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 Overview
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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.

Official Title
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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?

Conditions
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HIV/AIDS

Intervention / Treatment
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* Device: POC CD4
* Other: Programmatic Mentoring


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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 | |
| Experimental: POC Plus<br>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 CD4<br>* Point of Care device for CD4 count testing (to be used as a clinical monitoring tool)<br>* Other names: Alere PIMA;Other: Programmatic Mentoring<br>* Programmatic Mentoring aimed at messaging around CD4 count to encourage retention on lifelong ART for PMTCT patients, administered by trained clinical mentors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | Proportion of HIV positive pregnant women that are retained on ART, 12 months after initiation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-initiation | Median time-to-initiation between HIV positive diagnosis and enrolment onto Option B+ with or without POC CD4 and related counseling/support | 12 months | 
| Retention at 6 months | Proportion of HIV positive pregnant women that are retained on ART, 6 months after initiation in settings implementing option B+ with or without POC CD4 and related counseling/support | 6 months | 
| Retention by CD4 count | Proportion of women initiated and retained on ART at 6 and 12 months post ART initiation, according to different levels of CD4 count | 6 months , 12 months | 
| Cost per pregnant woman retained on ART |  | 6 months , 12 months | 
| Initiation within 1 month | Proportion of HIV positive pregnant women initiating ART within 1 month of positive HIV test | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of Mother to Child Transmission, PMTCT, Option B+, ART, Retention, Loss to Follow Up, Time to initiation, POC CD4, Clinical mentoring, Costing, HIV, AIDS, Zimbabwe