Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda
NCT ID: NCT04122144
Last Updated: 2019-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
980 participants
INTERVENTIONAL
2019-09-19
2022-09-19
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention
ENHANCED-SPS intervention implemented
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
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.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
15 Years
45 Years
FEMALE
Yes
Sponsors
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Infectious Diseases Research Collaboration, Uganda
OTHER
University of California, San Francisco
OTHER
Makerere University
OTHER
Responsible Party
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Principal Investigators
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Jane Kabami, MPH
Role: PRINCIPAL_INVESTIGATOR
Makerere University
Moses Kamya, PhD
Role: PRINCIPAL_INVESTIGATOR
Makerere University
Phillipa Musoke, PhD
Role: PRINCIPAL_INVESTIGATOR
Makerere University
Locations
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Jane Kabami
Kampala, Mbarara, Uganda
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS 2648
Identifier Type: OTHER
Identifier Source: secondary_id
REC REF 2018-074
Identifier Type: -
Identifier Source: org_study_id
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