NCT02295800

Brief Summary

The study design includes an observational prospective cohort of HIV-positive pregnant/postpartum women and their infants enrolled during antenatal clinics (or immediately postpartum) from prevention of mother-to-child transmission (PMTCT) programs and followed until the infants reach the age of 18 - 24 months and semi-structure interviews with a sub-set of these women. A second study component involves semi-structured interviews with health care workers (HCW) involved in the PMTCT programs and yearly facility surveys at the selected study facilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 4, 2018

Status Verified

November 1, 2014

Enrollment Period

3.1 years

First QC Date

October 15, 2014

Last Update Submit

January 2, 2018

Conditions

Mother-to-child HIV Transmission

Keywords

HIVPMTCTAntenatal Care

Outcome Measures

Primary Outcomes (1)

  • 18 - 24 month HIV-free survival of children born to HIV-positive pregnant women

    18 - 24 months

Secondary Outcomes (3)

  • HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages

    18 - 24 months

  • Infants and young children breastfed (exclusive or any breastfeeding) at various ages

    18 - 24 months

  • Adherence to the universal antiretroviral therapy (ARV) regimen among pregnant and postpartum women (Option B+) and their HIV-exposed children, including the proportion of study women with HIV RNA < 1000 copies/ml or > 2 log10 copies/mL decrease in viral

    18 - 24 months

Study Arms (3)

Mothers

HIV Infected mothers

Other: Standard of careOther: Semi-structured interviews

Infants

HIV exposed infants

Other: Standard of care

Healthcare workers

Facility based healthcare workers

Other: Semi-structured interviews

Interventions

Standard of careOTHER
InfantsMothers
Semi-structured interviewsOTHER
Healthcare workersMothers

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women identified as HIV infected during antenatal care and receiving PMTCT services (regardless of ARV regimen received) in the selected antenatal clinics in Kigali, Rwanda are eligible for study enrollment. The infants born to enrolled study women during the study pregnancy will also be study participants up to the age of 18 - 24 months.

You may qualify if:

  • Documented HIV infection
  • Pregnant, in the last trimester of pregnancy or within two weeks post-delivery.
  • Participation in the PMTCT program during antenatal care at one of the study sites
  • Planning on remaining in the Kigali area after delivery
  • Able and willing to give informed consent for study participation for herself and her infant(s).
  • If a pregnant woman is less than 18 years of age and still living with her parents, informed consent will also be required from one of her parents

You may not qualify if:

  • Women not willing to provide informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elizabeth Glaser Pediatric AIDS Foundation

Kigali, BP 2788, Rwanda

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma specimens collected from the adult participants at the time of viral load testing and dried blood spot (DBS) specimens drawn from the infant participants.

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Emily A. Bobrow, PhD, MPH

    Elizabeth Glaser Pediatric AIDS Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2014

First Posted

November 20, 2014

Study Start

April 1, 2013

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

January 4, 2018

Record last verified: 2014-11

Locations

RW(1)