NCT01932138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190,530

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

May 14, 2013

Last Update Submit

February 26, 2015

Conditions

Mother-to-child Transmission of HIVPregnancy

Keywords

Community-based interventionCommunity health workersAntenatal careHIVPMTCTHIV vertical transmissionPublic-sector health systems

Outcome Measures

Primary Outcomes (5)

  • Proportion of infants born to HIV-infected mothers who have acquired HIV

    During the first 2 years of life

  • Proportion of HIV-exposed infants tested for HIV

    During the first 2 years of life

  • Proportion of pregnant women making at least four antenatal clinic visits

    Between the first week of gestation and delivery

  • Proportion of pregnant women delivering at a healthcare facility

    At delivery

  • Proportion of HIV-positive women receiving PMTCT

    Between the first antenatal care visit and 1 week after stopping breastfeeding

Secondary Outcomes (4)

  • Number of weeks of gestation at which pregnant women have their first ANC visit

    Between the first week of gestation and delivery

  • 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

  • Proportion of pregnant women who were tested for HIV

    Between the first week of gestation and delivery

Study Arms (2)

Enhanced CHW intervention

EXPERIMENTAL

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

Standard of care

OTHER

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

Interventions

Enhanced CHW interventionOTHER

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.

Enhanced CHW intervention
Standard of careOTHER

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).

Standard of care

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Management and Development for Health

Dar es Salaam, 79810, Tanzania

Location

Related Publications (2)

  • 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, Ekstrom AM, Fawzi WW, Barnighausen 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.

    PMID: 25224756BACKGROUND

  • Geldsetzer P, Mboggo E, Larson E, Lema IA, Magesa L, Machumi L, Ulenga N, Sando D, Mwanyika-Sando M, Spiegelman D, Mungure E, Li N, Siril H, Mujinja P, Naburi H, Chalamilla G, Kilewo C, Ekstrom AM, Foster D, Fawzi W, Barnighausen T. Community health workers to improve uptake of maternal healthcare services: A cluster-randomized pragmatic trial in Dar es Salaam, Tanzania. PLoS Med. 2019 Mar 29;16(3):e1002768. doi: 10.1371/journal.pmed.1002768. eCollection 2019 Mar.

    PMID: 30925181DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Till Bärnighausen, MD ScD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

  • Guerino Chalamilla, MD PhD

    Management and Development for Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Global Health

Study Record Dates

First Submitted

May 14, 2013

First Posted

August 30, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 2, 2015

Record last verified: 2015-02

Locations

TA(1)