Status:
COMPLETED
Impact of Point-of-care (POC) Viral Load (VL) Testing During Pregnancy in Zimbabwe
Lead Sponsor:
Clinton Health Access Initiative Inc.
Collaborating Sponsors:
Ministry of Health and Child Welfare, Zimbabwe
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The Ministry of Health and Child Care (MOHCC) in collaboration with Clinton Health Access Initiative (CHAI) will conduct an observational cohort study to determine the impact and cost-effectiveness of...
Detailed Description
Twenty public health facilities that offer HIV care to pregnant women and maternity services will be included in the study with half offering VL testing at the first antenatal care visit using the cen...
Eligibility Criteria
Inclusion
- Sites will be selected for inclusion in the study based on following criteria:
- Offer HIV testing and antiretroviral therapy (ART) services
- Offer prevention of mother-to-child transmission (PMTCT) and maternity services
- Offer Viral load monitoring either using POC or through referral
- Availability of Second line ART
- Located in 2 provinces in which VL testing labs are located
- Have historic monthly ANC cohorts of ≥ 6 pregnant women living with HIV (PWLHIV) already on ART
- Patient
- Baseline Cohort:
- All women living with HIV on ART ≥7 months who deliver at the study facilities during the enrollment period, who do not meet the study criteria for the intervention cohort, were on ART at ANC1 and are of the age of consent (≥ 18 years old) will be offered participation. Informed consent will be obtained to collect a study-specific blood sample to perform a VL test in the central lab at the time of delivery. 7 months has been selected to be comparable to women in the intervention cohort who may present for ANC1 at 4 weeks prior to delivery who are on ART ≥ 6 months.
- Intervention Cohort:
- Pregnant women who are known to be living with HIV and on ART for ≥ 6 months and attend the study facilities for ANC services and have an anticipated due date ≥ 4 weeks, will be offered participation in the study. It is expected that a woman who is on ART \< 6 months may not yet have achieved viral suppression (using current NNRTI-containing regimens) and therefore conducting a VL at this time is not currently standard. According to Zimbabwe guidelines and consistent with normative guidance from the World Health Organization (WHO), any infant born to a woman living with HIV who is on ART for less than 4 weeks is considered at high risk of HIV transmission. Therefore, for this study the first ANC visit must be ≥ 4 weeks prior to delivery. Women must be at least the age of adult consent (≥ 18 years old) in Zimbabwe. If consent is obtained, a sample will be collected at ANC1 for VL testing.
- Patient
Exclusion
- Baseline Cohort
- PWLHIV not on ART at ANC1 or on ART \< 7 months at time of delivery
- Women who have enrolled in or are eligible for the intervention cohort
- Women who are not HIV positive
- Pregnant women who are newly diagnosed as HIV positive during pregnancy
- Women who cannot or do not provide informed consent
- Intervention Cohort
- Pregnant women who are newly diagnosed as HIV positive during pregnancy
- PWLHIV not on ART or on ART \< 6 months at their first ANC visit
- Women who are not HIV positive
- Women who cannot or do not provide informed consent
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
1715 Patients enrolled
Trial Details
Trial ID
NCT04048629
Start Date
August 5 2019
End Date
August 31 2020
Last Update
January 27 2021
Active Locations (20)
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1
Luveve Clinic
Bulawayo, Zimbabwe
2
Mpilo Central Hospital
Bulawayo, Zimbabwe
3
Nkulumane Clinic
Bulawayo, Zimbabwe
4
Pelandaba Clinic
Bulawayo, Zimbabwe