Family Planning Service Delivery Integration For HIV Positive And At-Risk Women In Botswana: A Hybrid Type 2 Clinical Intervention And Implementation Strategy

Not Applicable

Completed

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

• Registration Number: NCT03213028
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Study Start: 2017-08-18
• Primary Completion: 2018-08-10
• Study Completion: 2018-08-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 248

Inclusion Criteria

1. Female
2. English or Setswana speaking
3. Receiving CCP services at the clinic
4. 18-45 years of age
5. Able to give informed consent to study procedures, as determined by research/clinic staff

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Exclusion Criteria

1. Pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Full group	WHO Decision-Making Tool for Family Planning Clients and Providers	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.

Primary Outcome Measures

Name	Time	Method
Provider rating of feasibility	6 months	Likert scale 1-5, rating feasibility of offering family planning in this clinical setting
Provider report of adoption of the intervention	6 months	Comparing number of family planning methods offered by a provider pre- and post-intervention
Provider acceptability rating	6 months	Likert scale 1-5, rating acceptability of offering family planning in this clinical setting.

Trial Locations

Locations (1)

Princess Marina Hospital; 🇧🇼 Gabarone, Botswana