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OpenTrials
Completed

NCT Number: NCT07488221

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Project Malawi

Lilongwe, Malawi

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partner Notification Slip plus HIV Self-test kit

Other

Partner Notification Slip plus HIV Self-test kit

Partner Notification Slip only

Behavioral

Partner Notification Slip only

Primary outcomes

  1. Proportion of Male Partners Who Reported to Clinic

    Time frame: 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 outcomes

  1. Time Taken for Male Partners to Report to Clinic

    Time frame: within 30 days from female partner enrollment into the study

    Median time for partners who returned to the clinic within 30 days is reported.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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