NCT01891799

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+.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,518

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

3.2 years

First QC Date

June 28, 2013

Last Update Submit

February 8, 2018

Conditions

HIV/AIDS

Keywords

HIV/AIDSPMTCTOption B+Swaziland

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy

    Up to 24 months

  • Proportion of women and children retained in HIV care at 12 and 18 months postpartum

    Up to 24 months

  • Duration of ART/ARV received prior to delivery

    Up to 24 months

Study Arms (1)

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+

Interventions

Option B+OTHER

* 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

PMTCT Options Evaluation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Women already on ART when entering ANC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Good Shepherd Hospital

Siteki, Lubombo Region, Eswatini

Location

Siphofaneni

Siteki, Lubombo Region, Eswatini

Location

Siteki PHU

Siteki, Lubombo Region, Eswatini

Location

Family Life Association Clinic

Manzini, Eswatini

Location

King Soghuza II PHU

Manzini, Eswatini

Location

Lamvelase Clinic

Manzini, Eswatini

Location

Luyengo Clinic

Manzini, Eswatini

Location

Mankayane PHU

Manzini, Eswatini

Location

Mbabane Government Hospital

Manzini, Eswatini

Location

Mbikhwakhe Clinic

Manzini, Eswatini

Location

MSF Matsapha

Manzini, Eswatini

Location

Raleigh Fitkin Memorial Hospital

Manzini, Eswatini

Location

Related Publications (1)

  • 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.

    PMID: 30940149DERIVED

Biospecimen

Retention: NONE RETAINED

50 microliters of capillary blood will be drawn via heelstick or finger prick phlebotomy from infants using filter paper. Blood will be collected from infants at 6mos of age to conduct DNA PCR HIV testing, specifically for this study.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Elaine J Abrams, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology

Study Record Dates

First Submitted

June 28, 2013

First Posted

July 3, 2013

Study Start

August 1, 2013

Primary Completion

October 30, 2016

Study Completion

October 30, 2016

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

ES(12)