HIV InfectionsNCT07488221
Male Partner Engagement in HIV Testing Using Partner-notification Slip Plus Oral HIV Self-testing Kit
A study testing Partner Notification Slip plus HIV Self-test kit and Partner Notification Slip only in people with HIV Infections, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Partner Notification Slip plus HIV Self-test kit and Partner Notification Slip only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMalawi
- Study dates
- 8 Oct 2019to 17 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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
- Being tested
- Partner Notification Slip plus HIV Self-test kit, Partner Notification Slip only
- Keywords
- HIV self-test, HIV testing uptake, HIV Testing in Male Partners
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner Notification Slip plus HIV Self-test kitOther
Partner Notification Slip plus HIV Self-test kit
Partner Notification Slip onlyBehavioural
Partner Notification Slip only
| Study group | Role | What they receive |
|---|---|---|
| Partner Notification Slip only | Active comparator | Participants in this group receive standard of care (partner notification slip only) Receives: 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) Receives: Other: Partner Notification Slip plus HIV Self-test kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Male Partners Who Reported to Clinic
Proportion of male partners who reported to clinic within days of their female partner's enrollment into the study.
Measured: within 30 days of their female partner enrollment into the study
Secondary outcomes (1)
Time Taken for Male Partners to Report to Clinic
Median time for partners who returned to the clinic within 30 days is reported.
Measured: within 30 days from female partner enrollment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start8 Oct 2019
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maganizo B Chagomerana, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488221
- Sponsor's protocol ID
- 18-2227
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07488221
- Acronym / sponsor ID
- 18-2227
- Conditions
- HIV Infections
- Keywords
- HIV self-test, HIV testing uptake, HIV Testing in Male Partners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 23 Mar 2026 (actual)
- Results
- Posted 17 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Partner Notification Slip only | Active comparator | Behavioral: Partner Notification Slip onlyParticipants in this group receive standard of care (partner notification slip only) |
| Partner Notification Slip plus HIV Self-test Kit | Experimental | Other: Partner Notification Slip plus HIV Self-test kitParticipants in this group receive the experimental intervention (Partner Notification Slip plus HIV Self-test Kit) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partner Notification Slip plus HIV Self-test kitPartner Notification Slip plus HIV Self-test kit | Other | Partner Notification Slip plus HIV Self-test Kit |
| Partner Notification Slip onlyPartner Notification Slip only | Behavioural | Partner Notification Slip only |
Primary outcome
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.
1 secondary outcome
Time Taken for Male Partners to Report to Clinic
Time frame: within 30 days from female partner enrollment into the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maganizo B Chagomerana, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner Notification Slip plus HIV Self-test kit and Partner Notification Slip only in people with HIV Infections, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Male Partners Who Reported to Clinic (time frame: within 30 days of their female partner enrollment into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.