-
Burkina Faso
Trial participating centre
Biomolecular Research Center Pietro Annigoni (Centre de Recherche Biomoléculaire Pietro Annigoni (CERBA))
Ouagadougou
-
Burkina Faso
Trial participating centre
Saint Camille Medical Center (Centre Médical Saint Camille)
Saint Camille
-
Burkina Faso
Trial participating centre
Pissy Medical Center (Centre Médical Pissy)
Pissy
-
Burkina Faso
Trial participating centre
Youth Association for the Promotion of Orphans (Associations des Jeunes pour la Promotion des Orphelins (AJPO))
Ouagadougou
-
Burkina Faso
Trial participating centre
URLBS
Ouagadougou
-
Burkina Faso
Trial participating centre
Association of African Women Facing AIDS (Association des Femmes Africaines Face au Sida – (AFASI))
Ouagadougou
-
Burkina Faso
Trial participating centre
Lamizana Medical Center (Centre Médical Lamizana)
Lamizana
-
Burkina Faso
Trial participating centre
Positive Living Medical Center (Centre Médical Vie positive)
Ouagadougou
-
Burkina Faso
Trial participating centre
Schiphra Medical Center (Centre Médical Schiphra)
Schiphra
-
Burkina Faso
Trial participating centre
Kossodo Medical Center (Centre Médical Kossodo)
Kossodo
-
Burkina Faso
Trial participating centre
Paul VI Medical Center (Centre Médical Paul VI)
Ouagadougou
-
Burkina Faso
Trial participating centre
Ouargaye Medical Center (Centre Médical Ouargaye)
Ouargaye
-
Burkina Faso
Trial participating centre
Tenkodogo Regional Hospital (Centre Hospitalier Régional Tenkodogo)
Tenkodogo
-
Burkina Faso
Trial participating centre
Garango Medical Center (Centre Médical Garango)
Garango
-
Burkina Faso
Trial participating centre
Koupela Medical Center (Centre Médical Koupela)
Koupela
-
Burkina Faso
Trial participating centre
Zabré Medical Center (Centre Médical Zabré)
Zabré
-
Burkina Faso
Trial participating centre
Tenkodogo Medical Center (Centre Médical Tenkodogo)
Tenkodogo
-
Burkina Faso
Trial participating centre
Bittou Medical Center (Centre Médical Bittou)
Bittou
-
Burkina Faso
Trial participating centre
Pouytenga Medical Center (Centre Médical Pouytenga)
Pouytenga
-
Burkina Faso
Trial participating centre
Kaya Regional Hospital (Centre Hospitalier Régional Kaya)
Kaya
-
Burkina Faso
Trial participating centre
Kongoussi Medical Center (Centre Médical Kongoussi)
Kongoussi
-
Burkina Faso
Trial participating centre
Kaya Medical Center (Centre Médical Kaya)
Kaya
-
Burkina Faso
Trial participating centre
Bam District Medical Centre (Centre Médical District Bam)
Bam
-
Burkina Faso
Trial participating centre
Boulsa Medical Center (Centre Médical Boulsa)
Boulsa
-
Burkina Faso
Trial participating centre
Barsalogho Medical Center (Centre Médical Barsalogho)
Barsalogho
-
Burkina Faso
Trial participating centre
Sapouy Medical Center (Centre Médical Sapouy)
Sapouy
-
Burkina Faso
Trial participating centre
Réo Medical Center (Centre Médical Réo)
Réo
-
Burkina Faso
Trial participating centre
Koudougou Regional Hospital (Centre Hospitalier Régional Koudougou)
Koudougou
-
Burkina Faso
Trial participating centre
Kolbe Sabou Medical Center (Centre Médical Kolbe Sabou)
Sabou
-
Burkina Faso
Trial participating centre
Leo Medical Center (Centre Médical Léo)
Léo
-
Burkina Faso
Trial participating centre
Pô Medical Center (Centre Médical Pô)
Pô
-
Burkina Faso
Trial participating centre
Kombissiri Medical Center ( Centre Médical Kombissiri)
Kombissiri
-
Burkina Faso
Trial participating centre
Centre Médical Manga
Manga
-
Burkina Faso
Trial participating centre
Saponé Medical Center (Centre Médical Saponé)
Saponé
-
Burkina Faso
Trial participating centre
Fada Regional Hospital (Centre Hospitalier Régional Fada)
Fada
-
Burkina Faso
Trial participating centre
Bogandé Medical Center (Centre Médical Bogandé)
Bogandé
-
Burkina Faso
Trial participating centre
Diapaga Medical Center (Centre Médical Diapaga)
Diapaga
-
Burkina Faso
Trial participating centre
Manni Medical Center (Centre Médical Manni)
Manni
-
Burkina Faso
Trial participating centre
Pama Medical Center (Centre Médical Pama)
Pama
-
Burkina Faso
Trial participating centre
Day hospital (Hôpital de Jour)
Bobo-Dioulasso
-
Burkina Faso
Trial participating centre
Dafra Medical Center (Centre Médical Dafra)
Dafra
-
Burkina Faso
Trial participating centre
OST Bobo
Bobo-Dioulasso
-
Burkina Faso
Trial participating centre
Hope Medical Center and Life / Bobo (Centre Médical Espoir et Vie/Bobo)
Bobo-Dioulasso
-
Burkina Faso
Trial participating centre
Dô Medical Center (Centre Médical Dô)
Dô
-
Burkina Faso
Trial participating centre
Medical Center REVS+ (Centre Médical REVS+)
Bobo-Dioulasso
-
Burkina Faso
Trial participating centre
Yèrêlon Medical Center (Centre Médical Yerelon)
Yer
-
Burkina Faso
Trial participating centre
Houndé Medical Center (Centre Médical Houndé)
Houndé
-
Burkina Faso
Trial participating centre
Orodara Medical Center (Centre Médical Orodara)
Orodara
-
Burkina Faso
Trial participating centre
Ouahigouya Regional Hospital (Centre Hospitalier Régional Ouahigouya)
Ouahigouya
-
Burkina Faso
Trial participating centre
AMIE Medical Center (Centre Médical AMMIE)
-
Burkina Faso
Trial participating centre
Gourcy Medical Center (Centre Médical Gourcy)
Gourcy
-
Burkina Faso
Trial participating centre
Séguénéga Medical Center (Centre Médical Seguénega)
Seguénega
-
Burkina Faso
Trial participating centre
Titao Medical Center (Centre Médical Titao)
Titao
-
Burkina Faso
Trial participating centre
Yako Medical Center (Centre Médical Yako)
Yako
-
Burkina Faso
Trial participating centre
Boussu Medical Center (Centre Médical Boussé)
Boussé
-
Burkina Faso
Trial participating centre
Ziniaré Medical Center (Centre Médical Ziniaré)
Ziniaré
-
Burkina Faso
Trial participating centre
Zorgho Medical Center (Centre Médical Zorgho)
Zorgho
-
Burkina Faso
Trial participating centre
Dori Regional Hospital (Centre Hospitalier Régional Dori)
Dori
-
Burkina Faso
Trial participating centre
Djibo Medical Centre (Centre Médical Djibo)
Djibo
-
Burkina Faso
Trial participating centre
Medical Center Gorom-Gorom (Centre Médical Gorom-Gorom)
Gorom-Gorom
-
Burkina Faso
Trial participating centre
Sebba Medical Center (Centre Médical Sebba)
Sebba
-
Burkina Faso
Trial participating centre
Dano Medical Center (Centre Médical Dano)
Dano
-
Burkina Faso
Trial participating centre
Diébougou Medical Center (Centre Médical Diébougou)
Diébougou
-
Burkina Faso
Trial participating centre
University Medical Center Gaoua (Centre Médical Universitair Gaoua)
Gaoua
-
Burkina Faso
Trial participating centre
Gaoua Regional Hospital (Centre Hospitalier Régional Gaoua)
Gaoua
-
Burkina Faso
Trial participating centre
Tiebele Medical Center (Centre Médical Tiebele)
Tiebele
-
Burkina Faso
Sponsor information
Organisation
Institute of Social Studies, Erasmus University Rotterdam
Sponsor details
Kortenaerkade 12
The Hague
2518AX
Netherlands
+31-70-4260493
bedi@iss.nl
Sponsor type
University/education
Website
Organisation
Polytechnic University of Bobo-Dioulasso (Université Polytechnique de Bobo-Dioulasso)
Sponsor details
01 BP 1091 Bobo-Dioulasso 01
Bobo-Dioulasso
-
Burkina Faso
Sponsor type
University/education
Website
Organisation
Erasmus University Rotterdam
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Research organisation
Funder name
3ie-International Impact Evaluation Initiative
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Institute of Social Studies, Erasmus University Rotterdam
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
31/08/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list