ART Readiness in HIV-infected Pregnant Women

Study Overview
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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.

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

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

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: Enhanced Adherence Package
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care<br>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<br>* 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.<br>|
| Experimental: Enhanced adherence package<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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