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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT03213028
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH), University of Botswana (Other)
• Enrollment: 248
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.7
• Patients Per Site Per Month: 21.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Family Planning	Other: WHO Decision-Making Tool for Family Planning Clients and Providers	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 248 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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
• Actual Study Start Date: Aug 18, 2017
• Actual Primary Completion Date: Aug 10, 2018
• Actual Study Completion Date: Aug 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Provider acceptability rating [6 months]

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

2. Provider rating of feasibility [6 months]

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

3. Provider report of adoption of the intervention [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Marina Hospital	Gabarone		Botswana

Sponsors and Collaborators

• University of Pennsylvania
• National Institute of Allergy and Infectious Diseases (NIAID)
• University of Botswana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03213028
• Other Study ID Numbers: 823794
• First Posted: Jul 11, 2017
• Last Update Posted: Mar 1, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: HIV Seropositivity

Study Results

No Results Posted as of Mar 1, 2019