ART Readiness in HIV-infected Pregnant Women

September 14, 2018 updated by: University of North Carolina, Chapel Hill

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is qualitative and quantitative research exploring the issues of patient readiness to initiate lifelong ART among HIV-infected pregnant women, as well as ART adherence and retention in HIV care and treatment during pregnancy and after delivery.

The objectives of Phase 1 of the study are as follows:

  • To identify common themes about patient readiness for ART initiation in the days and weeks following ART eligibility in the context of pregnancy
  • To learn about strategies that HIV-infected women and partners of reproductive-age women believe will assist with daily adherence to triple-drug ART and retention in care during pregnancy and after delivery

The objectives of Phase 2 of the study are as follows:

  • To develop a screening instrument for assessing readiness of ART initiation during pregnancy
  • To pilot the ART readiness assessment tool and evaluate its acceptability and feasibility through qualitative research
  • To design a combination intervention that systematically addresses barriers to patient readiness and in so doing, may shorten time from HIV diagnosis to ART initiation and increase rates of ART adherence and retention in care in the short term

The objectives of Phase 3 of the study are as follows:

  • To evaluate an enhanced adherence package for improving timely ART initiation and retention in care, defined by attending follow-up ART visit(s), at 30 days after ART eligibility and by maternal HIV viral levels at time of delivery
  • To determine the accuracy of the screening instrument in predicting ART readiness by looking at early ART adherence and retention
  • To obtain early data about virologic response in pregnancy and postnatal period among HIV-infected women on Option B+
  • To obtain data about 6-week and 6-month MTCT rates of HIV among HIV-infected women on Option B+
  • To obtain data about renal function in pregnancy and postnatal period among HIV-infected women on Option B+, given that tenofovir is first-line in Zambia

Study Type

Interventional

Enrollment (Actual)

454

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Centre for Infectious Disease Research in Zambia

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

The criteria vary by study phase as follows:

Phase 1

Inclusion Criteria:

  • HIV-infected pregnant women not yet on ART OR
  • HIV-infected pregnant or postnatal women on ART OR
  • Partners of women who were recently or are currently pregnant

Exclusion Criteria:

  • Less than 18 years old
  • Known history of mental illness

Phase 2

Inclusion Criteria:

  • HIV-infected pregnant or postnatal women on ART who piloted tested the readiness assessment tool OR
  • Health care workers involved in provision of PMTCT and/or ART services at health facility who have pilot tested the readiness assessment tool

Phase 3

Inclusion Criteria:

  • Pregnant
  • HIV-infected
  • Never previously initiated or was on ART for her own health
  • Able to provide informed consent
  • Willing to undergo all study tests and procedures and be followed until 6 months post-partum

Exclusion criteria:

  • Less than 18 years old
  • Known intrauterine fetal demise
  • Known history of mental illness
  • Does not intend to receive antenatal care, labour and delivery care, and postnatal care at the government health facilities of Lusaka District

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard of Care
The MOH-recommended approach is opt out HIV testing in pregnancy followed by immediate initiation of ART for HIV-infected pregnant women. ART initiation is accompanied with counseling geared to educate and prepare women to take up and be retained on ART lifelong. Women who do not return for clinical or drug refill visits are traced by phone or in person.
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.
Experimental: Enhanced adherence package
The enhanced adherence package will be designed on the basis of the results of formative research. The intervention will support women who are eligible for ART under Option B+.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women who both initiate ART and are retained in care
Time Frame: Within 30 days of eligibility to begin ART under Option B+ policy
ART eligibility in the setting of Option B+ will generally be either the date of HIV diagnosis for pregnant women newly diagnosed with HIV infection during their antenatal care visit or the date of their first antenatal care visit for known HIV-infected pregnant women who are not already on ART
Within 30 days of eligibility to begin ART under Option B+ policy
HIV virologic suppression at time of delivery
Time Frame: Time of delivery
Outcome of virologic suppression at delivery will be analyzed for differences between the SOC arm and intervention arm.
Time of delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from ART eligibility to ART initiation
Time Frame: Time from ART eligibility to initiation from enrollment until 6 months post-partum
Time from ART eligibility to initiation from enrollment until 6 months post-partum
HIV transmission from mother to infant
Time Frame: At 6 weeks and 6 months of life
At 6 weeks and 6 months of life

Collaborators and Investigators

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

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Centers for Disease Control and Prevention
Centre for Infectious Disease Research in Zambia

Investigators

  • Principal Investigator: Mwangelwa Mubiana, MBChB, Centre for Infectious Disease Research in Zambia
  • Principal Investigator: Benjamin Chi, MD, University of North Carolina, Chapel Hill
  • Study Director: Michael J Vinikoor, MD, Centre for Infectious Disease Research in Zambia

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

Helpful Links

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)

May 9, 2018

Study Completion (Actual)

May 28, 2018

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-3884

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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