NCT02905461

Brief Summary

This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone text message on the acceptability of effective contraception in Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4 months (intervention) or a monthly text message not about contraception (control). 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
586

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

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
3 months until next milestone

Study Start

First participant enrolled

December 8, 2016

Completed
1.1 years 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

1.1 years

First QC Date

September 14, 2016

Last Update Submit

February 6, 2018

Conditions

Keywords

Reproductive health

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Use of effective contraception

    4 months

  • Acceptability of individual effective contraceptive methods

    4 months

  • Discontinuation of effective contraception

    4 months

  • Service uptake

    4 months

  • Unintended pregnancy

    4 months

  • +1 more secondary outcomes

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

Contraceptive text messages

Behavioral: Contraceptive text messages

Control

PLACEBO COMPARATOR

Text messages not about contraception

Other: Text messages not about contraception

Interventions

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-24 years
  • Own a personal mobile phone
  • Not using the pill, implant, injection, intrauterine device or patch
  • Live in the West Bank

You may not qualify if:

  • Cannot read Arabic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palestinian Family Planning and Protection Association

Jerusalem, Palestinian Territories

Location

Related Publications (3)

  • Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

  • McCarthy OL, Zghayyer H, Stavridis A, Adada S, Ahamed I, Leurent B, Edwards P, Palmer M, Free C. A randomized controlled trial of an intervention delivered by mobile phone text message to increase the acceptability of effective contraception among young women in Palestine. Trials. 2019 Apr 23;20(1):228. doi: 10.1186/s13063-019-3297-4.

  • McCarthy OL, Wazwaz O, Jado I, Leurent B, Edwards P, Adada S, Stavridis A, Free C. An intervention delivered by text message to increase the acceptability of effective contraception among young women in Palestine: study protocol for a randomised controlled trial. Trials. 2017 Oct 3;18(1):454. doi: 10.1186/s13063-017-2191-1.

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

December 8, 2016

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

February 7, 2018

Record last verified: 2017-09

Locations