Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
454 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-05-31
Study Completion Date
2018-05-28
Brief Summary
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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.
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Detailed Description
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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
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
Conditions
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Human Immunodeficiency Virus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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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.
Group Type
OTHER
Standard of Care
Intervention Type
OTHER
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.
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+.
Group Type
EXPERIMENTAL
Enhanced Adherence Package
Intervention Type
BEHAVIORAL
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.
Interventions
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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.
Intervention Type
BEHAVIORAL
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.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
* HIV-infected pregnant or postnatal women on ART OR
* Partners of women who were recently or are currently pregnant
* 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
* 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 history of mental illness
Phase 2
* 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
* Known history of mental illness
Phase 2
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Centre for Infectious Disease Research in Zambia
OTHER
Sponsor Role
collaborator
Centers for Disease Control and Prevention
FED
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mwangelwa Mubiana, MBChB
Role: PRINCIPAL_INVESTIGATOR
Centre for Infectious Disease Research in Zambia
Benjamin Chi, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Michael J Vinikoor, MD
Role: STUDY_DIRECTOR
Centre for Infectious Disease Research in Zambia
Locations
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Centre for Infectious Disease Research in Zambia
Lusaka, , Zambia
Site Status
Countries
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Zambia
References
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Reference Type
BACKGROUND
Mubiana-Mbewe M, Bosomprah S, Kadota JL, Koyuncu A, Kusanathan T, Mweebo K, Musokotwane K, Mulenga PL, Chi BH, Vinikoor MJ. Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial. AIDS Behav. 2021 Mar;25(3):992-1000. doi: 10.1007/s10461-020-03060-4. Epub 2020 Oct 8.
Reference Type
DERIVED
Related Links
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http://www.unc.edu
University of North Carolina website
Other Identifiers
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13-3884
Identifier Type: -
Identifier Source: org_study_id
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