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HIV testing uptake among male partners of pregnant women remains low. But the optimal way to engage the male partners is unknown. The antenatal setting, with nearly universal uptake of HIV testing for women, can serve as a way of reaching male partners. HIV self-testing (HIVST) is one approach to HIV testing that can be conducted out of health facility. HIVST is a rapid antibody test which can be performed by non-medical people and allows people to collect their own specimen, perform the test, and interpret the results in the privacy of their home or other preferred location. In this trial HIV-negative pregnant women who were attending antenatal care at Bwaila Hospital in Malawi will be randomized 1:1 to receive partner notification inviting their partners for clinic-based HIV testing (standard of care) or partner notification + HIV Self-test kit for partner testing at home (intervention).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partner Notification Slip only | Active Comparator | Participants in this group receive standard of care (partner notification slip only) |
|
| Partner Notification Slip plus HIV Self-test Kit | Experimental | Participants in this group receive the experimental intervention (Partner Notification Slip plus HIV Self-test Kit) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partner Notification Slip plus HIV Self-test kit | Other | Partner Notification Slip plus HIV Self-test kit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Male Partners Who Reported to Clinic | Proportion of male partners who reported to clinic within days of their female partner's enrollment into the study. | within 30 days of their female partner enrollment into the study |
| Measure | Description | Time Frame |
|---|---|---|
| Time Taken for Male Partners to Report to Clinic | Median time for partners who returned to the clinic within 30 days is reported. | within 30 days from female partner enrollment into the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maganizo B Chagomerana, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Project Malawi | Lilongwe | Malawi |
Deidentified individual data that supports the results will be shared beginning 6 to 12 months following publication provided the investigator who proposes to use the data has approval form an Institutional Review Board (IRB), Independent Ethics committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Beginning 6 and continuing for 12 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC
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Although both female participants and male partners participated in the study, only female participants consented and were considered enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Partner Notification Slip Only | Participants in this group receive standard of care (partner notification slip only) Partner Notification Slip only: Partner Notification Slip only |
| FG001 | Partner Notification Slip Plus HIV Self-test Kit | Participants in this group receive the experimental intervention (Partner Notification Slip plus HIV Self-test Kit) Partner Notification Slip plus HIV Self-test kit: Partner Notification Slip plus HIV Self-test kit |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Partner Notification Slip Only | Participants in this group receive standard of care (partner notification slip only) Partner Notification Slip only: Partner Notification Slip only |
| BG001 | Partner Notification Slip Plus HIV Self-test Kit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Male Partners Who Reported to Clinic | Proportion of male partners who reported to clinic within days of their female partner's enrollment into the study. | Posted | Number | proportion of male partners | within 30 days of their female partner enrollment into the study |
|
From the time of signing informed consent through Day 30, a total of up to 30 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Partner Notification Slip Only | Participants in this group receive standard of care (partner notification slip only) Partner Notification Slip only: Partner Notification Slip only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maganizo Chagomerana, PhD | University of North Carolina at Chapel Hill | 265996457968 | mchagomerana@unclilongwe.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2019 | Mar 27, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2019 | Mar 11, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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HIV-negative pregnant women will be randomized 1:1 to receive partner notification clip inviting their partners for clinic-based HIV testing (standard of care ) or partner notification slip + HIV Self-test kit for partner testing at home (intervention).
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| Partner Notification Slip only | Behavioral | Partner Notification Slip only |
|
Participants in this group receive the experimental intervention (Partner Notification Slip plus HIV Self-test Kit) Partner Notification Slip plus HIV Self-test kit: Partner Notification Slip plus HIV Self-test kit |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Time Taken for Male Partners to Report to Clinic | Median time for partners who returned to the clinic within 30 days is reported. | Posted | Median | Inter-Quartile Range | days | within 30 days from female partner enrollment into the study |
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|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Partner Notification Slip Plus HIV Self-test Kit | Participants in this group receive the experimental intervention (Partner Notification Slip plus HIV Self-test Kit) Partner Notification Slip plus HIV Self-test kit: Partner Notification Slip plus HIV Self-test kit | 0 | 100 | 0 | 100 | 0 | 100 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |