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

Not Applicable

Completed

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

• Registration Number: NCT01932138
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190530

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of HIV-exposed infants tested for HIV	During the first 2 years of life
Proportion of pregnant women delivering at a healthcare facility	At delivery
Proportion of infants born to HIV-infected mothers who have acquired HIV	During the first 2 years of life
Proportion of HIV-positive women receiving PMTCT	Between the first antenatal care visit and 1 week after stopping breastfeeding
Proportion of pregnant women making at least four antenatal clinic visits	Between the first week of gestation and delivery

Secondary Outcome Measures

Name	Time	Method
Proportion of HIV-infected pregnant women who completed PMTCT	Between the first antenatal care visit and 1 week after stopping breastfeeding
Proportion of HIV-exposed infants who received PMTCT	During the first 2 years of life
Number of weeks of gestation at which pregnant women have their first ANC visit	Between the first week of gestation and delivery
Proportion of pregnant women who were tested for HIV	Between the first week of gestation and delivery

Trial Locations

Locations (1)

Management and Development for Health; 🇹🇿 Dar es Salaam, Tanzania