Does Provision of Point of Care CD4 Technology and Early Knowledge of CD4 Levels Affect Early Initiation and Retention on Anti-retroviral Treatment (ART) in HIV Positive Pregnant Women in the Context of Option B+ for PMTCT?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

704 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

POC Plus

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

Group Type EXPERIMENTAL

POC CD4

Intervention Type DEVICE

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

Programmatic Mentoring

Intervention Type OTHER

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

Interventions

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POC CD4

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

Intervention Type DEVICE

Programmatic Mentoring

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

Intervention Type OTHER

Other Intervention Names

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Alere PIMA

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexio Mangwiro

Role: PRINCIPAL_INVESTIGATOR

Clinton Health Access Initiative, Nigeria

Locations

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