Clinical trial NCT04122144: Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda
Official title: Enhanced Viral Load Counseling and Standardized Peer Mother Support Study (ENHANCED-SPS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: pregnant woman
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Research Collaboration, Uganda
name: University of California, San Francisco
First posted: 2019-10-10
Enrollment: 980
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative effectiveness cluster-randomized trial
Primary purpose: OTHER

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

Eligibility 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

Primary outcomes:
measure: Viral suppression
timeFrame: 1 year
measure: Retention in care
timeFrame: 18 months
Secondary outcomes:
measure: Mother to child transmission rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Jane Kabami
state: Mbarara
Study officials:
affiliation: Makerere University
name: Jane Kabami, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Moses Kamya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Phillipa Musoke, PhD
role: PRINCIPAL_INVESTIGATOR
References: