ART Readiness in HIV-infected Pregnant Women

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459678
• Other study ID #: 13-3884
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 28, 2018

Study information

• Verified date: September 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: May 28, 2018
• Est. primary completion date: May 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

Country	Name	City	State
Zambia	Centre for Infectious Disease Research in Zambia	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centers for Disease Control and Prevention, Centre for Infectious Disease Research in Zambia

Country where clinical trial is conducted

Zambia, 

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* Note: There are 66 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who both initiate ART and are retained in care	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
Primary	HIV virologic suppression at 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	Time from ART eligibility to ART initiation		Time from ART eligibility to initiation from enrollment until 6 months post-partum
Secondary	HIV transmission from mother to infant		At 6 weeks and 6 months of life

External Links

•   University of North Carolina website