Trial Outcomes & Findings for A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use (NCT NCT03224390)

NCT ID: NCT03224390

Last Updated: 2024-06-28

Results Overview

Woman reports starting any modern method of contraception since the start of the study

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

4-months post-encouragement

Results posted on

2024-06-28

Participant Flow

Participant milestones

Participant milestones
Measure
Encouragement Arm
One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service).
Control Arm
Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service.
Overall Study
STARTED
56
56
Overall Study
COMPLETED
29
21
Overall Study
NOT COMPLETED
27
35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Encouragement Arm
n=56 Participants
One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service).
Control Arm
n=56 Participants
Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service.
Total
n=112 Participants
Total of all reporting groups
Age, Continuous
24.9 years
STANDARD_DEVIATION 4.6 • n=99 Participants
24.6 years
STANDARD_DEVIATION 5.0 • n=107 Participants
24.7 years
STANDARD_DEVIATION 4.8 • n=206 Participants
Sex: Female, Male
Female
56 Participants
n=99 Participants
56 Participants
n=107 Participants
112 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race/Ethnicity, Customized
Luhya Tribe
42 Participants
n=99 Participants
44 Participants
n=107 Participants
86 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 4-months post-encouragement

Woman reports starting any modern method of contraception since the start of the study

Outcome measures

Outcome measures
Measure
Encouragement Arm
n=56 Participants
One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service).
Control Arm
n=56 Participants
Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service.
Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study
17 Participants
9 Participants

SECONDARY outcome

Timeframe: 1-month post-encouragement

Population: data were not collected

Woman reports starting any long-acting method of contraception since the start of the study

Outcome measures

Outcome data not reported

Adverse Events

Encouragement Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Green

Duke University

Phone: 9196817289

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place