Condition category
Infections and Infestations
Date applied
07/03/2016
Date assigned
09/03/2016
Last edited
09/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

www.iss.nl/sms-hivremindersystem

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

http://www.iss.nl/fileadmin/ASSETS/iss/Documents/Research_and_projects/EDEM/Burkina_Faso/SMS_to_support_HIVAIDS_patients.pdf

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 measures

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

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)

-
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)

-
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

http://www.iss.nl

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes