- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01746758
Mobile Phone Text Messaging Referral (SMS4Health)
Establishing a Community Referral System to Improve Uptake of Adolescent Sexual Reproductive Health Services in Mwanza, Tanzania
The study hypothesis is that managed referral of patients at community level (from drug stores) increases uptake of reproductive health (RH) services at dispensary and health centre levels.
The intervention is currently being implemented in 2 districts (Magu and Sengerema) in Mwanza Region on the northwest shore of Lake Victoria. It is nested within the IntHEC Community Randomised Trial which aims to evaluate the impact of a complex RH intervention on the uptake and integration of reproductive health services in 2 Regions in Tanzania (Mwanza and Iringa) and Niger (Say and Aguie) respectively. 18 wards per region were stratified according to geographical and economic criteria and randomly assigned to intervention or comparison wards. The SMS intervention is being implemented in 9 intervention wards in Mwanza Region only. 9 wards are followed for comparison.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The SMS intervention was developed in 2 phases: (i) stakeholder consultation and (ii) technical design. Twenty-three consultation meetings were held with 78 drug store owners and attendants, 45 dispensary and health centre clinical officers and nurses, and 148 adolescents in communities. These stakeholders prioritised key deficiencies in existing RH provision and preferred strategies to address them. Detailed methods and results of these consultations are presented elsewhere (Consultation Paper in preparation). In brief government health facilities wanted an intervention that allows dispensaries and health centres to take charge of STI treatment and provide skilled service for other RH needs. Drug stores wanted an intervention that recognises and integrates their contribution to the health system, while adolescents wanted an intervention that promotes accessibility, confidentiality and trust of service providers. Through subsequent meetings, an SMS intervention strategy was identified because all clinical officers and drug store attendants demonstrated use mobile phones on a day-to-day basis.
The intervention design prioritised patients' ease of access to service: when a patient comes to a drug store to buy medicines for a RH related problem that may require a prescription drug, the drug store explains the referral system. If the patient accepts, the drug store sends a text message with the patient details to a toll-free number connected to a web-system. The system processes and forwards the patient details including a password to a dispensary matched with the referrer drug store. At the same time, that password is sent back to the referrer drug store so that it can be passed on to the patient. While at dispensary, patients with a password are received, matched with details received in text messages, and given fast track RH service, after which the dispensary sends a text message to the toll-free number confirming the completeness of patient treatment. This intervention is implemented in all 9 intervention wards in Mwanza. No intervention is implemented in the 9 comparison wards.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: John N Dusabe, MSc BSc
- Phone Number: 3247 +44 151 705 3247
- Email: john.dusabe@liverpool.ac.uk
Study Contact Backup
- Name: Kerry Millington, PhD BSc
- Phone Number: 2583 +44 151 705 2583
- Email: kmilling@liverpool.ac.uk
Study Locations
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-
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Mwanza, Tanzania
- Recruiting
- National Institute for Medical Research Tanzania
-
Contact:
- John Changalucha, MPhil
- Email: jchangalucha@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Only patients attending services at the drug store. Only patients seeking reproductive health care services. Only resident in study wards.
Exclusion Criteria:
Patients non-residence in study wards. Patients seeking non-reproductive health care services.
The primary and secondary outcomes will be measured in people aged 15-19 (our definition of adolescent), but the intervention accepts all age-groups during implementation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMS text messaging referral
The text messaging system has been designed to use codes of reproductive health conditions and their treatments.
Text messages are sent by drug stores and received at the dispensaries, forwarded by a bespoke software called Snapshot, which captures data online from any computer anywhere by use of a login for confidentiality.
|
The text messaging system has been designed to use codes of reproductive health conditions and their treatments.
Text messages are sent by drug stores and received at the dispensaries, forwarded by a bespoke software called Snapshot, which captures data online from any computer anywhere by use of a login for confidentiality.
|
No Intervention: Comparison arm
No intervention will be implemented in intervention arm.
Data on reproductive health conditions and treatments and data on referrals from drug stores in this arm will be obtained directly from ministry of health registers filled and filed at the dispensary and health centres, plus a tailor-made form which is filled by the dispensary and health centre clinicians whenever they receive a patient in the eligible categories.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase the number of patients receiving reproductive health services at dispensary and health centre level after referral from a drug store.
Time Frame: 12 months
|
This will be measured by comparing data of referred patients by text message in intervention wards with patients' data from comparison wards - comparing the number of referrals from drug stores in both arms.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Referred number of patients attending HIV, STI, pregnancy prevention (including numbers of condoms, VCT, and post-abortion care) and treatment
Time Frame: 12 months
|
Obtained from data on the text messaging system and from comparison communities
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12 months
|
Referred number of patients attending other contraceptives (the pill, intra-uterine devices, injection, female condom and sterilisation where available)
Time Frame: 12 months
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Obtained from data on the text messaging system and from comparison communities
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12 months
|
Referred number of patients testing HIV positive (where there is a testing service)
Time Frame: 12 months
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Obtained from data on the text messaging system and from comparison communities
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12 months
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Referred number of patients diagnosed with STIs (syndromic diagnosis)
Time Frame: 12 months
|
Obtained from data on the text messaging system and from comparison communities
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12 months
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Prevalence of HIV and STIs in the data from study areas
Time Frame: 12 months
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Obtained from data on the text messaging system and from comparison communities
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12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: John N Dusabe, MSc BSc, Liverpool School of Tropical Medicine
- Principal Investigator: Angela IN Obasi, MSc PhD MRCP, Liverpool School of Tropical Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11.94RS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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