Human Immunodeficiency VirusNCT02459678

ART Readiness in HIV-infected Pregnant Women

A study testing Enhanced Adherence Package in people with Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: Enhanced Adherence Package
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 454 participants
Where: 1 siteZambia
Study dates: May 2015to 28 May 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
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

Show all 11Show fewer

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

Who cannot join

Less than 18 years old
Known history of mental illness
Phase 2
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 locations and contacts

1 site in 1 country.

Zambia1 site

Centre for Infectious Disease Research in Zambia
Lusaka

Other trials in Zambia

About this study

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

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.

Read the 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

Conditions: Human Immunodeficiency Virus
Being tested: Enhanced Adherence Package, Standard of Care
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced Adherence PackageBehavioural
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.
Standard of CareOther
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.

Study groups in NCT02459678
Study group	Role	What they receive
Standard of Care	Other	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. Receives: Other: Standard of Care
Enhanced adherence package	Experimental	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+. Receives: Behavioral: Enhanced Adherence Package

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: Time of delivery

Secondary outcomes (2)

Time from ART eligibility to ART initiation
Measured: Time from ART eligibility to initiation from enrollment until 6 months post-partum
HIV transmission from mother to infant
Measured: At 6 weeks and 6 months of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201528 May 2018

First posted2 Jun 2015 (estimated)
Study startMay 2015
Primary completion9 May 2018
Study completion28 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (66)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 454 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02459678
Sponsor's protocol ID: 13-3884
Status last verified: Sep 2018
First submitted: 14 May 2015
Last updated: 18 Sep 2018
Results posted: No
Data monitoring committee: No

Publications

Millennium Development Goals Progress Report. 2011, Ministry of Finance and National Planning, UNDP: Lusaka.
National HIV/AIDS/STIs/TB Council, 2009 HIV Epidemiological Projections Report. 2009: Zambia.
Republic of Zambia Ministry of Health, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV, Directorate of Public Health and Research, Editor. 2010, Ministry of Health: Lusaka, Zambia.
Government of the Republic of Zambia, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV/AIDS, M.o. Health, Editor. 2008: Lusaka.
Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants: Recommendations for a Public Health Approach: 2010 Version. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK304944/
PubMed 26180894
Centers for Disease Control and Prevention (CDC). Impact of an innovative approach to prevent mother-to-child transmission of HIV--Malawi, July 2011-September 2012. MMWR Morb Mortal Wkly Rep. 2013 Mar 1;62(8):148-51.
PubMed 23446514
Government of the Republic of Zambia, Lifelong Antiretroviral Drugs (ARV's) for all HIV positive Pregnant Women in Zambia, M.o. Health, Editor. 2013: Lusaka.
Government of the Republic of Zambia, Adult and Adolescent Antiretroviral Therapy Protocols, M.o. Health, Editor. 2010: Lusaka.
Shaffer N, Abrams EJ, Becquet R. Option B+ for prevention of mother-to-child transmission of HIV in resource-constrained settings: great promise but some early caution. AIDS. 2014 Feb 20;28(4):599-601. doi: 10.1097/QAD.0000000000000144. No abstract available.
PubMed 24469000
Tenthani L, Haas AD, Tweya H, Jahn A, van Oosterhout JJ, Chimbwandira F, Chirwa Z, Ng'ambi W, Bakali A, Phiri S, Myer L, Valeri F, Zwahlen M, Wandeler G, Keiser O. Retention in care under universal antiretroviral therapy for HIV-infected pregnant and breastfeeding women ('Option B+') in Malawi. AIDS. 2014 Feb 20;28(4):589-598. doi: 10.1097/QAD.0000000000000143.
PubMed 24468999
UNAIDS. HIV and AIDS estimates 2009. [cited 2011 April 11]; Available from: http://www.unaids.org/en/regionscountries/countries/zambia/.
Zambia National HIV/AIDS/STI/TB Council, Zambia HIV Prevention Response and Modes of Transmission Analysis. 2009.
Mazimba C, C.W., , Kaseba C, Chi B, HIV-related maternal mortality in Lusaka, Zambia: 1993-2004, in 3rd IAS Conference on HIV Pathogenesis and Treatment: Rio de Janeiro, Brazil.
Moodley J, Pattinson RC, Baxter C, Sibeko S, Abdool Karim Q. Strengthening HIV services for pregnant women: an opportunity to reduce maternal mortality rates in Southern Africa/sub-Saharan Africa. BJOG. 2011 Jan;118(2):219-25. doi: 10.1111/j.1471-0528.2010.02726.x. Epub 2010 Sep 24.
PubMed 21159120
McIntyre J. Maternal health and HIV. Reprod Health Matters. 2005 May;13(25):129-35. doi: 10.1016/s0968-8080(05)25184-4.
PubMed 16035606

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ART Readiness in HIV-infected Pregnant Women: From Formative Qualitative Research to Individual Randomized Trial
ClinicalTrials.gov ID: NCT02459678
Acronym / sponsor ID: 13-3884
Conditions: Human Immunodeficiency Virus
Study type: Interventional
Recruitment status: Completed
Enrolment: 454 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Centre for Infectious Disease Research in Zambia, Centers for Disease Control and Prevention
Study start: May 2015 (actual)
Primary completion: 9 May 2018 (actual)
Study completion: 28 May 2018 (actual)
First posted: 2 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard of Care	Other	Other: Standard of CareThe 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.
Enhanced adherence package	Experimental	Behavioral: Enhanced Adherence PackageThe 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+.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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
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

Key exclusion criteria (7 listed)

Less than 18 years old
Known history of mental illness
Phase 2
Less than 18 years old
Known intrauterine fetal demise

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enhanced Adherence PackageThe 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.	Behavioural	Enhanced adherence package
Standard of CareCurrently, 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.	Other	Standard of Care

Primary outcome

Proportion of women who both initiate ART and are retained in care
Time frame: Within 30 days of eligibility 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.

2 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
BackgroundMillennium Development Goals Progress Report. 2011, Ministry of Finance and National Planning, UNDP: Lusaka.
BackgroundNational HIV/AIDS/STIs/TB Council, 2009 HIV Epidemiological Projections Report. 2009: Zambia.
BackgroundRepublic of Zambia Ministry of Health, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV, Directorate of Public Health and Research, Editor. 2010, Ministry of Health: Lusaka, Zambia.
BackgroundGovernment of the Republic of Zambia, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV/AIDS, M.o. Health, Editor. 2008: Lusaka.
Background: PubMed 26180894Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants: Recommendations for a Public Health Approach: 2010 Version. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK304944/
Background: PubMed 23446514Centers for Disease Control and Prevention (CDC). Impact of an innovative approach to prevent mother-to-child transmission of HIV--Malawi, July 2011-September 2012. MMWR Morb Mortal Wkly Rep. 2013 Mar 1;62(8):148-51.
BackgroundGovernment of the Republic of Zambia, Lifelong Antiretroviral Drugs (ARV's) for all HIV positive Pregnant Women in Zambia, M.o. Health, Editor. 2013: Lusaka.
BackgroundGovernment of the Republic of Zambia, Adult and Adolescent Antiretroviral Therapy Protocols, M.o. Health, Editor. 2010: Lusaka.
Background: PubMed 24469000Shaffer N, Abrams EJ, Becquet R. Option B+ for prevention of mother-to-child transmission of HIV in resource-constrained settings: great promise but some early caution. AIDS. 2014 Feb 20;28(4):599-601. doi: 10.1097/QAD.0000000000000144. No abstract available.
Background: PubMed 24468999Tenthani L, Haas AD, Tweya H, Jahn A, van Oosterhout JJ, Chimbwandira F, Chirwa Z, Ng'ambi W, Bakali A, Phiri S, Myer L, Valeri F, Zwahlen M, Wandeler G, Keiser O. Retention in care under universal antiretroviral therapy for HIV-infected pregnant and breastfeeding women ('Option B+') in Malawi. AIDS. 2014 Feb 20;28(4):589-598. doi: 10.1097/QAD.0000000000000143.
BackgroundUNAIDS. HIV and AIDS estimates 2009. [cited 2011 April 11]; Available from: http://www.unaids.org/en/regionscountries/countries/zambia/.
BackgroundZambia National HIV/AIDS/STI/TB Council, Zambia HIV Prevention Response and Modes of Transmission Analysis. 2009.
University of North Carolina websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mwangelwa Mubiana, MBChB principal investigator

Centre for Infectious Disease Research in Zambia

Benjamin Chi, MD principal investigator

University of North Carolina, Chapel Hill

Michael J Vinikoor, MD study director

Centre for Infectious Disease Research in Zambia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Adherence Package in people with Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 1 site in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of women who both initiate ART and are retained in care (time frame: Within 30 days of eligibility to begin ART under Option B+ policy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02459678, which also lists 66 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.