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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Harvard School of Public Health
Sponsor:
Collaborators:
Management and Development for Health, Tanzania
Elton John AIDS Foundation, UK
Comic Relief UK
Information provided by (Responsible Party):
Till Barnighausen, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01932138
First received: May 14, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Mother-to-child HIV Transmission
Other: Enhanced CHW intervention
Other: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation of Interventions to Achieve Universal Access to PMTCT Services and Reduce Mother-to-Child Transmission of HIV in Dar es Salaam, Tanzania

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Proportion of infants born to HIV-infected mothers who have acquired HIV [ Time Frame: During the first 2 years of life ] [ Designated as safety issue: No ]
  • Proportion of HIV-exposed infants tested for HIV [ Time Frame: During the first 2 years of life ] [ Designated as safety issue: No ]
  • Proportion of pregnant women making at least four antenatal clinic visits [ Time Frame: Between the first week of gestation and delivery ] [ Designated as safety issue: No ]
  • Proportion of pregnant women delivering at a healthcare facility [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Proportion of HIV-positive women receiving PMTCT [ Time Frame: Between the first antenatal care visit and 1 week after stopping breastfeeding ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of weeks of gestation at which pregnant women have their first ANC visit [ Time Frame: Between the first week of gestation and delivery ] [ Designated as safety issue: No ]
  • Proportion of HIV-infected pregnant women who completed PMTCT [ Time Frame: Between the first antenatal care visit and 1 week after stopping breastfeeding ] [ Designated as safety issue: No ]
  • Proportion of HIV-exposed infants who received PMTCT [ Time Frame: During the first 2 years of life ] [ Designated as safety issue: No ]
  • Proportion of pregnant women who were tested for HIV [ Time Frame: Between the first week of gestation and delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 153600
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced CHW intervention
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.
Other: Enhanced CHW intervention
The CHW employed in this study are a health worker cadre that already exists in the Tanzanian public-sector health system, so-called "home-base carers" (or HBC). The HBC in this study are supervised by another existing cadre, so-called "community-based health care workers" (or CBHC). The CBHC are clinic-based and are charged to organize community outreach activities in the Tanzanian public-sector health systems. The CBHC (1-2 per clinic) are also active in the control arm; in this intervention arm, there role is changed: they are actively supervising a large number of CHW. Per street (or mtaa), 1-2 CHW are assigned to carry out the enhanced CHW intervention.
Standard of care
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.
Other: Standard of care
The standard of care in the Tanzanian health care system does not include any CHW intervention to enhance ANC and PMTCT uptake and retention. The only community-based intervention are PMTCT follow-up organized by a health worker cadre who works out of ANC and primary care clinics (so-called CBHC).

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932138

Contacts
Contact: Till Bärnighausen, MD ScD tbaernig@hsph.harvard.edu

Locations
Tanzania
Management and Development for Health Recruiting
Dar es Salaam, Tanzania, 79810
Contact: Guerino Chalamilla, MD PhD    255-22-2150496    mdh@mdh-tz.org   
Sponsors and Collaborators
Harvard School of Public Health
Management and Development for Health, Tanzania
Elton John AIDS Foundation, UK
Comic Relief UK
Investigators
Principal Investigator: Till Bärnighausen, MD ScD Harvard School of Public Health
Principal Investigator: Guerino Chalamilla, MD PhD Management and Development for Health
  More Information

No publications provided

Responsible Party: Till Barnighausen, Associate Professor of Global Health, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01932138     History of Changes
Other Study ID Numbers: EJF22802
Study First Received: May 14, 2013
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board
Tanzania: National Institute of Medical Research

Keywords provided by Harvard School of Public Health:
Community-based intervention
Community health workers
Antenatal care
HIV
PMTCT
HIV vertical transmission
Public-sector health systems

ClinicalTrials.gov processed this record on October 21, 2014