Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
NCT ID: NCT04124536
Last Updated: 2021-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
341 participants
INTERVENTIONAL
2019-09-03
2020-09-07
Brief Summary
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Detailed Description
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HIV-positive and HIV-negative pregnant women will be randomized to one of two groups: partner notification alone or partner notification plus secondary distribution of HIV self-test kits. Women will return to the clinic 30 days after enrollment for an exit visit during which time information about their experience with the partner notification strategies will be collected.
A random sample of women and health care workers will also participate in qualitative interviews.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Intervention
In addition to standard partner notification services, the intervention arm will receive HIV self-test kits and structured counseling about HIVST, regardless of HIV status.
HIV self-testing with partner notification.
HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm, regardless of HIV status.
Control
Standard partner notification services, regardless of HIV status.
No interventions assigned to this group
Interventions
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HIV self-testing with partner notification.
HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm, regardless of HIV status.
Eligibility Criteria
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Inclusion Criteria
* Pregnant at time of enrollment based on antenatal record
* Documented HIV status (either positive or negative) in antenatal record
* Reports at least one current sexual partner
* Willingness to provide her own contact information
* Ability and willingness to provide informed consent
* Intent to remain in current geographical area of residence for the duration of follow-up activities
* Willingness to adhere to study procedures
Exclusion Criteria
* Women who have previously enrolled in the study will not be permitted to enroll again.
18 Years
50 Years
FEMALE
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Ben Chi, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Chipata Health Centre
Lusaka, , Zambia
Countries
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References
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Mutale W, Freeborn K, Graybill LA, Lusaka MM, Mollan KR, Mweemba O, Kasaro M, Lungu R, Kumwenda A, Saidi F, Powers KA, Maman S, Rosenberg NE, Chi BH. Addition of HIV self-test kits to partner notification services to increase HIV testing of male partners of pregnant women in Zambia: two parallel randomised trials. Lancet Glob Health. 2021 Dec;9(12):e1719-e1729. doi: 10.1016/S2214-109X(21)00393-4. Epub 2021 Nov 1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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19-0276
Identifier Type: -
Identifier Source: org_study_id
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