At a glance

ClinicalIndex Comparison Record

N/ACompleted· 454 enrolled

Drug / intervention

Enhanced Adherence Package +1 morebehavioral

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02459678

NCT02459678N/ACompleted

Compare CT.gov

ART Readiness in HIV-infected Pregnant Women: From Formative Qualitative Research to Individual Randomized Trial

University of North Carolina, Chapel Hill·interventional·Posted Jun 2, 2015·Updated Sep 18, 2018

In Brief

A clinical study evaluating Enhanced Adherence Package and Standard of Care for Human Immunodeficiency Virus. Completed, enrolled 454 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHuman Immunodeficiency Virus

CountriesZambia

CollaboratorsCentre for Infectious Disease Research in Zambia, Centers for Disease Control and Prevention

Timeline

N/ACompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartMay 2015

First PostedJun 2015

Primary CompletionMay 2018

Study CompletionMay 2018

TodayJul 2026

First PostedJun 2, 2015

Enrollment StartMay 1, 2015

Primary CompletionMay 9, 2018

Study CompletionMay 28, 2018

TodayJul 2, 2026

Enrollment to primary: 3.0 yearsPosted 11.1 years ago

Interventions

Enhanced Adherence Packagebehavioral

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.

Standard of Careother

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.