NCT03213028

Brief Summary

The goal of this pilot study is to assess both implementation outcomes (acceptability, feasibility and adoption) and clinical efficacy (contraceptive method uptake by women wishing to avoid pregnancy) using a Hybrid Type 2 study design of a family planning program being piloted by the Cervical Cancer Prevention Program in Gabarone, Botswana.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 18, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

May 3, 2017

Last Update Submit

February 27, 2019

Conditions

Family Planning

Outcome Measures

Primary Outcomes (3)

  • Provider acceptability rating

    Likert scale 1-5, rating acceptability of offering family planning in this clinical setting.

    6 months

  • Provider rating of feasibility

    Likert scale 1-5, rating feasibility of offering family planning in this clinical setting

    6 months

  • Provider report of adoption of the intervention

    Comparing number of family planning methods offered by a provider pre- and post-intervention

    6 months

Study Arms (1)

Full group

OTHER

Our goal is to assess the feasibility and acceptability of incorporating family planning (FP) service delivery, using a program validated by the World Health Organization (WHO), into the established Cervical Cancer Prevention (CCP) programs of Botswana.

Other: WHO Decision-Making Tool for Family Planning Clients and Providers

Interventions

WHO Decision-Making Tool for Family Planning Clients and ProvidersOTHER

Contraception decision-making tool

Full group

Eligibility Criteria

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

You may qualify if:

  • Female
  • English or Setswana speaking
  • Receiving CCP services at the clinic
  • years of age
  • Able to give informed consent to study procedures, as determined by research/clinic staff

You may not qualify if:

  • \. Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Marina Hospital

Gabarone, Botswana

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

July 11, 2017

Study Start

August 18, 2017

Primary Completion

August 10, 2018

Study Completion

August 10, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

BO(1)