- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01891799
Swaziland Safe Generations
Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women
Study Overview
Detailed Description
Purpose:
"Situkulwane Lesiphephile-Safe Generations" is an implementation science research study designed to evaluate an innovative PMTCT strategy that includes a modified Option B approach, where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV) therapy independent of CD4+ count (Option B+) and all HIV positive pregnant and postpartum women and their infants are engaged in the same structured appointment and follow-up protocols currently available only to women receiving antiretroviral therapy (ART). The study hypothesizes that this single, uniform and streamlined treatment and retention approach for all HIV positive pregnant women will eliminate delays, prevent losses and will: (1) result in a higher proportion of mothers and infants successfully completing the PMTCT cascade and fewer new pediatric infections; (2) lead to a higher proportion of ART-eligible women initiating triple ART earlier in pregnancy; (3) will be more feasible to implement; 4) have greater acceptability among staff and patients; and 5) will be more cost-effective compared to Option A.
Design:
Stepped wedge design at 10 health facilities with one facility transitioning from Option A to the Option B+ approach every month over 12 months. Outcome measures will be compared under Option A and Option B+ conditions for all sites as well as before and after the transition at each site. Routinely collected data from facility registers and medical records will be abstracted to determine study outcomes. In addition, two purposely selected cohorts of (1)120 PMTCT clients and; (2) approximately 50 health care workers will complete questionnaires at repeated time points to assess acceptability of Option A and Option B+ approaches.
Study Population:
All HIV positive pregnant women not on ART engaging in PMTCT services at the study sites will be part of the PMTCT Options Evaluation. This will include HIV+ women not on ART enrolling in PMTCT services and pregnant women newly testing HIV+ in the absolute neutrophil count (ANC). A subset of HIV+ pregnant women not on ART engaging in PMTCT services and health care workers providing PMTCT services at the study sites will be enrolled in an acceptability evaluation.
Study Size:
A total of approximately 2,600 HIV positive pregnant women enrolled in PMTCT services at ten Ministry of Health (MOH) facilities.
Primary Objective:
To compare the impact of implementing Option A and Option B+ on the composite endpoint of infant HIV-positive polymerase chain reaction (PCR) at 6 months postpartum or maternal loss to follow-up at 6 months postpartum.
Secondary Objectives:
- To compare Option A and Option B+ on proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy and on duration of ART received prior to delivery for ART-eligible pregnant women
- To compare Option A and Option B+ on the proportion of women and children retained in HIV care at 12, and 18 months postpartum
- To examine patient and provider level acceptability of Option A and Option B+
- To compare the cost-effectiveness of Option A and Option B+
Tertiary Objectives:
- To determine pregnancy and infant outcomes (including fetal losses, neonatal death, birth weight and gestational age) among HIV+ pregnant women receiving PMTCT and compare outcomes by maternal ARV regimens.
- To compare Option A and Option B+ on maternal and child adherence as measured by prescriptions dispensed for maternal and infant antiretroviral medications.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Manzini, Swaziland
- Family Life Association Clinic
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Manzini, Swaziland
- King Soghuza II PHU
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Manzini, Swaziland
- Lamvelase Clinic
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Manzini, Swaziland
- Luyengo Clinic
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Manzini, Swaziland
- Mankayane PHU
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Manzini, Swaziland
- Mbabane Government Hospital
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Manzini, Swaziland
- Mbikhwakhe Clinic
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Manzini, Swaziland
- MSF Matsapha
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Manzini, Swaziland
- Raleigh Fitkin Memorial Hospital
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Lubombo
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Siteki, Lubombo, Swaziland
- Good Shepherd Hospital
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Siteki, Lubombo, Swaziland
- Siphofaneni
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Siteki, Lubombo, Swaziland
- Siteki PHU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women at least 18 years of age
- Documented pregnancy (per routine ANC protocol in this setting)
- Documented HIV-infection (per routine ANC protocol in this setting)
- Infants born to eligible and enrolled women
Exclusion Criteria:
• Women already on ART when entering ANC
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PMTCT Options Evaluation
All HIV positive pregnant women not on ART engaging in PMTCT services at the study sites will be included.
This will include HIV+ women not on ART enrolling in PMTCT services and pregnant women newly testing HIV+ in the ANC.
All women will eventually receive the intervention of Option B+ as each clinic transitions from Option A to B+.
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of (1) infant HIV positive PCR at six months postpartum OR (2) mother lost to follow-up from at six months postpartum
Time Frame: Up to 24 months
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Combined maternal-child endpoint: The primary outcome will be measured on all HIV+ pregnant women not on ART at their first ANC visit at a participating study site, approximately 2600 women(becoming mother-infant pairs postpartum).
This includes women entering PMTCT with known HIV+ status, not on ART, and women testing HIV+ on entry into ANC.
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Up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy
Time Frame: Up to 24 months
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ART Initiation During Pregnancy: Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy
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Up to 24 months
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Proportion of women and children retained in HIV care at 12 and 18 months postpartum
Time Frame: Up to 24 months
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Maternal/Infant Retention in Care: Proportion of women and children retained in HIV care at 12 and 18 months postpartum
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Up to 24 months
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Duration of ART/ARV received prior to delivery
Time Frame: Up to 24 months
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ART/ARV Duration: Duration of ART/ARV received prior to delivery
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Up to 24 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- AAAL0661
- AID-OAA-A-12-000020 (OTHER_GRANT: USAID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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