Swaziland Safe Generations
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|ClinicalTrials.gov Identifier: NCT01891799|
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : February 12, 2018
|Condition or disease||Intervention/treatment|
|HIV/AIDS||Other: Option B+|
Hide Detailed Description
"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.
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.
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.
A total of approximately 2,600 HIV positive pregnant women enrolled in PMTCT services at ten Ministry of Health (MOH) facilities.
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.
- 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+
- 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 :||Observational|
|Actual Enrollment :||2518 participants|
|Official Title:||Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||October 30, 2016|
|Actual Study Completion Date :||October 30, 2016|
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+.
Other: Option B+
- 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 ]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.
- Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy [ Time Frame: Up to 24 months ]ART Initiation During Pregnancy: Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy
- Proportion of women and children retained in HIV care at 12 and 18 months postpartum [ Time Frame: Up to 24 months ]Maternal/Infant Retention in Care: Proportion of women and children retained in HIV care at 12 and 18 months postpartum
- Duration of ART/ARV received prior to delivery [ Time Frame: Up to 24 months ]ART/ARV Duration: Duration of ART/ARV received prior to delivery
Biospecimen Retention: None Retained
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): NCT01891799
|Good Shepherd Hospital|
|Siteki, Lubombo, Swaziland|
|Siteki, Lubombo, Swaziland|
|Siteki, Lubombo, Swaziland|
|Family Life Association Clinic|
|King Soghuza II PHU|
|Mbabane Government Hospital|
|Raleigh Fitkin Memorial Hospital|
|Principal Investigator:||Elaine J Abrams, MD||Columbia University|