Trial record 7 of 11 for:    Open Studies | "Reproductive Health"

Mobile Phone Text Messaging Referral (SMS4Health)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Liverpool School of Tropical Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Institute for Medical Research, Tanzania
Ministry of Health and Social Welfare, Tanzania
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01746758
First received: December 7, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition Intervention
HIV
Sexually Transmitted Infections
Contraception
Pregnancy
Behavioral: SMS text messaging referral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Establishing a Community Referral System to Improve Uptake of Adolescent Sexual Reproductive Health Services in Mwanza, Tanzania

Resource links provided by NLM:


Further study details as provided by Liverpool School of Tropical Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Referred number of patients attending HIV, STI, pregnancy prevention (including numbers of condoms, VCT, and post-abortion care) and treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Obtained from data on the text messaging system and from comparison communities

  • Referred number of patients attending other contraceptives (the pill, intra-uterine devices, injection, female condom and sterilisation where available) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Obtained from data on the text messaging system and from comparison communities

  • Referred number of patients testing HIV positive (where there is a testing service) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Obtained from data on the text messaging system and from comparison communities

  • Referred number of patients diagnosed with STIs (syndromic diagnosis) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Obtained from data on the text messaging system and from comparison communities

  • Prevalence of HIV and STIs in the data from study areas [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Obtained from data on the text messaging system and from comparison communities


Estimated Enrollment: 700
Study Start Date: August 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746758

Contacts
Contact: John N Dusabe, MSc BSc +44 151 705 3247 ext 3247 john.dusabe@liverpool.ac.uk
Contact: Kerry Millington, PhD BSc +44 151 705 2583 ext 2583 kmilling@liverpool.ac.uk

Locations
Tanzania
National Institute for Medical Research Tanzania Recruiting
Mwanza, Tanzania
Contact: John Changalucha, MPhil       jchangalucha@yahoo.com   
Sponsors and Collaborators
Liverpool School of Tropical Medicine
National Institute for Medical Research, Tanzania
Ministry of Health and Social Welfare, Tanzania
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
  More Information

Additional Information:
No publications provided

Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT01746758     History of Changes
Other Study ID Numbers: 11.94RS
Study First Received: December 7, 2012
Last Updated: December 7, 2012
Health Authority: Tanzania: National Institute for Medical Research

Keywords provided by Liverpool School of Tropical Medicine:
Reproductive health, mHealth, Cluster randomised trial

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 28, 2014