NCT04122144

Brief Summary

The ENHANCED -SPS study is a before and after cluster randomized trial that will be conducted in 14 public health facilities providing HIV care in Southwestern Uganda. The study will evaluate the effectiveness of a multi-component intervention package that targets barriers to achieving optimal viral suppression among pregnant and postpartum women infected with HIV. This will be in two phases; In Phase 1 ("Before"), all 14 clinics will have a baseline assessment of standard of care VL procedures and assess the barriers and facilitators to viral suppression for a period of 3 months. In Phase 2 ("After"), 7 clinics randomized to control arm will continue to experience standard of care counseling procedures, and 7 clinics randomized to intervention will initiate the ENHANCE-PS intervention. The Phase 2 ("After") phase I will last at least 12 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
980

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

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

September 19, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2022

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 8, 2019

Last Update Submit

October 16, 2019

Conditions

HIV

Keywords

pregnant woman

Outcome Measures

Primary Outcomes (2)

  • Viral suppression

    The proportion of women with HIV-1 RNA suppression at 12 months of follow up to assess the effect of the intervention

    1 year

  • Retention in care

    The proportion of women still in care at at 12 and 18 months postpartum

    18 months

Secondary Outcomes (1)

  • Mother to child transmission rate

    18 months

Study Arms (2)

Intervention

EXPERIMENTAL

ENHANCED-SPS intervention implemented

Behavioral: ENHANCED -SPS intervention

Control

NO INTERVENTION

Standard of care maintained. These are procedures conducted during the routine HIV care visits at the health facilities include ART card documentation as required, general/routine counseling, and adherence counseling to the non suppressors, ART drug supply based on the clinicians prescription and laboratory monitoring.

Interventions

ENHANCED -SPS interventionBEHAVIORAL

a) Enhanced VL counseling: Explanation of VL \& Importance of VL suppression,assessment of adherence, counseling based on VL result and schedule for next VL testing and the role of VL and the MTCT risk; b).Standardized peer mother support: includes training of peer mothers on mandatory enhanced VL counseling during the routine peer counseling and education, follow up of mothers and continued adherence counseling and disclosure support and bi-weekly phone calls to mothers to provide VL counseling and follow up

Intervention

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All Pregnant women and breastfeeding mothers enrolled in the mother baby care points/HIV clinics with documented HIV infection
  • HIV infected Pregnant women reporting for their first ANC within the study clinics or newly identified HIV positive mothers from the ANC clinics/breastfeeding

You may not qualify if:

  • All women who will be critically ill and unable to communicate
  • Those not willing to consent to participate in the study
  • Women who will not be able to understand all information concerning the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jane Kabami

Kampala, Mbarara, +256, Uganda

RECRUITING

Study Officials

  • Jane Kabami, MPH

    Makerere University

    PRINCIPAL INVESTIGATOR

  • Moses Kamya, PhD

    Makerere University

    PRINCIPAL INVESTIGATOR

  • Phillipa Musoke, PhD

    Makerere University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Kabami, MPH

CONTACT

+256776411044kabajane@yahoo.com

Moses Kamya, PhD

CONTACT

+256752900012mkamya@infocom.co.ug

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Comparative effectiveness cluster-randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

September 19, 2019

Primary Completion

September 19, 2021

Study Completion

September 19, 2022

Last Updated

October 17, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)