Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda

Not Applicable

• Conditions: HIV
• Interventions: Behavioral: ENHANCED -SPS intervention

• Registration Number: NCT04122144
• Lead Sponsor: Makerere University

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.

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

Study Timeline

• Study Start: 2019-09-19
• Status Verified: 2019-10
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Last Update Submitted: 2019-10-16
• Last Update Posted: 2019-10-17
• Primary Completion: 2021-09-19
• Study Completion: 2022-09-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 980

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	ENHANCED -SPS intervention	ENHANCED-SPS intervention implemented

Primary Outcome Measures

Name	Time	Method
Viral suppression	1 year	The proportion of women with HIV-1 RNA suppression at 12 months of follow up to assess the effect of the intervention
Retention in care	18 months	The proportion of women still in care at at 12 and 18 months postpartum

Secondary Outcome Measures

Name	Time	Method
Mother to child transmission rate	18 months	The proportion of HIV free children born to the HIV positive mothers enrolled in the study at 18 months of follow up.

Trial Locations

Locations (1)

Jane Kabami; 🇺🇬 Kampala, Mbarara, Uganda