Trial Outcomes & Findings for Male Partner Engagement in HIV Testing Using Partner-notification Slip Plus Oral HIV Self-testing Kit (NCT NCT07488221)
NCT ID: NCT07488221
Last Updated: 2026-06-11
Results Overview
Proportion of male partners who reported to clinic within days of their female partner's enrollment into the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
within 30 days of their female partner enrollment into the study
Results posted on
2026-06-11
Participant Flow
Although both female participants and male partners participated in the study, only female participants consented and were considered enrolled.
Participant milestones
| Measure |
Partner Notification Slip Only
Participants in this group receive standard of care (partner notification slip only)
Partner Notification Slip only: Partner Notification Slip only
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Male Partner Engagement in HIV Testing Using Partner-notification Slip Plus Oral HIV Self-testing Kit
Baseline characteristics by cohort
| Measure |
Partner Notification Slip Only
n=100 Participants
Participants in this group receive standard of care (partner notification slip only)
Partner Notification Slip only: Partner Notification Slip only
|
Partner Notification Slip Plus HIV Self-test Kit
n=100 Participants
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
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=20 Participants
|
100 Participants
n=20 Participants
|
200 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=20 Participants
|
100 Participants
n=20 Participants
|
200 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
100 Participants
n=20 Participants
|
100 Participants
n=20 Participants
|
200 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=20 Participants
|
100 Participants
n=20 Participants
|
200 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
Malawi
|
100 Participants
n=20 Participants
|
100 Participants
n=20 Participants
|
200 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: within 30 days of their female partner enrollment into the studyProportion of male partners who reported to clinic within days of their female partner's enrollment into the study.
Outcome measures
| Measure |
Partner Notification Slip Only
n=100 Participants
Participants in this group receive standard of care (partner notification slip only)
Partner Notification Slip only: Partner Notification Slip only
|
Partner Notification Slip Plus HIV Self-test Kit
n=100 Participants
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
|
|---|---|---|
|
Proportion of Male Partners Who Reported to Clinic
|
0.38 proportion of male partners
|
0.32 proportion of male partners
|
SECONDARY outcome
Timeframe: within 30 days from female partner enrollment into the studyMedian time for partners who returned to the clinic within 30 days is reported.
Outcome measures
| Measure |
Partner Notification Slip Only
n=100 Participants
Participants in this group receive standard of care (partner notification slip only)
Partner Notification Slip only: Partner Notification Slip only
|
Partner Notification Slip Plus HIV Self-test Kit
n=100 Participants
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
|
|---|---|---|
|
Time Taken for Male Partners to Report to Clinic
|
7 days
Interval 3.0 to 19.0
|
7 days
Interval 4.0 to 15.0
|
Adverse Events
Partner Notification Slip Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Partner Notification Slip Plus HIV Self-test Kit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maganizo Chagomerana, PhD
University of North Carolina at Chapel Hill
Phone: 265996457968
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place