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

Primary Purpose

Family Planning

Status
Completed
Phase
Not Applicable
Locations
Botswana
Study Type
Interventional
Intervention
WHO Decision-Making Tool for Family Planning Clients and Providers
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Family Planning

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Exclusion Criteria:

1. Pregnant

Sites / Locations

  • Princess Marina Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Full group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 3, 2017
Last Updated
February 27, 2019
Sponsor
University of Pennsylvania
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), University of Botswana
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1. Study Identification

Unique Protocol Identification Number
NCT03213028
Brief Title
Family Planning Service Delivery Integration For HIV Positive And At-Risk Women In Botswana: A Hybrid Type 2 Clinical Intervention And Implementation Strategy
Official Title
Family Planning Service Delivery Integration For HIV Positive And At-Risk Women In Botswana: A Hybrid Type 2 Clinical Intervention And Implementation Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), University of Botswana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Planning

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
WHO Decision-Making Tool for Family Planning Clients and Providers
Intervention Description
Contraception decision-making tool
Primary Outcome Measure Information:
Title
Provider acceptability rating
Description
Likert scale 1-5, rating acceptability of offering family planning in this clinical setting.
Time Frame
6 months
Title
Provider rating of feasibility
Description
Likert scale 1-5, rating feasibility of offering family planning in this clinical setting
Time Frame
6 months
Title
Provider report of adoption of the intervention
Description
Comparing number of family planning methods offered by a provider pre- and post-intervention
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female English or Setswana speaking Receiving CCP services at the clinic 18-45 years of age Able to give informed consent to study procedures, as determined by research/clinic staff Exclusion Criteria: 1. Pregnant
Facility Information:
Facility Name
Princess Marina Hospital
City
Gabarone
Country
Botswana

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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