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NCT03213028 Clinical Trial

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

Family Planning Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03213028
Other study ID # 823794
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 18, 2017
Est. completion date August 10, 2018

Study information
Verified date February 2019
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 248
Est. completion date August 10, 2018
Est. primary completion date August 10, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• WHO Decision-Making Tool for Family Planning Clients and Providers
Contraception decision-making tool

Locations
Country Name City State
Botswana Princess Marina Hospital Gabarone

Sponsors (3)
Lead Sponsor Collaborator
University of Pennsylvania National Institute of Allergy and Infectious Diseases (NIAID), University of Botswana

Country where clinical trial is conducted

Botswana, 

Outcome
Type Measure Description Time frame Safety issue
Primary Provider acceptability rating Likert scale 1-5, rating acceptability of offering family planning in this clinical setting. 6 months
Primary Provider rating of feasibility Likert scale 1-5, rating feasibility of offering family planning in this clinical setting 6 months
Primary Provider report of adoption of the intervention Comparing number of family planning methods offered by a provider pre- and post-intervention 6 months
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