Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda

Study Overview
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Brief Summary
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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
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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

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: ENHANCED -SPS intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: . 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparative effectiveness cluster-randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>ENHANCED-SPS intervention implemented | Behavioral: ENHANCED -SPS intervention<br>* 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<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnant woman