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Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda

NCT04122144 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 980

Last updated 2019-10-17

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

ENHANCED -SPS intervention

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

Sponsors & Collaborators

Principal Investigators

  • Jane Kabami, MPH · Makerere University

  • Moses Kamya, PhD · Makerere University

  • Phillipa Musoke, PhD · Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2021-09-19
Completion
2022-09-19

Countries

  • Uganda

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04122144 on ClinicalTrials.gov