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

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

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.

Study Overview

• Status: Unknown
• Conditions: HIV
• Intervention / Treatment: Behavioral: ENHANCED -SPS intervention

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 Type: Interventional
• Enrollment (Anticipated): 980
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Mbarara
    • Kampala, Mbarara, Uganda, +256
      • Recruiting
      • Jane Kabami
      • Contact: Jane Kabami; Phone Number: 0776411044; Email: kabajane@yahoo.com
      • Contact: Elizabeth Arinitwe, BNSc; Phone Number: +256752900542; Email: lizarinitwe10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; ENHANCED-SPS intervention implemented	Behavioral: ENHANCED -SPS intervention; 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
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: Makerere University
• Collaborators: University of California, San Francisco; Infectious Diseases Research Collaboration, Uganda
• Investigators: Principal Investigator: Jane Kabami, MPH, Makerere University; Principal Investigator: Moses Kamya, PhD, Makerere University; Principal Investigator: Phillipa Musoke, PhD, Makerere University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Anticipated): September 19, 2021
• Study Completion (Anticipated): September 19, 2022

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: pregnant woman
• Other Study ID Numbers: REC REF 2018-074; HS 2648 (Other Identifier: Uganda national council of science and technology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No