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.

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Partner Notification Slip only; Other: Partner Notification Slip plus HIV Self-test kit

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • UNC Project Malawi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Partner Notification Slip only; Participants in this group receive standard of care (partner notification slip only)	Behavioral: Partner Notification Slip only; Partner Notification Slip only
Experimental: Partner Notification Slip plus HIV Self-test Kit; Participants in this group receive the experimental intervention (Partner Notification Slip plus HIV Self-test Kit)	Other: Partner Notification Slip plus HIV Self-test kit; Partner Notification Slip plus HIV Self-test kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Male Partners Who Reported to Clinic	within 30 days of their female partner enrollment into the study

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Maganizo B Chagomerana, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): August 17, 2021
• Study Completion (Actual): August 17, 2021

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV self-test; HIV testing uptake; HIV Testing in Male Partners
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 18-2227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 and continuing for 12 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes