N/A
N=341
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
HIV
Bottom Line
View on ClinicalTrials.gov: NCT04124536 ↗Enrolled (actual)
341
Serious AEs
0.3%
Results posted
May 2021
Primary outcome: Primary: Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility — 3; 15; 3; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIV self-testing with partner notification. (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility |
3; 15; 3; 33 | — |
| SECONDARY Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility |
1; 4; 0; 9 | — |
| SECONDARY Number of Participants Reporting Social Harms |
0; 1; 0; 0 | — |
| SECONDARY Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative) |
9; 13; 10; 15 | — |
| SECONDARY Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) |
6; 4; 5; 3; 9; NA | — |
Summary
The overall objective of this study is to evaluate whether the addition of secondary distribution HIV self-test kits to existing partner notification guidelines increases the proportion of male partners who access facility-based HIV testing services, when compared to the partner notification strategy alone
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- 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 express concerns about IPV or social harms as a result of participation during the screening process will not be included.
- Women who have previously enrolled in the study will not be permitted to enroll again.
Data sourced from ClinicalTrials.gov (NCT04124536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.