Clinical trial NCT02459678: ART Readiness in HIV-infected Pregnant Women
Official title: ART Readiness in HIV-infected Pregnant Women: From Formative Qualitative Research to Individual Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
name: Centers for Disease Control and Prevention
First posted: 2015-06-02
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Eligibility 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

Primary outcomes:
measure: Proportion of women who both initiate ART and are retained in care
timeFrame: Within 30 days of eligibility to begin ART under Option B+ policy
measure: HIV virologic suppression at time of delivery
timeFrame: Time of delivery
Secondary outcomes:
measure: Time from ART eligibility to ART initiation
timeFrame: Time from ART eligibility to initiation from enrollment until 6 months post-partum
measure: HIV transmission from mother to infant
timeFrame: At 6 weeks and 6 months of life
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research in Zambia
Study officials:
affiliation: Centre for Infectious Disease Research in Zambia
name: Mwangelwa Mubiana, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Benjamin Chi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Infectious Disease Research in Zambia
name: Michael J Vinikoor, MD
role: STUDY_DIRECTOR
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