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

NCT07488221 | Completed Results

• 1 other identifier: 18-2227
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Male Partners Who Reported to Clinic

  within 30 days of their female partner enrollment into the study

Secondary Outcomes (1)

• Time Taken for Male Partners to Report to Clinic

  within 30 days from female partner enrollment into the study

Study Arms (2)

Partner Notification Slip only

ACTIVE COMPARATOR

Participants in this group receive standard of care (partner notification slip only)

Behavioral: 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)

Other: Partner Notification Slip plus HIV Self-test kit

Interventions

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

Partner Notification Slip only BEHAVIORAL

Partner Notification Slip only

Partner Notification Slip only

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to provide informed consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Project Malawi

Lilongwe, Malawi

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Maganizo Chagomerana, PhD
• Organization: University of North Carolina at Chapel Hill

mchagomerana@unclilongwe.org

265996457968

Study Officials

• Maganizo B Chagomerana, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 23, 2026
• Study Start: October 8, 2019
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Beginning 6 and continuing for 12 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC

Locations

MA (1)