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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
704
Point of Care device for CD4 count testing (to be used as a clinical monitoring tool)
Programmatic Mentoring aimed at messaging around CD4 count to encourage retention on lifelong ART for PMTCT patients, administered by trained clinical mentors
Bromley
Goromonzi, Mashonaland East Province, Zimbabwe
RECRUITINGHenry John Rheimer
Goromonzi, Mashonaland East Province, Zimbabwe
RECRUITINGKubatsirana
Goromonzi, Mashonaland East Province, Zimbabwe
RECRUITINGMelfort
Goromonzi, Mashonaland East Province, Zimbabwe
Retention
Proportion of HIV positive pregnant women that are retained on ART, 12 months after initiation
Time frame: 12 months
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
Time frame: 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
Time frame: 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
Time frame: 6 months , 12 months
Cost per pregnant woman retained on ART
Time frame: 6 months , 12 months
Initiation within 1 month
Proportion of HIV positive pregnant women initiating ART within 1 month of positive HIV test
Time frame: 1 month
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Mwanza RHC
Goromonzi, Mashonaland East Province, Zimbabwe
RECRUITINGBorder Church RHC
Marondera, Mashonaland East Province, Zimbabwe
RECRUITINGChipararwe
Marondera, Mashonaland East Province, Zimbabwe
RECRUITINGLustleigh
Marondera, Mashonaland East Province, Zimbabwe
RECRUITINGMasikana
Marondera, Mashonaland East Province, Zimbabwe
RECRUITINGCharehwa
Mutoko, Mashonaland East Province, Zimbabwe
RECRUITING...and 22 more locations