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

Sponsor
University of California, Berkeley (Other)
Overall Status
Completed
CT.gov ID
NCT03058484
Collaborator
Amref Health Africa (Other), Ministry of Health and Social Welfare, Tanzania (Other), International Initiative for Impact Evaluation (Other), Organisation for Public Health Interventions and Development (OPHID) (Other)
1,830
2
11

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Community Health Worker intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1830 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Mar 30, 2016
Actual Study Completion Date :
Mar 30, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Retention in HIV care [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.

Secondary Outcome Measures

  1. Adherence to ARVs [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.

  2. Timing of ART initiation [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).

  3. Initiation of ART [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sandra McCoy, Assistant Adjunct Professor, University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT03058484
Other Study ID Numbers:
  • TW7.18
  • 552553838b402
First Posted:
Feb 23, 2017
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2017