Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda

Makerere University980 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

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

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Viral suppression

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

Time frame: 1 year

Retention in care

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

Time frame: 18 months

Secondary Outcomes

Mother to child transmission rate

The proportion of HIV free children born to the HIV positive mothers enrolled in the study at 18 months of follow up.