Clinical trial NCT01891799: Swaziland Safe Generations
Official title: Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Keywords: HIV/AIDS
PMTCT
Option B+
Swaziland
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Ministry of Health, Swaziland
name: University of Cape Town
name: Elizabeth Glaser Pediatric AIDS Foundation
name: National Emergency Response Council on HIV and AIDS (NERCHA)
First posted: 2013-07-03
Enrollment: 2518
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for the PMTCT Options Evaluation is all HIV+ pregnant women not on ART at their first ANC visit at the 10 study facilities. A total of approximately 2600 mother-infant pairs (2600 HIV positive women + 2600 of their HIV exposed babies) will be observed.

Brief 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+.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of (1) infant HIV positive PCR at six months postpartum OR (2) mother lost to follow-up from at six months postpartum
timeFrame: Up to 24 months
Secondary outcomes:
measure: Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy
timeFrame: Up to 24 months
measure: Proportion of women and children retained in HIV care at 12 and 18 months postpartum
timeFrame: Up to 24 months
measure: Duration of ART/ARV received prior to delivery
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Siteki
country: Swaziland
facility: Good Shepherd Hospital
state: Lubombo
city: Siteki
country: Swaziland
facility: Siphofaneni
state: Lubombo
city: Siteki
country: Swaziland
facility: Siteki PHU
state: Lubombo
city: Manzini
country: Swaziland
facility: Family Life Association Clinic
city: Manzini
country: Swaziland
facility: King Soghuza II PHU
city: Manzini
country: Swaziland
facility: Lamvelase Clinic
city: Manzini
country: Swaziland
facility: Luyengo Clinic
city: Manzini
country: Swaziland
facility: Mankayane PHU
city: Manzini
country: Swaziland
facility: Mbabane Government Hospital
city: Manzini
country: Swaziland
facility: Mbikhwakhe Clinic
city: Manzini
country: Swaziland
facility: MSF Matsapha
city: Manzini
country: Swaziland
facility: Raleigh Fitkin Memorial Hospital
Study officials:
affiliation: Columbia University
name: Elaine J Abrams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DiCarlo AL, Gachuhi AB, Mthethwa-Hleta S, Shongwe S, Hlophe T, Peters ZJ, Zerbe A, Myer L, Langwenya N, Okello V, Sahabo R, Nuwagaba-Biribonwoha H, Abrams EJ. Healthcare worker experiences with Option B+ for prevention of mother-to-child HIV transmission in eSwatini: findings from a two-year follow-up study. BMC Health Serv Res. 2019 Apr 2;19(1):210. doi: 10.1186/s12913-019-3997-1.