Swaziland Safe Generations

HIV/AIDS Clinical Trial

Official title:

Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891799
• Other study ID #: AAAL0661
• Secondary ID: AID-OAA-A-12-000
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: February 8, 2018
• Start date: August 2013
• Est. completion date: October 30, 2016

Study information

• Verified date: February 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to understand how best to provide care and treatment services to human immunodeficiency virus (HIV) positive pregnant women and their babies in Swaziland. The study is designed to evaluate a new approach for Preventing Mother-to-Child Transmission (PMTCT)where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV) therapy regardless of their disease stage. The goal is to prevent delays in women accessing treatment for their own health and ensure that women and their children remain in care. This study will compare this new approach to PMTCT, known as Option B+, to Option A, which is the current standard of care for PMTCT in Swaziland. The study will be conducted at 10 health facilities in the Manzini and Lubombo regions in Swaziland. The study has three components: the main component is a PMTCT Options Evaluation where data from medical records will be abstracted on all HIV positive pregnant women attending antenatal services at the 10 selected study facilities; data will be abstracted on their HIV exposed infants as well. Other components of the study include a PMTCT Options Acceptability Evaluation using semi-structured questionnaires with PMTCT clients and health care workers (HCWs) as well as a cost effectiveness evaluation comparing costs under conditions of Option A and Option B+.

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:

1. 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

2. To compare Option A and Option B+ on the proportion of women and children retained in HIV care at 12, and 18 months postpartum

3. To examine patient and provider level acceptability of Option A and Option B+

4. To compare the cost-effectiveness of Option A and Option B+

Tertiary Objectives:

1. 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.

2. To compare Option A and Option B+ on maternal and child adherence as measured by prescriptions dispensed for maternal and infant antiretroviral medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2518
• Est. completion date: October 30, 2016
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Other:
• Option B+
Using one low toxicity triple ARV regimen [(tenofovir (TDF) + lamivudine/emtricitabine (3TC/FTC) + efavirenz (EFV)] for all women, rather than adapting regimens by CD4+ Engaging all pregnant and postpartum women and their infants in the structured appointment and follow-up system currently only available to women receiving ART Providing a simplified standardized public health approach both antenatally and postnatally, with adherence and retention support tailored to the particular health and social needs of peripartum women

Locations

Country	Name	City	State
Swaziland	Family Life Association Clinic	Manzini
Swaziland	King Soghuza II PHU	Manzini
Swaziland	Lamvelase Clinic	Manzini
Swaziland	Luyengo Clinic	Manzini
Swaziland	Mankayane PHU	Manzini
Swaziland	Mbabane Government Hospital	Manzini
Swaziland	Mbikhwakhe Clinic	Manzini
Swaziland	MSF Matsapha	Manzini
Swaziland	Raleigh Fitkin Memorial Hospital	Manzini
Swaziland	Good Shepherd Hospital	Siteki	Lubombo
Swaziland	Siphofaneni	Siteki	Lubombo
Swaziland	Siteki PHU	Siteki	Lubombo

Sponsors (6)

Lead Sponsor	Collaborator
Columbia University	Elizabeth Glaser Pediatric AIDS Foundation, Ministry of Health, Swaziland, National Emergency Response Council on HIV and AIDS (NERCHA), United States Agency for International Development (USAID), University of Cape Town

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of (1) infant HIV positive PCR at six months postpartum OR (2) mother lost to follow-up from at six months postpartum	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.	Up to 24 months
Secondary	Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy	ART Initiation During Pregnancy: Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy	Up to 24 months
Secondary	Proportion of women and children retained in HIV care at 12 and 18 months postpartum	Maternal/Infant Retention in Care: Proportion of women and children retained in HIV care at 12 and 18 months postpartum	Up to 24 months
Secondary	Duration of ART/ARV received prior to delivery	ART/ARV Duration: Duration of ART/ARV received prior to delivery	Up to 24 months