Enhancing Uptake of Family Planning Services by HIV-Infec... | NCT03019601

Studies
Enhancing Uptake of Family Planning Services by HIV-Infected Women Attending the PMTCT Program

NCT03019601

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

3,300Actual

Phase

Not Applicable

Conditions

Contraception

Interventions

Group Education

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UM1AI069530	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jan 10, 2017

First Submission Date that Met QC Criteria

Jan 11, 2017

First Posted Date

Jan 12, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Name	Class
MU-JHU CARE	OTHER
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A specific organized program utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to providing standard family planning messages currently used in the clinic.

Detailed Description

A planned group education structural intervention utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to the standard of care which consisted of providing standard family planning messages to women attending the PMTCT Clinic. The study had two phases.

The Formative Phase consisted of six focus group discussions and six in depth interviews.

In the Implementation Phase, patient attendance and family planning uptake summaries for during implementation were monitored and summarized daily. Weekly average summaries were considered as time points.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group education	Experimental	Non pregnant HIV+ mothers were exposed to a structured educational intervention on family planning facilitated by Peer Champions.	Behavioral: Group Education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group Education	Behavioral	Structured group education on family planning facilitated by Peer Champions	Group education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proportion of mothers who took up Family Planning		weekly for one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This being a program based intervention, all HIV positive mothers who utilize the PMTCT and post natal clinic during the study period will be enrolled.

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Peter Mudiope, MBChB, MSc	MU-JHU CARE	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided