Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda (ENHANCED-SPS)

Makerere University

Status: Unknown

Conditions: HIV

Treatments: Behavioral: ENHANCED -SPS intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04122144

HS 2648 (Other Identifier)

REC REF 2018-074

Details and patient eligibility

About

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.

Full 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

Enrollment: 980 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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980 participants in 2 patient groups

Intervention

Experimental group

Description:

ENHANCED-SPS intervention implemented

Treatment:

Behavioral: ENHANCED -SPS intervention

Control

No Intervention group

Description:

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.