Community Health Workers and Prevention of Mother-to-Child HIV Transmission in Tanzania

February 20, 2017 updated by: Sandra McCoy, University of California, Berkeley

Short-term Effectiveness of a Community Health Worker Intervention for HIV-infected Pregnant Women in Tanzania to Improve Treatment Adherence and Retention in Care: A Cluster-Randomized Trial

The investigators implemented and evaluated a pilot program in Shinyanga Region, Tanzania to bring prevention of HIV services to communities using community health workers (CHWs). The intervention aimed to integrate community-based maternal and child health services with HIV prevention, treatment, and care-bridging the gap between women and facility, and enhancing the potential benefits of Option B+. Option B+ is the current World Health Organization recommendation for prevention of mother-to-child transmission, but its success in sub-Saharan Africa may be threatened by overburdened clinics and staff. Consequently, paraprofessionals like CHWs can be key partners in the delivery and/or enhancement of health services in the community.

The study focuses on whether this approach: increases retention in care; improves adherence to antiretrovirals (ARVs); or improves the number of women initiating antiretroviral therapy and the timing of initiation. Investigators hypothesize improvements along primary and secondary outcome indicators in the treatment group. This evaluation helps illuminate both the impact and feasibility of the intervention, and the role that CHWs may play in the elimination of mother-to-child transmission services.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1830

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who were identified in one of the medical registers used for sampling at the facility, were HIV-positive, and had a child born in either the baseline or endline cohort time windows (January and December 2014 or April and October 2015).

Exclusion Criteria:

  • Did not have sufficient information to link them across registers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard of care, i.e. regular clinic services are provided prior to the study.
Experimental: Community Health Worker Intervention
This arm is a four-part behavioral intervention that includes: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool.
Behavioral: Community Health Worker intervention
The intervention included four integrated components: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in HIV care
Time Frame: 120 days postpartum
Binary variable taking the value of 1 if the women has had at least one clinic visit in the postpartum period (60-120 days after birth), and zero otherwise.
120 days postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to ARVs
Time Frame: Birth to 90 days postpartum
ART adherence will be measured through a binary variable taking the value of 1 when adherence is at least 95%, and the value of zero otherwise. We measure adherence using the medication possession ratio (MPR), computed as the number of days ARVs are prescribed or dispensed divided by the number of days in the interval. It has been shown to be associated with short-term virologic outcomes.
Birth to 90 days postpartum
Timing of ART initiation
Time Frame: ART initiation date, expressed as gestational week of pregnancy, up to 40 weeks
Defined by gestational week at start of ART, which was computed using standard approaches (i.e., 40 weeks prior to the date of birth or, when available, the expected delivery date based on last menstrual period).
ART initiation date, expressed as gestational week of pregnancy, up to 40 weeks
Initiation of ART
Time Frame: Through pregnancy and up to 90 days after birth
Measured as the number of HIV-infected women in the sample who had any evidence of beginning ART after pregnancy, among women without evidence of treatment prior to pregnancy (women who had initiated ART before the current pregnancy were excluded).
Through pregnancy and up to 90 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Collaborators

Ministry of Health and Social Welfare, Tanzania
International Initiative for Impact Evaluation
Amref Health Africa
Organisation for Public Health Interventions and Development (OPHID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

March 30, 2016

Study Completion (Actual)

March 30, 2016

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TW7.18
  • 552553838b402 (Registry Identifier: RIDIE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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