ART Readiness in HIV-infected Pregnant Women

University of North Carolina (UNC)

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Other: Standard of Care; Behavioral: Enhanced Adherence Package

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02459678

13-3884

Details and patient eligibility

About

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.

Full 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

Enrollment: 454 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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454 participants in 2 patient groups

Standard of Care

Other group

Description:

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.

Treatment:

Other: Standard of Care

Enhanced adherence package

Experimental group

Description:

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+.

Treatment:

Behavioral: Enhanced Adherence Package