NCT01746758

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 11, 2012

Status Verified

May 1, 2012

Enrollment Period

1.4 years

First QC Date

December 7, 2012

Last Update Submit

December 7, 2012

Conditions

Keywords

Reproductive health, mHealth, Cluster randomised trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    12 months

  • Referred number of patients attending other contraceptives (the pill, intra-uterine devices, injection, female condom and sterilisation where available)

    12 months

  • Referred number of patients testing HIV positive (where there is a testing service)

    12 months

  • Referred number of patients diagnosed with STIs (syndromic diagnosis)

    12 months

  • Prevalence of HIV and STIs in the data from study areas

    12 months

Study Arms (2)

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.

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.

Interventions

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.

SMS text messaging referral

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Only patients attending services at the drug store. Only patients seeking reproductive health care services. Only resident in study wards.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Medical Research Tanzania

Mwanza, Tanzania

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John N Dusabe, MSc BSc

    Liverpool School of Tropical Medicine

    PRINCIPAL INVESTIGATOR
  • Angela IN Obasi, MSc PhD MRCP

    Liverpool School of Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John N Dusabe, MSc BSc

CONTACT

Kerry Millington, PhD BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 11, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 11, 2012

Record last verified: 2012-05

Locations