Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000852459
Ethics application status
Approved
Date submitted
23/05/2016
Date registered
29/06/2016
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
WHISPER or SHOUT study: Efficacy of a mobile phone text messaging intervention for improving the health of female sex workers in Mombasa, Kenya.
Scientific title
Women’s Health Intervention using SMS for Preventing Unintended Pregnancy (WHISPER), or SMS intervention to improve nutritional Heath OUTcomes (SHOUT): A cluster randomised controlled trial assessing mHealth interventions among female sex workers in Mombasa, Kenya
Secondary ID [1] 289174 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unintended pregnancy 298708 0
HIV 298710 0
Anaemia 298711 0
Nutrition 298712 0
Sexually transmitted infections 298713 0
Condition category
Condition code
Reproductive Health and Childbirth 298765 298765 0 0
Contraception
Infection 298766 298766 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Blood 298767 298767 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mobile phone delivered health promotion intervention (mHealth intervention), addressing contraceptive options and their effectiveness and safety, and improvements in sexual and reproductive health self-efficacy, particularly through the promotion of long-acting reversible contraceptive methods (non user-dependent) methods.

The intervention consists of three components:
- Health messages sent through a series of SMS;
- Theory-guided role model stories sent in text message instalments, promoting positive norms and attitudes, and increased self-efficacy for healthier behaviour;
- On-demand system in which participants reply to texts free of charge to obtain more detailed information via SMS,

Messages will be delivered from an online platform and sent 2-3 times per week for one year. The messages sent and received by participants will be tracked to ensure the system is functioning as planned, and to monitor participant engagement with the system.
Intervention code [1] 294699 0
Prevention
Intervention code [2] 294700 0
Behaviour
Comparator / control treatment
Equal-attention control consisting of a parallel mHealth intervention addressing positive knowledge, attitudes and practices regarding locally applicable actions, which could improve nutritional status of women of childbearing age.

The parallel nutrition intervention will have the same three mobile phone-based components, with identical structure, duration, and message number and frequency.
Control group
Active

Outcomes
Primary outcome [1] 298376 0
Incidence of unintended pregnancy.
Pregnancy will be measured by urine pregnancy test at baseline and 6- and 12- months' follow-up, as well as self-reported during the interval since last test.
Intention will be assessed using the London Measure of Unintended Pregnancy (validated questionnaire scale) for any pregnancy that occurs during the trial.
Timepoint [1] 298376 0
6 and 12 months
Primary outcome [2] 298377 0
Prevalence of anaemia
This will be measured by laboratory-based full haemogram at baseline and 12 months.
Timepoint [2] 298377 0
12 months
Secondary outcome [1] 323973 0
Use of modern contraceptive methods and condoms consistently (dual protection) in past month with all partner types.
This will be assessed by self-report during study questionnaire at baseline and 6- and 12-month follow-up visits.
Timepoint [1] 323973 0
6 and 12 months
Secondary outcome [2] 323974 0
Current use of long-acting reversible contraceptive methods (contraceptive implant or intra-uterine device).
This will be assessed by self-report during study questionnaire at baseline and 6- and 12-month follow-up visits.
Timepoint [2] 323974 0
6 and 12 months
Secondary outcome [3] 323975 0
Incidence of induced abortion
This will be assessed by self-report during study questionnaire at 12-months. Participants who have become pregnant during the study will be asked about the outcome of the pregnancy, including induced abortion.
Timepoint [3] 323975 0
12 months
Secondary outcome [4] 323976 0
Mean haemoglobin level (g/dL).
This will be measured by laboratory-based full haemogram at baseline and 12 months.
Timepoint [4] 323976 0
12 months
Secondary outcome [5] 323977 0
Prevalence of malnutrition: either underweight (BMI < 18.5kg/m2) or overweight (BMI greater than or equal to 25 kg/m2).
Timepoint [5] 323977 0
12 months
Secondary outcome [6] 323978 0
Median score in nutrition knowledge.
This will be assessed by study questionnaire at baseline and 6- and 12-month follow-up visits, containing nutrition-related true/false knowledge statements.
Timepoint [6] 323978 0
6 and 12 months
Secondary outcome [7] 323979 0
Prevalence of healthy eating behaviour.
This will be assessed by study questionnaire at baseline and 6- and 12-month follow-up visits, containing self-reported dietary intake in previous 7 days.
Timepoint [7] 323979 0
6 and 12 months
Secondary outcome [8] 323980 0
HIV incidence
HIV will be measured by rapid diagnostic tests (Determine (Registered Trademark) HIV-1 and First response (Registered Trademark) HIV-1 rapid tests) at baseline and 6- and 12-month follow-up visits.
Timepoint [8] 323980 0
6 and 12 months
Secondary outcome [9] 323981 0
Syphilis incidence
This will be assessed by syphilis screening using rapid plasma reagin test at baseline and 6- and 12-month follow-up visits.
Timepoint [9] 323981 0
6 and 12 months

Eligibility
Key inclusion criteria
- Self-report engaging in paid sex work in the last six months
- Have a personal mobile phone with Safaricom or Airtel subscription, and be willing to provide the number to the researchers
- Self-report being ‘SMS literate’
- Not currently pregnant or planning pregnancy within 12 months
- Reside, and plan to continue to reside, within the site-specific catchment area for the next 12 months
- Willing to provide reliable contact information (e.g. home address) to be contacted by a member of the research team in the community
- Able and willing to give written informed consent for enrolment in the study.
Minimum age
16 Years
Maximum age
34 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Planning to travel or relocate from the study areas
- Participating in another mHealth intervention study
- Having a medical or non-medical issue incapacitating participation in the research, as decided by the local Principal Investigator.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of clusters to intervention arms will be done by central randomisation by computer. Allocation will be concealed from the study team and participants until after cluster enrolment is completed and all baseline questionnaires administered for that cluster.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster-randomised: each sex work venue constitutes one cluster, with up to 10 participants per cluster.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analysis will compare the primary endpoints (either unintended pregnancy incidence, or anaemia prevalence) between groups at 12 months and secondary analysis will compare groups at 6 months.
The sample size was calculated to obtain sufficient power to detect a 37% relative reduction in annual unintended pregnancy incidence, based on estimated pregnancy incidence in this population of 27%. This results in a sample size of 860 participants from a minimum of 86 clusters – 430 participants per arm. This estimate is calculated with 80% power and 5% significance level), and is adjusted for an expected 10% attrition rate and estimated inflation in standard error due to cluster randomisation.
Given the interval-censored nature of unintended pregnancy incidence, discrete-time survival models using generalised linear modelling will be used to compare unintended pregnancy incidence between FSW exposed to SRH intervention and those exposed to nutrition intervention messages.
These analyses will provide estimates with robust standard errors for FSW venue clustering. Standardised probability weighting will be applied in population-averaged analyses to account for any sampling bias where achieved sample cluster sizes vary. Where randomisation is not effective in removing allocation bias, adjusted models will be specified. In all analyses, associations will be considered statistically significant at the 5% level. The statistician will conduct the analysis blind to the intervention group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2016
Actual
15/09/2016
Date of last participant enrolment
Anticipated
Actual
18/05/2017
Date of last data collection
Anticipated
Actual
31/07/2018
Sample size
Target
860
Accrual to date
Final
882
Recruitment outside Australia
Country [1] 7890 0
Kenya
State/province [1] 7890 0
Mombasa, Coast Province

Funding & Sponsors
Funding source category [1] 293642 0
Government body
Name [1] 293642 0
National health and medical research council
Country [1] 293642 0
Australia
Primary sponsor type
Other
Name
Burnet Institute
Address
85 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 292476 0
None
Name [1] 292476 0
Address [1] 292476 0
Country [1] 292476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295078 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 295078 0
Ethics committee country [1] 295078 0
Australia
Date submitted for ethics approval [1] 295078 0
11/05/2016
Approval date [1] 295078 0
11/07/2016
Ethics approval number [1] 295078 0
CF16/1552 - 2016000812
Ethics committee name [2] 295079 0
Kenyatta National Hospital ethics and research committee
Ethics committee address [2] 295079 0
Ethics committee country [2] 295079 0
Kenya
Date submitted for ethics approval [2] 295079 0
02/05/2016
Approval date [2] 295079 0
18/07/2016
Ethics approval number [2] 295079 0
P354/05/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65734 0
A/Prof Stanley Luchters
Address 65734 0
Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
Country 65734 0
Australia
Phone 65734 0
+61385062378
Fax 65734 0
Email 65734 0
[email protected]
Contact person for public queries
Name 65735 0
Stanley Luchters
Address 65735 0
Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
Country 65735 0
Australia
Phone 65735 0
+61385062378
Fax 65735 0
Email 65735 0
[email protected]
Contact person for scientific queries
Name 65736 0
Stanley Luchters
Address 65736 0
Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
Country 65736 0
Australia
Phone 65736 0
+61385062378
Fax 65736 0
Email 65736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1164Study protocol    https://bmjopen.bmj.com/content/7/8/e017388



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWHISPER or SHOUT study: Protocol of a cluster-randomised controlled trial assessing mHealth sexual reproductive health and nutrition interventions among female sex workers in Mombasa, Kenya.2017https://dx.doi.org/10.1136/bmjopen-2017-017388
EmbaseUse of long-acting reversible contraception in a cluster-random sample of female sex workers in Kenya.2019https://dx.doi.org/10.1002/ijgo.12862
EmbaseEffect of a mobile phone intervention for female sex workers on unintended pregnancy in Kenya (WHISPER or SHOUT): a cluster-randomised controlled trial.2020https://dx.doi.org/10.1016/S2214-109X%2820%2930389-2
N.B. These documents automatically identified may not have been verified by the study sponsor.