Trial to Improve Access to PMTCT Services and Reduce HIV Transmission From Mother to Child (FS)

President and Fellows of Harvard College

Status: Completed

Conditions: Mother-to-child Transmission of HIV; Pregnancy

Treatments: Other: Standard of care; Other: Enhanced CHW intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01932138

EJF22802

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness, cost-effectiveness, feasibility and acceptability of an enhanced community health worker (CHW) intervention and outreach system to improve antenatal care and PMTCT uptake and retention, and to decrease mother-to-child HIV transmission.

Full description

Mother-to-child transmission of HIV/AIDS (MTCT) is still a major contributor to the burden of HIV infections among infants and children in Sub-Saharan Africa. Among the major challenges of each approach to achieving maximum benefits is late and incomplete antenatal care (ANC) attendance. While attendance to one ANC visit is almost universal, only about half of pregnant women attend the four WHO-recommended visits. Moreover, those that attend often book late in pregnancy. This nationwide challenge can lead to delays or interferences with the appropriate PMTCT medications for mothers -thus substantially diminishing the potential of PMTCT care to reduce mother-to child-transmission of HIV in Tanzania.

The investigators will examine the effectiveness, cost-effectiveness, feasibility, and acceptability of an enhanced community health worker intervention and outreach system for pregnant women to facilitate early and consistent ANC attendance, early and effective PMTCT uptake, with the aim to further reduce mother-to-child transmission of HIV. We will test the effectiveness hypothesis in a cluster-randomized controlled trial; the unit of randomization is the administrative unit of a ward, which is the geographical unit below a district in the Tanzanian government system. We randomly allocate all 60 wards in two of the three districts in Dar es Salaam, Tanzania -- Kinondoni and Ilala districts -- to receiving the enhanced community health worker intervention and outreach system vs. receiving the standard of care in the Tanzanian public-sector health system.

The results of this study will inform implementers and policy makers on whether and how a community outreach system and PMTCT algorithm may maximize benefits of antenatal care and PMTCT services in Tanzania and inform decisions surrounding future maternal and newborn health programs moving forward.

This study was initially designed to test both the effectiveness of the enhanced CHW intervention and outreach system and the effectiveness of WHO PMTCT option B (vs. A) in ensuring successful PMTCT in the Tanzanian public-sector health system. However, in reaction to a report of non-compliance by the investigator team (incomplete records of written informed consent among PMTCT patients in the public-sector PMTCT clinics) the IRB at the Harvard School of Public Health decided to stop involvement in the option A vs. B component of this study. The IRB approved continuation of the enhanced CHW intervention and outreach system in the study.

Enrollment: 190,530 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All pregnant women who are identified by the CHW during the routine household visits

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190,530 participants in 2 patient groups

Enhanced CHW intervention

Experimental group

Description:

CHWs will 1) identify pregnant women through home visits and refer them to ANC; 2) inform pregnant women on antenatal care ANC and PMTCT; 3) visit women at home to ascertain ANC attendance; and 4) follow up women who have missed ANC or PMTCT appointments.

Treatment:

Other: Enhanced CHW intervention

Standard of care

Other group

Description:

Clinic-based health workers follow-up patients who have missed scheduled PMTCT appointments (through telephone calls and/or in-person visits). The standard of care does not include any specific interventions to improve ANC attendance.

Treatment:

Other: Standard of care