Male Partner Engagement in HIV Testing Using Partner-notification Slip Plus Oral HIV Self-testing Kit

Assessing Male Partner Engagement in HIV Testing Using Partner-notification Slip Plus Oral HIV Self-testing Kit Among Male Partners of HIV-negative Pregnant Women.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07488221

Enrollment

200

Registered

2026-03-23

Start date

2019-10-08

Completion date

2021-08-17

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV self-test, HIV testing uptake, HIV Testing in Male Partners

Brief summary

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).

Interventions

OTHERPartner Notification Slip plus HIV Self-test kit

Partner Notification Slip plus HIV Self-test kit

BEHAVIORALPartner Notification Slip only

Partner Notification Slip only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Intervention model description

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).

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* HIV-negative pregnant woman * Must be available and willing to be contacted by phone within the next 30 days * Must be part of a heterosexual relationship for \>3 months * Must expects their male sexual partner to be able to come to clinic in the next 30 days

Exclusion criteria

* unable to provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Male Partners Who Reported to Clinic	within 30 days of their female partner enrollment into the study	Proportion of male partners who reported to clinic within days of their female partner's enrollment into the study.

Secondary

Measure	Time frame	Description
Time Taken for Male Partners to Report to Clinic	within 30 days from female partner enrollment into the study	Median time for partners who returned to the clinic within 30 days is reported.

Countries

Malawi

Contacts

PRINCIPAL_INVESTIGATORMaganizo B Chagomerana, PhD

University of North Carolina, Chapel Hill

Participant flow

Pre-assignment details

Although both female participants and male partners participated in the study, only female participants consented and were considered enrolled.

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	100 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	100 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment Malawi	100 Participants
Sex: Female, Male Female	100 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 100	0 / 100
other Total, other adverse events	0 / 100	0 / 100
serious Total, serious adverse events	0 / 100	0 / 100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026