NCT04122144

Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda

Enhanced Viral Load Counseling and Standardized Peer Mother Support Study (ENHANCED-SPS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 980 (estimated)
• Sponsor: Makerere University · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The Investigators will test the hypothesis that the Enhanced viral load (VL) counseling and standardized peer mother support (ENHANCED-SPS) intervention will increase viral load suppression among HIV-infected pregnant and post-partum women and increase retention of mothers in care hence resulting in reduced risk of vertical transmission in south western Uganda. Specific objectives are as follows: 1\) To evaluate the effectiveness of an enhanced VL counseling and standardized peer mother support intervention on viral suppression among HIV infected pregnant women at 12 months of follow up; 2) To evaluate the effect of the enhanced counseling and peer support intervention on retention in care at 18 months postpartum follow up; The investigators will randomize 14 HIV clinics to the ENHANCED-SPS multi-component intervention vs. standard of care procedures (intervention=7 clinics and control=7 clinics,n=70 mothers/health facility) ;3) To assess the facilitators and barriers of VL and enhanced VL counseling and peer mother support intervention at 9 \& 18 months of follow up.This will consider both patient and providers perspectives of the intervention implementation

Conditions

• HIV

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-09-19
• Primary completion: 2021-09-19
• Completion: 2022-09-19
• First posted: 2019-10-10
• Last updated: 2019-10-17

Locations

1 site across 1 country: Uganda