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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? — E4E  

HIV/AIDS Clinical Trial

Official title:
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?

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02070900
Study type Interventional
Source WHO, Department of Maternal, Newborn, Child and Adolescent Health
Contact Alexio Z Mangwiro
Email amangwiro@clintonhealthaccess.org
Status Recruiting
Phase N/A
Start date January 2014
Completion date July 2016
View Details
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