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ART Readiness in HIV-infected Pregnant Women

NCT02459678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2018-09-18

No results posted yet for this study

Summary

This study seeks to evaluate the readiness of HIV-infected pregnant women in Zambia to initiate, adhere to, and be retained in care under the Ministry of Health's Option B+ policy. Under a 3-phased research study the investigators will: (1) conduct formative research regarding readiness to start lifelong ART in the pregnant population; (2) translate the results of formative research into a readiness assessment tool and an enhanced adherence package for pregnant women eligible for Option B+ and (3) conduct an individual randomized trial of the enhanced adherence package.

Conditions

  • Human Immunodeficiency Virus

Interventions

BEHAVIORAL

Enhanced Adherence Package

The enhanced adherence package is yet to be designed, but may target all HIV-infected women with methods that are currently reserved only for late clients or clients of unknown status.

OTHER

Standard of Care

Currently, the standard of care is based on the 2010 national HIV care and treatment guidelines, health care providers are encouraged to use a number of different means to improve ART adherence.

Sponsors & Collaborators

Principal Investigators

  • Mwangelwa Mubiana, MBChB · Centre for Infectious Disease Research in Zambia

  • Benjamin Chi, MD · University of North Carolina, Chapel Hill

  • Michael J Vinikoor, MD · Centre for Infectious Disease Research in Zambia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-05-09
Completion
2018-05-28

Countries

  • Zambia

Study Locations

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Entities

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 NCT02459678 on ClinicalTrials.gov