ART Readiness in HIV-infected Pregnant Women
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|ClinicalTrials.gov Identifier: NCT02459678|
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Behavioral: Enhanced Adherence Package Other: Standard of Care||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||526 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||ART Readiness in HIV-infected Pregnant Women: From Formative Qualitative Research to Individual Randomized Trial|
|Actual Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
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.
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.
Experimental: 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+.
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.
- Proportion of women who both initiate ART and are retained in care [ Time Frame: Within 30 days of eligibilty to begin ART under Option B+ policy ]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
- HIV virologic suppression at time of delivery [ Time Frame: Time of delivery ]Outcome of virologic suppression at delivery will be analyzed for differences between the SOC arm and intervention arm.
- Time from ART eligibility to ART initiation [ Time Frame: Time from ART eligibility to initiation from enrollment until 6 months post-partum ]
- HIV transmission from mother to infant [ Time Frame: At 6 weeks and 6 months of life ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459678
|Contact: Mwangelwa Mubiana-Mbewe, MBChBemail@example.com|
|Contact: Michael J Vinikoor, MDfirstname.lastname@example.org|
|Centre for Infectious Disease Research in Zambia||Recruiting|
|Contact: Mwangelwa Mubiana-Mbewe email@example.com|
|Principal Investigator:||Mwangelwa Mubiana, MBChB||Centre for Infectious Disease Research in Zambia|
|Principal Investigator:||Benjamin Chi, MD||University of North Carolina, Chapel Hill|
|Study Director:||Michael J Vinikoor, MD||Centre for Infectious Disease Research in Zambia|