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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04122144
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 17, 2019
Infectious Diseases Research Collaboration, Uganda
University of California, San Francisco
Information provided by (Responsible Party):
Makerere University

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: ENHANCED -SPS intervention Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparative effectiveness cluster-randomized trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Enhanced Viral Load Counseling and Standardized Peer Mother Support Study (ENHANCED-SPS)
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : September 19, 2021
Estimated Study Completion Date : September 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.

Primary Outcome Measures :
  1. Viral suppression [ Time Frame: 1 year ]
    The proportion of women with HIV-1 RNA suppression at 12 months of follow up to assess the effect of the intervention

  2. Retention in care [ Time Frame: 18 months ]
    The proportion of women still in care at at 12 and 18 months postpartum

Secondary Outcome Measures :
  1. Mother to child transmission rate [ Time Frame: 18 months ]
    The proportion of HIV free children born to the HIV positive mothers enrolled in the study at 18 months of follow up.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04122144

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Contact: Jane Kabami, MPH +256776411044
Contact: Moses Kamya, PhD +256752900012

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Jane Kabami Recruiting
Kampala, Mbarara, Uganda, +256
Contact: Jane Kabami    0776411044   
Contact: Elizabeth Arinitwe, BNSc    +256752900542   
Sponsors and Collaborators
Makerere University
Infectious Diseases Research Collaboration, Uganda
University of California, San Francisco
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Principal Investigator: Jane Kabami, MPH Makerere University
Principal Investigator: Moses Kamya, PhD Makerere University
Principal Investigator: Phillipa Musoke, PhD Makerere University

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Responsible Party: Makerere University Identifier: NCT04122144     History of Changes
Other Study ID Numbers: REC REF 2018-074
HS 2648 ( Other Identifier: Uganda national council of science and technology )
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Makerere University:
pregnant woman