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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Mother-to-child Transmission of HIV; Pregnancy	Other: Enhanced CHW intervention; Other: Standard of care	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	190530 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	January 2013
Actual Primary Completion Date :	April 2014
Actual Study Completion Date :	April 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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).

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Tanzania
Management and Development for Health
Dar es Salaam, Tanzania, 79810

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Sando D, Geldsetzer P, Magesa L, Lema IA, Machumi L, Mwanyika-Sando M, Li N, Spiegelman D, Mungure E, Siril H, Mujinja P, Naburi H, Chalamilla G, Kilewo C, Ekström AM, Fawzi WW, Bärnighausen TW. Evaluation of a community health worker intervention and the World Health Organization's Option B versus Option A to improve antenatal care and PMTCT outcomes in Dar es Salaam, Tanzania: study protocol for a cluster-randomized controlled health systems implementation trial. Trials. 2014 Sep 15;15:359. doi: 10.1186/1745-6215-15-359.

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
First Posted:	August 30, 2013
Last Update Posted:	March 2, 2015
Last Verified:	February 2015

Keywords provided by Till Barnighausen, Harvard School of Public Health:

Community-based intervention; Community health workers; Antenatal care; HIV	PMTCT; HIV vertical transmission; Public-sector health systems