Brief Summary

The study will be conducted at 32 health care facilities in three provinces in Zimbabwe and will compare the impact of the provision Point of Care CD4 technology and early knowledge of CD4 levels on retention at 12 months, with or without POC CD4 and a programmatic mentoring package. Option B+ will be implemented at all sites and 16 intervention sites will receive POC CD4 machines and visits from a team of clinical mentors. The study also aims to assess rates of ART initiation and time to ART initiation of HIV positive pregnant women in settings implementing option B+ with or without POC CD4 and related counselling/support; rates of retention in care of HIV positive mothers at 6 months post ART initiation in settings implementing option B+ with or without POC CD4 and related counselling/support; rates of ART initiation and retention at 6 and 12 months post ART initiation according to different levels of CD4 count; cost of retaining HIV positive pregnant women until 6 and 12 months; acceptability and feasibility of POC CD4 as an adjunct to good clinical care of HIV positive pregnant women.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

704

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach

1 country

32 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

January 1, 2014

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed

7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed

Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

1.4 years

First QC Date

February 18, 2014

Last Update Submit

February 20, 2014

Conditions

HIV/AIDS

Keywords

Prevention of Mother to Child TransmissionPMTCTOption B+ARTRetentionLoss to Follow UpTime to initiationPOC CD4Clinical mentoringCostingHIVAIDSZimbabwe

Outcome Measures

Primary Outcomes (1)

Retention
Proportion of HIV positive pregnant women that are retained on ART, 12 months after initiation
12 months

Secondary Outcomes (5)

Time-to-initiation
12 months
Retention at 6 months
6 months
Retention by CD4 count
6 months , 12 months
Cost per pregnant woman retained on ART
6 months , 12 months
Initiation within 1 month
1 month

Study Arms (2)

Standard of Care

NO INTERVENTION

Sites implementing Option B+ for pregnant and lactating women according to the standard of care prescribed by the Ministry of health and Child Care national guidelines

POC Plus

EXPERIMENTAL

Sites implementing Option B+ according to the standard of care prescribed by the Ministry of Health and Child Care, as well as programmatic mentoring and POC CD4 machines

Device: POC CD4Other: Programmatic Mentoring

Interventions

POC CD4DEVICE

Point of Care device for CD4 count testing (to be used as a clinical monitoring tool)

Also known as: Alere PIMA

POC Plus

Programmatic MentoringOTHER

Programmatic Mentoring aimed at messaging around CD4 count to encourage retention on lifelong ART for PMTCT patients, administered by trained clinical mentors

POC Plus

Eligibility Criteria

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Pregnant at the time of booking
HIV positive diagnosis
Not on ART at the time of booking
Present up to 38 weeks into gestation
Presents more than 48 hours prior to delivery

You may not qualify if:

Already on ART at booking
Presents more than 38 weeks into gestation or less than 48 hours prior to delivery

Contact the study team to confirm eligibility.