Adults 18 to 50, female only, with HIV. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare FacilityPrimary· Enrollment - 30 days post enrollment of study participant
The number of participants who report their primary male partners getting tested for HIV at a healthcare facility when presented with partner notification plus secondary distribution of HIV self-test kits compared to partner notification alone
Group
Value
95% CI
HIV-Positive Intervention
3
HIV-Positive Control
15
HIV-Negative Intervention
3
HIV-Negative Control
33
Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare FacilitySecondary· Enrollment - 30 days post enrollment of study participant
The number of couples getting tested for HIV when presented with partner notification plus secondary distribution of HIV self-test kits will be compared to partner notification alone.
Group
Value
95% CI
HIV-Positive Intervention
1
HIV-Positive Control
4
HIV-Negative Intervention
0
HIV-Negative Control
9
Number of Participants Reporting Social HarmsSecondary· Enrollment - 30 days post enrollment of study participant
The number of participants reporting social harms associated with the HIV testing approaches. Participants were asked about social harms related to trial participation, including perceived stigma, discrimination, and intimate partner violence.
Group
Value
95% CI
HIV-Positive Intervention
0
HIV-Positive Control
1
HIV-Negative Intervention
0
HIV-Negative Control
0
Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)Secondary· 6 months after the start of enrollment
To gain deeper insights about the feasibility of male partner HIV testing strategies, healthcare workers from the study site were asked to participate in in-depth interviews. Participating healthcare workers were involved in different aspects of male partner HIV testing and included study staff members. Feasibility was defined as a positive rating about the intervention's potential performance in real-life conditions at the clinic and community levels.
Feasibility of partner notification for HIV-positive women
Group
Value
95% CI
Healthcare Workers
9
Feasibility of partner notification for HIV-negative women
Group
Value
95% CI
Healthcare Workers
13
Feasibility of HIV self-testing for HIV-positive women
Group
Value
95% CI
Healthcare Workers
10
Feasibility of HIV self-testing for HIV-negative women
Group
Value
95% CI
Healthcare Workers
15
Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)Secondary· In the first two months of enrollment
To gain deeper insights about the acceptability of the different male partner HIV testing strategies, subsamples of participants were selected based on study arm (intervention vs. control) and woman's HIV status (positive vs. negative). For the outcome measure, acceptability was defined as a positive rating of male partner HIV testing strategies from participants based on their experiences.
Acceptability of partner notification
Group
Value
95% CI
HIV-Positive Intervention
6
HIV-Positive Control
4
HIV-Negative Intervention
5
HIV-Negative Control
3
Acceptability of HIV self-testing
Group
Value
95% CI
HIV-Positive Intervention
9
HIV-Positive Control
NA
HIV-Negative Intervention
8
HIV-Negative Control
NA
Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any VenueSecondary· Enrollment - 30 days post enrollment of study participant
The number of participants who report their primary male partners getting tested for HIV at any venue when presented with partner notification plus secondary distribution of HIV self-test kits (SD-HIVST) compared to partner notification alone
Group
Value
95% CI
HIV-Positive Intervention
36
HIV-Positive Control
19
HIV-Negative Intervention
80
HIV-Negative Control
54
Adverse events — posted to ClinicalTrials.gov
Time frame: From study enrollment through follow-up, a total of approximately 30 -90 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 21 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04124536.