Contraceptive UsagePhase 1NCT04068870
Testing a Modified Family Planning Intervention for Postpartum Women in Uganda
A Phase 1 study testing Contraceptive management program in people with Contraceptive Usage, run by University of Vermont at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- Contraceptive management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUganda
- Study dates
- 5 Aug 2019to Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 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
Who cannot join
- Failure to meet the aforementioned inclusion criteria
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Nakaseke District Hospital
Nakaseke
John Mundaka, MD
About this study
Official title: Modification of an Evidence-based Family Planning Intervention for a New Target Population: Postpartum Women in Nakaseke District, Uganda - Pilot Phase, Two Arm
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.
- Conditions
- Contraceptive Usage
- Being tested
- Contraceptive management program
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive management programBehavioural
The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) incentivized visits.
| Study group | Role | What they receive |
|---|---|---|
| Contraceptive management program | Experimental | Not described Receives: Behavioral: Contraceptive management program |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period prevalence use of a prescription contraceptive
Period prevalence use of a prescription contraceptive
Measured: 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start5 Aug 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- African Community Center for Social Sustainability
- Responsible party
- Principal investigator, Sarah Heil, University of Vermont
- Investigators
- Sarah Heil, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068870
- Sponsor's protocol ID
- UGPPFP
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of an Evidence-based Family Planning Intervention for a New Target Population: Postpartum Women in Nakaseke District, Uganda - Pilot Phase, Two Arm
- ClinicalTrials.gov ID
- NCT04068870
- Acronym / sponsor ID
- UGPPFP
- Conditions
- Contraceptive Usage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- African Community Center for Social Sustainability
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contraceptive management program | Experimental | Behavioral: Contraceptive management program |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-45 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)
Key exclusion criteria (1 listed)
- Failure to meet the aforementioned inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contraceptive management programThe contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) incentivized visits. | Behavioural | Contraceptive management program |
Primary outcome
Period prevalence use of a prescription contraceptive
Time frame: 6 months after delivery
Period prevalence use of a prescription contraceptive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Heil, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Contraceptive management program in people with Contraceptive Usage, run by University of Vermont at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Heil, PhD (802-656-8712, sarah.heil@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period prevalence use of a prescription contraceptive (time frame: 6 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.