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

NCT04048629 | Completed

• 1 other identifier: POC VL during pregnancy
• Study Type: interventional
• Target: 1,715
• Locations: 1 country
• Sites: 20

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 POC VL testing for pregnant women. It is hypothesized that POC VL testing will enable an increased proportion of pregnant women to be virally suppressed at delivery, which will avert vertical transmission.

Conditions

HIV Infections

Keywords

Zimbabwe; HIV; Viral load; Point-of-care; GeneXpert

Outcome Measures

Primary Outcomes (1)

• Viral suppression at delivery

  The proportion of enrolled PWLHIV on ART ≥ 6 months at their first ANC visit who are virally suppressed at delivery

  Within 2 weeks after delivery

Secondary Outcomes (4)

• Viral suppression at delivery among those with an unsuppressed viral load at first antenatal care visit

  Within 2 weeks after delivery

• Infant HIV infection

  Within 6 weeks of birth

• Turnaround time to VL results available at facility

  Through end of the study, approximately 1 year

• Turnaround time to VL results available to patient

  Through end of the study, approximately 1 year

Other Outcomes (2)

• Costing of POC VL

  Through end of the study, approximately 1 year

• Acceptability of POC VL

  End of the study, approximately 1 year after study start

Study Arms (2)

Point-of-care (POC)

EXPERIMENTAL

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.

Device: Point-of-care (POC) viral load (VL) testing plus refresher training

Standard of care (SOC)

ACTIVE COMPARATOR

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.

Other: Standard of care central laboratory VL testing plus refresher training

Interventions

Point-of-care (POC) viral load (VL) testing plus refresher training DEVICE

VL testing at the first antenatal care visit will occur using POC VL testing in pregnant women, and a refresher training on Zimbabwe's guidelines will be provided at all facilities

Also known as: GeneXpert

Point-of-care (POC)

Standard of care central laboratory VL testing plus refresher training OTHER

VL testing at the first antenatal care visit will occur using central laboratory VL testing in pregnant women, and a refresher training on Zimbabwe's guidelines will be provided at all facilities

Standard of care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinton Health Access Initiative Inc.: lead
• Ministry of Health and Child Welfare, Zimbabwe: collaborator

Study Sites (20)

Luveve Clinic

Bulawayo, Zimbabwe

Location

Mpilo Central Hospital

Bulawayo, Zimbabwe

Location

Nkulumane Clinic

Bulawayo, Zimbabwe

Location

Pelandaba Clinic

Bulawayo, Zimbabwe

Location

United Bulawayo Hospital

Bulawayo, Zimbabwe

Location

Budiriro PolyClinic

Harare, Zimbabwe

Location

Chitungwiza Central Hospital

Harare, Zimbabwe

Location

Gleview

Harare, Zimbabwe

Location

Hatcliffe PolyClinic

Harare, Zimbabwe

Location

Highfield PolyClinic

Harare, Zimbabwe

Location

Kambuzuma

Harare, Zimbabwe

Location

Kuwadzana PolyClinic

Harare, Zimbabwe

Location

Mabvuku PolyClinic

Harare, Zimbabwe

Location

Mbare PolyClinic

Harare, Zimbabwe

Location

Rujeko

Harare, Zimbabwe

Location

Rutsanana PolyClinic

Harare, Zimbabwe

Location

Seke South Clinic

Harare, Zimbabwe

Location

St. Mary's Clinic

Harare, Zimbabwe

Location

Warren Park PolyClinic

Harare, Zimbabwe

Location

Zengeza Clinic

Harare, Zimbabwe

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Surgical Instruments; Viral Load

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Virus Physiological Phenomena; Microbiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is an observational cohort study with a baseline assessment, which will be used to conduct a difference in difference (DiD) analysis. The study design allows for assessment in more than one cross-section: 1) intervention clusters will be compared with control and 2) post-intervention clusters will be compared with an earlier baseline condition in control and intervention arms. The intervention (POC compared to centralized VL) is being offered at the facility level, as viral load testing is an intervention that is carried out on a clinic level, rather than at an individual patient level. The study is intended to investigate the effect of offering on-site POC VL testing on the proportion of enrolled PWLHIV who are virally suppressed at the time of delivery.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 7, 2019
• Study Start: August 5, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (20)