Impact of Point-of-care (POC) Viral Load (VL) Testing During Pregnancy in Zimbabwe
HIV Infections

About this trial
This is an interventional diagnostic trial for HIV Infections focused on measuring Zimbabwe, HIV, Viral load, Point-of-care, GeneXpert
Eligibility Criteria
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 Inclusion Criteria:
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 Criteria:
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
Sites / Locations
- Luveve Clinic
- Mpilo Central Hospital
- Nkulumane Clinic
- Pelandaba Clinic
- United Bulawayo Hospital
- Budiriro PolyClinic
- Chitungwiza Central Hospital
- Gleview
- Hatcliffe PolyClinic
- Highfield PolyClinic
- Kambuzuma
- Kuwadzana PolyClinic
- Mabvuku PolyClinic
- Mbare PolyClinic
- Rujeko
- Rutsanana PolyClinic
- Seke South Clinic
- St. Mary's Clinic
- Warren Park PolyClinic
- Zengeza Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Point-of-care (POC)
Standard of care (SOC)
All facilities will receive a refresher training on Zimbabwe's 2018 Guidelines. At POC facilities, at the first antenatal visit (ANC1), all women enrolled in the intervention cohort will have a blood sample collected for VL which will be tested onsite using an existing POC device. If a woman is virally unsuppressed (VL ≥1000 cpm), she will be given adherence counseling and, if necessary, a treatment regimen switch/infant prophylaxis per national guidelines.
All facilities will receive a refresher training on Zimbabwe's 2018 Guidelines. At SOC facilities, at ANC1, all women enrolled in the intervention cohort will have a blood sample collected for VL which will be sent to centralized labs for testing. If a woman is virally unsuppressed (VL ≥1000 cpm), she will be given adherence counseling and, if necessary, a treatment regimen switch/infant prophylaxis per national guidelines.