HIVSMS4HealthNCT01746758
Mobile Phone Text Messaging Referral
A study testing SMS text messaging referral in people with HIV and Sexually Transmitted Infections, run by Liverpool School of Tropical Medicine at 1 site in Tanzania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Infections, Contraception
- What is being tested?
- SMS text messaging referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteTanzania
- Study dates
- Aug 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Only patients attending services at the drug store. Only patients seeking reproductive health care services. Only resident in study wards.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site, 1 recruiting
- Recruiting
National Institute for Medical Research Tanzania
Mwanza
John Changalucha, MPhil, jchangalucha@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, Sexually Transmitted Infections, Contraception, Pregnancy
- Being tested
- SMS text messaging referral
- Keywords
- Reproductive health, mHealth, Cluster randomised trial
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS text messaging referralBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SMS text messaging referral | Experimental | 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. Receives: Behavioral: SMS text messaging referral |
| Comparison arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase the number of patients receiving reproductive health services at dispensary and health centre level after referral from a drug store.
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.
Measured: 12 months
Secondary outcomes (5)
Referred number of patients attending HIV, STI, pregnancy prevention (including numbers of condoms, VCT, and post-abortion care) and treatment
Obtained from data on the text messaging system and from comparison communities
Measured: 12 months
Referred number of patients attending other contraceptives (the pill, intra-uterine devices, injection, female condom and sterilisation where available)
Obtained from data on the text messaging system and from comparison communities
Measured: 12 months
Referred number of patients testing HIV positive (where there is a testing service)
Obtained from data on the text messaging system and from comparison communities
Measured: 12 months
Referred number of patients diagnosed with STIs (syndromic diagnosis)
Obtained from data on the text messaging system and from comparison communities
Measured: 12 months
Prevalence of HIV and STIs in the data from study areas
Obtained from data on the text messaging system and from comparison communities
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Ministry of Health and Social Welfare, Tanzania
- Responsible party
- Sponsor
- Investigators
- John N Dusabe, MSc BSc, Principal investigator, Liverpool School of Tropical MedicineAngela IN Obasi, MSc PhD MRCP, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746758
- Sponsor's protocol ID
- 11.94RS
- Acronym
- SMS4Health
- Status last verified
- May 2012
- First submitted
- 7 Dec 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Community Referral System to Improve Uptake of Adolescent Sexual Reproductive Health Services in Mwanza, Tanzania
- ClinicalTrials.gov ID
- NCT01746758
- Acronym / sponsor ID
- SMS4Health / 11.94RS
- Conditions
- HIV, Sexually Transmitted Infections, Contraception, Pregnancy
- Keywords
- Reproductive health, mHealth, Cluster randomised trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Ministry of Health and Social Welfare, Tanzania
- Study start
- Aug 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS text messaging referral | Experimental | Behavioral: SMS text messaging referralThe 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. |
| Comparison arm | No intervention | –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. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Only patients attending services at the drug store. Only patients seeking reproductive health care services. Only resident in study wards.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS text messaging referralThe 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. | Behavioural | SMS text messaging referral |
Primary outcome
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.
5 secondary outcomes
Referred number of patients attending HIV, STI, pregnancy prevention (including numbers of condoms, VCT, and post-abortion care) and treatment
Time frame: 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
Referred number of patients testing HIV positive (where there is a testing service)
Time frame: 12 months
Referred number of patients diagnosed with STIs (syndromic diagnosis)
Time frame: 12 months
Prevalence of HIV and STIs in the data from study areas
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John N Dusabe, MSc BSc principal investigator
Liverpool School of Tropical Medicine
Angela IN Obasi, MSc PhD MRCP principal investigator
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS text messaging referral in people with HIV and Sexually Transmitted Infections, run by Liverpool School of Tropical Medicine at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John N Dusabe, MSc BSc (+44 151 705 3247 ext. 3247, john.dusabe@liverpool.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2012.