MedTrace Logo

Early ART Initiation Among HIV-positive Pregnant Women in Central Mozambique

NCT02371265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 761

Last updated 2023-05-10

No results posted yet for this study

Summary

The overall objective of the study is to develop and test a pilot intervention in central Mozambique to implement the new WHO "Option B+" guidelines that seek to increase the proportion of HIV-positive pregnant women in six antenatal care clinics who start antiretroviral therapy (ART) prior to delivery, and are retained in care after 90- days.

Conditions

Interventions

OTHER

Adherence and retention package

Based on formative research findings, the following core components of the B+ study intervention have been designed and will be stepped in at the study sites to improve early retention in care and adherence: * Workflow modification: 1) Redefinition of key roles of MCH nurses and task shifting to community health workers (CHW's), and 2) enhanced patient tracking via improved management of registries/charts; * Adherence and retention package: 1) Creation of "Adherence Committees" at each site to coordinate and systematize patient follow-up, 2) active patient follow-up and home visits by community health workers (CHWs or activistas), 3) use of text messaging to patients by MCH nurses, 4) improved and intensified counseling coordinated with active CHW and text follow-up, and 5) intensified and improved Option B+ training and supportive supervision.

Sponsors & Collaborators

  • Health Alliance International

    collaborator OTHER

  • Beira Operations Research Center, Mozambique Ministry of Health

    collaborator UNKNOWN

  • University of Washington

    lead OTHER

Principal Investigators

  • Rachel Chapman, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Mozambique

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371265 on ClinicalTrials.gov