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

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.

Study Overview

• Status: Completed
• Conditions: Family Planning
• Intervention / Treatment: Other: WHO Decision-Making Tool for Family Planning Clients and Providers

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Botswana
  • Gabarone, Botswana
    • Princess Marina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Full group; 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; Contraception decision-making tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of Botswana

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2017
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: 823794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No