NCT02905526

Brief Summary

This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on use of effective contraception in Bolivia. Woman aged 16-24 will be randomised to have access to Centro de Investigacion, Educacion y Servicios's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 month follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
645

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

February 7, 2018

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

September 14, 2016

Last Update Submit

February 6, 2018

Conditions

Contraception

Keywords

Reproductive health

Outcome Measures

Primary Outcomes (2)

  • Use of effective contraception

    The proportion reporting current use of effective contraception (pill, intrauterine device, injection, implant, patch)

    4 months

  • Acceptability of at least one method of effective contraception

    The proportion reporting that at least one method of effective contraception is acceptable (pill, intrauterine device, injection, implant, patch)

    4 months

Secondary Outcomes (5)

  • Acceptability of individual effective contraceptive methods

    4 months

  • Discontinuation of effective contraception

    4 months

  • Service uptake

    4 months

  • Unintended pregnancy

    4 months

  • Induced abortion

    4 months

Other Outcomes (5)

  • Knowledge of effective contraception

    4 months

  • Perceived norms in relation to using and communicating with partners about contraception

    4 months

  • Personal agency in using and communicating with partners about contraception

    4 months

  • +2 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

App plus the contraceptive instant messages

Behavioral: Contraceptive instant messagesOther: Mobile phone app

Control

PLACEBO COMPARATOR

App only

Other: Mobile phone app

Interventions

Contraceptive instant messagesBEHAVIORAL

Contraceptive Instant messages

Intervention
Mobile phone appOTHER

Mobile phone app

ControlIntervention

Eligibility Criteria

Age16 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 16-24
  • Own a personal Android mobile phone
  • Live in El Alto or La Paz Bolivia
  • Sexually active
  • Not using the pill, implant, injection, intrauterine device or patch
  • Want to avoid a pregnancy

You may not qualify if:

  • Cannot read Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Investigacion, Educacion y Servicios

La Paz, Bolivia

Location

Related Publications (2)

  • McCarthy OL, Aliaga C, Torrico Palacios ME, Lopez Gallardo J, Huaynoca S, Leurent B, Edwards P, Palmer M, Ahamed I, Free C. An Intervention Delivered by Mobile Phone Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Randomized Controlled Trial. J Med Internet Res. 2020 Jun 22;22(6):e14073. doi: 10.2196/14073.

    PMID: 32568092DERIVED

  • McCarthy OL, Osorio Calderon V, Makleff S, Huaynoca S, Leurent B, Edwards P, Lopez Gallardo J, Free C. An Intervention Delivered by App Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Dec 18;6(12):e252. doi: 10.2196/resprot.8679.

    PMID: 29254910DERIVED

Study Officials

  • Caroline Free, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 19, 2016

Study Start

March 1, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

February 7, 2018

Record last verified: 2017-09

Locations

BO(1)