Condition category
Not Applicable
Date applied
29/03/2012
Date assigned
21/06/2012
Last edited
11/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Phillips

ORCID ID

Contact details

60 Haven Ave
B-2
New York
10032
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/a

Study information

Scientific title

Introducing Community Health Agents (CHA) to Accelerate Achievement of MDGs 4 and 5 in Tanzania: The Connect Project

Acronym

The Connect Project

Study hypothesis

The research will test the hypothesis that introducing the community health agents (CHA) cadre into the Tanzanian health system and the necessary system supports, and emergency referral systems, will result in reduction of child mortality, particularly newborn mortality, and produce efficiencies and cost-savings in the health system. It has an experimental design to measure the impact of the CHA intervention and also systems and operations research to test the approaches and costs.

Tanzania has a comprehensive primary healthcare program that provides a wide range of essential preventive and curative services. However, the system also has gaps in the services, particularly at community level, that prevent it from achieving its full potential.
To address these problems, Connect aims to strengthen the capacity of the health system by introducing the CHA with the necessary systems support structures to function most effectively. The project will be guided in these efforts by a framework created by the World Health Organization. The framework has identified the six areas of focus that have been shown to be critical to effective health systems development (HSD):
1. Integrated primary healthcare interventions that are known to reduce morbidity and mortality;
2. A health workforce that is trained, deployed, and accessible for addressing healthcare needs;
3. Essential information that is required for healthcare workers to provide appropriate services;
4. Essential supplies, equipment, and facilities for providing basic healthcare operations;
5. Resources and social protection mechanisms to finance and ensure economic accessibility of services;
6. Mechanisms of leadership and governance that provide direction to health system operations.

Ethics approval

1. Columbia University IRB, Jan 2012, ref: IRB-AAAF3452
2. National Institute for Medical Research (NIMR), Aug 2012
3. Ifakara Health Institute, June 2010

Study design

Two-celled randomized cluster trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infant and child mortality, maternal mortality

Intervention

The health workers will participate in focus group discussions and in-depth interviews on issues related to job satisfaction and retention and their expectations, reservations and ideas regarding the introduction of the CHA.

Connect is a randomized controlled trial by village cluster that contains a total of 101 villages – 50 treatment and 51 control. Assignment of villages to the treatment or control arm followed probability proportionate to size sampling procedures which ensured that each arm was comparable with regards to the population size of the villages in them. No other variable was used in the sampling frame. Within the treatment arm the number of CHA assigned to each village also followed probability proportionate to size methods whereby intervention villages with fewer than 1000 population received 1 CHA; villages with 1000-3999 population received 2 CHA; villages with 4000 – 6999 population received 3 CHA and villages with over 7000 population received for 4 CHA.

The CHA intervention integrates various primary health care functions into a single community-based work package that includes all stages of the oft-cited ‘continuum of care’: routine household visits and community education sessions focused on (a) general primary healthcare education and promotion; (b) comprehensive family planning including distribution of condoms and oral contraceptives, and education and focused referral for long term and permanent acting methods; (c) focused referral for antenatal care for pregnant women; (d) birth planning and referral assistance to ensure institutional delivery; (e) essential newborn care education and promotion and referral assistance for sick newborns; (f) community case management for malaria, diarrhea, and pneumonia; (g) general first aid other community health promotion functions; (h) HIV/STI prevention education, including condom distribution. The number of sessions is variable according to the various contextual and individual factors that affect CHA performance and this is followed through program monitoring processes.

There will be 12 focus group discussions on this issue (120 participants) and 12 in-depth interviews (12 subjects). The focus group discussions with community members will be about:
1. Family planning
2. Postnatal care and service seeking behavior, and
3. Health and care-seeking behaviors of women during pregnancy and delivery.

The family planning discussions will be held with men (married, aged 30-49) and women (married, aged 25-49) groups separately. The latter two types of focus group discussions will enroll women that had newborns in the past 12 months. For each of these focus group discussion types there will be the same number of subjects as laid down in the above discussion of health workers (120 focus group subjects and 48 in depth interview subjects).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The following discussion provides a subject population description for the three components of phase 1:
1. Sampling Research: This involves the use archival de-identified summary data that reflects the subject accrual of some 350,000 people in the Ifakara and Rufiji health and demographic surveillance system (HDSS). The catchment area of these HDSS areas is comprised of the village clusters that we will randomize into our study by the end of this phase. The Connect project will not enroll these people, but will use de-identified summary statistics that reflect on this population in order to inform our randomization.
2. Baseline Research (3000 subjects total, see below): this will involve the accrual of human subjects that reside within the catchment population of the Ifakara and Rufiji HDSS. The household survey will include roughly 3000 households. Households can be included only if they are among those accrued in the Ifakara and Rufiji HDSS and have women of reproductive age (15-49 years of age) and be the primary care takers of at least one under-five year old child. The population to be enrolled as participants in the household survey will, in most cases, be non-English speaking, educationally- and economically disadvantaged. Kiswahili is the national language of Tanzania and residents of rural villages are typically impoverished and with limited means to adequate schooling. An additional special populations that will figure prominently in this survey are pregnant women, which stands to reason given the objectives of Connect and its core impact and outcome indicators which are well explained in the attached protocol and study description. No children or minors will be enrolled.
3. Formative Research: With respect to the formative research, it will be conducted amongst health workers and members of the study population. The health workers will participate in focus group discussions and in-depth interviews on issues related to job satisfaction and retention and their expectations, reservations and ideas regarding the introduction of the CHA. The family planning discussions will be held with men's (married, aged 30-49) and women's (married, aged 25-49) groups separately. The latter two types of focus group discussions will enroll women that had newborns in the past 12 months.

Secondary outcome measures

1. Maternal mortality
2. Cause of death, fertility
3. Childhood morbidity
4. Burden of disease life years gained and key maternal and child health behaviors

Additional, key secondary outcomes cover a range of relevant reproductive, maternal, newborn and child health seeking and service utilization behaviors and are gathered at baseline and end-line using a sub-HDSS panel survey which is linked to the HDSS using shared respondent IDs. Baseline data were collected between May and July 2011 and the end-line data will be collected during the same period in 2015.

Overall trial start date

01/07/2010

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Human subjects that reside within the catchment population of the Ifakara and Rufiji HDSS.
2. The household survey will include roughly 3000 households. Households can be included only if:
2.1. Have women of reproductive age (WRA) (15-49 years of age) or be the primary care takers of at least one under-five year old child for women more than 49 years old.
2.2. The population to be enrolled as participants in the household survey will, in most cases, be non-English speaking, educationally- and economically disadvantaged. Kiswahili is the national language of Tanzania and residents of rural villages are typically impoverished and with limited means to adequate schooling. No children under the age of 15 will be enrolled. All WRA will be enrolled as subjects.
3. Health workers – Any Community Health Agents and government health employees within the study districts.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3664

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/2010

Recruitment end date

31/07/2014

Locations

Countries of recruitment

Tanzania

Trial participating centre

60 Haven Ave
New York
10032
United States of America

Sponsor information

Organisation

Columbia University (USA)

Sponsor details

Mailman School of Public Health
Heilbrunn Department of Population and Family Health
60 Haven Ave
B-2
New York
10032
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Doris Duke Charitable Foundation DDCF 2009058 (USA)

Alternative name(s)

DDCF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

Comic Relief (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23819587
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27391368

Publication citations

  1. Protocol

    Ramsey K, Hingora A, Kante M, Jackson E, Exavery A, Pemba S, Manzi F, Baynes C, Helleringer S, Phillips JF, The Tanzania Connect Project: a cluster-randomized trial of the child survival impact of adding paid community health workers to an existing facility-focused health system., BMC Health Serv Res, 2013, 13 Suppl 2, S6, doi: 10.1186/1472-6963-13-S2-S6.

  2. Results

    Tani K, Exavery A, Baynes CD, Pemba S, Hingora A, Manzi F, Phillips JF, Kanté AM, Unit cost analysis of training and deploying paid community health workers in three rural districts of Tanzania, BMC Health Serv Res, 2016 , 16, 1, 237.

Additional files

Editorial Notes

11/07/2016: Publication reference added.