ClinicalTrials.gov
ClinicalTrials.gov Menu

ART Readiness in HIV-infected Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02459678
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : June 28, 2017
Sponsor:
Collaborators:
Centre for Infectious Disease Research in Zambia
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Enhanced Adherence Package Other: Standard of Care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: ART Readiness in HIV-infected Pregnant Women: From Formative Qualitative Research to Individual Randomized Trial
Actual Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Proportion of women who both initiate ART and are retained in care [ Time Frame: Within 30 days of eligibilty 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

  2. 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.


Secondary Outcome Measures :
  1. Time from ART eligibility to ART initiation [ Time Frame: Time from ART eligibility to initiation from enrollment until 6 months post-partum ]
  2. HIV transmission from mother to infant [ Time Frame: At 6 weeks and 6 months of life ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459678


Contacts
Contact: Mwangelwa Mubiana-Mbewe, MBChB mwangelwa.mbewe@cidrz.org
Contact: Michael J Vinikoor, MD michael.vinikoor@cidrz.org

Locations
Zambia
Centre for Infectious Disease Research in Zambia Recruiting
Lusaka, Zambia
Contact: Mwangelwa Mubiana-Mbewe       mwangelwa.mbewe@cidrz.org   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Centre for Infectious Disease Research in Zambia
Centers for Disease Control and Prevention
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

Additional Information:
Publications:
Millennium Development Goals Progress Report. 2011, Ministry of Finance and National Planning, UNDP: Lusaka.
National HIV/AIDS/STIs/TB Council, 2009 HIV Epidemiological Projections Report. 2009: Zambia.
Republic of Zambia Ministry of Health, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV, Directorate of Public Health and Research, Editor. 2010, Ministry of Health: Lusaka, Zambia.
Government of the Republic of Zambia, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV/AIDS, M.o. Health, Editor. 2008: Lusaka.
World Health Organization, Use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants, in HIV/AIDS Programme. 2012: Geneva.
Government of the Republic of Zambia, Lifelong Antiretroviral Drugs (ARV's) for all HIV positive Pregnant Women in Zambia, M.o. Health, Editor. 2013: Lusaka.
Government of the Republic of Zambia, Adult and Adolescent Antiretroviral Therapy Protocols, M.o. Health, Editor. 2010: Lusaka.
UNAIDS. HIV and AIDS estimates 2009. [cited 2011 April 11]; Available from: http://www.unaids.org/en/regionscountries/countries/zambia/.
Zambia National HIV/AIDS/STI/TB Council, Zambia HIV Prevention Response and Modes of Transmission Analysis. 2009.
Mazimba C, C.W., , Kaseba C, Chi B, HIV-related maternal mortality in Lusaka, Zambia: 1993-2004, in 3rd IAS Conference on HIV Pathogenesis and Treatment: Rio de Janeiro, Brazil.
Central Statistical Office, Demographic Health Survey. 2007: Lusaka.
Krueger, R. and M. Casey, Focus Groups: A Practical Guide for Applied Research, 3rd edition. 2000, Thousand Oaks: Sage Publications.
Bernard, H.R., Research Methods in Anthropology. 1995, Walnut Creek Altamira Press 535.
Miles, M. and A. Huberman, Qualitative Data Analysis: An Expanded Sourcebook. 2nd ed. 1994, Thousand Oaks: Sage Publications.

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02459678     History of Changes
Other Study ID Numbers: 13-3884
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases