NCT04068870

Brief Summary

The purpose of this study is to test whether offering incentives to encourage women to attend one-on-one family planning education sessions and offering free, onsite prescription contraceptive methods increases use and continuation of prescription contraception among postpartum women in Uganda. This intervention is modified from one that has been effective outside of Uganda.

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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_1

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 5, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

August 22, 2019

Last Update Submit

August 22, 2019

Conditions

Contraceptive Usage

Outcome Measures

Primary Outcomes (1)

  • Period prevalence use of a prescription contraceptive

    Period prevalence use of a prescription contraceptive

    6 months after delivery

Study Arms (2)

Contraceptive management program

EXPERIMENTAL
Behavioral: Contraceptive management program

Usual care

NO INTERVENTION

Interventions

Contraceptive management programBEHAVIORAL

The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) incentivized visits.

Contraceptive management program

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Not planning on getting pregnant in the next 4 months
  • Less than 3 months postpartum
  • No history of tubal ligation or hysterectomy
  • No recent prescription contraceptive use (no pill, intrauterine device or implant use in the past 7 days or injection use in the past 3 months)
  • Medically eligible to use prescription contraceptives
  • Bringing baby to immunization clinic for the first time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nakaseke District Hospital

Nakaseke, Uganda

RECRUITING

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Sarah Heil, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Heil, PhD

CONTACT

802-656-8712sarah.heil@uvm.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

August 5, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

UG(1)